TRANSTEK TMB-2276-BT Blood Pressure Monitor User Manual

TRANSTEK TMB-2276-BT Blood Pressure Monitor

Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2276-BT.
Please read the user manual carefully and thoroughtly to ensure the safe usage of this product, Keep the manual well for further reference in case you have problems.

INTRODUCTION

General Description
Thank you for selecting TRANSTEK blood pressure monitor (TMB-2276-BT). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The warranty period is two years. Readings taken by the TMB-2276-BT 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:

• 60 mm×71.5 mm Digital LCD with white backlight
• 2 × 199 memory storage, Guest mode available
• Up-to-date measuring-during-inflation technology

Indications for Use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from ¹⁄3 ¹⁄516cm to 36cm (about 6 ˝-14 ˝), 22cm to 32cm (about 8¾˝-12½˝), 22cm to 42cm (about 8¾˝-16½˝) or 22cm to 45cm (about 8¾˝-17¾˝).
It is intended for at least 3 years of age or older and indoor use only.

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.

Receiving and Inspecting your Monitor
Check that the device packaging has not been tampered with and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

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

Precaution

• This device is intended for indoor, home use and is not intended for self-use in public areas.
• 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 non-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.
• Consult with your physician before using this monitor if you suffer from the following conditions: common arrhythmias such as premature ventricular beats or atrial fibrillation; peripheral arterial disease; pregnancy; preeclampsia; implantation with electrical devices; undergoing intravascular therapy; arteriovenous shunt or mastectomy. Please note that any of these conditions may affect measurement readings, in addition to patient motion, trembling or shivering.
• Do not use this device for diagnosis or treatment of any health problems or diseases. Please consult with your physician first whether the blood pressure or pulse rate readings can be used as an input in determining clinical actions. Please note that clinical actions can only be determined by the physician, otherwise it may lead to delayed treatment or other dangerous situations.
• 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.
• 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.
• The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment.
• Do not wash the cuff in a washing machine or dishwasher !
• 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.
• Blood Pressure Monitor is intended for use by medical staffs and lay persons, and patient is also an intended user or operater.

Caution

• Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out byauthorized service centers.
• 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). Please contact manufacturer or distributor for authorized service personnel.
• Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
• Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
• Dispose of accessories, detachable parts, and the device according to the local guidelines.

Warning

• Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
• Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
• Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
• Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
• Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which 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 (for example, by observation of the limb concerned) that the operation of the device does not result in prolonged impairment of patient blood circulation.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure > 300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
• Do not use this device with high-frequency (HF) surgical equipment at the same time.
• This device is not used in conjunction with oxygen-rich environments, not intended for use with flammable anesthetics, not intended for use in conjunction with flammable agents.
• Do not touch output of the batteries/adapter and the user simultaneously.
• 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.
• Do not use this device if you are allergic to polyester, nylon, or plastic.
• Only use accessories approved by the manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
• 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.
• Do not use the device while under maintenance, or being serviced.
• The air tube poses a risk of strangulation. Furthermore, the small parts of product and batteries present a choking hazard if swallowed. They should therefore always be kept away from infants/children.
• Sensor degradation or looseness may reduce performance of device or cause other problems.

Notice

• You can use this device to take your measurement, no third-party operator is required.
• Adapter is specified as a part of ME EQUIPMENT.
• At the request of authorized service personnel, circuit diagrams, part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
• The expected lifetime of the cuff may vary by the frequency of washing, skin condition, and storage state.
• Please report to the manufacturer and the competent authority of the Member State / the FDA in which you are established about any serious incident that has occurred about this device.

LCD Display Signal

Monitor Components

BEFORE YOU START

Choice of Power Supply

1. Battery-powered mode: 6VDC 4*AAA batteries (Optional!)
2. AC adaptor powered mode: 5V 1A
   Please use the AC adaptor(Optional!) and Type-C cable(Optional!) just like the following picture:
   CAUTION To get the best effect and protect your monitor, please use the right battery and special power adaptor which complies with local safety standard.

Installing and Replacing the Batteries

• Slide off the battery cover.
• Install the batteries by matching the correct polarity, as shown.
• Replace the battery cover.

Replace the batteries whenever the below happens

• The bAt Lo shows
• The display is dim
• The display does not light up

CAUTION

• New and used batteries, or different types of batteries shall not be used together. Remove batteries if the device is not likely to be used for some time.
• Do not heat or deform the batteries, or dispose of them in fire.
• Batteries should not be disposed of with household waste.
• Please check with your local authority for battery recycling advice.

Setting Date, Time and Voice
It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year:2022—2052 time:24H/12H)

1. When the monitor is off, press and hold the “USER” button, it will display the bluetooth symbol ****first. No operation within 30s or Press the “START/STOP” button, it will skip Bluetooth pairing and enter the [Year] setting. Press the “USER” or “MEM” button to change the [YEAR]. Each press will increase or decrease the numeral by one in a cycling manner.
2. When you get the right year, press “START/STOP” button to set down and turn to next step. Then the date format will flash. Press the “MEM” or “USER” switch the date format between [month/day] and [day/month].
3. Press the “START/STOP” button to confirm the date format, then the [Month] will flash. Repeat the same steps to set the [Month] and [Day].
4. Repeat the same steps to set the time format between[24H] and [12H].
5. Repeat the same steps to set the [Hour] and [Minute].
6. After confirming the [Minute], it will enter the voice setting. Press the “MEM” or “USER” button to change the vocie volume.
7. After confirming the voice setting, the LCD will display all the settings you have done, and then it will display “do nE” and the device will turn off automatically.

Pair a smart device with the monitor
You are the intended operator of this blood pressure monitor. You can measure your blood pressure and then save and send measurement data to a smart device (such as smartphone or tablet) with Bluetooth wireless connectivity.

1. Turn on Bluetooth and the app on your smart device. Make sure both are ON when the pair-up is proceeding.
2. When the monitor is off, press and hold the “START/STOP” button to start pair-up, the bluetooth symbol ****will flash.
3. If successful, the bluetooth symbol ****will not flash anymore and the monitor will display “do nE”, and then it will shut off after about several seconds automatically.

Note:

1. The date and time on your monitor will automatically be set after paired with your smart device successfully.
2. The device can also enter the Bluetooth pairing automatically when the battery is installed for the first time.

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

Specifications for Bluetooth Transmission

Bluetooth| Throughput| 2.5K-5K
Latency| 50ms
Error Rate| 0 when≥-70dBm
Operating Frequency| 2402-2480MHz
Transmission Power| same as report
Transmission Distance| 10m
Note:

1. The necessary Quality of Service (QoS) is fully considered here for wirelessly enabled functions.

2. Interference may occur in the vicinity of equipment marked with the following symbol. And TMB-2276-BT may interfere the vicinal electrical equipment.

3. Keep the monitor at least 20 centimeters away from the human body (especially the head) when data transmission is proceeding after measurement.

4. To enable the data transmission function, this device shall be paired to an appropriate BT mobile terminal.

Warning
About a wireless communication interference
The monitor operates in the unlicensed ISM band at 2.4 GHz. In case it is used around the other wireless devices including microwave and wireless LAN, which operate at the same frequency band as the monitor, there is a possibility that interference occurs between the monitor and such other devices. If such interference occurs, please stop the operation of other devices or relocate the monitor before using it or do not use it around the other wireless devices.

List of compatible devices:

• For iOS devices:
  The operating system must be iOS 13.0 or more.

• For Android devices:
  The operating system must be Android 5.0 or more.

Select the User
There are 3 user ID available. The user and , each with 199 memory spaces, are designed for 2 different people to save the measured values separately. The user , no memory space, is reserved for guests.

1. When the monitor is off, press the “USER ” button to enter user setting mode. The user ID will blink. Press the “USER” button again to switch the user ID among the user , and ****.
2. Press the “START/STOP” button to confirm the selected user ID, it will enter the measurement automatically.

MEASUREMENT

Applying the cuff
Only use a cuff that has been approved by the manufacturer for this device model. Before use, please confirm if it fits your arm circumference.

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. Make sure your sleeve is not too tight.

3. Hold your arm with your palm facing up and tie the cuff on your upper arm, align the Artery indicator with 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, that is your main Artery！

4. Make sure the bottom edge of the arm cuff 2 to 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:

   • Measure a silent room.
   • Rest for 5 minutes before a measurement.
   • Wait at least 3 minutes before another measurement. This allows your blood circulation to recover. Be relaxed and do not move and talk during the measurement procedure.
   • 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.

Start the Measurement

1. When the monitor is off, press “START/STOP” button to turn on the monitor, and it will finish the whole measurement.
   If the voice is on, it will speak “ Starting measurement, please remain still and quiet” first, and then complete the measurement process.
   (Take User 1 with vocie for example)
   Note: Any time, to stop the measurement, press the “START/STOP” button. If you don’t pair with the device or don’t keep the app ON, the bluetooth symbol ****will flash during the measurement.

2. Press “START/STOP” button to power off, otherwise it will turn off within 1 minute.

3. If your monitor is already paired with your smart device and both Bluetooth and app are ON, when the measurement completed, the measurement result will start transmitting. (only user 1 and 2 available)

   • If successful , the symbol “ ” will disappear first , after sevral seconds, “ ” will also disappear, and then the monitor will turn off automatically.
   • If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. In the case of a data transmission failure, up to 199 measurements are saved on the device and will be sent when a successful connection is achieved.

4. About the irregular pulse rate and excessive body motion during the measurement.

5. During a measurement, If an irregular pulse rate is detected, the symbol ****will display in the measurement result. See page 24 for more information.

6. During a measurement, when the excessive body motion, especially of the arm the cuff is worn is detected, the symbol will flash about 5 seconds and detect again. If it is no longer detected, the symbol will disappear; If still detected, the symbol will final display in the measurement result.
   Note: The measured blood pressure reading may not be accurate if this symbol is displayed.

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, press the “MEM” button to display the average value of last 3 readings. If the records are less than 3 groups, it will display the latest record instead.
   ( Take user 1 for example.)
   Note：

2. If the voice is on, it will broadcast the value for you.

3. When you pass the limit, every time you recall the records, the monitor will display “FULL” along with the group number “199”.

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

Note: If there is untransmitted data, the symbol ****and will display on the record. The latest record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (199) will be dropped from the list.

Delete the Records
Delete the records by following the steps below.
A: Delete one record (Example shown below for User 1)

1. Enter the memory recall mode as described in the previous section “Recall the records”, find out the record you want to delete.
2. Press and hold the “START/STOP” button about 3 seconds, the LCD will display “dELy” and blink.
3. Press the “START/STOP” button to confirm the deletion, the LCD will display “donE” and then the previous record will be displayed.

B: Delete all records (Example shown below for User 1)

1. Enter the memory recall mode as described in the previous section “Recall the records”.
2. Press and hold the “MEM” and “USER” button about 3 seconds, the LCD will display “dELAL”and blink.
3. Press the “START/STOP” button to confirm the deletion, the LCD will display “donE”. Several seconds later, it will display “—”.

INFORMATION FOR USER

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

Maintenance
To get the best performance, please follow the instructions below.

1. Cleaning Process:

   • Step 1: Make sure to switch off and unplug the device before cleaning.
   • Step 2: Use a soft cloth wetted with soapy water to clean the cuff first, and then use a soft cloth wetted with clear water to remove residual soap until there is no visible residual contaminants. Attention shall be paid to avoid liquid invasion into the cuff.
   • Step 3: Use a dry soft cloth to wipe the cuff, to remove residual moisture.
     Step 4: Dry the cuff at a well-ventilated place after cleaning.

2. Disinfection Process:

   • Step 1: Make sure to switch off and unplug the device before disinfection.
   • Step 2: Use a soft cloth wetted with 70% isopropanol to disinfect the cuff for about 3 minutes. Attention shall be paid to avoid liquid invasion into the cuff.
   • Step 3: Use a clean dry cloth or towel to wipe off the disinfectant until there is no visible residue.
   • Step 4: Dry the cuff at a well-ventilated place after disinfection.

Suggestion:

• Frequency of Cleaning and Disinfection:
  • For single patient multiple use, it’s recommended to clean the device surface once a month or whenever it’s necessary.
  • For multiple patients multiple use, it’s recommended to clean the device every time before and after usage. Maintenance procedures shall be taken as per instruction.

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 the World Health Organization (WHO) and the 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.

Irregular Pulse Rate Detector
An irregular pulse rate will be detected if there is an irregular pulse rhythm while measuring systolic and diastolic blood pressure. When measurements are performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average value, the irregular pulse symbol will be displayed along with measurement results.

CAUTION The appearance of the IPR icon indicates that a pulse irregularity consistent with an irregular pulse rate 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 irregular pulse rate detector only serves as a non-medical feature, and the results cannot be used directly for clinical judgment. Please seek medical advice from professionals before making any medical decisions.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please measure the same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

Is the result the same if measuring on the right 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

If any abnormality arises during use, please check the following points:

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

SPECIFICATIONS

pressure:

SYS: 60 mmHg ~ 230 mmHg

DIA: 40 mmHg ~ 130 mmHg

Pulse value: (40-199) beat/minute

Accuracy| Static Pressure: 5℃-40℃ within ±3mmHg Pulse value: ±5%

Clinical validation: Mean difference within ±5mmHg;

Standard deviation ≤8mmHg

Normal working condition| A temperature range of: +5°C to +40°C A relative humidity range of 15% to 90%,

non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa

An atmospheric pressure range of 700 hPa to 1060 hPa

Storage & transportation condition| Temperature:-20°C to +60°C

A relative humidity range of ≤ 93%, non-condensing,

at a water vapour pressure up to 50 hPa

An atmospheric pressure range of 500 hPa to 1060 hPa

Measurement perimeter of the upper arm| About 16-36 cm or 22-32 cm or 22-42 cm or 22-45cm
Degree of protection| Type BF applied part
Protection against ingress of water| IP21 It means the device could be protected against solid foreign objects of 12,5mm Ф and greater, and against vertically falling water drops.
Device Classification| Battery Powered Mode:

Internally Powered ME Equipment

AC Adapter Powered Mode: Class II ME Equipment

Expected Lifetime| Device: 3 years or 30,000 measurements (may vary

based on usage conditions)

Cuff: 10000 times

Alkaline battery: About 200-300 times

Types of use/reuse| Multiple patient multiple use

WARNING: No modification of this equipment is allowed.

Authorized Component
Please use the authorized adapter (Optional!).

Contact Information
For more information about our products, please visit www.transtekcorp.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

**EMC Guidance

**

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.

Essential performance:
Accuracy of measuring blood pressure and pulse rate

Measurement Range| Systolic pressure: 60-230 mmHg Diastolic pressure: 40-130 mmHg Pulse: 40-199 beats/minute
---|---
Rated Cuff Pressure| 0-299 mmHg (0-39.9 kPa)
Accuracy| Static Pressure: 5℃-40℃ within ±3mmHg Pulse value: ±5%

Clinical validation: Mean difference within ±5mmHg;

Standard deviation ≤8mmHg

The Basis Safety of the Blood Pressure Monitor (TMB-2276-BT) is as follows:

• Deviation from a normal operation that poses an unacceptable risk to the patient or operator.
• 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 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 about electromagnetic disturbances for the expected lifetime.
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 Not Applicable

100 kHz repetition frequency

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

±0.5 kV, ±1 kV, ±2 kV common mode

| ±0.5 kV, ±1 kV differential mode Not Applicable
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

FCC Statement

FCC ID: OU9TMB2276BT
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.

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

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

RF Exposure Compliance
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.

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

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