Transtek Medical Electronics TMB1598-B User Manual

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User Manual

Version:1.0

Guangdong Transtek Medical Electronics Co., Ltd.

Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China

Blood Pressure Monitor

TMB-1598-BS

Wrist Type

Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1598-BS.

Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for your further reference in case you have problems.

Table of Contents

INTRODUCTION ...............................................................

General Description

Measurement Principle Safety Information Indications for Use LCD Display Signal Monitor Components

BEFORE YOU START .......................................................... 8

Installing and Replacing the Batteries Setting Date, Time, Positioning Symbol and Measurement Unit

Pair up the Blood Pressure Monitor with Your Device

Positioning the Cuff

Setting the User ID

MEASUREMENT ...............................................................

Start Measurement

Data Management .....................................

Recall the Records

Delete the Records

INFORMATION FOR USER......................................................20

Tips for Measurement

Maintenance

ABOUT BLOOD PRESSURE.....................................................22

What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why do I get a different blood pressure at home compared to the hospital? Is the result the same if measuring on the right wrist?

TROUBLESHOOTING ......................................................... 24

SPECIFICATIONS ............................................................. 25

CONTACT INFORMATION...................................................... 26

COMPLIED STANDARDS LIST .................................... 27

EMC GUDIANCE ...................................................... 28......

.........................

...............

INTRODUCTION INTRODUCTION

General Description

Thank you for selecting TRANSTEK blood pressure monitor (TMB-1598-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime. Readings taken by the TMB-1598-BS 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 do read this user manual carefully and thoroughly before use.

FEATURES:

Systolic Blood Pressure

Diastolic Blood Pressure

Pulse Rate

Memory: Up to 60 pieces of records per user 1 and user 2

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 components. They are the requirement of standard and using.

Symbol for “THE OPERATION GUIDE MUST BE READ”

Caution: These notes must be observed to prevent any damage to the device.

Symbol for “MANUFACTURE DATE”

Symbol for “SERIAL NUMBER”

The Bluetooth Combination Mark

Symbol for “Including RF transmitter”

Symbol for “Recycle”

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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 “DIRECT CURRENT”

Symbol for “MANUFACTURER”

The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods.

Indications for Use

The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5-8.5 inches ). It is intended for adult indoor use only.

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, electronical 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 prior to 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 no-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 on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure. * When the device was 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. * Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. * When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.

INTRODUCTION

CAUTION

* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury. *Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around 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 an ecchymosis. *Please check that operation of the device does not result in prolonged impairment of patient blood circulation. * When measurement, 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 81060-2:2013. * 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 not suitable for use in the presence of a flammable anesthetic mixture with air of 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 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 requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction. * If you experience discomfort during a 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 pressures 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 serious danger.

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* 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. * Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair. * The operator shall not touch output of batteries and the patient simultaneously. * Cleaning :Dust environment may affect the performance of the unit. Please use the 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, 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 centers. * Please report to Transtek if any unexpected operation 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 to strangulation due to cables and hoses, particularly due to excessive length. * At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use. * This equipment needs to be installed and put into service in accordance with 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 caculated by the MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate. * Please use ACCESSORIES and detachable partes 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.

CAUTION

INTRODUCTION

LCD Display Signal

SYMBOL DESCRIPTION EXPLANATION

Systolic pressure

Diastolic pressure

Pulse display

Motion indicator

Low battery

kPa

mmHg

Irregular heartbeat

Current time

Average value The average value of blood pressure

Heartbeat

Memory

User 1

User 2

Blood pressure level indicator

Positioning symbol

Bluetooth icon Indicate the Bluetooth is working.

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Data storage

High blood pressure

Low blood pressure

Pulse in beats per minute

Motion may result in an inaccurate measurement

Batteries are low and need to be replaced

Measurement unit of the blood pressure (1kPa=7.5mmHg) Measurement unit the blood pressure (1mmHg=0.133kPa)

Blood pressure monitor is detecting an irregular heartbeat during measurement.

Year/Month/Day,Hour/Minute

Blood pressure monitor is detecting a heartbeat during measurement.

Indicate it is in the memory mode

Start measurement and save the results for user 1

Start measurement and save the results for user 2

Indicate the blood pressure level

The correct position gives you an accurate measurement

Indicate the data is waiting to be transmitted.

Monitor Components

SYSTOLIC PRESSURE

DIASTOLIC PRESSURE

PULSE RATE

SET BUTTON

Component list of pressure measuring system:

1. PCBA;

2. Air Pipe;

3. Pump;

4. Valve;

5. Cuff.

BATTERY

COMPARTMENT

List

1.Blood Pressure Monitor (TMB-1598-BS)

3.User Manual

2. 2×AAA batteries

TIME

GRADE

LCD DISPLAY

MEMORY BUTTON

START/STOP BUTTON

CUFF (Type BF applied part)

BEFORE YOU START

Installing and Replacing the Batteries

Slide off the battery cover.

•

Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2×AAA batteries.)

•

Replace the cover.

The typical service life of the new and unused batteries is 54 measurements for the operation time is 60s.

Replace the batteries whenever the below happen

The 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 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 Date, Time, Positioning Symbol and Measurement Unit

It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of year is 2016 ~ 2056. Time format: 24H)

When the monitor is off, press “ ” button,it will display the time.Then

1. press and hold “ ” button to enter the mode for year setting.

Notes:

1.During the process of setting, you can press “ ” button to stop setting at any time.

2. If there is no operation during the process of setting, it will turn off within 1 minute.

Press “ ” button to change

2. 3. the [YEAR]. Each press will increase the numeral by one in a cycling manner.

When you get the right year, press “ ” button to confirm and it will turn to next step.

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BEFORE YOU START

4.Repeat steps 2 and 3 to confirm [MONTH] and [DAY].

5.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE].

5.Repeat steps 2 and 3 to confirm [Positioning symbol] on or off.

6.Repeat steps 2 and 3 to confirm the measurement unit.

7.After confirming the meausrement unit, the LCD will display “donE”,

then display all the settings you have done one by one and then the monitor will shut off.

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BEFORE YOU START

Pair up the Blood Pressure Monitor with Your Device

1.Turn on Bluetooth and the “MedM Health” app. Make sure both are ON when pair-up is proceeding.

2.When the monitor is OFF, press and hold the “ ” button to start pair-up.

The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding.

If SUCCEED, symbol will

be shown on the LCD.

If FAIL

, symbol will be

shown on the LCD.

3.The monitor will shut off automatically

after Pair-up process is complete.

Tie the Cuff

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.

Roll or push up your sleeve to expose the skin.

Apply the cuff to your wrist with your palm facing up.

Position the edge of the cuff about 1cm~1.5cm from wrist joints.

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.

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.

Helpful tips for Patients, especially for Patients with Hypertension:

Rest for 5 minutes before first measuring. 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 and talk during the measurement procedure. The cuff should maintain at 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 wrist, or as directed by a physician.

Bluetooth Module No.: nRF51822 RF Frequency Range: 2.402 - 2.480 GHz Output Power Range: 4 dBm Supply Voltage: 3.3V Transmitting Distance: 1-10 meters

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BEFORE YOU START

MEASUREMENT

Select the User ID

Before you start the measurement, please select the desired user ID first.

When the blood pressure monitor is off, press and hold “ ” button until the user ID blinks. Then press “ ” button to change the user ID between user 1 and user 2. Press “ ” button to confirm your selection.

After confirming the user ID, the LCD will display “User ID+donE” and

then turn off. Then you can start your measurement now.

Start the Measurement

When the monitor is off, press “ ” button to turn on the monitor, and it will finish the whole measurement. (Take user 1 for example.)

Inflating and measuring.

Adjust the zero. LCD display

Display and save the result. The year, date and time will dispaly alternately.

2.After finishing the measurement, the

LCD displays the blinking icon ‘ ’, and transmits the data.

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MEASUREMENT

DATA MANAGEMENT

Note: (1). The symbol “ ” will disappear after successful data transmission, and you may check your personal health data stored in your mobile device. (2). If the data transmission fails, the symbol “ ” will remain. The pending measurement data will be transmitted to your mobile device when next measurement is complete. (3). If you have set the [Positioning Symbol] 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 measurements and will display blinking symbol “ ” until you have the correct position. If you get the correct position, it will display “ ” for about 3 seconds, and then finish the whole measurement.

During the measurement or when the

measurement is finished, press “ ” button to turn off the monitor. Otherwise it will power off in one minute.

Tips:

1. There are two users in total. Each user has 60 records.

2. You can press “ ” button to stop measuring during the process of the measurement at any time.

3. If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display “out”.

CAUTION

Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1598-BS may interfering vicinity 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 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement. To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz.

How to mitigate possible interference?

The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range.

To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor.

Recall the Records

When the monitor is off, press “ ” button to show the average value of the latest three measurement records. If the records are less than 3 groups, it will display the latest record instead.

Press “ ” button or “ ” button to get the record you want.

The record number is No.1. Six records in total.

The record number, time and date of the measurement records will display alternately.

The corresponding time is 22:36.

The corresponding date is 8th May.

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DATA MANAGEMENT

If you want to check the other user’s measurement records, please press “ ” button to turn off the blood pressure monitor. Then press and hold “ ” button to enter the selecting user mode, press “ ” again to change the user, when the desired user ID blinks, press “ ” button to confirm. Then press “ ” button to check the records of the selected user.

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 (60) is dropped from the list.

Delete the Records

If you did not get the correct measurement, you can delete all the results for the selected user by following steps. (Take user 1 for example.)

In the memory mode, hold pressing “ ” button about 3 seconds, the flash display “dEL ALL” +User ID will show.

2. Press “ ” button to confirm deleting , the LCD displays “ User ID+dEL donE” and then turns off.

Note: To exit out of delete mode without deleting any records, press “ ” button before pressing “ ” button to confirm any delete commands.

If there is no record, when you press “ ” button to check the record, the right display will show.

1918

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

Within 1 hour

after dinner or drinking

Within 20 minutes after taking a bath

In a very cold environment

Immediate measurement after tea, coffee, smoking

When talking or moving your fingers

When you want to discharge urine

Maintenance

In order to get the best performance, please follow the

instructions below.

Put in a dry place and avoid the

sunshine

Avoid intense shaking

and collisions

Using wet cloths to remove dirt

Avoid touching water,

clean it with a dry cloth in case.

Avoid dusty and unstable-

temperature environment

Avoid washing the cuff

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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 chart on the right is the standard blood pressure classification published by American Heart Association (AHA).

AHA Home Guideline for Upper Limit of Normal BP

SYS 135 mm Hg

DIA 85 mm Hg

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.

This chart reflects blood pressure categories defined by American Heart Association.

Blood Pressure Category

Normal

Prehypertension

High Blood Pressure

(Hypertension) Stage 1

High Blood Pressure

(Hypertension) Stage 2

Hypertensive Crisis

(Emergency care needed)

Systolic mmHg (upper#)

less than 120

120-139

140-159

160 or higher

Higher than 180

and

Diastolic mmHg (lower#)

less than 80

80-89

90-99

100 or higher

Higher than 110

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 theaverage value of ±15%,the irregular heartbeat symbol appears on the display when the measurement results are 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

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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.

Why do I get a different blood pressure at home

attention to when you measure your 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

beginning will be better for measuring.

minutes until you calm down.

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

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

Advice: Relax yourself for 4-5

TROUBLESHOOTING

SPECIFICATIONS

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.

PROBLEM SYMPTOM CHECK THIS REMEDY

Batteries are exhausted.

Batteries are inserted incorrectly.

Batteries are low.

The cuff is too tight or too loose.

The monitor detected motion,talking or the pulse is too poor while measuring.

The measurement process does not detect the pulse signal.

The treatment of the measurement failed.

A calibration error occurred.

(XX can be some digital symbol,such as 01, 02,etc., if this similar situation appear, all belong to calibration error.)

Out of measurement range.

Failure of pairing up your monitor with your mobile device.

No power

Low batteries

Error message

Display will not

light up.

Display is dim or display

E 01 shows

E 02 shows

E 03 shows

E 04 shows

EE XX,shows on the display.

“oUt ” shows

“E 12 ” shows

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Replace with new batteries

Insert the batteries

correctly

Replace with new batteries

Refasten the cuff and then measure again.

Relax for a moment and then measure again.

Loosen the clothing on the wrist and then measure again.

Relax for a moment and then measure again.

Retake the measurement. contact the retailer or our If the problem persists,

customer service

department for further

assistance.Refer to the

warranty for contact

information and return

instructions.

Follow the instructions in user manual and measure again.

Please check below items:

-Bluetooth is ON.

-App Collector is ON.

-Both devices are within the transmission distance of Bluetooth.

Power supply

Display mode

Measurement mode Oscillographic testing mode

Measurement range

Accuracy

Normal working condition

Storage & transportation

condition

Measurement perimeter

of the wrist

Weight

External dimensions

Attachment

Mode of operation

Degree of protection Type BF applied part

Protection against

ingress of water

Software version

Device classification

WARNING: No modification of this equipment is allowed.

Battery powered mode: 2*AAA alkaline batteries (3V DC)

Digital LCD V.A.45mm×33mm

Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute

Pressure: 5°C-40°C within±3mmHg(0.4kPa) Pulse value:±5%

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

Temperature:-20°C to +60°C

A relative humidity range of ≤ 93%,

non-condensing, at a water vapour pressure up to 50hPa

About 13.5cm-21.5cm

Approx.100g(Excluding the dry cells)

Approx.86mmx66mmx22mm

2×AAA batteries,user manual Continuous operation

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.

A01

Internally Powered ME Equipment

CONTACT INFORMATION

Complied Standards List

EN ISO 14971:2012 / ISO 14971:2007 Medical devices -

Contact Information

Risk management

For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime.

Manufactured by: Company: Address:

Guangdong Transtek Medical Electronics Co., Ltd.

Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China

Labeling

User manual

General Requirements for Safety

FCC Statement

FCC ID: OU9TMB1598-B

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, pursuant to 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 in accordance with 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 receiver.

-- Connect the equipment into 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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Electromagnetic compatibility

Performance requirements

Clinical investigation

Usability

Software life-cycle processes

Bio-compatibility

Application of risk management to medical devices

EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements

EN 1041:2008 Information supplied by the manufacturer of medical

devices

EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical

equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical

equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical

equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:

Requirements and test methods for non-automated measurement type

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -

Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test

procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

EN 62366-1:2015/ Application of usability engineering to medical devices

EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device

software - Software life-cycle processes

ISO 10993-1:2009 Biological evaluation of medical devices- Part

1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices -

Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices -

Part 10: Tests for irritation and skin sensitization

COMPLIED STANDARDS LIST

IEC 62366-1:2015 Medical devices - Part 1:

EMC GUIDANCE

EMC Guidance

1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.

2)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.

3)Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!

4)* Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emissions test Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Compliance

Group 1

Class B

Class A

Complies

The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The device is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Table 2

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC61000-4-5

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

IEC 61000-4-11

Power frequency

(50Hz/60Hz) magnetic field

IEC 61000-4-8

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

IEC 60601 test level

±8 kV contact ±15 kV air

power supply lines: ±2 kV

input/output lines: ±1 kV

line(s) to line(s): ±1 kV line(s) to earth: ±2 kV

100 kHz repetition frequency

0%UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°,225°,270° and 315° 0%U

; 1 cycle and 70%U

; 25/30 cycles Single phase: at 0° 0% U

; 300 cycle

30 A/m 50Hz/60Hz

Compliance level

±8 kV contact ±15 kV air

power supply lines: ±2 kV

line(s) to line(s): ±1 kV

100 kHz repetition frequency

0% U

; 0.5 cycle At 0°, 45°, 90°, 135°, 180°,225°,270° and 315° 0% U

; 1 cycle and 70% U

; 25/30 cycles Single phase: at 0° 0% U

;300 cycle

30 A/m 50Hz/60Hz

Electromagnetic environment - guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

28 29

EMC GUIDANCE

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

IEC 60601 Test level

150 kHz to 80 MHz: 3 Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz

10V/m, 80% Am at 1kHz

Compliance level

150 kHz to 80 MHz: 3 Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz

10V/m, 80% Am at 1kHz

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances: d=0.35 ;

d=1.2

80 MHz to 800 MHz: d=1.2

800 MHz to 2.7 GHz: d=2.3

where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

EMC GUIDANCE

Table 4

Recommended separation distances between portable and mobile RF communications equipment and the device.

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

(W)

0.01

0.1

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz

3.5

0.12 0.12

0.37

1.2

3.8

=d 1.2

0.38

1.2

3.8

0.23

0.73

2.3

7.3

2.3=d

30 31

EMC GUIDANCE

Table 5

Guidance and manufacturer’s declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment.

Radiated RF

Test

Band a)

IEC61000-4-3

Frequency

(Test

(MHz) specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: E=

Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.

385

450 380-390

710 704-787

745

780

810

870

930

1720

1845

1970

5240

5785

Service a) Modulation b) Modulation b)

(MHz)

380-390 TETRA

800-960

17001990

2570

51005800

400

GMRS 460， FRS 460

LTE Band 13, 17

GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4,25; UMTS

Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

WLAN

802.11 a/n

Pulse modulation b) 18Hz

FM c) ± 5kHz deviation 1kHz sine

Pulse modulation b) 217Hz

Pulse modulation b) 18Hz

Pulse modulation b) 217Hz

Pulse modulation b) 217 Hz

Distance (m)

(W)

1.8

0.3 27

2 0.3 28

0.2 0.3 9

0.3 28

0.3 282450 2400-

0.2

0.3 9

IMMUNITY TEST LEVEL (V/m)

Transtek Medical Electronics TMB1598-B User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual