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TMB-1583-BT User manual | Users Manual | 5.77 MiB | ||||
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1 | TMB-1583-BT User manual | Users Manual | 5.77 MiB |
version:1.0 User Manual Blood Pressure Monitor TMB-1583-BT Arm Type MEM START STOP SET 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-1583-BT. Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. CATALOGUE CATALOGUE INTRODUCTION...................................................................................................................2 Table of Contents General Description Indications for Use Safety Information LCD Display Signal Monitor Components BEFORE YOU START...........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Measurement Principle Setting Date, Time, Measurement Unit and Clock Mode Select the User Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT...................................................................................................................14 Tie the Cuff Start the Measurement DATA MANAGEMENT...........................................................................................................17 Recall the Records Delete the Records SPECIAL FUNCTION............................................................................................................19 About the Clock Mode About the Lock Button INFORMATION FOR USER..................................................................................................20 Tips for measurement Maintenances ABOUT BLOOD PRESSURE................................................................................................22 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
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..........................................................................................................24 SPECIFICATIONS................................................................................................................25 AUTHORIZED COMPONENT .............................................................................................26 CONTACT INFORMATION...................................................................................................26 COMPLIED STANDARDS LIST............................................................................................27 FCC STATEMENT.................................................................................................................28 EMC GUIDANCE..................................................................................................................29 1 INTRODUCTION General Description Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1583-BT). 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-1583-BT are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using the product. Read the manual thoroughly before using the product. Features:
84mm73 mm Digital LCD display Maximum 60 records 3rd technonoly: Measuring during inflation
(The updated technology in the world) 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. INTRODUCTION 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 TYPE BF APPLIED PARTS Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE F1 T1A/250V 3.6*10CCC The Bluetooth Combination Mark Caution: These notes must be observed to prevent any damage to the device. 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 For indoor use only Symbol for Class II Equipment Symbol for Including RF transmitter CAUTION 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 suitable for use on pregnant women, patients with implanted, electrocical devices, patients with pre-elcampsia, 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 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. Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal. 2 3 INTRODUCTION CAUTION This device is intended only for adult use in homes. This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than arm or for functions other than obtaining a blood pressure measurement. 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. 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. Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT. Dont 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. The maximum temperature that the applied part can be achieved is 42.5 while the environmental temperature is 40.(only for wrist blood pressure monitor) 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. This unit is not suitable for continuous monitoring during medical emergencies or operations. This device cannot be used with HF surgical equipment at the same time. This device is not intended for patient transports outside a healthcare facility. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. The operator shall not touch output of batteries/adapter and the patient simultaneously. Manufacturer will make available on request circuit diagrams, component parts list etc. 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.Never apply the cuff over hurt skin. Do not use the unit in case of existing polyester resp. synthetic allergies. Be careful to strangulation due to cables and hoses, particularly due to excessive length. Do not connect the air hose to other medical equipment, as this could cause air to be pumped into intravascular systems or high pressure, what could lead to dangerous injuries. Before use, make sure the device functions safely and is in proper working condition. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will been impacted and reduced. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorized service centers. Please report to Manufacturer if any unexpected operation or events occur. The device doesnt need to be calibrated in two years of reliable service. Please use the soft cloth to clean the whole unit. Dont use any abrasive or volatile cleaners. 4 LCD display signal INTRODUCTION SYMBOL DESCRIPTION Systolic blood pressure High pressure result EXPLANATION Diastolic blood pressure Low pressure result Pulse per minute Beats per minute, BPM Average value Memory kPa mmHg The average value of the latest three records The displayed measurement values is from the memory. Measurement Unit of the blood pressure
(1kPa=7.5mmHg) Measurement Unit of the blood pressure
(1mmHg=0.133kPa) Low battery Batteries are low and need to be replaced Irregular heartbeat Irregular heartbeat Detection Grade Current Time The grade of the blood pressure Year/Month/Day(M/D or D/M), Hour/Minute 5 INTRODUCTION INTRODUCTION SYMBOL DESCRIPTION Error EXPLANATION Error Hour Minute Second Heartbeat User 1 User 2 The hour in the clock mode The minute in the clock mode The second in the clock mode Heartbeat detection during the measurement Start measurement,save and transmit the measuring results for User 1 Start measurement,save and transmit the measuring results for User 2 Bluetooth icon The bluetooth icon blinks when the bluetooth is working Monitor Components LCD DISPLAY AIR HOSE MEM START STOP SET MEM BUTTON START/STOP BUTTON LOCK BUTTON Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve BATTERY COMPARTMENT CUFF SET BUTTON List 1.Blood Pressure Monitor
(TMB-1583-BT) MEM START STOP SET DC POWER SOCKET AIR CONNECTOR PLUG 2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm)
(Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) 6 7 3. 4AAA alkaline batteries 4.User manual 5. AC Adaptor
(KH0601000UW !) BEFORE YOU START BEFORE YOU START The Choice of Power Supply 1.Battery powered mode:
6VDC 4AAA alkaline batteries 2.AC adaptor powered mode:
6V 1A START STOP MEM
(Please only use the recommended AC adaptor model). Please unplug the adaptor to depart from the using utility power. CAUTION SET AC adaptor In order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with U.S. safety standard. Installing and Replacing the Batteries
.Open the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the cover. Replace the batteries whenever the below happen The shows The display dims The display does not light up CAUTION Remove batteries if the device is not likely to be used for some time. The old batteries are harmful to the environment, do not dispose with other daily trash. Remove the old batteries from the device and follow your local recycling guidelines. Do not dispose of batteries in fire. Batteries may explode or leak. 8 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 air 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. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Setting Date, Time, Measurement Unit and Clock Mode 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 :20142054 time format:12H/24H) 1.When the monitor 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]. Each press will increase the numeral by one in a cycling manner. 9 BEFORE YOU START 3.When you get the right year, press SET button to set down and turn to next step to set the date format between M/D or D/M. 4.Repeat steps 2 and 3 to set the [DATE FORMAT], then set the
[MONTH] and [DAY]. 5
.Repeat steps 2 and 3 to set the [TIME FORMAT] between 12H or 24H, then set the [HOUR] and [MINUTE]. BEFORE YOU START 6.Repeat steps 2 and 3 to set the [UNIT]. 7.Repeat steps 2 and 3 to set the clock mode. 8.After the clock mode is set,the LCD will display done and then turn off. 10 11 BEFORE YOU START Select the User 1.When the monitor is off , press and hold the MEM button to enter user setting mode. The user ID will blink. 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 START/STOP button to start pair-up. The bluetooth symbol will blink, indicating pair-up is proceeding. 2.Then press MEM button again, select the user ID between user 1 and user 2. 3.Then please select the user ID you want to connect with your smartphone on the app to continute the pair-up. If SUCCEED, symbol will be shown on the LCD. If FAIL, only bluetooth symbol will be shown on the LCD. 3. After selecting the suitable user ID, press SET button to confirm. Then the LCD will turn off. 4.The monitor will shut off after Pair-up process is complete. Bluetooth Module No.: AW2540MV1 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -1 dBm Supply Voltage: 2V-3.6 V Transmitting Distance: 10 meters 12 13 MEASUREMENT Tie the cuff 1.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. 2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 2~3cm 3.Sit comfortably with your tested arm resting on a flat surface. 4
.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 arm supported. Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician. 14 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.
(Take User 1 for example.) LCD display Adjust to zero. Inflating and measuring. Display and save the measurement results. 15 MEASUREMENT 2.This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting. If the data transmission fails, the LCD will display . If the data transmission succeeds, the LCD will display . 3.Press the START/STOP button to power off, otherwise it will turn off within 1 minute. Tips: Maximum 60 records are both for User 1 and User 2. 16 DATA MEASUREMENT Recall the Records 1. When the monitor is off, please press MEM button to show the average value of the latest three records.
(Take User 1 for example.) 2. Press MEM button or SET button to get the record you want. The current No. is No. 6. The corresponding date is April 19th. The corresponding time is 9:37 P.M.. The order, date and time of the record will be shown 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. 17 DATA MANAGEMENT SPECIAL FUNCTION Delete the Records If you did not get the correct measurement, you can delete all results by following steps below.(Take User 1 for example) 1.Hold pressing MEM button for 3 seconds when the monitor is in the memory recall mode ,the flash display User ID+ dEL ALL will show. 2.Press SET button to confirm deleting and the monitor will display dEL dOnE and then turn off. About the Clock mode If you set the clock mode on in the setting mode, when you turn off the blood pressure monitor, the backlight of the LCD will turn off, the LCD will display the current time. When the backlight of the LCD is off, press any buttons to light it up, the following display will show. Note: To exit out of delete mode without deleting any records, press START/STOP button before pressing "SET" to confirm any delete commands. 3. If there is no record. the following display will show. About the Lock Button The unnecessary keys touch will make the blood pressure monitor turn on and waste electricity. To avoid this, you can press the Lock button to lock the keys if necessary. Hold pressing the Lock button until the LCD displays OFF, this indicates the touch keys
(such as MEM, START/STOP, SET) have been locked. Hold pressing the Lock button until the LCD displays ON to unlock the keys. 18 19 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Maintenance In order to get the best performance, please follow the instructions below. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers MEM START STOP SET MEM STARTSTOP SET Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. M E M S T S A T R O T P S E T Avoid intense shaking and collisions MEM START STOP SET Avoid dusty and unstable temperature environment MEM START STOP SET Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. In a very cold environment When you want to discharge urine 20 21 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE Systolic blood discharging artery What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classification published by American Heart Association
(AHA). Systolic mmHg (upper#) Blood Pressure Category less than 120 press Normal and Diastolic mmHg (lower#) less than 80 This chart reflects blood pressure categories defined by American Heart Association. Diastolic blood entering vein relax AHA Home Guideline for Upper Limit of Normal BP SYS DIA 135 mm Hg 85 mm Hg Prehypertension High Blood Pressure
(Hypertension) Stage 1 High Blood Pressure
(Hypertension) Stage 2 120-139 140-159 160 or higher Hypertensive Crisis
(Emergency care needed) Higher than 180 or or or or 80-89 90-99 100 or higher Higher than 110 CAUTION Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed. 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. 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. 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. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the white coat effect, which means blood pressure usually increases in clinical settings. Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. 22 23 TROUBLESHOOTING SPECIFICATIONS 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 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. Err shows Data communication is failed. E 1 shows E 2 shows E 3 shows E10 or E11 shows Error massage E20 shows E21 shows EExx,shows on the display. The cuff is not secure. The cuff is very tight The pressure of the cuff is excess. The monitor detected motion,talking or the pluse is too poor while measuring. The measurement process does not detect the pulse signal. The treatment of the measurement failed. A calibration error occurred. 24 Replace with new batteries Check if the App/Bluetooth is on or not,try data transmission again. Refasten the cuff and then measure again. Refasten the cuff and then measure again. Relax for a moment and then measure again. Relax for a moment and then measure again. Loosen the clothing on the arm and then measure again. Relax for a moment and then measure again. 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. Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Net Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software Version Battery powered mode:
6VDC 4AAA alkaline batteries AC adaptor powered mode:
6V 1A
(Please only use the recommended AC adaptor model). Digital LCD V.A.84mm73mm Oscillographic testing mode Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg) pulse value: (40-199) beat/minute Pressure:
5-40within0.4kPa(3mmHg) pulse value:5%
Temperature:5 to 40 Relative humidity: 85%RH Atmospheric pressure: 86kPa to 106kPa Temperature:-20-60 Relative Humidity: 10%RH-93%RH Atmospheric Pressure: 50kPa-106 kPa About 22cm~32cm or 22cm~42cm Approx.250g(Excluding the dry cells and cuff) Approx.107mm103mm118mm 4AAA alkaline batteries,user manual Continuous operation Type BF applied part IP21 V01 WARNING: No modification of this equipment is allowed. 25 AUTHORIZED COMPONENT COMPLIED STANDARDS LIST Authorized Component 1.please use the TRANSTEK authorized adapter. Adapter TypeKH0601000UW Input100~240V~
50/60Hz, 0.4A Max Output6V 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 A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Complied Standards List Risk management ISO/EN 14971:2012 Medical devices Application of risk management to medical devices Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements and Clinical investigation Software life-cycle processes Usability ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements EN 1041: 2008 Medical equipment manufacturers to provide information IEC 60601-1: 2005+A12012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-11 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 IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO81060-2 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes IEC 62366 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and essential performance - collateral standard : Usability 26 27 FCC STATEMENT FCC Statement FCC ID: OU9TMB1583-B 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. 28 EMC GUIDANCE EMC Guidance 1) This equipment needs to be installed and put into service in accordance with the information provided in the user manual;
2) 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=3,3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m) 29
frequency | equipment class | purpose | ||
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1 | 2015-09-30 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2015-09-30
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1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
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1 | FCC Registration Number (FRN) |
0021999248
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1 | Physical Address |
Zone A, No.105,Dongli Road
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1 |
Zhongshan, Guangdong, N/A 528437
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1 |
China
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app s | TCB Information | |||||
1 | TCB Application Email Address |
a******@babt.com
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 | Grantee Code |
OU9
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1 | Equipment Product Code |
TMB1583-B
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K**** T******
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1 | Title |
R&D Director
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1 | Telephone Number |
+86-7********
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1 | Fax Number |
+86-7********
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1 |
q******@transtekcorp.com
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app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
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 is peak 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 |
TUV SUD Certification and Testing (China) Co., Ltd
|
||||
1 | Name |
R**** G****
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1 | Telephone Number |
00867********
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1 | Fax Number |
00867********
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1 |
r******@tuv-sud.cn
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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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