FCC ID: OU9TMB1776BS Blood Pressure Monitor

version:1.0 User Manual Blood Pressure Monitor TMB-1776-B Arm Type FCC ID:OU9TMB1776BS Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1776-B. Please 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 CATALOGUE Table of Contents INTRODUCTION..................................................................................................................2 General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List Tie the Cuff Start the Measurement Recall the Records Delete the Records Tips for measurement Maintenances BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time Select the user MEASUREMENT................................................................................................................12 DATA MANAGEMENT........................................................................................................15 INFORMATION FOR USER...............................................................................................17 ABOUT BLOOD PRESSURE.............................................................................................20 What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

Irregular heartbeat detector Why does my blood pressure fluctuate throughout the day?

Why do I get a different blood pressure at home compared to the hospital?

Is the result the same if measuring on the right arm?

TROUBLESHOOTING........................................................................................................21 SPECIFICATIONS..............................................................................................................22 AUTHORIZED COMPONENTS..........................................................................................23 CONTACT INFORMATION.................................................................................................23 FCC STATEMENT............................................................................................................. 23 COMPLIED STANDARDS LIST.........................................................................................24 EMC GUIDANCE................................................................................................................25 1 INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK arm type blood pressure monitor

(TMB-1776-B). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the TMB-1776-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. Features:

80mm58.5mm Digital LCD display Maximum 60 records 3rd technonoly: Measuring during inflation Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm(about 8-16). It is intended for adult indoor use only. Contraindications 1.The device should not be used by any person who may be suspected of,or is pregnant . 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a zero pressure equivalent to the atmopheric 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 signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for THE OPERATION GUIDE MUST BE READ Symbol for Class II Equipment Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for MANUFACTURE DATE F1 T1A/250V 3.6*10CCC Symbol for TYPE BF APPLIED PARTS Symbol for ENVIRONMENT PROTECTION -

Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice Caution: These notes must be observed to prevent any damage to the device. For indoor use only Symbol for DIRECT CURRENT Symbol for RECYCLE CAUTION

* This device is intended for adult use in homes only.

* The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.

* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.

* The device is not intended for patient transport outside a healthcare facility.

* The device is not intended for public use.

* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.

* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.

* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.

* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.

* When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.

* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. 2 3 INTRODUCTION CAUTION

* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair.

* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.

* The operator shall not touch output of batteries /adapter and the patient simultaneously.

* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Dont use any abrasive or volatile cleaners.

* The device doesnt need to be calibrated within two years of reliable service.

* If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Dont open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.

* Please report to Transtek if any unexpected operation or events occur.

* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.

* Be careful to strangulation due to cables and hoses, particularly due to excessive length.

* At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.

* This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;

* Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.

* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user/patients.

* There is no luer lock connectors are used in the construction of tubing. If there has, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.

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

* When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.

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

*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.

*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure 300mmHg or constant pressure 15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.

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

* When measuring, please avoid compression or restriction of the connection tubing.

* The device cannot be used with HF surgical equipment at the same time.

* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER is clinically investigated according to the requirements of ISO 81060-2:2013.

* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.

* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.

* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.

* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the patients arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.

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

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

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

* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.

* Warning: No servicing/maintenance while the ME equipment is in use.

* The patient is an intended operator.

* The patient can measure, transmit data and change batteries under normal circumstances and maintain the device and its accessories according to the user manual.

* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

*The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don't use this device.

* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.

* Adaptor is specified as a part of ME EQUIPMENT.

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

* Do not wash the cuff in a washing machine or dishwasher!

* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.

* It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).

* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. 4 5 INTRODUCTION LCD display signal SYMBOL DESCRIPTION EXPLANATION Systolic pressure High blood pressure Diastolic pressure Low blood pressure Pulse display Pulse in beats per minute mmHg Blood pressure level indicator Low battery Measurement Unit of the blood pressure

(1mmHg=0.133kPa) Indicate the blood pressure level Batteries are low and need to be replaced Irregular heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement. Current Time Year/Month/Day, Hour : Minute

Heartbeat Average value User A/ User B Memory Data pending to transmit Blood pressure monitor is detecting a heartbeat during measurement. The average value of blood pressure Start measurement and save the measuring results for User A/User B Indicate it is in the memory mode and which group of memory it is. Measurement data stored in the device INTRODUCTION Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve USER BUTTON MEMORY BUTTON START/STOP BUTTON DC POWER SOCKET Monitor Components CUFF AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY List 1.Blood Pressure Monitor

(TMB-1776-B) 2.Cuff (Type BF applied part)

(22cm~42cm) 3.User manual BATTERY COMPARTMENT

(Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) 4. 4AA batteries 5.AC adaptor

(BLJ06L060100P-U) 6.Carry bag Data transmitting Data transmission succeeds. 6 7 BEFORE YOU START BEFORE YOU START 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 :20192059;

Time format:12H) AC adaptor 1. When the monitor is off, hold pressing START/STOP button for 3 seconds to enter the mode for year setting. The Choice of Power Supply 1.Battery powered mode:

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

6V 1A

(Please only use the recommended AC adaptor model). Please unplug the adaptor to depart from the using utility power. CAUTION In order 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 Open 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 shows The display is dim The display does not light up. CAUTION Do not use new and used batteries together. Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines. 8 2. Press MEM or USER button to change the [YEAR]. Each press will increase/decrease the numeral by one in a cycling manner. 3. Press START/STOP button to confirm [YEAR]. Then the monitor diverts to

[MONTH] and [DAY] setting. 9 BEFORE YOU START BEFORE YOU START 4.Repeat step 2 and 3 to set the [MONTH] and [DAY]. Select the User ID 1. Before you start the measurement, please select the desired user ID first. When the blood pressure monitor is off, press USER button the user ID will blink. Then press USER button again to change the user ID between user A and user B. 5

.Repeat step 2 and 3 to set the [HOUR] and [MINUTE]. 6 After HOUR and MINUTE is set,the LCD will display donE and then turn off. 2. Confirming the user ID, press the START/STOP button to confirm ,the LCD will display USER ID+donE and then turn off. 10 11 BEFORE YOU START MEASUREMENT Pair up with Your Device Tie the cuff

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

(2)When the monitor is OFF, press and hold the MEM button to start pair-up. The below picture will be shown on the LCD alternatively,indicating pair-up is proceeding. 2~3cm 1. 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, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery. 4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 5. 6. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. Helpful tips for Patients, especially for Patients with Hypertension:

Rest for 5 minutes before first measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. The patient must relax as much as possible and do not move and talk during the measurement procedure. The cuff should maintain at the same level as the right atrium of the heart. Please sit comfortably. Do not cross your legs and keep your feet flat on the ground. Keep your back against the backrest of the chair. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

(3)Then connect with your smartphone on the app to continute the pair-up. If SUCCEED, the below picture will be shown on the LCD. If FAIL, the below picture will be shown on the LCD.

(4)The monitor will shut off after Pair-up process is complete. 12 13 MEASUREMENT MEASUREMENT If the data transmission fails, the Bluetooth symbol blinks all the time until it turns off. 1. Start the Measurement When the monitor is off, press START/STOP button to turn on the monitor, the user ID will blink ,confirm the User ID, then press START/STOP button again and it will finish the whole measurement.

(Take user A for example.) LCD display Adjust the zero. Inflating and measuring. Display and save the measurement result. If the data transmission succeeds, the Bluetooth symbol will not blink and then turn off. CAUTION 1.With TMB-1776-B successfully pair-up with your mobile device, the measurement data will be automatically transmitted to your mobile device via Bluetooth. 2.The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device. 3.If the data transmission fails, the symbol will remain. The pending measurement data will be transmitted to your mobile device when next measurement is complete. 14 15 DATA MANAGEMENT DATA MANAGEMENT Recall the Records 1. When the monitor is off, please press MEM button to confirm the User, then press START/STOP button to show the latest record . Press the MEM button again to show the average value of the latest three records.If the records are less than 3 groups, it will display the latest record instead. Delete the Records If you did not get the correct measurement, you can delete the result for the selected user by following steps below . 2 . Press the MEM button or SET button to get the record you want. A: Delete one record 1.Hold pressing MEM button for 3 second when the monitor is in the memory recall mode

(except average),the flash display dEL yES will show to delete the one group result. 2. Press MEM button or SET button the flash displays dEL no or dEL yES. 3. Press START/STOP button to confirm deleting this group result when it shows dEL yES and display User + donE,then display the latest record. Tips: Press START/STOP button when it shows dEL no , it will drop out. The date and time of the record will be shown alternately. 16 The current No. is No 3. The corresponding date is January 1st. The corresponding time is A.M. 7:08. 17 DATA MANAGEMENT B: Delete all records 1.Hold pressing both USER button and MEM botton for 3 second when the monitor is in the memory recall mode,the flash display dEL yES +

will show to delete all result. 2. Press USER button or MEM button the flash displays dEL no or dEL yES . 3. Press START/STOP button to confirm deleting when it shows dELyES,then the monitor with turn off when it shows User +

donE. Tips: Press START/STOP button when it shows dEL no ,it will drop out. 4. If there is no record, press MEM button, the right display will be shown. 18 INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. 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 19 INFORMATION FOR USER ABOUT BLOOD PRESSURE Maintenance instructions below. In order to get the best performance, please follow the Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Avoid intense shaking and collisions Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. 20 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 chart on the right is the standard blood pressure classifi-

cation published by American Heart Association (AHA). This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#) Normal Elevated less than 120 and less than 80 120-129 and less than 80 High Blood Pressure

(Hypertension) Stage 1 High Blood Pressure

(Hypertension) Stage 2 130-139 80-89 or or 140 or higher 90 or higher Hypertensive Crisis

(Consult your doctor immediately) Higher than 180 and/or Higher than 120 CAUTION Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals , the difference between each interval and the average is more than the average value of 25% , or there are four or more pulse intervals ,the difference between each interval and the average is more than the average value of 15%, then the irregular heartbeat symbol will appear on the display with the measurement result. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. 21 ABOUT BLOOD PRESSURE TROUBLE SHOOTING 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. 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. 22 This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will not light up. Low batteries Display is dim or show E 1 shows E 2 shows E 3 shows Error message Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly. AC adaptor is inserted incorrectly. Insert the AC adaptor tightly. Batteries are low. Replace with new batteries The cuff is too tight or too loose. Refasten the cuff and then measure again. The monitor detected motion while measuring. The measurement process does not detect the pulse signal. Movement can affect the measurement.Relax for a moment and then measure again. Loosen the clothing on the arm and then measure again. E 4 shows The treatment of the measurement failed. Relax for a moment and then measure again. EExx,shows on the display. A calibration error occurred. (XX can be some digital symbol, such as 01, 02,etc., if this similar situation appear, all belong to calibration error.) Warning message out shows Out of measurement range Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician. 23 SPECIFICATIONS AUTHORIZED COMPONENTS Authorized Components 1.please use the TRANSTEK authorized adapter. Power supply Display mode Battery powered mode:

6VDC 4AA batteries AC adaptor powered mode: 6V 1A

(Please only use the recommended AC adaptor model). Digital LCD display V.A.80mm58.5mm Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure:

0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure:

SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Pressure:

5-40within3mmHg(0.4kPa) Pulse value:5%

A temperature range of :+5C to +40C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of :

700 hPa to 1060 hPa Temperature:-20C to +60C A relative humidity range of 93%, non-condensing, at a water vapour pressure up to 50hPa About 22cm~42cm Approx.283g(Excluding the dry cells and cuff) Approx.140.4mm110.4mm64.8mm Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Weight External dimensions Attachment 4AA batteries,user manual,AC adaptor ,carry bag Mode of operation Degree of protection Continuous operation Type BF applied part Protection against ingress of water Device Classification Software Version IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Battery Powered Mode:

Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment A04 Adaptor Type:

Input:

Output:

BLJ06L060100P-U 100-240V 50-60Hz,0.2Amax 6V 1000mA Contact Information For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by:

Company:

Address:

Guangdong Transtek Medical Electronics Co., Ltd. Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China 24 WARNING: No modification of this equipment is allowed. 25 FCC STATEMENT COMPLIED STANDARDS LIST FCC Statement FCC ID:OU9TMB1776BS This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-- Reorient or relocate the receiving antenna.

-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-- Consult the dealer or an experienced radio/TV technician for help. FCC Radiation Exposure Statement:

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Complied Standards List Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -

Application of risk management to medical devices Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation Usability Software life-cycle processes Bio-compatibility EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:

Requirements and test methods for non-automated measurement type EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -

Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:

Clinical validation of automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -

Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices -

Part 10: Tests for irritation and skin sensitization 26 27 EMC GUIDANCE EMC GUIDANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments Table 2 WarningDont near 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. WarningPortable 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-1776-B, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description 1all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2Guidance and manufacturers declaration -electromagnetic emissions and Immunity Table 1 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 28 Group 1 Class [ B ]

Class A Comply Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV,2 kV common mode 0.5 kV, 1 kV,2 kV common mode 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 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. 29 Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance Power frequency magnetic field IEC 61000-4-8 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency

(MHz) Band

(MHz) Service Modulation Distance (m) IMMUNITY Modulation

(W) 385 380-390 TETRA 1.8 0.3 TEST LEVEL

(V/m) 27 28 9 28 0.3 0.3 0.3 0.3 28 430-470 704-787 800-960 1700-

1990 400 GMRS 460 FRS 460 Pulse modulation b) 18Hz FM c) 5kHz deviation 1kHz sine LTE Band 13, 17 Pulse modulation b) 217Hz Pulse modulation b) 18Hz Pulse modulation b) 217Hz GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 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 2 0.2 2 2 2 2450 2400-

2570 Pulse modulation 217 Hz 0.3 28 5100-

5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 EMC GUIDANCE Table 3 Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicatio ns equipment) 450 710 745 780 810 870 930 1720 1845 1970 5240 5500 5785 30

Model TMB-1776-B Rating: 4AA batteries, 6V AC adaptor powered mode: 6V 1A

(Please use the AC adaptor which authorized by the manufacturer!) Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China FCC ID:OU9TMB1776BS 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. SN BS1008191000001D IP Classification:IP21 2019-10

To:

Federal Communications Commission Office of Engineering and Technology Laboratory Division 7435 Oakland Mills Rd. Columbia MD 21046 From: Guangdong Transtek Medical Electronics Co.,Ltd Zone A, No.105, Dongli Road Torch Development District Zhongshan, Guangdong 528437 China Regarding: Confidentiality Request regarding application for FCC ID: OU9TMB1776BS LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby requests confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions BOM 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 for [0] days from the grant date. If the device is marketed within aforementioned days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Kevin Tan On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: nicole.hu@transtekcorp.com Signature:

Title: R&D Director

SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Address Grantee Code FCC ID Contact Email Contact Phone a) b) c) d) e) Applicant Legal Business Name Guangdong Transtek Medical Electronics Co.,Ltd Zone A, No.105 ,Dongli Road Torch Development District Zhongshan , Guangdong China 528437 OU9 OU9TMB1776BS nicole.hu@transtekcorp.com

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

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:

labeling the equipment with the exact FCC ID as specified in this application,

(1)

(2) compliance statement labeling pursuant to the applicable rules,

(3) 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 ISO17065, 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) 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. g) 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 Applicant Signature:

Date: 2020/07/13 Print Name:

Title:

Kevin Tan R&D Director Applicant Declaration Rev:0.0

*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Declaration Rev:0.0

Date: 2020/07/13 TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB1776BS To whom it may concern:

We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch and Keny Xu in SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch 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. Print Name: Kevin Tan On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: nicole.hu@transtekcorp.com Signature:

Title: R&D Director