FCC ID: OU9-TMB2287B Blood pressure monitor

Version:A/0 User Manual Blood Pressure Monitor Model:TMB-2287-B Arm Type MEMORY TIME/DATE Pul/min Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2287-B. Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. CATALOGUE Table of Contents INTRODUCTION..................................................................................................................2 General Description Indications for Use Measurement Principle Receiving and Inspecting your Monitor Safety Information LCD Display Signal Monitor Components List Choice of Power Supply Installing and Replacing the Batteries Setting Date and Time Pair a smart device with the monitor Setting a user ID BEFORE YOU START..........................................................................................................8 MEASUREMENT................................................................................................................15 Applying the cuff Start the Measurement DATA MANAGEMENT........................................................................................................19 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................22 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................24 What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

Irregular pulse rate 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 arm?

TROUBLESHOOTING.......................................................................................................26 SPECIFICATIONS..............................................................................................................27 AUTHORIZED COMPONENT ...........................................................................................28 CONTACT INFORMATION.................................................................................................28 EMC GUIDANCE................................................................................................................29 FCC STATEMENT...............................................................................................................33

INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK blood pressure Monitor (TMB-2287-B). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The warranty period is two years. Readings taken by the TMB-2287-B 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:

60.5 mm92.5 mm Digital LCD display Maximum 199 records per user 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

It is intended for adult 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 airpressure. 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. Recyclable Direct Current Type BF applied part Serial Number Date of manufacture Manufacturer For indoor use only Class II Equipment Consult instructions for use or consult electronic instructions for use Batch code Refer to instruction manual/booklet To signify that the instruction manual/ booklet must be read. Note: The background color of the symbol is blue MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling.

INTRODUCTION INTRODUCTION 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. Do not use it on children and adolescents unless otherwise instructed by a medical professional.

* 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

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

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

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

* 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.

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

discolored skin.

* This device is not used in conjunction with oxygen rich environments, not intended for use with flammable anaesthetics, 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 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 own 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, component 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 in relation to this device.

INTRODUCTION LCD display signal MEMORY START STOP TIME/DATE Pul/min SYMBOL Pul/min bAt Lo +

EXPLANATION DESCRIPTION Systolic blood pressure High blood pressure Diastolic blood pressure Low blood pressure Pulse display Pulse in beats per minute Deflation symbol Memory Cuff wearing mmHg Low battery Irregular pulse rate Blood pressure level indicator Current Time User A/User B Excessive body motion detector Pulse rate The average value Bluetooth icon The cuff is deflating. Indicate it is in the memory mode and which group of memory it is. The cuff is secured. Measurement Unit of the blood pressure Batteries are low and need to be replaced. Blood pressure monitor is detecting an irregular pulse rate during measurement. Indicate the blood pressure level. Year/Month/Day, Hour/Minute Start measurement and save the measuring results for User A/User B Appears when talking, moving, or shaking of the arm with the cuff on is detected during a measurement. Blood pressure monitor is detecting a pulse rate during measurement. The average value of the latest three records. Indicate the bluetooth is working. INTRODUCTION Monitor Components CUFF AIR HOSE AIR CONNECTOR PLUG TIME/DATE Pul/min LCD DISPLAY MEMORY USER BUTTON TYPE-C PORT MEM BUTTON SET BUTTON STARTSTOP BUTTON BATTERY COMPARTMENT List 1. Blood Pressure Monitor

MEMORY TIME/DATE Pul/min 2. Cuff Upper arm cuff:22-32cm or Upper arm cuff:22-42cm or Upper arm cuff:22-45cm or Upper arm cuff:40-52cm. 3. 4AAA batteries

4. User manual

Data transmitting Data is transmitting.

BEFORE YOU START BEFORE YOU START Choice of Power Supply 1.Battery powered mode:

6VDC 4AAA batteries 2.AC adaptor powered mode:

5V 1A

(Please use the AC adapter which is

Please unplug the adaptor to depart from the using utility power. TIME/DATE TIME/DATE MEMORY AC adapter TIME/DATE Pul/min Pul/min STO Pul/min Type-C cable CAUTION In order to get the best effect and protect your monitor,please use the the right batteries and special power adapter which complies with local safety standard. Installing and Replacing the Batteries Open the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the battery cover. Setting Date and Time 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 :2023-2053 time format:12H/24H) 1.When the monitor is off, press and hold the SET button, it will display the bluetooth symbol first. No operation within 60s or Press STARTSTOP button, it will skip Bluetooth pairing and enter the [Year] setting. 2.Press MEM or SET button to change the [Year]. Each press will increase or decrease the numeral by one in a cycling manner. Replace the batteries whenever the below happens bAt Lo +

The 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.

BEFORE YOU START BEFORE YOU START BEFORE YOU START 3. When you get the right year, press STARTSTOP button to set down and turn to next step. Repeat the same steps to set the date format between

[month/day] and [day/month]. 5.Repeat the same steps to set the time format between 24H and 12H. 4.Repeat the same steps to set the [Month] and [Day]. 6.Repeat the same steps to set the [Hour] and [Minute]. 7.After the [Minute] is set,the LCD will display do nE, and then it will turn off automatically.

BEFORE YOU START BEFORE YOU START 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

connectivity. 1. Turn on Bluetooth and the app on your smart device. Make sure both are ON when pair-up is proceeding. 2. When the monitor is off, press and hold the MEM button to start pair-upthe bluetooth symbol will flash. 3. If successful, the bluetooth symbol will not flash any more 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. Bluetooth Specifications for Bluetooth Transmission Throughput 2.5K-5K 50ms Latency

Error Rate 2402-2480MHz Operating Frequency Transmission Power

Transmission Distance 10m Note:

functions. 2. Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-2287-B may interfere the vicinal electrical equipment. 3. Keep the monitor at least 20 centimeters away from the human body (especially the

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.

BEFORE YOU START Setting a user ID There are 2 user ID available. The user and , each with 199 memory spaces, are designed for 2 different people to save the measured values separately. 1.When the monitor is off, Switch USER button to select the user ID between the user and . 2. Press STARTSTOP button to confirm the selected user ID, the monitor will enter the measurement automatically. Press MEM button to confirm the selected user ID, the monitor will enter the memory query automatically. Note:

You can select User A or User B by switching the USER button during the process of measurement or when it is in the memory mode. 5. 6. 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. MEASUREMENT 2. 3. 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. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. 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 2~3cm 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. 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. Take 5-6 deep breaths and let's start measuring!

Helpful tips:

Take the measurement in 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.

MEASUREMENT MEASUREMENT Start the Measurement 1.When the monitor is off, press STARTSTOP button to turn on the monitor,

Adjust the zero MEMORY Cuff wrap detection MEMORY MEASUREMENT Note:

Any time, to stop the measurement, press STARTSTOP button. If you dont pair with the device or dont keep the app ON, the bluetooth symbol will flash during the measurement. 3. If your monitor is already paired with your smart device and both Bluetooth and app are ON, when the measurement completed, the measurement

If successful, the symbol will disappear first , after sevral seconds, will also disappear, and then the monitor will turn off automatically MEMORY S S TIME/DATE Pul/min TIME/DATE Pul/min Inflating and measuring MEMORY Display and save the measurement result MEMORY S S TIME/DATE Pul/min 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. TIME/DATE Pul/min TIME/DATE Pul/min 2.Press STARTSTOP button to power off, otherwise it will turn off within 1 minute. START STOP

MEASUREMENT DATA MANAGEMENT 4. About the irregular pulse rate and excessive body motion during the measurement. During a measurement, If an irregular pulse rate is detected, the symbol will display in the measurement result. See page 24 for more information. During a measurement, when the excessive body motion, 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. MEMORY Recall the Records 1. When the monitor is off, press MEM button, the user ID will blink. 2. 3. You can switch USER button to select the user ID between user and . press STARTSTOP button to confirm the selected user ID. Then the LCD will display the average value of last 3 readings. When the records are less than three groups, it will display the latest record.

4. Press MEM or SET button to display the next record. MEMORY MEMORY TIME/DATE Pul/min

TIME/DATE Pul/min TIME/DATE Pul/min Date and Time will display alternately. The current record is Group 1. The corresponding year is 2023. The corresponding date is January 1st. The corresponding

Note If there is untransmitted data, the symbol and will display on the record.

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

DATA MANAGEMENT DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete results by following steps below. A: To delete a single measurement:

1. Enter the memory recall mode as described in section [Recall the Records]. Pres MEM or SET button to get the measurement you would like to erase. 2. Press and hold MEM button for about 5 seconds, and the display will show a blinking dEL y. 3. Use MEM or SET button to switch between dEL y and dEL no, Press STARTSTOP to confirm the selection. If dEL y is selected, the LCD will display do nE, and then the previous record will be displayed. If dEL no is selected, it will stop the deletion. B: To delete all measurements:

1. Enter the memory recall mode as described in section [Recall the Records]. 2. Press and hold MEM and SET button button for 5 seconds, and the display will show a blinking dEL AL along with the user ID. 3. Use MEM or SET button to switch between dEL AL and dEL no, Press START/STOP to confirm the selection. If dEL AL is selected, the LCD will display do nE , and delete all the record of the current user. Several seconds later, it will display ---. If dEL no is selected, it will stop the deletion. dEL AL blinks dEL no blinks dEL y blinks dEL no blinks Deletion is done

Deletion is done No record INFORMATION FOR USER 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. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine 1. Cleaning Process:

Step 1: Make sure to switch off and unplug the device prior to 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, in order 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 prior to disinfection. Step 2: Use a soft cloth wetted with 70% isopropanol to disinfect the cuff for about 10 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, its recommended to clean the device surface once a month or whenever its necessary. For multiple patient multiple use, its 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. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification?

The blood pressure classification published by

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

SYS DIA Optimal Normal High-normal Mild Moderate Severe

<120 120-129 130-139 140-159 160-179

<80 80-84 85-89 90-99 100-109

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 were 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 judgement. Please seek medical advice from professionals before making any medical decisions.

ABOUT BLOOD PRESSURE Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. 2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home 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. 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.

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

PROBLEM SYMPTOM CHECK THIS REMEDY No power Display can not light up. Batteries are depleted. Replace with new batteries. Batteries are inserted incorrectly. Adapter is inserted incorrectly. Insert the batteries correctly. Insert the AC adapter correctly. High Battery bAt H shows The battery is too high. Replace with new batteries. The battery is too low. Replace with new batteries. Low Battery Error message bAt Lo &

shows E 1 shows E 2 or shows E 3 shows E 4 shows The cuff is not wrapped or wrapped incorrectly, or the cuff air plug is loose. Excessive body motion

(such as shaking of the

or weak pulse is detected. Pulse is not detected during measuring. The measurement failed. EEx shows Hardware error

(X can be some digital symbol, such as1, 2,

USb Err shows The voltage of the adapter is too high or too low. Warning message out shows Out of measurement range Refasten the cuff and insert air tube plug correctly then measure again. Relax for 5 minutes. and then keep still, measure again. Loosen the clothing on the arm and measure again. Relax for 5 minutes and measure again. Turn off monitor and measure again. If EEx still appears on the display, please contact the retailer or our customer service. Replace with the authorized adapter. Relax for a moment and then measure again. If the problem persists, contact your physician. Power supply Battery powered mode: 6VDC 4*AAA batteries AC adaptor powered mode:

(Please use the AC adapter which is authorized

5V 1A Display mode Digital LCD V.A.60.5 mm 92.5 mm Measurement mode Oscillographic testing mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Net Weight External dimensions Mode of operation Degree of protection Protection against ingress of water Device Classification Software Version Expected Lifetime Rated cuff pressure: 0mmHg~299mmHg Measurement pressure:

SYS: 60mmHg~230mmHg DIA: 40mmHg~130mmHg

Static Pressure: 5-40 within 3mmHg Pulse value: 5%

Clinical validation: Mean difference within 5mmHg;

A temperature range of: +5C to +40C A relative humidity range of 15% to 90%, non-condensing, but notrequiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of 700 hPa to 1060 hPa Temperature:-20C to +60C

at a water vapour pressure up to 50 hPa An atmospheric pressure range of 500 hPa to 1060 hPa About 22cm-32cm or 22cm-42cm or 22cm-45cm or 40cm-52cm

Approx.140mm130mm55.6mm Continuous operation Type BF applied part IP21 It means the device could be protected against

against vertically falling water drops. Battery Powered Mode:

Internally Powered ME Equipment AC Adaptor Powered Mode:

Class II ME Equipment A01 Device: 3 years or 30,000 measurements (may vary

Cuff: 10000 times Alkaline battery: About 200-300 times Multiple patient multiple use 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.

Types of use/reuse WARNING: No modification of this equipment is allowed.

AUTHORIZED COMPONENT Authorized Component

Adapter Type: BLJ06L050100U-U Input: 100-240V, 50-60Hz, 0.2A max Output:

5V 1000 mA Contact Information For more information about our products, please visit www.transtekcorp.com. Manufactured by:

Company:

Address:

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 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 Rated Cuff Pressure Accuracy Systolic pressure: 60-230 mmHg Diastolic pressure: 40-130 mmHg Pulse: 40-199 beats/minute

Static Pressure: 5-40 within 3mmHg Pulse value: 5%

Clinical validation: Mean difference within 5mmHg;

Deviation from normal operation that poses an unacceptable risk to the patient or operator. Warning: Dont 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

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

EMC GUIDANCE EMC GUIDANCE Technical description 1all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the expected lifetime. 2Guidance and manufacturers declaration -electromagnetic emissions and Immunity Table 1 Guidance and manufacturers declaration - electromagnetic emissions Emissions test 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 Comply Table 2 Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic

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.

EMC GUIDANCE Table 3 Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency

Band

Service Modulation Modulation Power

Distance

IMMUNITY TEST LEVEL

Compliance level

(V/m 1.8 2 0.2 2 2 0.3 0.3 0.3 0.3 27 28 9 28 27 28 9 28 0.3 28 28 Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communica-

tions

380-390 TETRA 400 430-470 704-787 GMRS 460FRS 460 LTE Band 13,17 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 18Hz FM 5kHz deviation 1kHz sine Pulse modulation 217Hz Pulse modulation 18Hz 1700-

1990 2400-

2570 Pulse modulation 217Hz Pulse modulation 217 Hz 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 7 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 2 0.3 28 28 9 5100-

5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 EMC GUIDANCE FCC Statement FCC ID: OU9-TMB2287B This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

interference that may cause undesired operation. FCC Regulatory Compliance Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 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. 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.

label PO#2BEB1267 TMB-2287-B Dimension50X15mm,Thickness0.05mm Materialadhesive label with water proof 60#+

Colour+Pantone Reflex Blue C+877c SN:2EB1267230300001--2EB1267230300050 TMB-2287-B Model AC adaptor powered mode: 5V 1AOptional!

(Please use the AC adaptor which authorized by the manufacturer!) Rating: 4AAA batteries, 6V Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China IP Classification: IP21 FCC ID: OU9-TMB2287B 2023-03 GS1 Datamatrix

(UDI) I A N H C N I E D A M

(01)XXXXXXXXXXXXXX SN (21)2EB1267230300001 50.000.20 R2.00 0 2

. 0 0 0

. 5 1 Location

SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name Guangdong Transtek Medical Electronics Co.,Ltd Address Grantee Code FCC ID Zone A, No.105 ,Dongli Road Torch Development District Zhongshan , Guangdong, 528437, China OU9 OU9-TMB2287B Authorized Contact Name Jerry Fan Contact Email Contact Phone gt-rateam@transtekcorp.com

+86-760-85166220 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;

a) b) c) d) e) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:

(1)

(2)

(3) labeling the equipment with the exact FCC ID as specified in this application, compliance statement labeling pursuant to the applicable rules, compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.

(1)

(2)

(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) g) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List

[Guangdong Transtek Medical Electronics Co.,Ltd] (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules.

[Guangdong Transtek Medical Electronics Co.,Ltd] (the applicant) certifies that, as of the date of the filing of the application, the applicant [is not] identified on the Covered list, established pursuant to 1.50002, as an entity producing covered equipment. Applicant Signature:

Date: 2023/09/05 Print Name:

Jerry Fan Title:

RA Manager

*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 1 Original Issue: Jan. 4, 2021

Guangdong Transtek Medical Electronics Co.,Ltd TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9-TMB2287B To whom it may concern:

Date: 2023/09/05 We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Guangdong Transtek Medical Electronics Co.,Ltd. This authorization is valid until further written notice from the applicant. Sincerely, Print Name: Jerry Fan Title: RA Manager Signature:

On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com

Guangdong Transtek Medical Electronics Co.,Ltd TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding:

Confidentiality Request regarding application for FCC ID: OU9-TMB2287B LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. aforementioned days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. If the device is marketed within External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Jerry Fan Title: RA Manager Signature:

On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com

UNITED STATES DESIGNATED AGENT LETTER Date: 20230905 TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant Company Name: Guangdong Transtek Medical Grantee Code:

Electronics Co.,Ltd OU9 Contact Name:

Jerry Fan Address:

Zone A, No.105 ,Dongli Road Torch Development District U.S. designated agent Company Name: MIO LABS INC. FRN:

Contact Name:

Address:

0032569972 Chengcen Su 4500 Great America Pkwy Suite 1023 City/Province/Zip: 95054 City/Province/Zip: Zhongshan , Telephone:

Telephone:

Fax:

Guangdong/528437

+86-760-85166220

+86-760-86742877 Fax:

Email:

157 286 6685 ext. 28(301-

910-0529)

mio@transtekcorp.com Email:

gt-rateam@transtekcorp.com Applicable Equipment: FCC ID: <OU9-TMB2287B>

ATTN: Director of Certification:

We, < Guangdong Transtek Medical Electronics Co.,Ltd > and <MIO LABS INC.> understand and acknowledge the applicants consent and the designated agents obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and e-

mail of the designated agent listed above. We, < Guangdong Transtek Medical Electronics Co.,Ltd > and <MIO LABS INC.> acknowledge the applicants acceptance of its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant U.S. designated agent Name (Printed): Jerry Fan Name (Printed):Chengcen Su Title: RA Manager Signature:

Title:Sales Manager Signature: