Kinetik Wellbeing TMB-2080 Advanced Blood Pressure Monitor User Manual

June 9, 2024
kinetik WELLBEING

TMB-2080 Advanced Blood Pressure Monitor

Kinetik Wellbeing Advanced Blood Pressure Monitor

Product Information

The Kinetik Wellbeing Advanced Blood Pressure Monitor is a
digital monitor intended for use in measuring the blood pressure
and pulse rate of those with an arm circumference ranging from 22
cm to 42 cm. It uses the Oscillometric Measuring method to detect
blood pressure. The device is intended for indoor, adult use only
and is not suitable for use on women who are or may be pregnant or
patients with implanted electrical devices, such as cardiac
pacemakers or defibrillators.

Contents/Product Includes

  • Kinetik TMB-2080 Blood Pressure Monitor
  • Cuff (22-42cm)
  • User Manual

Product Usage Instructions

Before You Start

Before using the Kinetik Wellbeing Advanced Blood Pressure
Monitor, ensure that you have installed the batteries and set the
date and time. The device requires 4 AAA batteries.

The Choice of Power Supply

The device requires 4 AAA batteries.

Installing and Replacing the Batteries

  1. Locate the battery compartment at the back of the device.
  2. Slide the compartment cover off.
  3. Insert the batteries, matching the polarity (+/-) signs.
  4. Slide the cover back on until it clicks into place.

Setting the Date and Time

  1. Press and hold the “SET” button until the year starts to
    flash.

  2. Use the “+” and “-” buttons to set the year.

  3. Press “SET” again to confirm and move on to the next setting
    (month, day, hour, minute).

  4. Repeat step 2 for each setting.

Setting a user ID

The Kinetik Wellbeing Advanced Blood Pressure Monitor allows up
to 2 users to store their readings separately. To set a user
ID:

  1. Press and hold the “SET” button until the user ID flashes.
  2. Use the “+” and “-” buttons to select User 1 or User 2.
  3. Press “SET” again to confirm and exit.

Measurement

To measure your blood pressure using the Kinetik Wellbeing
Advanced Blood Pressure Monitor:

  1. Sit quietly for 5 minutes before taking a measurement.

  2. Remove tight-fitting clothing from your upper arm and make sure
    it is exposed.

  3. Place the cuff around your upper arm, ensuring it is snug but
    not too tight.

  4. Press the “START/STOP” button to begin the measurement.

Data Management

The device can store up to 120 measurement records, with up to
60 records per user. To recall or delete records:

  1. Press the “M” button to enter memory mode.

  2. Use the “+” and “-” buttons to select the record you wish to
    recall or delete.

  3. Press “START/STOP” to recall the record or “M” to delete
    it.

Information for User

To ensure accurate readings, it is recommended to take
measurements at the same time each day and avoid eating, drinking,
smoking, or exercising for at least 30 minutes prior to
measurement. Make sure to keep the device clean and dry, and avoid
exposing it to extreme temperatures or humidity.

About Blood Pressure

Blood pressure is the force of blood pushing against the walls
of arteries. Systolic pressure refers to the pressure in your
arteries when your heart beats, while diastolic pressure refers to
the pressure when your heart is at rest between beats. The standard
blood pressure classification is as follows:

  • Normal: less than 120/80 mmHg
  • Elevated: 120-129/less than 80 mmHg
  • Hypertension Stage 1: 130-139/80-89 mmHg
  • Hypertension Stage 2: 140 or higher/90 or higher mmHg
  • Hypertensive Crisis: higher than 180/higher than 120 mmHg

The Kinetik Wellbeing Advanced Blood Pressure Monitor also has
an irregular heartbeat detector that alerts you if it detects any
irregularities in your heartbeat. Blood pressure can fluctuate
throughout the day due to various factors, such as stress, physical
activity, and medication. It is common for blood pressure to be
higher in a clinical setting, such as a hospital, compared to when
measured at home. It is recommended to measure blood pressure on
the same arm each time for consistent results.

User Manual
Advanced Blood Pressure Monitor

Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China
Medical Device Safety Service GmbH EC REP Schiffgraben 41, 30175 Hannover, Germany

Kinetik TMB-2080 UK IB 20210903

TMB-2080
Thank you for selecting the Kinetik Wellbeing Advanced Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product. Keep this manual for future reference in case any issues arise.

TABLE OF CONTENTS
SUPPORT………………………………………………………………………………………………………………2
INTRODUCTION……………………………………………………………………………………………………..3 General Description Indications for Use Contraindications Measurement Principle Safety Information Display and Symbols Name of Each Part Contents/Product Includes
BEFORE YOU START…………………………………………………………………………………………….10 The Choice of Power Supply Installing and Replacing the Batteries Setting the Date and Time Setting a user ID
MEASUREMENT……………………………………………………………………………………………………14 Applying the cuff Start a Measurement
DATA MANAGEMENT…………………………………………………………………………………………….17 Recall the Records Delete the Records
INFORMATION FOR USER…………………………………………………………………………………….21 Tips for measurement Maintenance
ABOUT BLOOD PRESSURE…………………………………………………………………………………..23 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Irregular heartbeat detector Why does my blood pressure fluctuate throughout the day? Why do I get a different blood pressure at home compared to the hospital? Is the result the same if measuring on the right arm?
TROUBLE SHOOTING…………………………………………………………………………………………..26 SPECIFICATIONS………………………………………………………………………………………………….27 AUTHORISED COMPONENT …………………………………………………………………………………28 CONTACT INFORMATION………………………………………………………………………………………28 EU Declaration of Conformity (DoC)…………………………………………………………………………28 EMC GUIDANCE…………………………………………………………………………………………………..29
1

SUPPORT
Support
Our manual should provide you with all the information you need to set up and use this product. If you have a question, have a look at our Troubleshooting page! For further assistance, why not contact our Customer Care team directly? We’re here to help! Our Customer Care team are available from 9am-5pm, Monday to Friday (excluding bank holidays). We promise to respond to all queries and will ensure to resolve any issue you may be having. You can reach us by… Phone: +44 1483 937969 Live Chat: Simply visit www.kinetikwellbeing.com and send us a message. Email: customercare@kinetikwellbeing.com Post: Kinetik Medical Devices Limited Unit 3, Perrywood Business Park, Honeycrock Lane, Salfords, Redhill. RH1 5DZ
2

INTRODUCTION
General Description
Thank you for purchasing the Kinetik Wellbeing Advanced Blood Pressure Monitor (TMB-2080). This monitor features blood pressure measurements, pulse rate measurements and 2 x 90 memory storage. The design provides you with two years of reliable service. FEATURES: · 60 mm × 64 mm Digital LCD display · Systolic, Diastolic Blood Pressure & Pulse Display · Date / Time Indication · Irregular Heartbeat detection · 2 × 90 memory storage, Guest mode available · Up-to-date measuring-during-inflation technology
Indications for Use
The Kinetik Wellbeing Blood Pressure Monitor is a digital monitor intended for use in measuring the blood pressure and pulse rate of those with an arm circumference ranging from 22 cm to 42 cm. It is intended for indoor, adult use only.
Contraindications
1.The device is not suitable for use on women who are or may be pregnant. 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers or defibrillators.
Measurement Principle
This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.
3

INTRODUCTION
Safety Information
The symbols below might be in the user manual, labeling or other component. They are the requirement of standard and using.
Symbol for “The operation guide must be read”
Symbol for “Type BF applied parts” Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Symbol for “ENVIRONMENT PROTECTION – Electrical waste 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 “Recycle” SN Symbol for “Serial Number” Symbol for “Direct Current” Symbol for “Manufacturer”
Symbol for “Manufacture date”
For indoor use only
Symbol for “Class II Equipment”
EC REP Symbol for “European Authorised Representative (EC Rep)”
Symbol for “Complies with MDD 93/42/EEC requirements”
4

INTRODUCTION
CAUTION

  • This device is intended for indoor, home use. This device is not intended for public use. This device is portable, but it is not intended for use during patient transport. This device is not suitable for continuous monitoring during medical emergencies or operations. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is
    not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood pressure measurement. This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional. Do not use this device on pregnant women, including pre-eclamptic patients. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers or defibrillators. The effectiveness of this device has not been established for use: -on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, -on users with peripheral arterial disease, -on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use. Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional. If you are taking medication, consult your physician to determine the proper time to measure your blood pressure. This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse. Report any unexpected operation or events to the manufacturer. Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached. Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result in injury. Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries. Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation. Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries. Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). It is recommended to take measurements on the unaffected side. Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time. Please check that the operation of the device do not result in prolonged impairment of patient blood circulation. Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin. Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
    5

INTRODUCTION
CAUTION

  • Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
  • The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
  • Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
  • You can use this device to take your own measurement, no third-party operator is required. Please use the device under the environment which is provided in the user manual. Otherwise,
    the performance and lifetime of the device will be impacted and reduced.
    The device may require up to 30 minutes to warm up / cool down from the minimum / maximum
    storage temperature before it is ready for use. Warning: Excessive cuff tube lengths could cause strangulation if you don’t manage them
    properly.
    Warning: Do not touch output of the batteries/adapter and the user simultaneously. Adapter is specified as a part of ME EQUIPMENT. Warning: The power cord is considered the disconnect device for isolating this equipment from
    supply mains. Do not position the equipment so that it is difficult to reach or disconnect. The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient
    environment.
    Warning: Do not use this device if you are allergic to polyester, nylon, or plastic. Warning: Only use accessories approved by manufacturer. Using unapproved accessories
    might cause damage to the unit and injure users.
    Warning: If you experience discomfort during a measurement, such as pain in the arm or other
    complaints, press the Power button immediately to release the air from the cuff. No calibration is required within two years of reliable service. Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by
    authorised service centers. At the request of authorised service personnel, circuit diagrams, component part lists,
    descriptions, and calibration procedures will be made available by the manufacturer or distributor.
    It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg). Warning: Do not use the device while under maintenance, or being serviced. Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it. Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage. Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of choking or strangulation if used improperly. Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural detergent. Do not use alcohol, benzene, or other harsh chemicals. Do not wash the cuff in a washing machine or dishwasher! The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times. Dispose of accessories, detachable parts, and the device according to the local guidelines.
    6

Display and Symbols
13

INTRODUCTION

1

2

12 11

10 9
8

765

43

1 Systolic blood pressure reading
2 Blood pressure level
3 Diastolic blood pressure reading
4 Pulse display
5 Memory symbol 6 Heartbeat symbol /
Irregular heartbeat 7 Date / Time display

8 User ID symbol 9 mmHg 10 Average value symbol
11 Cuff wearing OK symbol 12 Excessive body motion
detector symbol 13 Battery symbol /
High power symbol / Low battery symbol

7

INTRODUCTION

SYMBOL EXPLANATION

1

Systolic blood pressure reading

2 Blood pressure level (See the blood pressure classifcation on page 23-24)

3 Diastolic blood pressure reading

4 Pulse display (Pulse rate appears after the measurement.)

5

Memory symbol Indicate it is in the memory mode and which the group of memory it is.

Heartbeat symbol

6

Flashes when detected during a measurement.

Irregular heartbeat symbol Appears when detected during a measurement. Refer to page 24 for more information.

7 Date / Time display

8

User ID symbol Appears when the monitor is operated by the selected user.

9

mmHg Measurement Unit of the blood pressure

Average value symbol

10

Appears when viewing the average value of last 3 readings under

the memory mode.

11

Cuff wearing OK symbol Appears when the cuff is wrapped well.

Excessive body motion detector symbol

Appears when talking, moving, or shaking of the arm with the cuff

12

on is detected during a measurement.

NOTE: The measured blood pressure reading may not be accurate

when this symbol is displayed with the reading.

Battery symbol / High power symbol

Appears when inserting the batteries or adapter. / Indicate the DC

13

power is too high when it appears along with the error symbol “BAt H”.

Low battery symbol

Indicate the battery is too low when appears with the symbol

.

8

Name of Each Part
CUFF
AIR HOSE

AIR CONNECTOR PLUG

mmHg mmHg /min

INTRODUCTION
LCD DISPLAY MICRO USB PORT
[START/STOP] button
[MEMORY/Pairing/BACKWARD] button [USER/FORWARD] button
BATTERY COMPARTMENT BATTERY COVER

Contents/Product Includes
· Blood Pressure Monitor (TMB-2080) · Cuff (Type BF applied part)
Upper arm circumference: 22-42 cm · User manual · 4x AAA batteries

9

BEFORE YOU START

The Choice of Power Supply
1. Battery powered mode: 6V DC 4× AAA batteries
mmHg
2. AC adapter powered mode: 5V 1A mmHg
(Please only use AC adapter authoris/mined by the manufacturer!) (Not included) Please unplug the adapter to depart from the using utility power, when you finish the measurement.

AC adapter
(Not included)
USB cable

CAUTION
In order to get the best effect and protect your monitor, please use the right batteries and special power adapter which complies with local safety standard.

Installing and Replacing the Batteries
· Slide off the battery cover. · Install or replace 4 AAA size batteries
according to the polarity indications inside the battery compartment. · Place the battery cover back on.
Any time the battery is low, it will display the icon & “Lo bAt ” and then power off automatically after about 5 seconds.

Replace the batteries: · When the low battery symbol appears. (see the LCD display on the right picture) · When any button is pressed and nothing is displayed on the screen.

Low Battery

CAUTION
Do not use new and used batteries together. Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines.
10

BEFORE YOU START

Setting the Date and Time

It is important to set the date and time before using your blood pressure monitor for the first time, so that a correct time stamp can be assigned to each record that is stored in the memory. (The setting range of the year: 2021–2050, Time format: 24H / 12H)

1. When the monitor is off, press and hold the button to display the

date format. Press the or

button to switch the date format

between [month/day/year] and [day/month/year].

[month/day/year] format [day/month/year] format

2. Press the button to confirm the date format, then the year will

flash. Press the or

button to change the year.

Press and hold the Press and hold the

button to quickly advance the years. button to quickly go backwards through the years.

3. Press the button to confirm the year, then the month will flash. Repeat the same steps to change the month, day, time format, hour, and minute.

11

BEFORE YOU START

Year

Month

Day

Time format

Hour

Minute

4. After confirming the minute, the LCD will display “do nE” and the monitor will shut off after several seconds.

BEFORE YOU START

Setting a user ID

There are 3 user ID

available. The user and , each with 90

memory spaces, are designed for 2 different people to save the measured

values separately. The user , no memory space, is reserved for guest.

1. When the monitor is off, press the button to display the current

user ID and blink. Press the the user and and.

button to switch the user ID between

2. Press the button to confirm the selected user ID, the User ID will not blink any more and the monitor will turn off after several seconds.

12

13

MEASUREMENT

Applying the cuff

1. Remove all jewelry, such as watches and bracelets from your left arm. Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm.
2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.
3. Hold your arm with your palm facing up and tie the cuff on your upper arm, align the Artery indicator with the main Artery (on the inside of your arm). Note: Locate the main Artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest, that is your main Artery

2~3cm

4. Make sure the bottom edge of the arm cuff is 2 to 3 cm above the inside elbow. Then wrap the cuff securely. Note: The cuff should be snug but not too tight.
You should be able to insert one finger between
the cuff and your arm.
5. Sit upright in a comfortable chair with your back against the backrest of the chair. Keep your feet flat and your legs uncrossed. Place your arm resting comfortably on a flat table. The cuff worn on your arm should be placed at the same level as your right atrium of the heart.

6. Take 5-6 deep breaths and let’s start measuring!

Helpful tips:
Take the measurement in a silent room. Rest for 5 minutes before a measurement. Wait at least 3 minutes before another measurement. This allows your blood circulation to recover. Be relax and do not move and talk during the measurement procedure. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

14

MEASUREMENT

Start a measurement
You can use your monitor without pairing to a smart device. To pair your monitor with a smart device refer to the foregoing chapters.

1. When the monitor is off, press the will flash.

button, the current user ID

2.Remain still and do not talk until the full measurement is complete. (Example shown below for User 1)

Display user ID

Cuff wrap detection

Inflating and measuring a heartbeat is detected)

Display and save the measurement result

Note Any time, to stop the measurement, press the

button.

15

MEASUREMENT
4. Press the button to turn off the monitor, or it will shut off after about 1 minute. Note Both user and can store maximum 90 groups of record. When you pass that limit, every time you take the measurement, the monitor will prompt “FULL” first and the oldest record will be dropped from the list after the measurement.
5. About the irregular heartbeat and excessive body motion during the measurement. During a measurement, If an irregular heartbeat is detected, the symbol will display in the measurement result. See page 24 for more information. During a measurement, if there is excessive body motion, especially of the arm the cuff is worn, the symbol will flash about 5 seconds and detect again. If it is no longer detected, the symbol will disappear; If still detected, the symbol will final display in the measurement result. Note The measured blood pressure reading may not be accurate if this symbol is displayed.
16

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, press the

button, the LCD will display

the total groups of the memory records, with the user ID blinking.

2. Press the press the

button to switch the user ID between user and .

button or

button to confirm the selected user ID.

3. Then the LCD will display the average value of last 3 readings. When the records are less than three groups, it will display the latest record. (Example shown below for User 1)

4. Press the

or

button to display the next record.

Date and Time will display alternately.

The current record is Group 1.

The corresponding date is January 1st.

The corresponding time is 08:00 (a.m.).

Note
The latest record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (90) will be dropped from the list.

17

DATA MANAGEMENT

Delete the Records

Delete the records by following the steps below. A: Delete one record (Example shown below for User 1) 1. Enter the memory recall mode as described in the previous section “Recall the records”, find out the record you want to delete.

2. Press and hlod the

button about 3 seconds, the LCD will display

“dEL yES” and blink.

3. Press the button to confirm the deletion, the LCD will display “dEL donE” and then the previous record will be displayed.

DATA MANAGEMENT

B: Delete all records (Example shown below for User 1)
1. Enter the memory recall mode as described in the previous section “Recall the records”.

2. Press and hlod the and

button about 5 seconds, the LCD

will display “dEL ALL” and blink.

3. Press the button to confirm the deletion, the LCD will display “dEL ALL donE”.

Note Before you confirm the deletion, you could press the or button to switch the LCD display from “dEL yES” to “dEL no” Then press the button, you could stop clearing the memory.
18

Note Before you confirm the deletion, you could press the or button to switch the LCD display from “dEL ALL” to “dEL no” Then press the button, you could stop clearing the memory.
19

DATA MANAGEMENT
4. Once deleted, your readings cannot be restored. The LCD will display “–” like the following picture. Press the button to turn off the monitor, otherwise it will power off automatically after about 1 minute.

INFORMATION FOR USER
Tips for Measurement Measurements may be inaccurate if taken in the following circumstances.

Within 1 hour after dinner or drinking

Immediate measurement after tea, coffee, smoking

Within 20 minutes after taking a bath When talking or moving your fingers

In a very cold environment

When you need to use the toilet

20

21

INFORMATION FOR USER
Maintenance
In order to get the best performance, please follow the instructions below.

mmHg mmHg /min

mmHg mmHg /min
Put in a dry place and avoid the sunshine
Avoid intense shaking and collisions
mmHg mmHg /min
Using wet cloths to remove dirt

mmHg mmHg /min

Avoid touching water, clean it with a dry cloth in case.

mmHg /min

mmHg

Avoid dusty and unstable temperature environment

Do not attempt to clean the reusable cuff with water and never immerse
the cuff in water.

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

Systolic
blood discharging artery

Diastolic
blood entering vein

press

relax

What is the standard blood pressure classification?
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

22

23

ABOUT BLOOD PRESSURE

Blood Pressure

Level Optimal Normal High-normal

Mild

Moderate Severe

(mmHg)

SYS

<120 120-129 130-139 140-159 160-179 180

DIA

<80 80-84

85-89

90-99 100-109 110

CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculate the average; if there are two or more pulse intervals, the difference between each interval and the average is more than the average value of ±25%, or there are four or more pulse intervals, the difference between each interval and the average is more than the average value of ±15%, the irregular heartbeat symbol appears on the display when the measurement results are appeared.
CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

24

ABOUT BLOOD PRESSURE

Why does my blood pressure fluctuate throughout the day?
1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement.

What you need to pay attention to

Why do I get a different when you measure your blood

blood pressure at home pressure at home:

compared to the hospital? If the cuff is tied properly.

The blood pressure is different even throughout the day due to weather, emotion, exercise etc. Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax for 4-5 minutes

until you calm down.

Is the result the same if measuring on the right arm?

It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

25

TROUBLE SHOOTING
If any abnormality arises during use, please check the following points:

PROBLEM SYMPTOM

CHECK THIS

REMEDY

No power

Display can not light up.

Batteries are depleted. Replace with new batteries.

Batteries are inserted incorrectly.
Adapter is inserted incorrectly.

Insert the batteries correctly.
Insert the AC adapter correctly.

High Battery bAt H shows The battery is too high. Replace with new batteries.

Low Battery Lo bAt & shows E 1 shows

Error message

E 2 or shows

E 3 shows E 4 shows EEx shows

Warning message

Err & Usb shows
out shows

The battery is too low. Replace with new batteries.

The cuff is not wrapped Refasten the cuff and insert or wrapped incorrectly, air tube plug correctly then or the cuff air plug is measure again. loose.

Excessive body motion (such as shaking of the arm with the cuff on) or weak Pulse is detected.

Relax for 5 minutes
and then keep still, measure again.

Pulse is not detected during measuring.

Loosen the clothing on the arm and measure again.

The measurement failed.

Relax for 5 minutes and measure again.

Hardware error

Turn off monitor and

(X can be some digital measure again. If EEx still

symbol, such as 1, 2, 3, appears on the display,

etc.)

please contact the retailer

or our customer service.

Adapter error

Replace with the authorised adapter.

Out of measurement range

Relax for a moment and then measure again. If the problem persists, contact your physician.

NOTE: If the product still does not work, contact Customer Service. Under no
circumstance should you disassemble or attempt to repair the unit by yourself.
26

SPECIFICATIONS

External dimensions

Approx.100 mm × 129 mm × 45 mm

Display mode Weight

Digital LCD V.A.60 mm × 64 mm Approx.216 g (Excluding the batteries and cuff)

Measurement mode

Oscillographic testing mode

Mode of operation

Continuous operation

Measurement range

Rated cuff pressure: 0 mmHg~299 mmHg Measurement pressure: SYS: 60 mmHg ~ 230 mmHg DIA: 40 mmHg ~ 130 mmHg Pulse value: (40-199) beat/minute

Accuracy

Pressure: 5°C-40°C within ±3 mmHg Pulse value: ±5%

Normal working condition

A temperature range of: +5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of : 700 hPa to 1060 hPa

Storage & transportation condition

Temperature: -20°C to +60°C A relative humidity range of 93%, non-condensing,

at a water vapour pressure up to 50 hPa

Measurement perimeter

of the upper arm

About 22-42 cm

Degree of protection Protection against ingress of water
Device Classification

Type BF applied part
IP20 It means the device could protected against solid foreign objects of 12.5mm and greater, and there is no special protection for water or moisture.
Battery Powered Mode: Internally Powered ME Equipment AC Adapter Powered Mode: Class II ME Equipment

WARNING: No modification of this equipment is allowed.
27

AUTHORISED COMPONENT
Authorised Component
please use the authorised adapter (Not included).

Adapter Type: BLJ06L050100U-B
Input: 100-240V, 50-60Hz, 0.2A max Output: 5V 1000 mA

AC adaptor

Contact Information
For more information about our products, please visit www.kinetikwellbeing.com
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District,
528437 Zhongshan, Guangdong, China
EU Declaration of Conformity (DoC)
Hereby, Transtek, declares that this blood pressure monitor is in compliance with the essential requirements and other relevant provisions of Radio Equipment Directive 2014/53/EU. The declaration of conformity may be consulted at https://usimg.bjyyb.net/sites/54000/54167/20210720090946176.jpg

28

EMC GUIDANCE

EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-2080 including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test

Compliance

RF emissions CISPR 11
RF emissions CISPR 11

Group 1 Class [ B ]

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Comply

29

EMC GUIDANCE

Table 2

Guidance and manufacturer’s declaration ­ electromagnetic Immunity

Immunity Test

IEC 60601-1-2 Test level

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV signal input/output 100 kHz repetition frequency

±2 kV for power supply lines Not applicable 100 kHz repetition frequency

Surge IEC61000-4-5

±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

Power frequency magnetic field IEC 61000-4-8

30 A/m 50 Hz / 60 Hz

30 A/m 50 Hz / 60 Hz

Conduced RF IEC61000-4-6

3 V 0,15 MHz ­ 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz

3 V 0,15 MHz ­ 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz

Radiated RF IEC61000-4-3

10 V/m 80 MHz ­ 2,7 GHz 80% AM at 1 kHz

10 V/m 80 MHz ­ 2,7 GHz 80% AM at 1 kHz

NOTE UT is the a.c. mains voltage prior to application of the test level.

30

EMC GUIDANCE

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF Test

Band

IEC61000-4-3 Frequency (MHz)

(Test

(MHz)

specifications

for ENCLOSURE 385

380-390

PORT

IMMUNITY to

RF wireless

communica-

450

430-470

tions

equipment)

710

704-787

745

780

Service
TETRA 400
GMRS 460FRS 460 LTE Band 13,17

Modulation
Pulse modulation
18Hz FM ± 5kHz deviation 1kHz sine Pulse modulation 217Hz

Modulation Distance IMMUNITY Compliance

Power

(m)

TEST

level

(W)

LEVEL (V/m)

(V/m)

1.8

0.3

27

27

2

0.3

28

28

0.2

0.3

9

9

810

800-960 GSM

Pulse

800/900, modulation

870

TETRA 800, 18Hz

2

0.3

28

28

iDEN 820,

CDMA 850,

930

LTE Band 5

1720 1845

17001990

GSM 1800; Pulse CDMA 1900; modulation GSM 1900; 217Hz DECT;

2

0.3

28

28

1970

LTE Band 1,

3,

4,25; UMTS

2450

2400- Bluetooth, Pulse

2570 WLAN,

modulation

802.11

217 Hz

b/g/n, RFID

2

0.3

28

28

2450, LTE

Band 7

5240

5100- WLAN

Pulse

5500

5800

802.11 a/n

modulation 217 Hz

0.2

0.3

9

9

5785

31

References

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