RENPHO TMB-1872-B Smart Blood Pressure Monitor User Manual

Introduction

Thank you for selecting the RENPHO Arm Type Blood Pressure Monitor (TMB-1872-B). This monitor features blood pressure measurement, pulse rate measurement, and result storage, designed to provide reliable service.

The readings from the TMB-1872-B are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.

This manual contains important safety and care information, and provides step-by-step instructions for using the product. Please read the manual thoroughly before using the product.

Features:

• 2.36*2.91in Digital LCD display
• Maximum 120 records per user
• Measuring during inflation technology

Indications for Use

The RENPHO Blood Pressure Monitor is a digital monitor intended for measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm (approximately 8"-16½"). It is intended for indoor use by adults only.

Contraindications

1. The device should not be used by any person who may be pregnant.
2. The device is not suitable for 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 each measurement, the unit establishes a "zero pressure" equivalent to atmospheric pressure. It then starts inflating the arm cuff, while detecting pressure oscillations generated by beat-to-beat pulsatile, which is used to determine systolic and diastolic pressure, and pulse rate.

Safety Information

The following signs may be found in the user manual, labeling, or other components:

• Symbol for "THE OPERATION GUIDE MUST BE READ"
• Symbol for "MANUFACTURER"
• Symbol for "SERIAL NUMBER"
• Symbol for "TYPE BF APPLIED PARTS"
• 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 "MANUFACTURE DATE"
• Symbol for "Authorised Representative in the European Community"
• Symbol for "Authorised Representative in the United Kingdom"
• Symbol for "DIRECT CURRENT"
• Symbol for "RECYCLE"
• Caution: These notes must be observed to prevent any damage to the device.
• Symbol for "COMPLIES WITH MDD 93/42/EEC REQUIREMENTS"

CAUTION

• This device is intended for adult use in homes only.
• The device is not suitable for neonatal patients, pregnant women, patients with implanted electronic devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral arterial disease, and patients undergoing intravascular therapy or arterio-venous shunt, or people who received a mastectomy. Consult your doctor prior to use if you suffer from illnesses.
• The device is not suitable for measuring the blood pressure of children. Consult your doctor before using it on older children.
• The device is not intended for patient transport outside a healthcare facility.
• The device is not intended for public use.
• 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 functions other than obtaining a blood pressure measurement.
• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without consulting a physician for treatment advice.
• If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change prescribed medication without consulting your physician.
• Do not take any therapeutic measures on the basis of a self-measurement. Never alter the dose of medicine prescribed by a doctor. Consult your doctor if you have any questions about your blood pressure.
• When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Consult your physician about the result.
• Do not kink the connection tube during use, otherwise, the cuff pressure may continuously increase, which can prevent blood flow and result in injury to the PATIENT.
• When using this device, pay attention to the following situations which may interrupt blood flow and influence blood circulation of the patient, thus causing injury: connection tubing kinking, too frequent and consecutive multiple measurements; application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.
• Warning: Do not apply the cuff over a wound; otherwise, it can cause further injury.
• Do not inflate the cuff on the same limb where other monitoring ME equipment is applied simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm may lead to ecchymosis.
• Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
• When measuring, avoid compression or restriction of the connection tubing.
• The device cannot be used with HF surgical equipment at the same time.
• The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2.
• To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
• This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
• This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient's arm and fingers will become anaesthetic, swollen, and even purple due to a lack of blood.
• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust, and direct sunlight. Never place any heavy objects on the storage case.
• This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Warning: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator.
• The patient can measure, transmit data, and change batteries under normal circumstances and maintain the device and its accessories according to the user manual.
• To avoid measurement errors, please avoid conditions of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
• The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon, or plastic, please do not use this device.
• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with the requirements of ISO10993-5 and ISO10993-10. It will not cause any potential sensation or irritation reaction.
• Adaptor is specified as a part of ME EQUIPMENT.
• If you experience discomfort during measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when the pressure reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.
• Please use ACCESSORIES and detachable parts specified/authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
• There are no luer lock connectors in the construction of tubing. There is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
• Please use the device under the environment which is indicated in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD Display Signal

The LCD display shows various indicators:

Monitor Components

The blood pressure monitor consists of the following parts:

• CUFF
• AIR HOSE
• AIR CONNECTOR PLUG
• LCD DISPLAY
• USB INTERFACE
• USER BUTTON
• MEM BUTTON
• START/STOP BUTTON
• BATTERY COMPARTMENT

Component list of pressure measuring system:

1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve

List of Included Items

1. Smart Blood Pressure Monitor (TMB-1872-B)
2. Cuff (Type BF applied part) (22~42cm/8.66~16.53in)
3. User Manual
4. Quick Guide
5. USB Cable
6. Carrying Case
7. 4*AAA Batteries

App Operation Guide

Download

1. Search and download "Renpho Health" from Apple Store / Google Play or scan the QR code to download the app.

(Images shown are for illustration purposes only and may not be an exact representation due to app updates.)

2. Open the app. Register with your email address and fill in your personal information (required for accurate health measurements). If you already have an account, tap "Log in".

Add Device

1. After logging in, you will be directed to the homepage.

2. Activate Bluetooth on your phone. Press the User button of the blood pressure monitor (the Bluetooth icon will flash on the display).

3. A pop-up window will appear to allow you to pair your phone with the device.

Alternatively, click "+" on the right corner to connect manually:

1. Activate Bluetooth on your smartphone.
2. Click "+" on the right corner.
3. Click "Blood Pressure Monitor (Bluetooth)" to search for the device.
4. Press the User button on the blood pressure monitor (the Bluetooth icon will flash on the display).
5. Click to connect.

Select the "Blood Pressure Monitor" on the "Device" page to connect for next use. Swipe left and click to delete to disconnect the device.

Note: The blood pressure monitor can be paired with one device only. If you want to connect it with another device, please ensure it is fully disconnected from any prior device.

Add User 1

After pairing, you need to add a user profile if you connect the device for the first time. After filling in the user information, click "Next step" to save. You will be directed to the homepage ("Records" interface). The “Bluetooth” icon will light up once the device has been paired successfully.

Synchronize the Existing Data

After entering the homepage, synchronize the existing measurement data of the device on the app.

Check Measurement Record

Check your measurement data on a daily, weekly, monthly, or yearly basis on the "Records" page.

Click any measurement data to add remarks. Swipe left and click to delete the data.

Check Calendar

1. Enter the "Calendar" page to get a holistic view of the dates of measurement.
2. Click the day with a blue dot to check the measurement data of that day.
3. Click the data to add remarks or swipe left to delete, as mentioned in "Check Measurement Record".

Share

Enter the "Share" page and select the time period to share your measurement results in CSV file.

You can click "Choose Data" to delete multiple data at once.

Setting

Enter the "Setting" page to adjust the following functions.

Add User 2

1. Ensure the device is paired with the app (“Bluetooth” icon solid on the "Records" interface).
2. Enter the "Setting" page and select "Add User”. Add the user profile following the in-app instructions.
3. After adding the user, you can switch between "User 1" and "User 2" on the "Records" interface. Ensure the device has been disconnected from the app ("Bluetooth” icon turned off) when you switch the user.

Before You Start

The Choice of Power Supply

1. Battery-powered mode: 6VDC 4*AAA batteries
2. AC adaptor powered mode: 5V=1A

Please use the AC adaptor (not included) and USB cable as shown in the picture.

CAUTION: In order to get the best effect and protect your monitor, please use the right battery and special power adaptor which complies with local safety standards.

Installing and Replacing the Batteries

• Slide off the battery cover.
• Install the batteries by matching the correct polarity, as shown.
• Place the battery cover back.

Replace the batteries whenever:

• The "Lo+ 🔋" symbol shows.
• The display is dim.
• The display does not light up.

CAUTION:

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

Notice: The symbol on the device or its packaging indicates: Do not dispose of electrical appliances as unsorted municipal waste; use separate collection facilities. Contact your local authority for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being. When replacing old appliances with new ones, the retailer is legally obliged to take back your old appliance for disposal at least free of charge.

Setting Date, Time

It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record stored in the memory. (The setting range of the year: 2020--2060)

1. When the monitor is off, press and hold the "START/STOP" button for 3 seconds to enter the mode for year setting.
2. Press the "USER" button or "MEM" button to change the [YEAR]. Each press will increase or decrease the numeral by one in a cycling manner.
3. When you get the right year, press the "START/STOP" button to set and turn to the next step.
4. Repeat step 2 and step 3 to set the [MONTH] and [DAY].
5. Repeat step 2 and step 3 to set the [HOUR] and [MINUTE].

6. After the [MINUTE] is set, the LCD will display "donE" first, then display all the settings you have done, and then it will turn off.

Select the User

1. When the monitor is off, press the "USER" button shortly to enter the user setting mode.
2. Then press the “USER” button again to select the user ID between user 1 and user 2.
3. After selecting the suitable user ID, press the “START/STOP” button to confirm, and it will start to measure.

Measurement

Tie 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, then position the tube off-center toward the inner side of the arm in line with the little finger. Or position the artery mark ● over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2cm/0.79in above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt strongest. This is your main artery.
4. 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 comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
6. Helpful tips for Patients, especially for Patients with Hypertension:
   • Rest for 5 minutes before the first measurement.
   • Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
   • Take the measurement in a silent room.
   • The patient must relax as much as possible and do not move or talk during the measurement procedure.
   • The cuff should maintain the same level as the right atrium of the heart.
   • Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.
   • Keep your back against the backrest of the chair.
   • 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 the Measurement

1. When the monitor is off, press the "START/STOP" button to turn on the monitor, and it will finish the whole measurement.
2. Press the "Start/Stop" button to power off, otherwise, it will turn off after about 1 minute.

Data Management

Recall the Records

1. When the monitor is off, press the "MEM" button to show the recent record. If the records are less than 3 groups, it will display the latest record instead. Take user 1 for example.
2. Press the "MEM” button to get the record you want.

The date and time of the record will be shown alternately.

The current No. is No. 1. The corresponding date is 2019 year July 1st. The corresponding time is 10:38.

Delete the Records

If you did not get the correct measurement, you can delete the results by following the steps below:

A: Delete one record

1. Hold pressing the “MEM" button for 3 seconds when the monitor is in the memory recall mode; the flash display "dEL one+User ID" will show.
2. Press the "USER" button or "MEM" button and the flash displays "dEL n" or "dEL y".
3. Press the "START/STOP” button shortly to confirm deleting this group result when it shows "dEL y" and displays "USER ID + DEL donE", then the device will show the latest record.

Tips: Press the “START/STOP" when it shows "dEL n", it will drop out.

B: Delete all records

1. Hold pressing the “MEM” button and "USER" button for 3 seconds when the monitor is in the memory recall mode, and the flash display "USER ID+dELy U5Er" will show.
2. Press the "USER" button or "MEM" button and the flash displays "dEL n" or "dEL y".
3. Press the "START/STOP" button shortly to confirm deleting this group result when it shows "dEL y" and displays "USER ID + dEL donE", then the device will turn off.

Tips: Press the "START/STOP" when it shows "dEL n", it will drop out.

4. If there is no record, it will display like the right picture.

Information for Users

Tips for Measurement

Measurements may be inaccurate if taken under 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 want to discharge urine ❌

Maintenance

Please calibrate the blood pressure monitor in a specific institute once every two years to ensure precise measurements. In order to get the best performance, please follow the instructions below for storage:

• Put in a dry place and avoid the sunshine.
• Avoid touching the water; clean it with a dry cloth in case.
• Avoid intense shaking and collisions.
• Avoid dusty and unstable temperature environment.
• Use wet cloths to remove dirt.
• 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, press

Diastolic: blood entering, vein, relax

What is the standard blood pressure classification?

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

Graph Description: A scatter plot showing blood pressure classifications based on systolic and diastolic pressure. The x-axis represents Systolic blood pressure (mmHg) from 120 to 180, and the y-axis represents Diastolic blood pressure (mmHg) from 80 to 110. Different zones are color-coded and labeled with classifications like Optimal Blood Pressure, Normal Blood Pressure, High-normal Blood Pressure, Subgroup: borderline, Grade 1 hypertension (mild), Grade 2 hypertension (moderate), and Grade 3 hypertension (severe).

CAUTION: Please consult a physician if your measuring result falls outside 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 device is measuring systolic pressure and diastolic pressure. During each measurement, the blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. 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%, then the irregular heartbeat symbol 💕 will appear on the display with the measurement result.

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 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.

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.

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.

Advice: Relax yourself for 4-5 minutes until you calm down. Taking 2-3 deep breaths before beginning will be better for measuring.

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.

Authorized Components

1. Please use the manufacturer-authorized AC adaptor (Not included).

Adapter Specifications: Input: 100~240V, 50~60Hz, 0.2Amax. Output: 5V=1000mA. Model: BLJ06L050100U-B

Contact Information

Please feel free to contact RENPHO if there is anything we can help. We'll try our best to improve the product quality and service. All products come with warranty and lifetime support.

• Web: www.renpho.com
• Email: support-eu@renpho.com
• TEL: +44(0)7434 666088 (UK)
• Monday-Friday 9:00AM-5:00PM (GMT)

Troubleshooting

Specifications

• Power supply: Battery powered mode: 6VDC 4*AAA batteries. AC adaptor powered mode: 5V=1A (Not included). Please use the AC adaptor authorized by the manufacturer.
• Display mode: Digital LCD display V.A.2.36in*2.91in (60mm*74mm).
• Measurement mode: Oscillographic testing mode.
• Measurement range: Rated cuff pressure: 0mmHg~299mmHg. Measurement pressure: SYS: 60mmHg~230mmHg, DIA: 40mmHg~130mmHg. Pulse value: (40-199)beat/minute.
• Accuracy: Pressure: ±3mmHg (5°C-40°C). Pulse value: ±5%.
• Normal working condition: Temperature range of: 41°F to +104°F (+5°C to +40°C). Relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50hPa. Atmospheric pressure range of: 700hPa to 1060hPa.
• Storage & transportation condition: Temperature: -4°F to +140°F (-20°C to +60°C). Relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa.
• Measurement perimeter of the upper arm: About 8.66in~16.53in (22cm~42cm).
• Net Weight: Approx.184g (Excluding the batteries).
• External dimensions: Approx.3.66in*5.12in*1.28in (93mm*130mm*33mm).
• Attachment: 4*AAA batteries, cuff, USB cable, carrying case, user manual, quick guide.
• Mode of operation: Continuous operation.
• Device Classification: Battery Powered Mode: Internally Powered ME Equipment. AC Adaptor Powered Mode: Class II ME Equipment.
• Degree of protection: Type BF applied part.
• Protection against ingress of water: IP21 It means the device could be protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
• Software Version: A01

WARNING: No modification of this equipment is allowed.

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.

Warning: Do not 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-1872-B 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

Table 2: Guidance and manufacturer's declaration – electromagnetic Immunity

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

Table 3: Guidance and manufacturer's declaration - electromagnetic Immunity