kinetik WELLBEING TMB-2080 Blood Pressure Monitor User Manual

kinetik WELLBEING TMB-2080 Blood Pressure Monitor User Manual

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

INTRODUCTION

General Description

Thank you for purchasing the Kinetik Wellbeing 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 blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8¾-12½), 22cm to 42cm (about 8¾-16½), It is intended for adult indoor 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.

Safety Information

The symbols below might be in the user manual, labeling or other component. They are the requirement of standard and using.
Refer to instruction manual/booklet To signify that the instruction manual/ booklet must be read.

⚠ 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.

⚠ 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 centres.
• 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.

Display and Symbols

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

Name of Each Part

Contents/Product Includes

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

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.

⚠ 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.

⚠ 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.

Setting the Date and Time

Setting a user ID

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

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. Keep your back against the backrest of the chair.
   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.

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.

DATA MANAGEMENT

Recall the Records

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.

Delete the Records

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 World Health Organization (WHO) and 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 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.

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.
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.

TROUBLE SHOOTING

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

please use the authorised adapter (Not included).

Contact Information

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

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

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.

References

• usimg.bjyyb.net/sites/54000/54167/20210720090946176.jpg

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