Kinetik TMB-1970 Fully Automatic Blood Pressure Monitor User Manual

Kinetik TMB-1970 Fully Automatic Blood Pressure Monitor

TMB-1970
Thank you so much for selecting the Kinetik Wellbeing Fully Automatic Blood Pressure Monitor
Please read the user manual carefully and thoroughtly so as to ensure the safe usage of this product. Keep the manual safe for future reference in case you have problems.

SUPPORT

• Our manual should provide you with all the information you need to set up and use this product.
• If you have a question, have a look at our Troubleshooting page!
• For further assistance, why not contact our Customer Care team directly? We’re here to help!
• Our Customer Care team are available from 9am-5pm, Monday to Friday (excluding bank holidays).
• We promise to respond to all queries and will ensure to resolve any issue you may be having.

You can reach us by…
Phone:
+44 1483 937969
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
[email protected]
Post:
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ

INTRODUCTION

General Description
Thank you for selecting Kinetik arm type blood pressure monitor
(TMB-1970). 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-1970 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:

• 52 mm × 58 mm Digital LCD display
• Maximum 90 records
• 3rd technology: Measuring during inflation

Indications for Use

The Kinetik Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm (about 8¾˝-16½˝).
It is intended for adult indoor use only.

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 or defibrillators.

Measurement Principle
This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

INTRODUCTION

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, 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 arm or for functions other than obtaining a blood pressure measurement.

• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without 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 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.

• 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 pressurisation on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.

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

• Do not inflate the cuff on the same limb 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 measure-ment, open the cuff immediately. Prolonged high pressure (cuff pressure ＞ 300mmHg or constant pressure ＞ 15mmHg for more than 3 minutes) applied to the arm may lead to 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 arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.

• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.

• This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.

• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.

• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air 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 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 sensation or irritation reaction.

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

• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the arm 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).

• 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 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, please contact the SERVICE PERSONNEL of Kinetik Wellbeing. 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 authorised sales/service centers.

• Please report to Kinetik Wellbeing 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 of 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 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 MANUFAC-TURE. 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 signal

Monitor Components

BEFORE YOU START

Installing and Replacing the Batterie

• Open the battery cover.
• Install the batteries as indicated in the battery compartment. (Always select the authorised / specified battery: Four AAA-size batteries).
• Replace the battery cover.

CAUTION

• Do not use new and used batteries together.
• not use different types of batteries together.
• Do not dispose the batteries in fire. Batteries may explode or leak.
• Remove batteries if the device is not likely to be used for some time.
• Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines.

Setting the Date and Time
It is important to set the date and time before using your blood pressure monitor for the first time, so that a correct time stamp can be assigned to each record that is stored in the memory.
(The setting range of the year: 2021—2050, Time format: 24H / 12H)

1. When the monitor is off, press “SET” button shortly, it will display the date format. Then press “SET” or “MEM” button to switch the date format.

2. Then press the “START/STOP” button to confirm the date format, and the year will flash. Press the “MEM” or “SET” button to change the year. Each press will increase the numeral by one in a cycling manner.
   Press and hold the “MEM” button to quickly advance the years.
   Press and hold the “SET” button to quickly go backwards through the years.

3. Press “START/STOP” button to confirm the year, then the month will flash. Repeat the same steps to change the month, day, time format, hour, and minute.

4. After confirming the minute, the LCD will display “do nE” and the monitor will shut off after several seconds.

About user ID

There is only one user ID available. The user has 90 memory spaces, and is designed for 1 person to save measured values.

MEASUREMENT

Tie the Cuff

1. Remove all jewelry, such as watches and bracelets from your left arm.Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm.
2. Roll or push up your sleeve to expose the skin.
3. Make sure your sleeve is not too tight. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.
4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.
5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart.  Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
6. Helpful tips for Patients, especially for Patients with Hypertension:
   • Rest for 5 minutes before first measurement .
   • Wait at least 3 minutes between measurements.
   • This allows your blood circulation to recover.
   • Take the measurement in a silent room.
   • The patient must relax as much as possible and do not move 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 arm, as directed by a physician.

Start the Measurement

1. When the monitor is off, press the “START/STOP” button, the LCD display will show shortly.
2. Remain still and do not talk until the full measurement is complete.
3. Press the “START/STOP” button to turn off the monitor, otherwise it will turn off after about 1 minute.

Recall the Records

1. When the monitor is off, press the “MEM” button, the lastest record will display.
2. Press “SET” or “MEN” button to find the record you want.

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 (90) is dropped.

DATA MANAGEMENT

Delete the Records
If you did not get the correct measurement, you can delete one record or all records by following steps below.

Delete one record:

1. Press the “MEM” button to enter the memory mode, then press the “MEM” or “SET” buton to find the record you want to delete. Then hold and press “START/STOP” button for about 3 seconds, the LCD will display and flash “dEL yES”.
2. Press the ‘SET’ or ‘MEM’ button to toggle between deleting this reading (dEL YES) or not (dEL no).
3. If you do wish to delete this reading, then press the “START/STOP” button when the screen is flashing “dEL YES”. This reading will disappear and the LCD will display “dEL donE”.

Delete all records:

1. Press the ‘MEM’ button to enter the memory mode, then press and hold the ‘SET’ button. The LCD will display and flash ‘dEL ALL’.
2. Press the ‘SET’ or ‘MEM’ button to toggle between deleting all readings (dEL ALL) or not (dEL no)
3. If you do wish to delete all memories, then press the “START/STOP” button when the screen is flashing “dEL ALL”. All the readings will disappear and the LCD will display “dEL donE”.
   After step 3 the right picture will show automatically. Press “START/STOP” button to turn off the monitor, otherwise it will turn off automatically after about 1 minute. Note: If you replace the batteries, all the records will disapear, and the LCD will display the same as the right picture.

INFORMATION FOR USER

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.

Maintenance

In order to get the best performance, please follow the instructions below .

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

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

CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Level

Blood

Pressure (mm Hg)

|

Optimal

|

Normal

|

High-normal

|

Mild

|

Moderate

|

Severe

---|---|---|---|---|---|---
SYS| <120| 120-129| 130-139| 140-159| 160-179| ≥180
DIA| <80| 80-84| 85-89| 90-99| 100-109| ≥110

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 heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
2. If the person takes medicine, the pressure will vary more. 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 arm? It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

TROUBLESHOOTING

No power

|

Display

will not light up.

| Batteries are exhausted.| Replace with new batteries
Batteries are inserted incorrectly.| Insert the batteries correctly
Low

battery

| Display is dim or show   __| Battery is low.| Replace with new batteries

Error message

| E 1 shows| The cuff is not secure or very tight.| Refasten the cuff and then measure again.

E 2 shows

| The monitor detected

motion,talking or the pluse is too poor while measuring.

| 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 arm and then measure again.

E 4 shows| The treatment of the measurement failed.| Relax for a moment and then measure again.
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.

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

SPECIFICATIONS

WARNING: No modification of this equipment is allowed.

CONTACT INFORMATION

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

Manufactured by : Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China
Authorized European Representative:
Company: Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany

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-1970, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description：

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

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

Conduced 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 prior to 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 communica- ti-ons equipment)

| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

385| 380-390| TETRA 400| Pulse modulation b) 18Hz| 1.8| 0.3| 27

450

|

430-470

| GMRS 460

FRS 460

| ，FM c) ± 5kHz deviation 1kHz

sine

|

2

|

0.3

|

28

710| 704-787| LTE Band 13,17| Pulse modulation b) 217Hz|

0.2

|

0.3

|

9

745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

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

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3,

4,25; UMTS

| Pulse modulation b) 217Hz| 2|

0.3

|

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
5240| 5100-

5800

| WLAN 802.11

a/n

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

Guangdong Transtek Medical Electronics Co., Ltd Zone A, No.105, Dongli Road, Torch Development
District, 528437 Zhongshan, Guangdong, China
EC REP Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany

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