TRANSTEK TMB-2092-G Pro Cellular Blood Pressure Monitor User Manual

TRANSTEK TMB-2092-G Pro Cellular Blood Pressure Monitor

INTRODUCTION

General Description
Thank you for choosing this arm type Pro Cellular Blood Pressure Monitor (TMB-2092-G). It is equipped with the following key features. Please read this manual to know how to use your Blood Pressure Monitor safely and correctly. Keep the manual well for future reference.

Indications for Use
This Pro Cellular Blood Pressure Monitor TMB-2092-G is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 to 42 cm (or 22 to 45 cm). It is intended for adult.

Contraindications

1.  The device is not suitable for use on neonates, infants, or children.
2.  The effectiveness of this device has not been eatablished in pregnant,including pre-eclamptic, patients.

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.

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

• This device is intended for indoor use.

• This device is portable, but it is not intended for use during patient transport.

• This device is not suitable for continuous monitoring during medical emergencies or operations.

• 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 any purpose other than obtaining a blood pressure measurement.

• This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.

• The effectiveness of this device has not been established for use:

  •  on the women in pregnant, including pre-eclamptic, patients,
  • on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators,
  • on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
  • on users with peripheral arterial disease,
  • on users undergoing intravascular therapy, or with arteriovenous (AV) shunt.
  • Consult a medical professional before use.

• Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.

•  If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.

•  This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.

•  Report any unexpected operation or events to the manufacturer.

•  Warming: Do not kink,fold,stretch,compress,or otherwise deform the tube during measuring, as the cuff

•  Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
  pressure might continuously increase, which could prevent blood flow and result injury.

•  Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.

•  Do not place the cuff on the arm on the same side of a mastectomy(especially when lymph nodes have been removed).it is recommended to take measurements on the unaffected side.

•  Do not wrap the cuff on the same arm to which another monitoring device is applied.One or both devices could temporarily stop functioning if you try to use them at the same time.

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

•  Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.

•  Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.

•  The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

•  Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations,walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.

•  You can use this device to take your own measurement, no third-party operator is required.

• Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

• The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.

• Warning: Do not touch output of the batteries/adapter and the user simultaneously.

• Adapter is specified as a part of ME EQUIPMENT.

• Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains.Do not position the equipment so that it is difficult to reach or disconnect.

• Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.

• Warning: Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.

• Warning: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.

• No calibration is required within two years of reliable service.

• Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.

• At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.

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

• Warning: Do not use the device while under maintenance, or being serviced.

• Make sure the rubber tube of the cuff is not squeezed,stretched,or kinked during storage.

• Warning:Keep the device,cuff,and batteries away from children as they may pose a risk of choking or strangulation if used improperly.

• Do not use alcohol, benzene, or other harsh chemicals. Do not wash teh 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.

• Dispose of accessories, detachable parts, and the device according to the local guidelines.

Display and Symbols

4

| **| Heartbeat icon**

Flashes when detected during the measurement.

5| warning messages, refer to page 22 for more information.

6

| **| Measurement reminder icon**

When it is activated, appear on the display and remind the user to measure at the certain time.

7

| **| Triple Measurement icon**

Indicates the current measurement mode is [Triple Mode], and which measurement progress                        it is.

8

| **| Cuff wearing detection icon**

will appear if the cuff is not wrapped or wrapped too loose when measuring.

9

| **| Cuff abnormal icon**

Appears when the air connector plug is not properly plugged in or a leak of the cuff is detected.

10

| ****

| Excessive body motion detector icon

Appears when talking, moving, or shaking of the arm with the cuff on is detected during a measurement.

NOTE: The measured blood pressure reading may not be accurate when this symbol is displayed with the reading.

11

| **| SIM card error icon**

Appears when the SIM card is abnormal or the SIM is not properly plugged in.

12

| **| Data pending to transmit icon**

Appears when the data transmission failed. Up to 500 measurements can be temporarily saved on the device and send to your account when the Cellular internet is available.

13

| **| Signal indication icon**

Indicates no cellular coverage or cellular connection error.

14| **| Adapter Insert Indicator**

Appears when the power is supplied from the adapter.

15

| **| Battery Indicator**

Indicate the current battery.

 | Low battery symbol

Indicate the battery is too low when appears with .

Name of Each Part

Contents/Product Includes

1. Pro Cellular Blood Pressure Monitor (TMB-2092-G) 1 Cuff (Type BF applied part)
   •  Upper arm circumference: 22-45 cm
   • Upper arm circumference: 22-42 cm (optional) 1 User Manual
   • 1 Quick Start Guide
   • 4 “AA” size batteries
   • 1 AC Adapter ( BLJ06L060100P-U) (optional)

BEFORE YOU START

The Choice of Power Supply

1.  DC 6V, 4 AA size batteries
2.  AC adapter, 6V 1A

Please use the AC adapter authorized by the manufacturer! Please unplug the adapter to depart from the using utility power, when you finish the measurement.

Installing and Replacing the Batteries

• Slide off the battery cover..
• Install or replace 4 AA size batteries according to the polarity indications inside the battery compartment.
• Place back the battery cover.

Replace the batteries whenever the below happens • appear on the LCD display.

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.

Note A:
When you insert or replace batteries into the device, the LCD displays as below first, and then it will turn off after about 5 seconds.
The device will then search and pair with the mobile network automatically after it is turned off. If unsuccessful, the monitor will stop searching and enter the standby mode.

Note B:
This device is equipped with function of Measurement Reminder. Contact Customer Support to enable or disable it, maximum 5 group of measurement Reminder (by default, it is disabled).
Once enabled, every day when the appointment time is reached, the blue LED of the device button will light up in the form of breathing light to remind the user to measure, and the breathing light will be cancelled after the startup or 30 minutes without operation. (If the user does not measure the blood pressure according to the reminder, the reminder icon of measurement will not be displayed when the user starts the measurement next time)

MEASUREMENT

Applying 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 youre right arm.

2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.

3. Hold your arm with palm facing up and tie the cuff on your upper arm, then align the air tube toward the center of your arm.

4. Make sure the bottom edge of the arm cuff
   1 inch (2-3 cm) above the inside elbow. Then wrap the cuff securely.
   Note: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 upright in a comfortable chair with your back against the backrest of the chair. Keep your feet flat and your legs uncrossed.
   Place your arm resting comfortably on a flat table. The cuff worn on your arm should be placed at the same level as your right atrium of the heart.

6.  Take 5-6 deep breaths and let’s start measuring!

Helpful tips to help ensure an accurate reading

Take the measurement in a silent room.
Rest for 5 minutes before a measurement.
Be relaxed, Remain still and DO NOT talk while taking a measurement.
For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

A: Using Single Measurement Mode

Start a measurement
When the “TRIPLE MODE” button is located on “OFF”, the monitor is under the Single Measurement mode. When the monitor is OFF, press the “START/STOP” button to turn on, and then it will complete the whole measurement automatically.

1. After the measurement, the data transmission starts. The symbol will appear on the LCD.
   If successful, the symbol the LCD will display “

2. Press the ”START/STOP” button to turn off the device, otherwise it will power off automatically within several seconds

3. During the data transmission, If the data transmission error or server connection error occurs, The symbol will appear on the LCD. Refer to page 22 for more information.

4. During the data transmission, If no cellular coverage or cellular connection error occurs, The symbol will appear on the LCD. Refer to page 22 for more information.

B: Using Triple Measurement Mode
When the “TRIPLE MODE” buton is located on “ON”, the monitor is under the Triple Measurement mode.

1. When the monitor is off , press the “START/STOP” button to turn on, and then it will complete the whole measurement automatically.

2. When the first measurement is done, it won’t show the readings. It will start the second measurement after 60 seconds.

3.  Then it will repeat the steps to finish the third measurement. When three measurements are done, the LCD will display the average of 3 readings.
   Tip:
   If the measurement fails in the process of 3 munimes, it will report an error and repeat the current measurement. If the error
   occurs for 2 times in a row, the mode of 3 times measurement will be automatically quit.

4.  After the measurement, it will repeat the data transmission steps as described on pape 14.

Tip:
You can press the “START/ STOP” button to stop the measurement any time.

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 following chart is the standard blood pressure classificatio n published by American Heart Association (AHA). This chart reflects blood pressure categories defined by American Heart Association.
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| Systolic mmHg (upper#)|  | Diastolic mmHg (lower#)
Normal| less than 120| and| less than 80
Elevated| 120-129| and| less than 80
High Blood Pressure (Hypertension) Stage 1|

130-139

|

or

|

80-89

High Blood Pressure (Hypertension) Stage 2|

140 or higher

|

or

|

90 or higher

Hypertensive Crisis (Consult your doctor immediately)|

Higher than 180

|

and/or

|

Higher than 120

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 peease 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 different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather,emotion,exercise etc.Also,there is the “white coat”effect,which means blood pressure usually increases in clinical settings.
What you need to pay attention to when you measure your blood pressure at home:

• If the cuff is tied properly.
• If the cuff is too tight or too loose.
• If the cuff is tied on the upper arm.
• If you feel anxious.
• Taking 2-3 deep breaths before beginning will be better for measuring.
• Advice: Relax yourself for 4-5 minutes until you calm down.
• 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 can not light up.

| Batteries are exhausted.| Replace with new batteries.
Batteries are installed incorrectly or Adapter is not plugged in properly.|

Install the batteries or plug in the adapter properly.

High Battery|  | The DC supply voltage is too high or too low.| Replace with the authorized adapter.
Low Battery|  |

The battery is too low.

|

Replace with new batteries.

Error message

|  | The cuff is not wrapped or wrapped too loose.| Wrap and fasten the cuff and measure again.
 | The air connector plug is not properly plugged in or a leak is detected.| Insert the air tube plug correctly,

then measure again. If the issue persists，check the cuff leakage.

| Excessive body motion (such as shaking of the arm with the cuff on) is detected.| Relax and then measure again. When the issue persists twice,

will display on the LCD, please contact customer support.

| Pulse is not detected during measuring.| Relax and then measure again. When the issue persists twice,

will display on the LCD, please contact customer support

or contact your physician.

| Out of measurement range
 | Data transmission error or Server connection error| Move to another area, preferably closer to a window, try again. Use the device at a location where you get strong cellular signal with your mobile phone. If the issue persists, contact customer support.
 |

No cellular coverage or Cellular connection error

 |

SIM card is not detected or SIM card is abnormal.

| Check and re-install the SIM card. If the issue persists, contact customer support.
 |

Hardware error

| Retake measurement. If the issue persists, contact customer support.

SPECIFICATIONS

Measurement range

| Rated cuff pressure:0mmHg~299mmHg Measurement pressure:

SYS: 60 mmHg ~ 230 mmHg

DIA: 40 mmHg ~ 130 mmHg Pulse value: (40-199) beat/minute

Accuracy

| Pressure: 5°C-40°C within ±3 mmHg Pulse value: ±5%

Normal working condition

| Temperature: +5°C to +40°C

Relative humidity: 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa

Atmospheric pressure: 700 hPa to 1060 hPa

Storage condition & transportation condition

| Temperature: -20°C to +60°C

Relative humidity: ≤93%, non-condensing, at a water vapour pressure up to 50 hPa

Measurement perimeter of the upper arm|

About 22-42 cm or 22-45 cm

Degree of protection| Type BF applied part

Device Classification

| Battery Powered Mode:

Internally Powered ME Equipment

AC Adaptor Powered Mode: Class II ME Equipment

Protection against ingress of water

| IP21, It means the device could protected against solid foreign objects of 12.5 mm and greater, and protect against vertically falling water drops.

Expected Lifetime

| 5 years or 10,000 measurements (may vary based on usage conditions)

WARNING: No modification of this equipment is allowed.

AUTHORIZED COMPONENT
Please use the authorized adapter

• Adapter
• Type: BLJ06L060100P-U
• Input: 100-240V, 50-60Hz, 0.2A max Output: 6V 1000 mA

CONTACT INFORMATION
For more information about our products, please visit www.transtekcorp.com. Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China

EMC GUIDANCE

• The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for
• magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning: Use of this equipment adjacent to or stacked with other equipment should
• be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased
• electromagnetic immunity of this equipment and result in improper operation.
• Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment
• TMB-2092-G including cables specified by t he 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| Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3| Comply

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, ±4 kV, ±8 kV, ±15 kV air

| ****

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| ±2 kV for power supply lines NA

100 kHz repetition frequency

Surge IEC61000-4-5| ±0.5 kV, ±1 kV, differential mode

±0.5 kV, ±1 kV, ±2 kV common mode

| ****

N/A

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

IEC 61000-4-11

| ****

0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°.

0% UT; 1 cycle and 70% UT ; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

| 0% UT; 0,5 cycle. At 0°, 45°,

90°, 135°,

180°, 225°, 270° and 315°.

0% UT; 1 cycle and 70% UT ; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

Power frequency magnetic field IEC 61000-4-8| ****

30 A/m

50 Hz / 60 Hz

| ****

30 A/m

50 Hz / 60 Hz

Conduced RF IEC61000-4-6

| ****

3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz

80% AM at 1 kHz

| ****

3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz

80% AM at 1 kHz

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

communicati- ons

equipment)

|

Test Frequency (MHz)

|

Band (MHz)

|

Service

|

Modulation

|

Maximum Power (W)

|

Distance(m)

| IEC 60601-1-2

Test Level

(V/m)

|

Compliance level (V/m)

385

|

380-390

|

TETRA 400

| Pulse modulation 18 Hz|

1.8

|

0.3

|

27

|

27

450

|

430-470

|

GMRS 460,

FRS 460

| FM ± 5k Hz

deviation 1 kHz sine

|

2

|

0.3

|

28

|

28

710|

704-787

| LTE Band 13,

17

| Pulse modulation 217 Hz|

0.2

|

0.3

|

9

|

9

745
780

810

|

800-960

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

|

Pulse modulation 18 Hz

|

2

|

0.3

|

28

|

28

870

930

1720

|

1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3, 4,25; UMTS

|

Pulse modulation 217 Hz

|

2

|

0.3

|

28

|

28

1845

1970

2450

|

2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

|

Pulse modulation 217 Hz

|

2

|

0.3

|

28

|

28

5240|

5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz|

0.2

|

0.3

|

9

|

9

5500
5785

FCC Statement

FCC ID: OU9TMB2092-G
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.

FCC Radiation Exposure Statement:
To maintain compliance with FCC’s RF Exposure guidelines, this equipment should be installed and operated with minimum distance between 20cm the radiator your body: Use only the supplied antenna.

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