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04 User Manual | Users Manual | 807.88 KiB | December 19 2018 | |||
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1 | 05 Block Diagram | Block Diagram | December 19 2018 | confidential | ||||
1 | 06 SCH | Schematics | December 19 2018 | confidential | ||||
1 | 07 Operation description | Operational Description | December 19 2018 | confidential | ||||
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1 | 04 User Manual | Users Manual | 807.88 KiB | December 19 2018 |
version:1.0 User Manual Blood Pressure Monitor TMB-1583-BS Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Thank you for selecting a TRANSTEK Blood Pressure Monitor. Please read the user manual carefully and thoroughtly to ensure the safe usage of this product,Keep the manual well for further reference in case you have problems. CATALOGUE Table of Contents INTRODUCTION..................................................................................................................2 General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................9 The Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT................................................................................................................16 Tie the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................19 Recall the Records Delete the Records SPECIAL FUNCTION..........................................................................................................21 About the Lock Button INFORMATION FOR USER...............................................................................................22 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................24 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular 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.......................................................................................................26 SPECIFICATIONS..............................................................................................................27 AUTHORIZED COMPONENT ...........................................................................................28 CONTACT INFORMATION.................................................................................................28 FCC STATEMENT...............................................................................................................29 COMPLIED STANDARDS LIST..........................................................................................30 EMC GUIDANCE................................................................................................................31 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. Symbol for THE OPERATION GUIDE MUST BE READ Symbol for TYPE BF APPLIED PARTS Symbol for RECYCLE Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE F1
The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods. 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 Symbol for Class II Equipment For indoor use only Caution: These notes must be observed to prevent any damage to the device. General Description Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-1583-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-1583-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:
73 mm84 mm Digital LCD display Maximum 60 records per each user 3rd technonoly: Measuring during inflation Indications for Use The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging
It is intended for adult indoor use only. Contraindications 1.The device should not be used by any person who may be suspected of,or is pregnant . 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a zero pressure equivalent to the atmospheric 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.
INTRODUCTION CAUTION
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.
before using it on older children.
pressure.It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
to measure your blood pressure. Never change a prescribed medication without consulting your physician.
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.
increase which can prevent blood flow and result in harmful injury to the PATIENT.
blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or
mastectomy.
around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
measurement, open the cuff immediately. Prolonged high pressure (cuff pressure 300mmHg or constant pressure may lead to an ecchymosis.
patient blood circulation. INTRODUCTION CAUTION
was clinically investigated according to the requirements of ISO 81060-2:2013.
the manufacturer.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
circulation and injuries.
operations.Otherwise, the patients arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
manufacturer cannot be held liable for damage caused by incorrect application.
the storage and operating conditions described in this booklet.
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
can measure ,transmit data and change batteries under normal circumstances and maintain the device and its accessories according to the user manual.
radiated interference signal or electrical fast transient/burst signal.
device.
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.
complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
from the arm and press the START/STOP button to stop inflation.
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.
INTRODUCTION INTRODUCTION CAUTION
storage state. The typical service life is 10000 times.
maintenance and repair, by retesting at least the requirements in limits of the error of the
according to the local guidelines.
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.
cloth to clean the whole unit before and after use. Dont use any abrasive or volatile cleaners.
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.
any unexpected operation or events occur.
swallowing of small parts. It is dangerous or even fatal.
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.
provided in the ACCOMPANYING DOCUMENTS;
cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least adistance 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.
Otherwise, it may cause damage to the unit or danger to the user/patients.
might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
performance and lifetime of the device will be impacted and reduced.
LCD display signal SYMBOL EXPLANATION DESCRIPTION Systolic blood pressure High blood pressure Diastolic blood pressure Low blood pressure Pulse display kPa mmHg Low battery Irregular heartbeat Blood pressure level indicator Current Time User 1 User 2 Bluetooth icon The average value Motion indicator Memory Bluetooth connection Heartbeat Pulse in beats per minute Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Batteries are low and need to be replaced Blood pressure monitor is detecting an irregular heartbeat during measurement. Indicate the blood pressure level Month/Day/Year, Hour/Minute Start measurement,save and transmit the measuring results for User 1 Start measurement,save and transmit the measuring results for User 2 The bluetooth icon blinks when the Bluetooth is working The average value of the latest three records Motion may result in an inaccurate measurement Indicate it is in the memory mode and which group of memory it is. It blinks when the bluetooth connection fails or the data is not sent. Blood pressure monitor is detecting a heartbeat during measurement.
INTRODUCTION Monitor Components LCD DISPLAY AIR HOSE MEM BUTTON START/STOP BUTTON LOCK BUTTON Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve CUFF SET BUTTON BATTERY COMPARTMENT BEFORE YOU START The Choice of Power Supply 1.Battery powered mode:
6VDC 4AAA batteries 2.AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
Please unplug the adaptor to depart from the using utility power. CAUTION 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 local safety standard. Installing and Replacing the Batteries
Open the battery cover.
Install the batteries by matching the correct polarity, as shown.
Close the cover. DC POWER SOCKET AIR CONNECTOR PLUG List 1.Blood Pressure Monitor
2.Cuff
3. 4AAA batteries 4.User manual 5. AC Adaptor
The typical service life of the new and unused batteries is 300 measurements for the operation time is 60s. Replace the batteries whenever the below happen 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 BEFORE YOU START Setting Date, Time 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 the year :20182058 time format:24H) 4.Repeat step 2 and 3 to set the [MONTH] and [DAY]. 5
.Repeat step 2 and 3 to set the [HOUR] and [MINUTE]. 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. 3.When you get the right year, press SET button to confirm then it will turn to next step.
BEFORE YOU START 6.Repeat step 2 and 3 to set the [UNIT]. 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. 7 After UNIT is set, the LCD will display donE first, then display all the settings you have done and then turn off. 2.Then press MEM button again, select the user ID between user 1 and user 2. 3. After selecting the suitable user ID, press SET button to confirm. The LCD will show User ID+ donE and then turn off.
BEFORE YOU START BEFORE YOU START List of compatible devices:
For iOS devices:
The operating system must be iOS 8 or more, such as iPhone 4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on. For Android devices:
The operating system must be 4.3 or more. CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1583-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
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
1. 2. 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 symbol + and user ID will be shown on the LCD alternatively, indicating pair-up is proceeding. MEASUREMENT If SUCCEED, the symbol +
and user ID will be shown on the LCD. If FAIL, the symbol +
and user ID will be shown on the LCD. 3.The monitor will shut off after Pair-up process is complete. Bluetooth Module No.: LS51802 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: Supply Voltage: 2V-3.6 V Transmitting Distance: 10 meters
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.
LCD display Adjust the zero. Inflating and measuring. Display and save the measurement results. 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. Or position the artery mark over the main artery (on the inside of
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. 2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 3.Sit comfortably with your tested arm resting on a flat surface. 2~3cm
.Patients with Hypertension:
4 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.
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 symbol will disappear. 1 Recall the Records When the monitor is off, please press the MEM to show the average value of the latest three records.If the records are less than three groups,it will display the latest record first. (Take user 1 for
2. Press MEM button or SET button to get the record you want. DATA MANAGEMENT 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. The current No. is No. 1. The corresponding date is April 27th. The corresponding time is 9:37. The order, date and time of the record will be shown alternately. CAUTION
dropped from the list.
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 User ID
+ dEL ALL will flash on the display. 2.Press SET button to confirm deleting and the monitor will display dEL dOnE+User ID and then turn off. 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,
Hold pressing the Lock button until the LCD displays ON to unlock the keys. You can press any buttons to use the blood pressure monitor. Note: To exit the 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 be shown.
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 Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Within 20 minutes after taking a bath When talking or moving your fingers Avoid intense shaking and collisions Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. In a very cold environment When you want to discharge urine
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classifi-
cation published by American
This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Normal Elevated High Blood Pressure
High Blood Pressure
Systolic
less than 120 120-129 130-139 140 or higher Diastolic
and and or or less than 80 less than 80 80-89 90 or higher Hypertensive Crisis
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. ABOUT BLOOD PRESSURE 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. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the white coat effect, which means blood pressure usually increases in clinical settings. Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. What you need to pay attention to when you measure your blood pressure at home:
If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down.
TROUBLESHOOTING SPECIFICATIONS 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 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 The cuff is too tight or too loose. Refasten the cuff and then measure again. No power Display will not light up. Low batteries Display is dim or show E 01 shows E 02 shows Error message E 03 shows E 04 shows The monitor detected motion, talking,or the pulse is too poor while measuring. The measurement process does not detect the pulse signal. The treatment of the measurement failed. EExx,shows on the display. A calibration error occurred. Warning message out shows Out of measurement range 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. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician. 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 Device Classification Software Version Battery powered mode:
6VDC 4AAA batteries AC adaptor powered mode: 6V 1A
(Please only use the recommended AC
Digital LCD V.A.84mm73mm Oscillographic testing mode Rated cuff pressure:
Measurement pressure:
Pressure:
5-40 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
non-condensing,at a water vapour pressure up to 50hPa About 22cm~32cm or 22cm~42cm
Approx.107mm103mm118mm 4AAA batteries,user manual , AC adaptor 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 A01
WARNING: No modification of this equipment is allowed.
AUTHORIZED COMPONENT Authorized Component 1please use the TRANSTEK authorized adapter. Adapter ModelBLJ06L060100P-U InputAC 100-240V 50/60Hz 0.2A 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 B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China COMPLIED STANDARDS LIST FCC STATEMENT FCC Statement FCC ID:OU9TMB1583BS This device complies with Part 15 of the FCC Rules. Operation is subject
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
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help. FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
Complied Standards List Complied Standards List Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements EN 1041:2008 Information supplied by the manufacturer of medical devices EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation Usability Software life-cycle processes Bio-compatibility
EMC GUIDANCE EMC GUIDANCE EMC GUIDANCE EMC Guidance
installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
fields, near the unit. This may result in incorrect operation of the unit.
other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. Table 1 Guidance and manufacturers declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 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 Complies
Complied Standards List Complied Standards List Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements EN 1041:2008 Information supplied by the manufacturer of medical devices EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation Usability Software life-cycle processes Bio-compatibility
EMC GUIDANCE EMC GUIDANCE EMC GUIDANCE EMC Guidance
installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
fields, near the unit. This may result in incorrect operation of the unit.
other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. Table 1 Guidance and manufacturers declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 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 Complies
EMC GUIDANCE Table 2 Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electrostatic discharge IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. power supply lines:
2 kV input/output lines:
1 kV
1 kV
2 kV 100 kHz repetition frequency 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 ; 300 cycle power supply lines:
2 kV
1 kV 100 kHz repetition frequency 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 ;300 cycle Electrical fast transient/burst IEC 61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50Hz/60Hz magnetic field IEC 61000-4-8 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. b EMC GUIDANCE EMC GUIDANCE Table 3 Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6 150 kHz to 80 MHz:
3 Vrms 6Vrms (in ISM and amateur
80% Am at 1kHz 150 kHz to 80 MHz:
3 Vrms 6Vrms (in ISM and amateur
80% Am at 1kHz Radiated RF IEC 61000-4-3 10V/m, 80% Am at 1kHz 10V/m, 80% Am at 1kHz Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances:
d=0.35 ;
d=1.2 80 MHz to 800 MHz:
d=1.2 800 MHz to 2.7 GHz:
d=2.3 P P P P where, P is the maximum output power rating of the
according to the transmitter manufacturer, d is the recommended separation distance in
strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level b in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
a NOTE 1 NOTE 2 absorption and reflection from structures, objects and people. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by a telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
EMC GUIDANCE Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
communications equipment. Rated maximum output power of transmitter
Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
=d 3.5 P
=d 1.2 P 2.3=d P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d transmitter, where P transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. EMC GUIDANCE EMC GUIDANCE Table 5 Guidance and manufacturers declaration - electromagnetic immunity
Test Frequency
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment. Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicatio
TEST LEVEL
27 GMRS 460 FRS 460 380-390 TETRA 430-470
IMMUNITY 450 400 385
0.3 0.3 1.8 28 2 Pulse
18Hz
deviation 1kHz sine Pulse
217Hz Pulse
18Hz Pulse
217Hz Pulse
217 Hz Pulse
217 Hz 710 745 780 810 870 930 1720 1845 1970 704-787 LTE Band 13, 17 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 1700-
1990 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 WLAN 802.11 a/n 2450 2400-
2570 5100-
5800 5240 5500 5785 0.2 2 2 2 0.3 0.3 9 28 0.3 28 0.3 28 0.2 0.3 9 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
IEC 61000-4-3.
not represent actual modulation, it would be worst case. The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
E=
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-12-19 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-12-19
|
||||
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
|
||||
1 |
Zhongshan, Guangdong, 528437
|
|||||
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 |
TMB1583BS
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K****** T****
|
||||
1 | Title |
R&D Director
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
q******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
k**** x******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
0755-********
|
||||
1 | Fax Number |
0755-********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
J******** S******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
0755-********
|
||||
1 | Fax Number |
0755-********
|
||||
1 |
J******@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 |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
K******** X******
|
||||
1 | Telephone Number |
+86 (********
|
||||
1 |
K******@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 | 0.0018000 |
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