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version:1.0 User Manual Blood Pressure Monitor TMB-995-BS Arm Type START STOP Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-995-BS. To use the monitor correctly and safely, please read the manual thoroughly. Please keep well this manual in order to reference in future. Table of Contents INTRODUCTION...................................................................................................................2 CATALOGUE 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 and Time Select the User MEASUREMENT.................................................................................................................13 DATA MANAGEMENT..........................................................................................................16 INFORMATION FOR USER................................................................................................19 ABOUT BLOOD PRESSURE..............................................................................................21 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........................................................................................................23 SPECIFICATIONS...............................................................................................................24 AUTHORIZED COMPONENT ............................................................................................25 CONTACT INFORMATION..................................................................................................25 FCC STATEMENT................................................................................................................26 EMC GUIDANCE.................................................................................................................27 1 INTRODUCTION General Description Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-995-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-995-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:
80*60mm Digital LCD display Maximum 60 records per each user Measuring during inflation technology 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 22 cm to 32 cm ( about 8-12 ) or 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. INTRODUCTION 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 deter-
mine the systolic pressure and diastolic pressure as well as pulse rate. Safety Information The signs below might be in the user manual, labeling or other components. They are the requirement of standard and using. Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read. Symbol for Type BF applied part Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. Symbol for Recycle SN Symbol for Serial Number Symbol for Direct Current Symbol for Manufacturer Symbol for Date and Country of manufacture For indoor use only Symbol for Class II Equipment 2 3 INTRODUCTION CAUTION
* This device is intended for indoor, home use.
* This device is not intended for public use.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.
* Do not use on the women in pregnant, including pre-eclamptic, patients.
* The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.
* The effectiveness of this device has not been established for use:
-on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
-on users with peripheral arterial disease,
-on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
* If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.
* Report any unexpected operation or events to the manufacturer.
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
* Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries. frequently for irritation.
* Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site
* Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
* Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time. INTRODUCTION CAUTION
* Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
* The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
* You can use this device to take your own measurement, no third-party operator is required.
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
* The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.
* Warning: Excessive cuff tube lengths could cause strangulation if you don't manage them
* Warning: Do not touch output of the batteries/adapter and the user simultaneously.
* Adapter is specified as a part of ME EQUIPMENT.
* Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient properly. environment.
* Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
* Warning: Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
* Warning: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.
* No calibration is required within two years of reliable service.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
* At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
* It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
* Warning: Do not use the device while under maintenance, or being serviced.
* Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of
* Please check that the operation of the device do not result in prolonged impairment of patient choking or strangulation if used improperly. blood circulation.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural
* Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during detergent. Do not use alcohol, benzene, or other harsh chemicals. measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
* Do not 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.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
* Dispose of accessories, detachable parts, and the device according to the local guidelines. 4 5 INTRODUCTION LCD Display Signal Monitor Components CUFF INTRODUCTION AIR HOSE AIR CONNECTOR PLUG SET/DOWN BUTTON START/STOP BUTTON MEM/UP BUTTON Component list of pressure measuring system:
1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve List START STOP LCD DISPLAY BATTERY COMPARTMENT SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result PUL.
/min. Pulse/minute CUFF air is exhausting of deflating Time(year:month:day:hour:minute) If MEM shows, the displayed measurement values is from the memory. Measurement Unit of the blood pressure Measurement Unit of the blood pressure Battery Indicator Indicate the current battery Irregular heartbeat Irregular heartbeat Pulse Deflating Current Time Memory mmHg kPa Grade Heartbeat User 1 User 2 Shocking reminder Shocking will result in inaccurate 1. Blood Pressure Monitor
(TMB-995-BS) 2. Cuff (22~32cm or 22~42cm)
(Type BF applied part) 3. User manual The grade of the blood pressure START STOP Heartbeat dectetion during measurement Start measurement and transmit the results for User 1 Start measurement and transmit the results for User 2 4. 4*AA batteries 5. AC adaptor
(BLJ06L060100P-U) 6 7 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. (year :20182058 time:12 H) 1.When the unit is off, hold pressing SET button for 3 seconds to enter the mode for year setting. 2.Press the MEM button to change the
[YEAR]. START STOP START STOP BEFORE YOU START The Choice of Power Supply 1.Battery powered mode:
6VDC 4*AA batteries 2.AC adaptor powered mode:
6V 1A
(Please use the AC adaptor which authorized by the manufacturer!) Right picture is the hole in for power adaptor. CAUTION In order to get the best effect and protect your monitor,please use the the right batteries and special power adapter which complies with CE safety standard. Installing and Replacing the Batteries 1.Slide off the battery cover. 2.Install the batteries by matching the correct polarity, as shown. 3.Replace the cover. Replace the batteries whenever the below happens The shows The display dims 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. The typical service life of the new and unused batteries is 180 measurements for the operation time is 60s. Remove the old batteries from the device following your local recycling guidelines. 8 9 BEFORE YOU START 3.When you get the right year, press SET button to set down and turn to next step. BEFORE YOU START 5.Repeat step 2 and 3 to set the [HOUR] and [MINUTE]. START STOP START STOP START STOP 4.Repeat step 2 and 3 to set the [MONTH] and [DAY]. 6.After the [UNIT] is set, the LCD will display donE, and then turn off. START STOP START STOP START STOP 10 11 BEFORE YOU START Select the User 1.When the monitor is off , press the SET button to enter user setting mode. MEASUREMENT Tie the Cuff 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. 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. 6. Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first measurement. 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. 2.Then press SET button again, select the user ID between user 1 and user 2 . 2~3cm START STOP START STOP 3. After selecting the suitable user ID, press START/STOP button to save the setting you have done then the device will turn off. 12 13 MEASUREMENT MEASUREMENT Start the Measurement 1.When the monitor is off,press the START/STOP button to turn on the monitor, and it will finish the whole measurement, save and transmit the measurement data for the desired user. (Take User 1 for example.) START STOP LCD display Adjust the zero . 3.If the data is successfully transmitted, the Bluetooth symbol doesnt blink any more, and the will disappear. If the data transmission fails, the will proceed. Inflating and measuring. Display and save the results. The data transmission will proceed. 2.This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting. 14 4.Press START/STOP button to power off, otherwise it will turn off within 1 minute. START STOP Tips:
A. You can press START/STOP button at any time to stop measuring during the process of measurement. B. Maximum 60 records are both for USER 1 and USER 2. C. 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-995-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. 15 DATA MANAGEMENT DATA MANAGEMENT Recall the Records 1.When the monitor is off, please press MEM button 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. Displays different colors at different levels when the monitor is under the memory enquiry mode.
(Take user 1 for example.) Delete the Records If you did not get the correct measurement, you can delete all results of the selected user by following steps below . 1.Hold pressing MEM button for 3 seconds when the monitor is under the memory enquiry mode. The LCD will display the blinking Use ID + dEL ALL. 2. Press the MEM or SET button again to rotate the records. The order of the record, date and time will be displayed alternatively. 2.Press MEM button to confirm deleting all the memories , the LCD will display Use ID + dEL dOnE and the monitor will turn off. The current is the No. 1. Twenty records in total. The corresponding date is July 30th. The corresponding time is A.M.9:00. 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. Bluetooth Module No.: LS51802 RF Frequency Range: 2.402 - 2.480 GHz Output Power Range: -2.36 dBm Supply Voltage: 1.8V - 3.6V Transmitting Distance: 1-10 meters 16 17 DATA MANAGEMENT INFORMATION FOR USER 3.Hold pressing SET button for 3 seconds when the monitor is under the memory enquiry mode (excluding the LCD displays AVG). The LCD will display the blinking Use ID + dEL ONE. Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. 4.Press MEM button to confirm deleting the last record, the LCD will display Use ID + dEL dOnE and the monitor will turn off. wait at least 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking 5.If you dont want to delete the records, press the START/STOP button, it will turn off and quit the deletion. Or when it is in the deleting memory mode, it will turn off and quit the deletion if there is no operation in one minute. 6. If there is no record, the LCD will be shown as below:
Wait at least 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine 18 19 INFORMATION FOR USER ABOUT BLOOD PRESSURE Maintenance In order to get the best performance, please follow the instructions below. Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. STARTSTOP START STOP Avoid intense shaking and collisions Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Avoid washing the cuff START STOP S S T T A O R P T START STOP 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 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 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 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. 21 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. 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 product is 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 shows Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. AC adaptor is inserted incorrectly. Insert the batteries correctly Insert the AC adaptor tightly Batteries are low. Replace with new batteries E 1 shows Communication error E 3 shows The cuff is not secure. Check if the APP is on, operate and send the data again. Readjust the cuff and relax for a moment and then measure again. Movement can affect the measurement.Relax for a moment and then measure again. The monitor detected motion,talking or the pluse is too poor while measuring. The measurement process does not detect the pulse signal. Loosen the clothing on the arm and then measure again The treatment of the measurement failed. Relax for a moment and then measure again. Error message E10 or E11 shows E20 shows E21 shows EExx,shows on the display. A calibration error occurred. 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 COMPONENT Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Device Classification Battery powered mode:
AC adaptor powered mode:
(Please only use the recommended AC adaptor model). 6VDC 4AA batteries 6V 1A Digital LCD V.A.60mm*80mm 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:
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~32cm or 22cm~42cm Approx.300g(Excluding the batteries) Approx.102mm*143mm*73mm 4AA batteries,user manual,AC adapter Continuous operation Type BF applied part 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 Software Version A01 WARNING: No modification of this equipment is allowed. 24 Authorized Component 1.please use the TRANSTEK authorized adapter. 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.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 25 FCC STATEMENT EMC GUIDANCE FCC Statement FCC ID:OU9TMB995BS2 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. EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Dont be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-995-BS including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2. Guidance and manufacturers declaration-electromagnetic emissions and Immunity. Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance 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 ]
Class A Comply 26 27 EMC GUIDANCE Table 2 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, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 2 kV for power supply lines Not Applicable 100 kHz repetition frequency Surge IEC61000-4-5 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV, 2 kV common mode 0.5 kV, 1 kV differential mode Not Applicable Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle Power frequency magnetic field IEC 61000-4-8 30 A/m 50 Hz / 60 Hz 30 A/m 50 Hz / 60 Hz Conduced RF IEC61000-4-6 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz Radiated RF IEC61000-4-3 10 V/m 80 MHz 2,7 GHz 80% AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80% AM at 1 kHz NOTE U T is the a.c. mains voltage prior to application of the test level. 28 Table 3 Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicati-
ons equipment) Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency
(MHz) Band
(MHz) Service Modulation Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) 1.8 0.3 27 Compliance level
(V/m) EMC GUIDANCE 27 28 9 0.3 28 0.2 0.3 9 0.3 28 28 0.3 28 28 Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 2 2 2 2 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 800-960 1700-
1990 LTE Band 13, 17 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 7 710 745 780 810 870 930 1720 1845 1970 5240 5500 5785 2450 2400-
2570 0.3 28 28 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 9 29
1 | Label | ID Label/Location Info | 523.37 KiB | August 17 2022 |
PO#2BEBS0384 TMB-995-BS Dimension49.7X16.8mm,Thickness0.2mm Label Materialadhesive label with water proof Colourblack text with silver background SN:2BS0384220600001--2BS0384220600050 Model TMB-995-BS Rating:Battery powered mode: 4x AA size alkaline batteries,6V AC adaptor powered mode: 6V 1A
(Please use the AC adaptor which authorized by the manufacturer!) IP Degree:IP21 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China FCC Statement FCC ID:OU9TMB995BS2 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. GS1 Datamatrix
(UDI) 2022-06 SN
(01)XXXXXXXXXXXXXX
(21)2BS0384220600001 Model TMB-995-BS Rating:Battery powered mode: 4x AA size alkaline batteries,6V AC adaptor powered mode: 6V 1A
(Please use the AC adaptor which authorized by the manufacturer!) IP Degree:IP21 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China FCC ID:OU9TMB995BS2 FCC Statement 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. GS1 Datamatrix
(UDI) 2022-06 SN
(01)XXXXXXXXXXXXXX
(21)2BS0384220600001
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: OU9TMB995BS2 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: OU9TMB995BS2 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 |
TMB995BS2
|
||||
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