LifeHood TMB-2085 Wrist Blood Pressure Monitor User Manual

LifeHood TMB-2085 Wrist Blood Pressure Monitor

Product Information

Specifications

• General Description: WRIST TYPE Blood Pressure Monitor
• Version: 1.0
• Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.
• Address: Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China
• Model: TMB-2085

Introduction

General Description

The LifeHood Blood Pressure Monitor is a wrist-type digital monitor designed to measure blood pressure and heartbeat rate. It is equipped with an LCD display and various features for easy usage.

Indications for Use

This Transtek Blood Pressure Monitor is intended for indoor, adult use only. It is suitable for individuals with a wrist circumference ranging from 13.5 cm to 21.5 cm.

Contraindications

• The device is not suitable for use on pregnant women.
• The device is not suitable for use on patients with implanted
  electrical devices, such as cardiac pacemakers or defibrillators.

Measurement Principle

This product utilizes the Oscillometric Measuring Method to detect blood pressure. Before each measurement, the unit establishes a zero point equivalent to atmospheric pressure. It then inflates the cuff and detects pressure oscillation generated by beat-to-beat pulsatile. This information is used to determine the systolic pressure, diastolic pressure, and pulse rate.

Safety Information

The product includes various symbols and signs that indicate important information:

• Refer to   instruction manual/booklet: This symbol signifies that the instruction manual/booklet must be read.
• Date of manufacture: Indicates the date of manufacture of the product.
• Symbol for MANUFACTURER: Represents the manufacturer of the product.
• SN: Symbol for SERIAL NUMBER
• Symbol for RECYCLE: Indicates that the product should be sent to separate collection facilities for recovery and recycling.
• Symbol for DIRECT CURRENT
• Symbol for TYPE BF APPLIED PART: Indicates that the product is a Type BF Applied Part.
• Caution: Indicates that caution is necessary when operating the device or control close to where the symbol is placed.

Product Usage Instructions

Installing and Replacing the Batteries

To install or replace the batteries, follow these steps:

1. Locate the battery compartment on the back of the monitor.
2. Open the battery compartment cover.
3. Insert the batteries, ensuring correct polarity.
4. Close the battery compartment cover securely.

Setting Date, Time and Measurement Unit

To set the date, time, and measurement unit, follow these steps:

1. Press the menu button to enter the menu mode.
2. Use the up/down buttons to navigate to the “Settings” option and press the menu button to confirm.
3. Use the up/down buttons to select “Date/Time” and press the menu button to confirm.
4. Use the up/down buttons to set the date, time, and measurement unit as desired.
5. Press the menu button to save the settings and exit the menu mode.

Setting Voice and Clock Reminder

To set the voice and clock reminder, follow these steps:

1. Press the menu button to enter the menu mode.
2. Use the up/down buttons to navigate to the “Settings” option and press the menu button to confirm.
3. Use the up/down buttons to select “Voice/Clock” and press the menu button to confirm.
4. Use the up/down buttons to enable or disable the voice and clock reminder as desired.
5. Press the menu button to save the settings and exit the menu mode.

WRIST POSITIONING GUIDE

Proper wrist positioning is crucial for accurate measurements. Follow these guidelines:

• Place the monitor on your wrist, with the display facing upwards.
• Position the cuff at heart level.
• Ensure a snug fit without causing discomfort.

Pair a smartphone or a tablet with the monitor

To pair a smartphone or tablet with the monitor, follow these steps:

1. Ensure that Bluetooth is enabled on your smartphone or tablet.
2. Press and hold the Bluetooth button on the monitor until the Bluetooth icon starts flashing.
3. Open the Bluetooth settings on your smartphone or tablet.
4. Select the monitor from the list of available devices.
5. Follow any additional on-screen instructions to complete the pairing process.

MEASUREMENT

Tie the Cuff

To tie the cuff, follow these steps:

1. Place the cuff around your wrist, ensuring it is positioned correctly.
2. Wrap the cuff snugly around your wrist, but not too tight.
3. Secure the cuff using the hook and loop closure.

Start the Measurement

To start the measurement, follow these steps:

1. Press the start button on the monitor.
2. Remain still and keep your wrist at heart level during the measurement.
3. Wait for the measurement to complete.
4. Read and record the displayed blood pressure and pulse rate values.

DATA MANAGEMENT

Recall the Records

To recall the records, follow these steps:

1. Press the menu button to enter the menu mode.
2. Use the up/down buttons to navigate to the “Records” option and press the menu button to confirm.
3. Use the up/down buttons to scroll through the recorded measurements.
4. Press the menu button to exit the records mode.

Delete the Records

To delete the records, follow these steps:

1. Press the menu button to enter the menu mode.
2. Use the up/down buttons to navigate to the “Records” option and press the menu button to confirm.
3. Use the up/down buttons to scroll through the recorded measurements.
4. Press and hold the delete button to delete the selected record.
5. Press the menu button to exit the records mode.

INFORMATION FOR USER

Tips for Measurement

For accurate measurements, follow these tips:

• Rest for at least 5 minutes before taking a measurement.

• Avoid eating, drinking, smoking, or exercising for at least 30
  minutes before taking a measurement.

• Sit in a quiet and comfortable environment.

• Keep your back straight and supported.

Maintenance

To ensure proper functioning and longevity of the monitor,
follow these maintenance tips:

• Clean the monitor with a soft, dry cloth.
• Avoid exposing the monitor to extreme temperatures or humidity.
• Avoid dropping or subjecting the monitor to impact. Store the monitor in a cool and dry place.

FAQ

What are systolic pressure and diastolic pressure?

Systolic pressure is the maximum pressure exerted on the arteries when the heart contracts, while diastolic pressure is the minimum pressure exerted on the arteries when the heart is at rest between beats.

What is the standard blood pressure classification?

The standard blood pressure classification is as follows:

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

Irregular heartbeat detector

• The monitor is equipped with an irregular heartbeat detector that can detect irregularities in your heartbeat during the measurement.

Why does my blood pressure fluctuate throughout the day?

• Various factors can cause blood pressure fluctuations, including stress, physical activity, medication, time of day, and diet.

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

• Home measurements may

INTRODUCTION

General Description

• This product features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service.
• Readings taken by this blood pressure monitor TMB-2085 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 this blood pressure monitor. Read the manual thoroughly before using this product.

Features:

• Systolic blood pressure
• Diastolic blood pressure
• Pulse rate
• 199 records for each user

Indications for Use

• This Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5 cm to 21.5 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, and defibrillators.

Measurement Principle

This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate.

Safety Information

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

CAUTION

• This device is intended for adult use in homes only.

• The device is not suitable for use on 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. Please consult your doctor before using the unit if you suffer from illnesses.

• The device is not suitable for measuring the blood pressure of children. Ask 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 wrist 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 asking 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 a prescribed medication without consulting your physician.

• Do not take any therapeutic measures based on a self-measurement. Never alter the dose of a 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. Please consult your physician about the result.

• Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.

• Do not inflate the cuff on the same limb to which 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 wrist may lead to ecchymosis.

• Please check that the operation of the device does not result in prolonged impairment of patient blood circulation.

• When measuring, please 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 81060-2:2018.

• 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 wrist 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 maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃.

• The equipment is not AP/APG equipment and is not suitable for use in the presence of a flammable anesthetic mixture with air 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 data change batteries under normal circumstances and maintain the device and its accessories according to the user manual.

• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

• The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don’t 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 ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensitisation or irritation reaction.

• If you experience discomfort during measurement, such as pain in the wrist or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist.

• 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 wrist and press the START/STOP button to stop inflation.

• Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or danger. 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.

• It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).

• Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

• The manufacturer will make available on request circuit diagrams, part lists, descriptions, calibration instructions, etc., to assist service personnel in parts repair.

• The operator shall not touch the output of the batteries and the patient simultaneously.

• Cleaning: A dust environment may affect the performance of the unit. Please use a soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners.

• The device doesn’t need to be calibrated within two years of reliable service.

• If you have any problems with this device, such as setting up, maintaining or using it, please contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized
  sales/service centres.

• Please report to Transtek if any unexpected operations or events occur.

• Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.

• Be careful of strangulation due to cables and hoses, particularly due to excessive length.

• At least 30 minutes are required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use.

• At least 30 minutes are required for ME equipment to cool from the maximum storage temperature between uses until it is ready for the intended use.

• This equipment needs to be installed and put into service under the information provided in the ACCOMPANYING DOCUMENTS;

• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.

• 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 is no luer lock connectors are used 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 was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD Display Symbol

Monitor Components

Component list of pressure measuring system:

1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.

List

1. Blood Pressure Monitor TMB-2085
2. 2× AAA Batteries
3. User manual

BEFORE YOU START

Installing and Replacing the Batteries

• Slide off the battery cover.
• Install the batteries as indicated in the battery compartment. Always use the correct battery type (2× AAA batteries).
• Replace the battery cover.
• The typical service life of the new and unused batteries is about 45 measurements for the operation time is 60.
• Replace the batteries whenever the below happen
• The DAT LO 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 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 Date and Time

• It is important to set the Date and Time before using your blood pressure monitor so that a time stamp can be assigned to each record that is stored in the memory. (Year Range: 2021-2050; Time Format: 12/24 H)

1. When the monitor is off, press and hold the “START/ STOP ” button to display the date format. Press the “MEM” button to switch the date format between [month/day] and [day/month].
2. Press the “START/ STOP ” button to confirm the date format, then the year will flash. Press the “MEM” button to change the year.
3. When you get the right year, press the “START / STOP” button to confirm the year. The screen will then show a blinking number representing the [MONTH].
4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
5. Repeat steps 2 and 3 to set the time format.
6. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
7. Repeat steps 2 and 3 to confirm whether [Wrist Positioning Guide] is on or off.
   • Note: When the Wrist Positioning Guide is OFF, the instruction will not appear at the start of the measurement.
8. After confirming the [Wrist Positioning Guide], the LCD will display “do nE” and then the monitor will turn off.

WRIST POSITIONING GUIDE

• When using a wrist blood pressure monitor, it is important to measure while relaxing your wrist at heart level. This will help ensure an accurate reading will be taken.
• Because it is difficult to find the ideal location for a wrist measurement, we have included an optional Wrist Positioning Sensor that will assist in directing your wrist to the ideal location for a blood pressure measurement.
• Each time you take a measurement, the display will illuminate with different icons that are designed to help you move your wrist.
• Once the ideal location is found, the wrist symbol will flash and after several seconds, measurement will begin. Keep your arm still until the measurement is completed.
• Wrist in an ideal position, the symbol flash. Do not move, Measurement starts.
• Note: Due to differences in individual sizes and physique, this feature may not be helpful in all cases and you may wish to turn this feature OFF. If you feel the suggested wrist position does not match your heart level, please turn this feature OFF and follow your judgment.

Pair a smartphone or a tablet 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 smartphone or tablet with Bluetooth wireless connectivity and application.

1. Turn on Bluetooth and the application. Make sure both are ON when the pair-up is proceeding.
2. When the monitor is OFF, press and hold the “MEM” button to start pair-up. The symbol will be shown on the LCD alternatively, indicating pair-up is proceeding.

• If successful, the Bluetooth symbol will not flash any more, the LCD will display “Done” and the monitor will shut off after several seconds.
• If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off.
• Bluetooth Module No.: B2085
• RF Frequency Range: 2402 MHz to 2480 MHz
• Output Power Range: ≤ -2.5 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-2085 may interfere with the vicinity’s electrical equipment.
• Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.
• Keep the monitor at least 20 centimetres away from the human body (especially the head) when the data after the transmission is proceeding with 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 no obstacles between the device and the BT end to obtain a quality connection and to 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.

MEASUREMENT

Tie the Cuff

1. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one.
2. Roll or push up your sleeve to expose the skin.
3. Apply the cuff to your wrist with your palm facing up.
4. Position the edge of the cuff about 1cm~2cm from wrist joints.
5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate.
6. Sit comfortably with your tested wrist 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.
7. Patients with Hypertension:

• The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported.
• Rest for 5 minutes before measuring.
• Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
• Measure a silent room.
• The patient must relax as much as possible and do not move and talk during the measurement procedure.
• The cuff should maintain at the same level as the right atrium of the heart.
• Do not cross your legs and keep your feet 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 wrist, 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 the display will show a blinking number representing the current [USER], at this process, you can switch the user from User 1 to User 2 or User G (gusset) by pressing “MEM” button.

   • After choosing the right user, press the “START/STOP” button to confirm, it will display the latest record of the current user, and after that, it will complete the whole measurement automatically.
     (Take user 1 for example.)

   • A step-by-step guide showing what you’ll see while taking a measurement.

2. Adjust to zero.

   • After the measurement is finished, the symbol will display, and the data will start transmitting.
   • Inflating and measuring.
   • Display and save the measuring result.

3. If the data transmits successfully, the symbol and symbol will disappear, the right picture will be shown, and then the monitor will turn off after several seconds.

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

   • (Note: the symbol will be shown in the next measurement)

5. Press the “START/STOP” button to power off, otherwise, it will shut off after several seconds.

• Notes: If you have set the [Wrist Positioning Guide] on, when you start the measurement, the blood pressure monitor will detect the position first. The wrist must beat the angle between 30° and 45°.
• If it’s out of this angle, the LCD won’t start any measurement until you have the ideal position.
• If you get the correct position, it will display for about 3 seconds, and then finish the whole measurement. For more details, please see.
• Display the current User
• Display the latest record of the current User
• Ideal position measurement start
• Adjust to zero.

DATA MANAGEMENT

Recalling the Records

1. When the monitor is off, press the “MEM” button the user ID will blink， and the memory number of the reading will be shown. you can switch the user from User 1 to User 2 by pressing the “MEM” button. After choosing the right user, press “START/STOP” button to confirm. If there are less than 3 records, it will display the latest record of the current user.
   • If there are more than 3 records, it will show the average of the latest three records first.
   • If there are no records, it will “—”.
2. Press the “MEM” button to get the record you want.
   • If the symbol appears along with the record, that means the record is pending transmission.

CAUTION

• 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 (199) is dropped from the list.

Deleting the Records

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

A: To delete a single measurement:

1. When the monitor is off, press the “MEM” button to show the memory recall mode (you could use the “MEM” button to switch between users).
2. Several seconds later, press the “MEM” button to find the measurement you would like to erase, press and hold the “MEM” button for 3 seconds, and the display will show a blinking “dEL yES” and the memory number of the reading.
3. Use the “MEM” buttons to toggle between YES and NO. Press “START/STOP” to confirm the selection. If YES is selected, the unit will delete the record and return to the last momery record. All the records are pushed forward one digit (e.g., 03 becomes 02, and so on)

B: To delete ALL measurements:

1. When the monitor is off, press the “MEM” button to show the memory recall mode (you could use the “MEM” button to switch between users).

2. Several seconds later, hold pressing the “MEM” +” START/STOP” button for 5 seconds,
   the display will show a blinking “dEL ALL” and the User ID.

3. Use the “MEM” buttons to toggle between ALL and NO. Press “START/STOP” to confirm the selection. If “dEL ALL” is selected, the unit will display “dEL do nE” + User ID and delete all the records of the current user. Several seconds later, it will display “–

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

Maintenance
To obtain 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, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure.

What is the standard blood pressure classification?

• The chart on the right is the standard blood pressure classification published by the American Heart Association (AHA).
• This chart reflects blood pressure categories defined by the American Heart Association.

Blood Pressure Category| Systolic

mmHg (upper#)

|  | Diastolic mmHg (lower#)
---|---|---|---

Normal

|

less than 120

|

and

|

less than 80

Elevated| 120-129| and| less than 80
High Blood Pressure (Hypertension) Stage 1|

130-139

|

or

|

80-89

High Blood Pressure (Hypertension) Stage 2|

140 or higher

| or|

90 or higher

Hypertensive Crisis (Consult your doctor immediately)|

Higher than 180

|

and/or

|

Higher than 120

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 if 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 measure 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.

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

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

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

TROUBLESHOOTING

batteries
Low batteries| bAt Lo+ shows| Batteries are low.| Replace with new batteries
Error message| E 1 shows| The cuff is not secure| Refasten the cuff and then measure again.
E 2 shows| The monitor detected motion, talking, or the pulse was too poor while measuring.| movement can affect the measurement. Relax for a moment and then measure again.
E 3 shows| The measurement process

does not detect the pulse signal.

| Loosen the clothing on the wrist and then measure again.
E 4 shows| The treatment of the measurement failed.| Relax for a moment and then measure again.
PROBLEM| SYMPTOM| CHECK THIS| REMEDY
---|---|---|---
Error message| EExx shows on the display.| A calibration error occurred.| Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions.
Warning message| “out ” shows| Out of measurement range| Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

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

SPECIFICATIONS

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%
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 50hPa

Measurement perimeter of the wrist| About 13.5-21.5 cm
Weight| Approx.103 g (Excluding the batteries)
External dimensions| Approx. 85.7 mm × 60.8 mm × 24.7 mm (Excluding the cuff)
Attachment| 2x AAA batteries, user manual
Mode of operation| Continuous operation
---|---
Degree of protection| Type BF applied part
Device Classification| Internally Powered ME Equipment

IP Classification

| IP22: The first number 2: Protected against solid foreign objects of 12,5mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15º. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15º on either side of the vertical.
Software Version| A01

• WARNING: No modification of this equipment is allowed.

Contact Information

• For more information about our products, please visit www.transtekcorp.com. You can get customer service, usual problems and customer downloads, LifeHood will serve you anytime.

Manufactured by:

• Company: Guangdong Transtek Medical Electronics Co., Ltd.
• Address: Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China

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-2085, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description:

• All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
• 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| Group 1
RF emissions CISPR 11|

Class B

Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not applicable

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, ±4kV, ±8 kV, ±15 kV air

| ±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| Not applicable| Not applicable
Surge IEC61000-4-5|

Not applicable

|

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| Not applicable| Not applicable
---|---|---
Power frequency magnetic field IEC 61000-4-8| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Conducted RF IEC61000-4-6| Not applicable| Not applicable
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 before application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communication- ons equipment)

| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Maximum Power (W)| Distance (m)| IEC 60601-1-2

Test Level (V/m)

| Compliance level

(V/m)

385| 380-390| TETRA 400| Pulse modulation 18 Hz| 1.8| 0.3| 27| 27
450| 430-470| GMRS 460,

FRS 460

| FM ± 5k Hz

deviation 1 kHz sine

| 2| 0.3| 28| 28
710| 704-787| LTE Band 13,

17

| Pulse modulation 217 Hz| 0.2| 0.3| 9| 9
745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation 18 Hz| 2| 0.3| 28| 28
870
930
 | 1720| 1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3, 4,25; UMTS

| Pulse modulation 217 Hz| 2| 0.3| 28| 28
---|---|---|---|---|---|---|---|---
1845
1970
2450| 2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation 217 Hz| 2| 0.3| 28| 28
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 0.2| 0.3| 9| 9
5500
5785

FCC Statement

FCC ID: OU9TMB2085-K

• This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. this device may not cause harmful interference, and
2. this device must accept any interference received, including interference that may cause undesired operation.

Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, under Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used under the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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