kinetik WELLBEING TMB-2088 Smart Blood Pressure Monitor User Manual

kinetik WELLBEING TMB-2088 Smart Blood Pressure Monitor

Thank you very much for selecting the Kinetik Wellbeing Smart Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product, keep the manual safe for future reference in case you have problems.

INTRODUCTION

General Description
Thank you for selecting Kinetik Wellbeing Smart Blood Pressure Monitor (TMB-2088). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service.

FEATURES

• 124 mm x 76 mm Digital LCD display
• Systolic, Diastolic Blood Pressure & Pulse Display
• Date/Time Indication
• Irregular Heartbeat detection
• 2 x 250 memory storage, Guest mode available
• Up-to-date measuring-during-inflation technology

Indications for Use
The Kinetik Wellbeing Smart 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, as well as pulse rate.

Safety Information

The symbols below might be in the user manual, labeling, or other component. They are the requirement of standard and use.

CAUTION

• This device is intended for indoor and 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 non-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 on women who may be or are pregnant, 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 problems. 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 operations 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 the cuff to areas on the patient where the skin is delicate or damaged. Check the 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 does 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.

• Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetics 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 measurements, 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 the output of the batteries/adapter and the user simultaneously.

• The 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’s environment.

• Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.

• Warning: Only use accessories approved by the 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 authorized service centers.

• At the request of authorized service personnel, circuit diagrams, 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 within 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, and 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 the 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 l[e is 10000 times.

• Dispose of accessories, detachable parts, and the device according to the local guidelines.

Display and Symbols

Name of Each Part

Contents/Product Includes

• Blood Pressure Monitor (TMB-2088)
• Cuff (Type BF applied part) Upper arm circumference: 22-42 cm
• User manual
• 4x AA batteries
• Type-C cable (not included)
• AC Adapter (not included)
  • Reference model: BLJ06L050100U-V (with European plug)
  • Reference model: BLJ06L0501 00U-S (with Australian plug)
  • Reference model: BLJ06L050100U-B (with UK plug)

BEFORE YOU START

The Choice of Power Supply

1. Battery powered mode: 6V DC 4x AA batteries
2. AC adapter powered mode: 5V 1A
   (Please only use the AC adapter authorised by the manufacturer – AC adapter is not included).
   Note: Please unplug the adapter to depart from the using utility power, when you finish the measurement.

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

Installing and Replacing the Batteries

• Slide off the battery cover.

• Install or replace 4x AA 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 & “bAt Lo” and then power off automatically after about 5 seconds.
  Replace the batteries:

• When the low battery symbol appears. (see the LCD on the right picture)

• When any button is pressed nothing is displayed on the screen.

CAUTION

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose of the batteries in a 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 of daily garbage.
• Remove the old batteries from the device following your local recycling guidelines.

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].

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 button to quickly advance the years.
   Press and hold the button to quickly go backward 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.

4. Press the button to store the setting, then it will enter BP trends time setting mode. Repeat steps 2 and 3 to set the start time and then the end time.

   • By default,
   • BP trends start time: 06:00 (a.m.).
   • BP trends end time: 10:00 (a.m.).

5. After confirming the BP trends end time, the LCD will display “do nE” and the monitor will shut off after several seconds.

Note:

• The date and time will automatically be set when the monitor is paired with the “MedM health” app. Refer to the section “Pair a smart device with the monitor”.
• If you need to reset the date and time, replace batteries or press and hold the button, then set the date and time as shown in the above steps.

Setting a user ID

There are 3 user IDs available. The user and , each with 250 memory spaces, is designed for 2 different people to save the measured values separately. The user has no memory space, and is reserved for a guest.

1. When the monitor is off, press the button to display the current user ID. Press the button to switch the user ID between the user and .
   Note
   Only the user and can be selected in this setting mode.

2. Press the button to confirm the selected user ID, and the monitor will display “do nE” and shut off after several seconds.

Pair a smart device with the monitor
You are the intended operator of this blood pressure monitor. You can measure your blood pressure and then save and send measurement data to a smart device (such as a smartphone or tablet) with Bluetooth wireless connectivity and the MedM Health application.

1. Download the Blood Pressure Diary by MedM app or the MedM Health app from the App Store or Google Play.

2. Install the app, and register an account.

3. Enable Bluetooth and the MedM Health app on your smart device. Make sure both Bluetooth and the app are ON when the pair-up is proceeding.

4. When the monitor is off, press and hold the button to start pair-up, and the Bluetooth symbol will flash.

5. In the app, select the menu in the top left corner of the screen. Then select ‘My Devices’.
   If successful, the Bluetooth symbol will not flash anymore and the monitor will display “do nE”.
   Press the button to turn off the device, or the monitor will automatically shut off after about 1 minute.
   Note
   The date and time on your monitor will automatically be set after being paired with your smart device successfully.

6. At the bottom of the screen select Add New. This will automatically start scanning for a new device.
   When detected, select the TMB-2088.

7. Once selected you will be asked if you would like to transmit and receive blood pressure measurement data automatically. To store automatically you will need to select Yes on this screen. If you select No you will need to manually input results.

If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off.

Bluetooth Module information:

• Bluetooth Module No.: B2088-T
• RF Frequency Range: 2402 MHz to 2480 MHz
• Output Power Range: 0 dBm
• Supply Voltage: 1.8-3.6 V
• Transmitting Distance: 10 meters

List of compatible devices:

• For iOS devices:
  The operating system must be iOS 13.0 or more.

• For Android devices:
  The operating system must be Android 5.0 or more.

CAUTION

• Interference may occur in the vicinity of equipment marked with the following symbol And TMB-2088 may interfere in the vicinity of electrical equipment.
• Sensitive people, including pregnant women, pre-eclamptic, patients, and those patients with implanted, electrical devices should avoid using this product whenever possible.
• Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after the measurement.
• To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz.

How to mitigate possible interference?

1. The range between the device and the BT end should be reasonably close, from 1 meter to 10 meters. Please ensure there are no obstacles between the device and the BT end to obtain a quality connection and lower the RF output range.
2. To avoid interference, other electronic devices (particularly those with wireless transmission/ Transmitter) should be kept at least 1 meter away from the monitor. And BT end to obtain a quality connection and lower the RF output range.

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, and 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!

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 the right atrium of the heart.

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

Helpful tips:

• Measure 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 relaxed 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.

Start a measurement
You can use your monitor without pairing it to a smart device. To pair your monitor with a smart device.

1. When the monitor is off, press the button, and the current user ID will flash.

2. Press the t3l button to switch the user or or . press the button to confirm the selected user ID.

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

   • When the selected user has a history memory record, the monitor will display its last measurement record first before starting “cuff wrap detection”.
   • Any time, to stop the measurement, press the button.

4. Press the button to turn off the monitor, or it will shut off after about 1 minute.

5. If your monitor is already paired with your smart device and both Bluetooth and the app are ON, when the measurement is completed, the measurement result will start transmitting. (only users 1 and 2 are available)

   • If successful, both symbols will disappear and the monitor will display “do nE”.

   • Press the button to turn off the device, or the monitor will automatically shut off after about 1 minute.

   • If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. In the case of a data transmission failure, up to 250 measurements are saved on the device and will be sent when a successful connection is achieved.
     Note

   • Both users  and can store a maximum of 250 groups of records. When you pass that limit, every time you take the measurement, the monitor will prompt “FULL” first and the oldest record will drop from the list after the measurement.

6. About the irregular heartbeat and excessive body motion during the measurement.

   • During a measurement, If an irregular heartbeat is detected, the symbol will be displayed in the measurement result. See page 29 for more information.
   • During a measurement, if there is excessive body motion, especially of the arm the cuff is worn, the symbol will flash for roughly 5 seconds and detect again. If it is no longer detected, the symbol will disappear; If still detected, the symbol will final displayed in the measurement result.

Note
The measured blood pressure reading may not be accurate if this symbol

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, press the button, and the LCD will display the total groups of the memory records, with the user ID blinking.

2. Press the button to switch the user ID between IDs. user and . press the button to confirm the selected user

3. Then the LCD will display the average value of all the records of the last 7 days and the BP Trends chart of a specified period of the last 7 days, with the histogram of the latest day blinking. (Example shown below for User 1)
   Note

   • BP trends is a histogram, designed to display the average blood pressure value of a specified period of last 7 days, to help the user to visually know their blood pressure changes.
   • To set the specified period of the BP trends, please refer to the section “Setting the Date and Time”.
   • If there is no measurements for that period on a given day, the histogram for that day will be blank.
   • For the BP trends chart, the X-axis of the histogram represents the time (from left to right, from Sunday, Monday, Tuesday, Wednesday, Thursday, Friday to Saturday), while the Y-axis of the histogram represents the average value of systolic (high) pressure and diastolic (low) pressure of the specified period each day.
   • The data displayed on the top left is the maximum average systolic pressure value in the past 7 days, while the bottom left is the minimum diastolic pressure value in the past 7 days.
   • When the maximum average systolic pressure is higher than or equal to 130 mmHg, a top horizontal line will display. When the minimum average diastolic pressure value pressure is lower than 85 mmHg, a lower horizontal line will display.
   • If there is no lower horizontal line displayed or if the histogram is higher than this top horizontal line, that means these days your blood pressure is beyond the optimal blood pressure, it is suggested you should pay more attention to rest. If the problem persists, contact your physician. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. (according to WHO blood pressure classification, the optimal blood pressure is systolic <130 mmHg, while diastolic <85 mmHg. see page 28 for more information)

4. Press the or button to display the next record.

Note

• when your monitor is paired with your smart device and both Bluetooth and the app are ON, the records will start transmitting with the symbol blinking. Once successful, the symbol will disappear.
• The most recent 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 (250) is dropped from the list.

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”, and find out the record you want to delete.
2. Press and hold the button for about 3 seconds, and the LCD will display “dELE yES” with “yES” blinking.

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 hold the and button at the same time for about 5 seconds, the LCD will display “dELE ALL” with “ALL” blinking.

INFORMATION FOR USER

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

Maintenance

In order to get the best performance, please follow the instructions below.

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.

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

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 calculates 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 appear.

CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat 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.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please measure 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 when you measure your blood pressure at home:

• If the cuff is tied properly.
• 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.

Why do I get a different blood pressure at home compared to the hospital?
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.

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.

TROUBLESHOOTING

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

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.

SPECIFICATIONS

WARNING: No modification of this equipment is allowed.

AUTHORISED COMPONENT

Authorized Component
Please use the authorized adapter (Not included).

Adapter

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

Contact Information

For more information about our products, please visit www.kinetikwellbeing.com.

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 is available from 9 am-5 pm, 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:
  +44 148 3 937969

• Live Chat:
  Simply visit www.kinetikwellbeing.com and send us a message.

• Email:
  customercare@kinetikwellbeing.com

• Post:
  Kinetik Medical Devices Limited Unit 11, Perrywood Business Park, Honeycrock Lane, Salfords, Redhill. RH1 5JQ

EU Declaration of Conformity (DoC)

• Hereby, Transtek, declares that this blood pressure monitor complies 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.

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-2088 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 about electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.

Table 1

Table 2

Table 3

Documents / Resources

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