Transtek Medical Electronics TMB1014BS User Manual

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User Manual

Wrist Blood Pressure Monitor

Version:1.0

TMB-1014-BS

Wrist Type

Guangdong Transtek Medical Electronics Co., Ltd.

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

Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor TMB-1014-BS.

To use the monitor correctly and safely, please read the manual

Please keep this manual well in order to reference in future.

thoroughly.

CATALOGUE

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

General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Symboll Monitor Components List

BEFOREYOU START

Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User ID Pair-up the Blood Pressure Monitor with Your Device

MEASUREMENT

Tie the Cuff Start the Measurement

DATA MANAGEMENT 25

Recalling the Records Deleting the Records

INFORMATION FOR USER

Tips for Measurement Maintenance

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Irregular heartbeat detector 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 SPECIFICATIONS CONTACT INFORMATION

FCC STATEMENT..................................................................................................

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

EMC GUIDANCE

...................................................................................... 13

.............................................................................................. 21

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................................................................................ 27

............................................................................... 29

..................................................................................... 32

........................................................................................... 34

................................................................................. 36

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INTRODUCTION

General Description

Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1014-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the TMB-1014-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. Read the manual thoroughly before using the product.

Features:

Systolic blood pressure Diastolic blood pressure Pulse rate 60 records for one user

Indications for Use

The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging

from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ).

It is intended for adult indoor use only.

INTRODUCTION

Contraindications

1.The device should not be used by any person who may be suspected of,or is pregnant .

2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, 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.

INTRODUCTION

Safety Information

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

Symbol for “THE OPERATION GUIDE MUST BE READ”

Symbol for “MANUFACTURE DATE”

Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Symbol for “RECYCLE”

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

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”

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

INTRODUCTION

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. * 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.

INTRODUCTION

CAUTION

*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.

INTRODUCTION

CAUTION

* The patient can measure 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. * 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).

* 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.

INTRODUCTION INTRODUCTION

CAUTION

* 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 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 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.

LCD Display Symbol

SYMBOL DESCRIPTION EXPLANATION

Systolic Blood Pressure

Diastolic Blood Pressure

Pulse display

Low Battery

Unit

High blood pressure

Low blood pressure

Pulse in beats per minute

Low battery and please replace the batteries.

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

INTRODUCTION

SYMBOL DESCRIPTION EXPLANATION

Time

IHB Detector

Bluet ooth Successful Bluetooth Connection

Error

User ID

Memory

Heartbeat

Average value

Blood pressure level indicator

10 11

Hour:Minute (Month/Day/Year)

Blood pressure monitor is detecting an irregular heartbeat during measurement.

Data communication has failed

The selected User ID

Indicate it is in the memory mode

Blood pressure monitor is detecting a heartbeat during measurement.

The average value of the latest three groups bood pressure value

Indicate the blood pressure level

Monitor Components

SYSTOLIC

DIASTOLIC

PULSE RATE

LCD DISPLAY

MEM/UP BUTTON

START/STOP BUTTON

TIME

SET/DOWN BUTTON

INTRODUCTION

Component List pressure measuring system:

1. PCBA;

2. Air Pipe;

3. Pump;

4. Valve;

5. Cuff.

List

1) Wrist Blood Pressure Monitor TMB-1014-BS

2) 2×AAA Batteries

3) User manual

CUFF

(Type BF applied part)

BATTERY COMPARTMENT

Installing and Replacing the Batteries

• Open the battery door.

• Insert the batteries according to the polarity indications.

(Always select the authorized / specified battery:

Two AAA-size batteries).

• Replacing the battery door.

The typical service life of the new and unused batteries is 138 measurements for the operation time is 60s.

BEFORE YOU START

1312

BEFORE YOU START

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 and Time

Please proceed to time setting before your initial use so as to ensure each piece of record are labled with a time stamp. (Year Range: 2018-2058; Time Format: 12 Hours)

When the monitor is off, hold pressing “SET” button for about 3

seconds to enter into setting mode. The blinking numeral represents [HOUR].

2. Press “MEM” button to change the [HOUR] . Each press will increase the numeral by one in a cycling manner.

MEM

SET

MEM

SET

1514

BEFORE YOU START BEFORE YOU START

3.When you get the right hour,Press “SET” button again to confirm [HOUR]. Then it will turn to the next step.

MEM

5.Repeat step 2 and 3 to confirm [MONTH], [DAY] and [YEAR].

MEM

4.Repeat step 2 and 3 to confirm [MINUTE].

SET

6.After confirming [YEAR], the LCD will display “donE” then the monitor will turn off .

MEM

SET

1716

BEFORE YOU START

Select the User ID

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

1.When the blood pressure monitor is off, press the MEM button for 3 seconds, then the user ID will blink.

2. Press the MEM button shortly to change the user ID between User 1 and User 2 .

BEFORE YOU START

Pair-up the Blood Pressure Monitor

with Your Device

MEM

SET

MEM

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

2.When the monitor is OFF, press and hold the START/STOP button to start pair-up. The symbol “ + ”and user ID will be shown on the LCD alternatively, indicating pair-up is proceeding.

3. After selecting the suitable user ID, press SET button to confirm then the LCD will turn off.

SET

If SUCCEED, the symbol “ + ”and user ID will be shown on the LCD.

1918

BEFORE YOU START

If FAIL, the symbol “ + ” will be shown on the LCD.

3.The monitor will turn off after Pair-up process is complete.

Bluetooth Module No.: RF Frequency Range: Output Power Range: Supply Voltage:

Transmitting Distance:

LS51802

2402 MHz to 2480 MHz

≤4dBm

2 V to 3.6V

10 meters

Tie the Cuff

MEASUREMENT

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.

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. 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. 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.

2120

MEASUREMENT

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.(Take user 1 for example.)

Adjust to zero.

Display and save the measuring result.

START

STOP

Inflating and measuring.

MEASUREMENT

2.This device will proceed to data transmission after measurement. The Bluetooth symbol will blink.

3.If the data transmission succeeds, the Bluetooth symbol will light on , the LCD will display as pictured to the right,then the device will turn off.

2322

MEASUREMENT

DATA MANAGEMENT

If the data transmission fails,the LCD will display “ ”

as pictured to the right, then the device will turn off.

CAUTION

Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1014-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.

Recalling the Records

1. When the monitor is off, please press the “MEM” to show the average value of the latest three records.If the records are less than three groups,it will display the latest record first.

2. Press “MEM” button or “SET” button to rotate the history records.“MEM” to go forward;“SET” to go backward.

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.

MEM

SET

MEM

SET

DOWN

2524

DATA MANAGEMENT

Deleting the Records

If you did not get the correct measurement, you can delete all results

by following steps below.

ABOUT BLOOD PRESSURE

1.Hold pressing “MEM” for 3 seconds when the monitor is in the memory recall mode ,the “dEL ALL” will blink on the display.

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

2.Press “SET” to confirm deleting and the monitor will display

“dEL donE” then turn off.

3.If you don’t want to delete the records,

press START/STOP” to escape.

START

STOP

4. If there is no record, the right display will be showed.

Within 1 hour

after dinner or drinking

SET

When talking or

moving your fingers

Immediate measurement after tea, coffee, smoking

In a very cold environment

Within 20 minutes after taking a bath

When you want to

discharge urine

2726

INFORMATION FOR USER

Maintenance

To obtain the best performance, please follow the instructions below.

Put in a dry place and

avoid the sunshine

TROUBLESHOOTING

Avoid dusty environment and

unstable temperature surrounding

Avoid immersing it in the water. Clean it with a dry cloth in case.

Use the slightly damp cloth

to remove the dirt.

Avoid shaking and collision.

Avoid washing the cuff

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 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

Elevated

High Blood Pressure

(Hypertension) Stage 1

High Blood Pressure

(Hypertension) Stage 2

Hypertensive Crisis

(Emergency care needed)

symbol

displayed

Systolic

mmHg (upper#)

less than 120

120-129

130-139

140 or higher

Higher than 180

and/or

and

Diastolic

mmHg (lower#)

less than 80

90 or higher

Higher than 120

80-89

2928

ABOUT BLOOD PRESSURE

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, 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.

ABOUT BLOOD PRESSURE

Why does my blood pressure

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.

fluctuate throughout the day?

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

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

Replace with new batteries

Insert the batteries correctly

Replace with new batteries

Refasten the cuff and then

Refasten the cuff and then measure again.

Relax for a moment and then measure again.

movement can affect the measurement. Relax for a moment and then measure again.

Loosen the clothing on the arm and then measure again.

Relax for a moment and then measure again.

Display is dim or

No power

will not light up.

Low batteries

E 01 shows

E 02 shows The cuff is very tight

E 03 shows

E 10 or E 11 shows

E 20 shows

Error message

E 21 shows

Batteries are exhausted.

Batteries are inserted incorrectly.

Show on

Batteries are low.

the display

The cuff is not secure.

The pressure of the cuff is excess.

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

The measurement process does not detect the pulse signal.

Measure incorrectly.

measure again.

PROBLEM SYMPTOM CHECK THIS REMEDY

Error message

Warning message

Error + shows

EExx,shows on the display.

“out ” shows

Data communication has failed

A calibration error occurred.

Out of measurement range

Make sure that phone’s Bluetooth is on or within the distance range

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.

Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

TROUBLESHOOTING

SPECIFICATIONS

EMC GUIDANCE

SPECIFICATIONS

Power supply

Display mode

Measurement mode

Measurement range

Accuracy

Working condition

Storage & transportation

condition

Measurement perimeter

of the upper arm

External dimensions

Attachment

Weight

Battery powered mode: 2*AAA batteries

Digital LCD V.A.36mmx41mm

Oscillographic testing mode

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.120g(Excluding the batteries)

Approx.80mm×65mm×22mm(Excluding the cuff)

2*AAA batteries,user manual

Mode of operation

Continuous operation

Degree of protection Type BF applied part

Device Classification

IP Classification

Software Version

Internally Powered ME Equipment

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

WARNING: No modification of this equipment is allowed.

CONTACT INFORMATION

Contact Information

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:

Authorized European Representative: 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

MDSS - Medical Device Safety Service GmbH

Schiffgraben 41, 30175 Hannover, Germany

FCC Statement

FCC ID:OU9TMB1014BS

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.

COMPLIED STANDARDS LIST COMPLIED STANDARDS LIST

Complied Standards List

Risk management

Labeling

User manual

General Requirements for Safety

Electromagnetic compatibility

Performance requirements

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

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+A1:2013/ 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

Clinical investigation

Usability

Software life-cycle processes

Bio-compatibility

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

IEC 80601-2-30:2009+A1:2013 Medical electrical equipmentPart 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+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes

ISO 10993-1:2009 Biological evaluation of medical devicesPart 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 -

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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.

EMC GUIDANCE

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.

EMC GUIDANCE

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

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

Compliance level

±8 kV contact ±15 kV air

power supply lines: ±2 kV

line(s) to line(s): ±1 kV

100 kHz repetition frequency

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.

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

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

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

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

EMC GUIDANCE

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.

4342

EMC GUIDANCE

Table 5

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

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

EMC GUIDANCE

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:

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.

Table 5

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

0.12

0.37

1.2

3.8

80 MHz to 800 MHz 800 MHz to 2.7 GHz

3.5

1.2

0.12

0.38

1.2

3.8

0.23

0.73

2.3

7.3

EMC GUIDANCE

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

2.3=d

PORT IMMUNITY to RF wireless communicatio

ns equipment)

385

450 380-390

710 704-787

745

780

810

870

930

Service a) Modulation b) Modulation b)

(MHz)

380-390 TETRA

400

GMRS 460， FRS 460

LTE Band 13, 17

GSM

800-960

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

Pulse

modulation b)

18Hz

FM c) ± 5kHz

deviation 1kHz sine

Pulse

modulation b)

217Hz

Pulse

modulation b)

18Hz

(W)

1.8

2 0.3 28

0.2 0.3 9

Distance (m)

0.3 27

0.3 28

IMMUNITY TEST LEVEL

(V/m)

Table 5

EMC GUIDANCE

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)

217Hz

Pulse

modulation b)

217 Hz

Pulse

modulation b)

217 Hz

0.3 28

0.3 282450 2400-

0.2

0.3 9

1700-

1720

1990

1845

1970

2570

5240

51005800

5240

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:

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.

5785

Transtek Medical Electronics TMB1014BS User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual