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Version:1.0 User Manual Wrist Blood Pressure Monitor TMB-1598-BS Wrist Type 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 Wrist Blood Pressure Monitor TMB-1598-BS. To use the monitor correctly and safely, please read the manual thoroughly. Please keep this manual well in order to reference in future. INTRODUCTION
............................................................................................. 2 CATALOGUE General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Symbol Monitor Components List Tie the Cuff Start the Measurement Recall the Records Delete the Records Tips for Measurement Maintenance ABOUT BLOOD PRESSURE BEFORE YOU START
...................................................................................... 13 Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User ID Pair up the Blood Pressure Monitor with Your Device MEASUREMENT
.............................................................................................. 24 DATA MANAGEMENT
...................................................................................... 28 INFORMATION FOR USER
................................................................................ 32
............................................................................... 34 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 wrist?
TROUBLESHOOTING SPECIFICATIONS CONTACT INFORMATION FCC STATEMENT EMC GUIDANCE
..................................................................................... 37
........................................................................................... 39
................................................................................. 41
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............................................................................................. 42 1 INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1598-BS). 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-1598-BS 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:
Systolic blood pressure Diastolic blood pressure Pulse rate 60 records for one user Indications for Use The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 21.5 cm ( about 5-8 ). 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 point equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate. 2 3 INTRODUCTION INTRODUCTION Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read. Date and Country of manufacture Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for RECYCLE Symbol for DIRECT CURRENT Symbol for TYPE BF APPLIED PART 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. 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. 4 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 wrist 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.
* 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. 5 INTRODUCTION CAUTION
*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 wrist may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the patients wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
* The maximum temperature that the applied part can be achieved is 42.5 while the environmental temperature is 40.
* 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. 6 INTRODUCTION CAUTION
* 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 and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensation or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously. 7 INTRODUCTION CAUTION
* 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 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. 8 LCD Display Symbol INTRODUCTION SYMBOL DESCRIPTION Systolic pressure EXPLANATION High blood pressure Diastolic pressure Low blood pressure Pulse display Motion indicator Low battery Pulse in beats per minute Motion may result in an inaccurate measurement Batteries are running low and need to be replaced 9 INTRODUCTION SYMBOL DESCRIPTION kPa mmHg Irregular heartbeat Current time Average value Heartbeat Memory User 1 User 2 Blood pressure level indicator Positioning symbol EXPLANATION Measurement unit of the blood pressure Measurement unit of the blood pressure
(1kPa=7.5mmHg) Measurement unit the blood pressure
(1mmHg=0.133kPa) Blood pressure monitor is detecting an irregular heartbeat during measurement. Month/Day,Hour/Minute The average value of lastest 3 groups blood pressure Blood pressure monitor is detecting a heartbeat during measurement. Indicate it is in the memory mode Start measurement and save the results for user 1 Start measurement and save the results for user 2 Indicate the blood pressure level The correct position gives you an accurate measurement. Bluetooth icon Indicate the Bluetooth is working. Data storage Indicate the data is waiting to be transmitted. 10 Monitor Components SYSTOLIC PRESSURE DIASTOLIC PRESSURE PULSE RATE SET BUTTON INTRODUCTION TIME GRADE LCD DISPLAY MEMORY BUTTON START/STOP BUTTON 11 INTRODUCTION Component list of pressure measuring system:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff. CUFF
(Type BF applied part) BEFORE YOU START Installing and Replacing the Batteries Slide off the battery cover. Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2AAA batteries.) Replace the cover. The typical service life of the new and unused batteries is 54 measurements for the operation time is 60s. BATTERY COMPARTMENT List 1) Blood Pressure Monitor TMB-1598-BS 2) 2AAA batteries 3) User manual 12 13 BEFORE YOU START 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. BEFORE YOU START Setting Date, Time, Positioning Symbol and Measurement Unit 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 year is 2016 ~ 2056. Time format: 24H) 1. When the monitor is off, press button, it will display the time.Then press and hold button to enter the mode for year setting. 14 15 BEFORE YOU START BEFORE YOU START 4.Repeat step 2 and 3 to confirm [MONTH] and [DAY]. Notes:
1.During the process of setting, you can press button to stop setting at any time. 2. If there is no operation during the process of setting, it will turn off within 1 minute. 2. Press button to change the
[YEAR]. Each press will increase the numeral by one in a cycling manner. 3 When you get the right year, press button to confirm and it will turn to next step. INFORMATION FOR USER 5. Repeat step 2 and 3 to confirm [HOUR] and [MINUTE]. 16 17 BEFORE YOU START BEFORE YOU START BEFORE YOU START 6.Repeat step 2 and 3 to confirm [Positioning symbol] on or off. 8.After confirming the meausrement unit, the LCD will display donE, then display all the settings you have done one by one and then the monitor will turn off. 7.Repeat step 2 and 3 to confirm the measurement unit. 18 19 BEFORE YOU START Select the User ID 2. After confirming the user ID, the LCD will display User ID+donE and then turn off. BEFORE YOU START MEASUREMENT Before you start the measurement, please select the desired user ID first. 1. When the blood pressure monitor is off, press and hold button until the user ID blinks. Then press button to change the user ID between user 1 and user 2. Press SET button to confirm your selection. 20 21 BEFORE YOU START BEFORE YOU START Pair up the Blood Pressure Monitor with Your Device 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 button to start pair-up. The symbol and the symbol will be shown on the LCD alternindicating pair-up is proceeding. If FAIL, the symbol + will be shown on the LCD. 3.The monitor will shut off automatically after Pair-up process is complete. If SUCCEED, the symbol + will be shown on the LCD. Bluetooth Module No.:
RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range:
Supply Voltage: 2 V to 3.6V
-2.51 dBm LS51802 Transmitting Distance: 10 meters 22 23 MEASUREMENT Tie the Cuff 1. 2. 3. 4. 5. 6. 7. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. Roll or push up your sleeve to expose the skin. Apply the cuff to your wrist with your palm facing up. Position the edge of the cuff about 1cm~1.5cm from wrist joints. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. Sit comfortably with your tested wrist 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. Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported. Rest for 5 minutes before 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. Do not cross your legs and keep your feet 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 wrist, or as directed by a physician. MEASUREMENT Start the Measurement 1. When the monitor is off, press button to turn on the monitor, and it will finish the whole measurement. (Take user 1 for example.) LCD display Adjust the zero point. Inflating and measuring. Display and save the result. The year, date and time will dispaly alternately. 24 25 MEASUREMENT MEASUREMENT 2.After finishing the measurement, the LCD displays the blinking icon ,and transmits the data. Note:
(1). The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device.
(2). 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.
(3). If you have set the [Positioning Symbol] on, when you start the measurement, the blood pressure monitor will detect the position first. The wrist must beat the angle between 30and 45. If its out of this angle, the LCD wont start any measurements and will display blinking symbol until you have the correct position. If you get the correct position, it will display for about 3 seconds, and then finish the whole measurement. 26 3. During the measurement or when the measurement is finished, press button to turn off the monitor. Otherwise it will power off in one minute. Tips:
1. There are two users in total. Each user has 60 records. 2. You can press button to stop measuring during the process of the measurement at any time. 3. If the measurement result is out of the measurement range (SYS:
60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse:
40-199 pulse/minute), the LCD will display out. CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1598-BS may interfering vicinity electrical equipment. Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible. Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement. To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. How to mitigate possible interference?
The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range. To avoid interference, other electronic devices (particularly those with wireless transmission /
Transmitter) should be kept at least 1 meter away from the monitor. 1. 2. SET 27 DATA MANAGEMENT DATA MANAGEMENT Recall the Records 1. When the monitor is off, press button to show the average value of the latest three measurement records. If the records are less than 3 groups, it will display the latest record instead. 2. Press button or button to get the record you want. DATA MANAGEMENT 3. If you want to check the other users measurement records, please press button to turn off the blood pressure monitor. Then press and hold button to enter the selecting user mode, press again to change the user, when the desired user ID blinks, press button to confirm. Then press button to check the records of the selected user. The record number is No.1. Two records in total. The corresponding date is 25th December. The corresponding time is 6:35. The record number, date and time of the measurement records will display alternately. CAUTION The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 28 29 DATA MANAGEMENT DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete all the results for the selected user by following steps.
(Take user 1 for example.) 3. If there is no record, press button he below display will be shown. 1. Hold pressing button about 3 seconds when the monitor is in the memory recall mode , the dEL All
+User ID will flash on the display. 2. Press button to confirm ,the LCD displays User ID+dEL donE and then turns off. Note: To exit out of delete mode without deleting any records, press button before pressing button to confirm any delete commands. 30 31 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Maintenance To obtain 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 MM Put in a dry place and avoid the sunshine Avoid immersing it in the water. Clean it with a dry cloth in case. TROUBLESHOOTING Avoid shaking and collision. When talking or moving your fingers In a very cold environment When you want to discharge urine Avoid dusty environment and unstable temperature surrounding Use the slightly damp cloth to remove the dirt. Avoid washing the cuff 32 33 ABOUT BLOOD PRESSURE EMC GUIDANCE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure. 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 High Blood Pressure
(Hypertension) Stage 1 High Blood Pressure
(Hypertension) Stage 2 less than 120 120-129 130-139 less than 80 less than 80 80-89 and and or or 140 or higher 90 or higher Hypertensive Crisis
(Consult your doctor immediately) Higher than 180 and/or Higher than 120 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. ABOUT BLOOD PRESSURE 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 heartbeat 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. 34 35 ABOUT BLOOD PRESSURE TROUBLESHOOTING 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. This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the product is not operating as you think it should, check here before arranging for servicing. 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 wrist?
It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time. 36 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 wrist. 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. PROBLEM SYMPTOM CHECK THIS REMEDY No power Display is dim or will not light up. Batteries are inserted incorrectly. Batteries are exhausted. Replace with new batteries Insert the batteries correctly Low batteries Show on the display Batteries are low. Replace with new batteries E 01 shows E 02 shows The cuff is too tight or too loose. The monitor detected motion, while measuring. Refasten the cuff and then measure again. Relax for a moment and then measure again. Error message E 03 shows The measurement process does not detect the pulse signal. Loosen the clothing on the arm and then measure again. E 04 shows Measure incorrectly. Relax for a moment and then measure again.
+ Err shows The wrist angle is not correct The wrist must beat the angle between 30 and 45 when you have set the
[Positioning Symbol] on, . 37 TROUBLESHOOTING SPECIFICATIONS PROBLEM SYMPTOM CHECK THIS REMEDY Error message EExx,shows on the display. A calibration error occurred.
(XX can be some digital symbol,such as 01,02,etc., if this similarsituation appear, all belong to calibration error.) Retake the measurement.If the problem persists,contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. Warning message out shows Out of measurement range Relax for a moment. Refasten the cuff and thenmeasure again. If the problem persists, contact your physician. Power supply Display mode Measurement mode Measurement range Accuracy Working condition Storage & transportation condition Measurement perimeter of the wrist Weight External dimensions Attachment Battery powered mode: 2*AAA batteries Digital LCD V.A.45mmx33mm Oscillographic testing mode 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:5C-40C within3mmHg(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 13.5cm-21.5cm Approx.100g(Excluding the batteries) Approx.86mm66mm22mm(Excluding the cuff) 2*AAA batteries,user manual 38 39 SPECIFICATIONS CONTACT INFORMATION Mode of operation Continuous operation Degree of protection Type BF applied part Device Classification Internally Powered ME Equipment IP22: The first number 2: Protected against solid foreign objects of 12,5mm and greater. The second number:
Protected against vertically falling water drops when enclosure titled up to 15. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15 on either side of the vertical. IP Classification Software Version A01 WARNING: No modification of this equipment is allowed. Contact Information For more information about our products, please visit www.transtekcorp.com.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 A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China FCC Statement FCC ID: OU9TMB1598B2 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. 40 41 EMC GUIDANCE EMC Guidance EMC GUIDANCE The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments Guidance and manufacturers declaration - electromagnetic emissions 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. Emissions test Compliance 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-1598-BS, 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 Group 1 Class B Not application Not application 42 43 EMC GUIDANCE EMC GUIDANCE Table 5 Table 5 Table 2 Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC61000-4-5 44 Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable EMC GUIDANCE EMC GUIDANCE Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency magnetic field IEC 61000-4-8 Conduced RF IEC61000-4-6 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Not applicable Not applicable Radiated RF IEC61000-4-3 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz NOTE UT is the a.c. mains voltage prior to application of the test level. 45 Guidance and manufacturers declaration - electromagnetic Immunity 0.3 28 28 Table 5 EMC GUIDANCE Table 3 Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicati-
ons equipment) 450 430-470 0.3 28 Test Frequency
(MHz) Band
(MHz) 385 380-390 704-787 800-960 710 745 780 810 870 930 Service Modulation Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz 2 2 TETRA 400 GMRS 460, FRS 460 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) 1.8 0.3 27 Compliance level
(V/m) 27 28 9 0.2 0.3 9 0.3 28 28 EMC GUIDANCE 1700-
1990 1720 1845 1970 2450 2400-
2570 Pulse modulation 217 Hz Pulse modulation 217 Hz 2 2 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 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 5240 5500 5785 0.3 28 28 0.2 0.3 9 9 46 47
1 | Label | ID Label/Location Info | 355.55 KiB | August 17 2022 |
SN 2BS0300220600001 ----------------> SN 2BS0300220600050 Model TMB-1598-BS Rating: 2AAA batteries, 3V Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China FCC ID: OU9TMB1598B2 FCC STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subjectto the following two conditions:
(1) this device may not cause harmfulinterference, and (2) this device must accept any interference received,including interference that may cause undesired operation. IP Classification: IP22 GS1 Datamatrix
(UDI) 2022-06
(01)XXXXXXXXXXXXXX
(21)2BS0300220600001 SN 35.00
1 | FCC Authority letter | Cover Letter(s) | 54.93 KiB | August 17 2022 |
Guangdong Transtek Medical Electronics Co.,Ltd Date: 2022/06/30 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB1598B2 To whom it may concern:
We, the undersigned, hereby authorize Compliance Certification Services (Kunshan) Inc and Kidd Yang in Compliance Certification Services (Kunshan) Inc 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: Jerry Fan Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com Title: RA Manager
1 | FCC Confidentiality Letter | Cover Letter(s) | 121.49 KiB | August 17 2022 |
Guangdong Transtek Medical Electronics Co.,Ltd TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Confidentiality Request regarding application for FCC ID: OU9TMB1598B2 Regarding:
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. Sincerely, Print Name: Jerry Fan Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com Title: RA Manager
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-08-17 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-08-17
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
||||
1 | FCC Registration Number (FRN) |
0021999248
|
||||
1 | Physical Address |
Zone A, No.105,Dongli Road Torch Development District
|
||||
1 |
Zone A, No.105,Dongli Road
|
|||||
1 |
Zhongshan, Guangdong, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OU9
|
||||
1 | Equipment Product Code |
TMB1598B2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** F********
|
||||
1 | Title |
RA Manager
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
g******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
K**** Y********
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
K******** Y********
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood pressure monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
A****** Z******
|
||||
1 | Telephone Number |
+86 7********
|
||||
1 |
A******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0006000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC