Version:1.0 User Manual Blood Pressure Monitor TMB-1580-BT Wrist Type 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-1580-BT. To use the monitor correctly and safely, please read the manual thoroughly. Please keep this manual well in order to reference in future. CATALOGUE CATALOGUE INTRODUCTION ............................................................... 2 General Description Indications for Use Safety Information LCD Display Signal Monitor Components BEFORE YOU START .......................................................... 5 Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT ...............................................................12 Tie the Cuff Select the User ID Start the Measurement DATA MANAGEMENT
.......................................................... 16 Recall the Records Delete the Records INFORMATION FOR USER..................................................... 18 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE.................................................... 20 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 wrist?
TROUBLESHOOTING ......................................................... 22 23 SPECIFICATIONS ............................................................. CONTACT INFORMATION ...................................................... 24 FCC STATEMENT 24 COMPLIED STANDARDS LIST
..................................................................... 26 EMC GUIDANCE ......................................................27 1
............................................................. INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1580-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-1580-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:
Systolic blood pressure Diastolic blood pressure Pulse rate 60 records per each user Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5-8 ). It is intended for adult indoor use only. 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 The Bluetooth Combination Mark Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE 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 Including RF transmitter Caution: These notes must be observed to prevent any damage to the device. 2 Symbol for KEEP DRY CAUTION This device is intended for adult use only. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician. If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation. To avoid measurement errors, carefully read this manual before using the product. 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. The operator shall not touch output of batteries and the patient simultaneously. Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RFequipment) that radiates interference signal or electrial fast transient/ burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patients wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential alergic reaction or contact injury. The device doesnt need to be calibrated whith the two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result. This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown. Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal. Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: too frequent and consecutive multiple measurements; the application of the CUFF and its pressurization on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the wrist on the side of a mastectomy. Do not apply the cuff over a wound, otherwise it can cause further injury. Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT. Dont kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers. 3 INTRODUCTION LCD Display Signal Monitor Components SYMBOL DESCRIPTION Systolic blood pressure Diastolic blood pressure Pulse Shocking remainding Low battery kPa mmHg Irregular heartbeat EXPLANATION High pressure result Low pressure result Pulse/minute; heartbeats/minute Shocking will result in inaccurate Batteries are low and need to be replaced Measurement unit of the blood pressure
(1kPa=7.5mmHg) Measurement unit the blood pressure
(1mmHg=0.133kPa) Irregular heartbeat detection Current time Month/Day/Year,Hour/Minute LCD DISPLAY GRADE TIME MEM BUTTON Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff. BATTERY COMPARTMENT INTRODUCTION SYSTOLIC DIASTOLIC PULSE RATE SET BUTTON START/STOP BUTTON CUFF
(Type BF applied part) Grade Heartbeat User 1 User 2 The grade of the blood pressure Heartbeat detection during the measurement Start measurement and save the measuring results for user 1. Start measurement and save the measuring results for user 2. 4 List 1) Blood Pressure Monitor TMB-1580-BT 2) 2AAA batteries 3) User manual 5 BEFORE YOU START BEFORE YOU START Installing and Replacing the Batteries
.Slide off the battery cover. Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2 x AAA batteries). Replace the cover. 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.
(year :20142054,time format:24 H/12 H) 1. When the monitor is off, hold pressing S button for about 3 seconds to set the time format. 2. Press the M button to change the [TIME FORMAT] between 12 hours and 24 hours. 3. When you get the right time format, press S button to confirm your selection and it will turn to the next step. 7 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. 6 BEFORE YOU START BEFORE YOU START 4.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE]. 7.Repeat steps 2 and 3 to confirm the [MEASUREMENT UNIT]. 5.Then the monitor diverts to date format setting. Select the date format. Repeat steps 2 and 3 to confirm the date format between DM and MD. 8.After confirming the meausrement unit, the LCD will display dOnE and then turn off. 6.Repeat steps 2 and 3 to confirm the [MONTH] , [DAY] and [YEAR]. 8 9 BEFORE YOU START BEFORE YOU START 4 .The monitor will shut off automatically 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:
2 V to 3.6V Transmitting Distance: 10 meters 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 START/STOP button about 3 seconds to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. 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, symbol will be shown on the LCD. 10 11 MEASUREMENT MEASUREMENT Tie the Cuff 1.Remove all accessories (watch, bracelet, etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. 2.Roll or push up your sleeve to expose the skin. 3.Apply the cuff to your wrist with your palm facing up. 4. Position the edge of the cuff about 1-1.5cm. 5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. 6. 7. Sit comfortably with your tested wrist resting on a flat surface. Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the heart;
Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported. Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. The patient must relax as much as possible and do not talk during the measurement procedure. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same wrist, or as directed by a physician. Select the User ID Before you start the measurement, please select the desired user ID first. 1.When the blood pressure monitor is off, press and hold the MEM button until the user ID blinks. Then press M button to change the user ID between user 1 and user 2. Press S button to confirm your selection. 2. After confirming the user ID, the LCD will turn off. Then you can start your measurement now. 12 13 MEASUREMENT Start the Measurement DATA MANAGEMENT 1.When the monitor is off, press 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. 2. This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting. Inflating and measuring. Display and save the result. If the data transmission fails, lights all the time. If the data transmission succeeds, the LCD will display User ID+ + . 14 15 3. Press 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. DATA MANAGEMENT Recall the Records 1. When the monitor is off, press M button to show the average value of the latest three measurement records. (Take User 1 for example.) 2. Press M button or S button to get the record you want. The date and time will display alternately. The corresponding time is 9:10. The corresponding date is May 11 .th 3. If you want to check the other users measurement records, please press START/STOP button to turn off the blood pressure monitor. Then press and hold M button to enter the selecting user mode, press M again to change the user, when the desired user ID blinks, press S button to confirm. Then press M button to check the records of the selected user. 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. 16 DATA MANAGEMENT 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. In the memory mode, hold pressing M button for 3 seconds, the flash display User ID+ dEL All will show. 2.Press S to conf irm deleting , the LCD displays dEL dOnE and the monitor will turn off. Note: To exit out of delete mode without deleting any records, press START/STOP button before pressing S to confirm any delete commands. 3.If there is no record. the right display will show. 17 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. Wait at least 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. Wait at least 20 minutes after taking a bath When talking or moving your fingers Avoid intense shaking and collisions Avoid dusty and unstable-
temperature environment In a very cold environment When you want to discharge urine CAUTION Using wet cloths to remove dirt Avoid washing the cuff If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of TRANSTEK. Dont open or repair the device by yourself. Please report to TRANSTEK if any unexpected operation or events occur. 19 18 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE Diastolic blood entering vein Systolic blood discharging artery What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure. What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classification published by American Heart Association
(AHA). This chart reflects blood pressure categories defined by American Heart Association. Systolic mmHg (upper#) Diastolic mmHg (lower#) Blood Pressure Category less than 120 less than 80 press relax Normal and 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 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. 20 1. Individual blood pressure varies Why does my blood pressure fluctuate throughout the day?
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 wrist?
It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time. What you need to pay attention to when you measure your blood pressure at home:
If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the wrist. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down. 21 TROUBLESHOOTING SPECIFICATIONS This section includes a list of error messages and frequently asked questions for problems you may encounter with your wrist 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 is dim or will not light up. Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly Low batteries Show on the display Batteries are low. E 1 shows Data communication is failed. Err 1 shows The cuff is too loose. Error massage Err 2 shows The cuff is very tight Err 3 shows The pressure of the cuff is excess. EExx,shows on the display. A calibration error occurred. Replace with new batteries Check if the Bluetooth function of the smartphone is on or it is during the range of distance Refasten the cuff and then measure again. Refasten the cuff 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. 22 Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Battery powered mode:
2*AAA batteries (3V DC) Digital LCD V.A.35mm46mm 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 Storage & transportation condition Temperature:-20 to 60 Relative humidity: 10%RH to 93%RH Atmospheric pressure: 50kPa to 106kPa Measurement perimeter of the wrist Net Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification About 13.5cm-21.5cm Approx.120g(Excluding the dry cells) Approx.64mmx90mmx57mm (Exclude the cuff) 2*AAA batteries,user manual Continuous operation Type BF applied part IPX0 V01 Internally Powered ME Equipment WARNING: No modification of this equipment is allowed. 23 CONTACT INFORMATION 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 FCC Statement FCC ID: OU9TMB1580-B Label 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. FCC STATEMENT FCC Statement 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. To assure continued compliance, any changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate this equipment. Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and it also complies with Part 15 of FCC RF Rules. CAUTION:
To comply with the limits of the Class B digital device, pursuant to Part 15 of the FCC Rules, this device is comply with Class B limits. All peripherals must be shielded and grounded. Operation with non-certified peripherals or non-shielded cables may results in interference to radio or reception. MODIFICATION:
Any changes or modifications not expressly approved by the grantee of this device could void the users authority to operate the device. 24 25 COMPLIED STANDARDS LIST EMC GUIDANCE Complied Standards List 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) 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 ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers 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