User Manual

FCC ID: OU9TMB1591-B

Users Manual

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FCCID_2877849

version:1.0 User Manual Blood Pressure Monitor TMB-1591 Arm Type Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1591. To use the monitor correctly and safely, please read the manual thoroughly. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Please keep this manual well in order to reference in future. Zhongshan,528437,Guangdong,China

CATALOGUE CATALOGUE Table of Contents INTRODUCTION........................................................................................2 General Description Safety Information Indications for Use LCD Display Signal Monitor Components BEFORE YOU START................................................................................7 The Choice of Power Supply Installing and Replacing the Batteries MEASUREMENT.......................................................................................8 Pairing Tie the Cuff Start the Measurement INFORMATION FOR USER......................................................................13 Tips for measurement Maintenances ABOUT BLOOD PRESSURE....................................................................15 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..............................................................................17 SPECIFICATIONS.....................................................................................18 AUTHORIZED COMPONENT ..................................................................19 CONTACT INFORMATION........................................................................19 COMPLIED STANDARDS LIST.................................................................20 FCC STATEMENT......................................................................................21 IC STATEMENT..........................................................................................22 EMC GUIDANCE.......................................................................................23 1

INTRODUCTION INTRODUCTION General Description Safety Information The signs below might be in the user manual, labeling or other Thank you for selecting TRANSTEK arm type blood pressure component. They are the requirement of standard and using. monitor (TMB-1591). The monitor features blood pressure Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED measurement, pulse rate measurement and the result storage. GUIDE MUST BE READ” PARTS” The design provides you with two years of reliable service. Symbol for “ENVIRONMENT Readings taken by the TMB-1591 are equivalent to those PROTECTION – Electrical waste The Bluetooth Combination obtained by a trained observer using the cuff and stethoscope products should not be disposed Mark of with household waste. Please auscultation method. followlocal guidelines.” This manual contains important safety and care information, Symbol for “MANUFACTURER” Symbol for “DIRECT CURRENT” and provides step by step instructions for using the product. Read the manual thoroughly before using the product. For indoor use only Symbol for “Class II Equipment” Features: Caution: These notes must be F1 T1A/250V Φ3.6*10CCC 68mm*90mm Digital LCD display with White backlight observed to prevent any damage to the device. Maximum 99 records Measuring during inflation technology WARNING:These warning notes must be observed to preventany SN Symbol for “SERIAL NUMBER” injury to the user. Indications for Use IP22 The ingress protection: the device could protected against solid foreign objects of 12.5mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15° The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm Symbol for “KEEP DRY” circumference ranging from 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor use only. Measurement Principle WARNING 1. The device is not suitable for measuring the blood pressure of children. Ask your This product uses the Oscillometric Measuring method to doctor before using it on older children. detect blood pressure. Before every measurement, the unit 2. The device is not suitable for use on pregnant women, patients with implanted, electrocical devices, patients with pre-elcampsia, premature ventricular beats, atrial establishes a “zero pressure” equivalent to the air pressure. Then fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or it starts inflating the arm cuff, meanwhile, the unit detects pressure arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses oscillations generated by beat-to-beat pulsatile, which is used to 3.Do not take any therapeutic measures on the basis of a self measurement. Never alter determine the systolic and diastolic pressure, and also pulse rate. the dose of a medicine prescribed by a doctor. Consult your doctor if you have any The device also compares the longest and the shortest time question about your blood pressure. 4.Please keep the unit out of reach of infants, children or pets, since inhalation or intervals of detected pulse waves to mean time interval then swallowing of small parts is dangerous or even fata. calculates standard deviation. The device will display a warning 5. Do not dispose of batteries in fire. Batteries may explode or leak. signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. 2 3

INTRODUCTION INTRODUCTION LCD Display Signal 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 SYS blood pressure measurement. mmHg 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. DIA On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, mmHg 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 PULSE and injuries. /MIN 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. Don’t 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. SYMBOL DESCRIPTION EXPLANATION 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. Systolic blood pressure High pressure result 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. Diastolic blood pressure Low pressure result 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. Pulse Pulse/minute 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 mmHg Measurement Unit of the blood pressure 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. Irregular heartbeat Irregular heartbeat detection 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 Battery Indicator Indicate the current battery 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. Grade The grade of the blood pressure 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. Shocking reminder Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to Shocking will result in inaccurate 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. Data transmission error Data transmission error Please report to Manufacturer if any unexpected operation or events occur. The device doesn’t need to be calibrated in two years of reliable service. Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. The patient is an intended operator.The patient can measure and change battery under Heartbeat Heartbeat dectetion during measurement normal circumstances and maintain the device and its accessories according to the user manual. Don't press or restrict the connection tubing during measurement. The device is not intended for public use. 4 5

INTRODUCTION BEFORE YOU START Monitor Components The Choice of Power Supply CUFF 1.Battery powered mode: 6VDC 4*AA alkaline batteries (Notes: A groups of new batteries can be used about 750 times. AIR HOSE 2.AC adaptor powered mode: 6V 1A (Can be supplied by AC adaptor model UE08WCP-060100SPA !) AIR CONNECTOR PLUG Right picture is the hole in for power adaptor. LCD DISPLAY CAUTION In order to get the best effect and protect your monitor,please use the right ON/STANDBY BUTTON battery and special power adaptor. The power adapter is a part of the device. After using, please pull out the adaptor plug insulates from the main supply. Do not position the device in a position where it is difficult to disconnect from Component list of the supply mains. DC POWER SOCKET pressure measuring system 1 Cuff 2 Air pipe Installing and Replacing the Batteries 3 PCBA 4 Pump BATTERY COMPARTMENT １.Slide off the battery cover. 5 Valve ２.Install the batteries by matching the correct polarity, List as shown. 1. Blood Pressure Monitor 2. Cuff (22cm~42cm) ３.Replace the cover. (TMB-1591) (Type BF applied part) Replace the batteries whenever the below happen The shows The display dims The display does not light up 3. 4*AA alkaline Batteries 4. User manual 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. 5. AC adaptor (UE08WCP-060100SPA) Remove the old batteries from the device and follow your local recycling 6 guidelines. 7

MEASUREMENT MEASUREMENT Pairing Tie the Cuff Turn on Bluetooth and APP. Make sure both are ON when pairing is proceeding. 1.Tie the cuff on your upper arm, then position the tube off-center When the blood pressure monitor is off, press On/Standby button for toward the inner side of arm in 2 full seconds to enter bluetooth pairing mode. The symbol line with the little finger. flashes, indicating the pairing is proceeding. 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 arm resting on a flat surface. 2~3cm 4.Correct position: - Bare your arm or wear tights only when starting measurement. - Sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported. The center of the cuff should be at Then please select the user ID you want to connect with your the same level as the right atrium smartphone on the app to continute the pair-up. of the heart. If succeed, symbol will be shown. Then blood pressure monitor will turn off. Rest for 5 minutes before measuring. If fail, symbol will flash all the time until the blood pressure Wait at least 3 minutes between turns off. measurements. This allows your blood circulation to recover. For a meaningful comparison, Bluetooth Module No.: AW2540MV1 try to measure under similar RF Frequency Range: 2402 MHz to 2480 MHz conditions. For example, take daily Output Power Range: -1 dBm Supply Voltage: 2V-3.6 V measurements at approximately Transmitting Distance: 10 meters the same time, on the same upper arm, or as directed by a physician. 8 9

MEASUREMENT MEASUREMENT Start Measurement The blood pressure monitor will proceed to data transmission after measurement. The bluetooth symbol flashes on the LCD indicates When the blood pressure monitor is off, press On/Standby button to data is transmitting. turn it on, it will finish the whole measurement. LCD display Adjust to zero. After successful transfer, the device powers off the Bluetooth radio and the icon (and rectangle) are removed. If the user presses and releases the On/Standby button, another reading is initiated. Inflating and Measuring Display and save the result. If the user presses and holds the On/Standby button for 2 seconds, the device powers down. Or if there is no operation, after a 10 seconds of inactivity, the device powers down. Notes: During inflation, the heart icon in the upper left blinks in accordance with the user’s pulse rate. Additionally, during inflation the progress metre to the right of the digits builds vertically up as the pressure increases according to the table below. Segments Pressure Segments Pressure 1 >= 0 5 >= 140 2 >= 40 6 >= 160 3 >= 80 7 >= 180 4 >= 120 8 >= 200 10 11

MEASUREMENT INFORMATION FOR USER Tips for Measurement During the measurement, if you press the On/Standby button to stop Measurements may be inaccurate if taken in the the measurement, the numerics are cleared. It will display as below: following circumstances. Immediate measurement wait at least 1 hour after dinner after tea, coffee, smoking or drinking If you press and release the On/Standby button, another reading is initiated. If you press and hold the On/Standby button for 2 seconds, the device powers down. Wait at least 20 minutes after When talking or moving your fingers Or if there is no operation, after a 10 seconds of inactivity, the device taking a bath powers down. 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 oldest record (99) is In a very cold environment When you want to discharge urine dropped from the list. 12 13

INFORMATION FOR USER ABOUT BLOOD PRESSURE What are systolic pressure and diastolic Maintenance pressure? In order to get the best performance, please follow the When ventricles contract and pump blood Systolic Diastolic out of the heart, the blood pressure blood discharging blood entering instructions below. reaches its maximum value in the cycle, artery vein which is called systolic pressure. When press relax 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 This chart reflects blood pressure categories defined by American Heart Association. the standard blood pressure classification Blood Pressure Category Systolic Diastolic Avoid touching water, published by American Put in a dry place and avoid the mmHg (upper#) mmHg (lower#) clean it with a dry cloth in case. Heart Association sunshine (AHA). Normal less than 120 and less than 80 Prehypertension 120-139 or 80-89 AHA Home Guideline for High Blood Pressure Upper Limit of Normal BP (Hypertension) Stage 1 140-159 or 90-99 High Blood Pressure 160 or higher or 100 or higher SYS 135 mm Hg (Hypertension) Stage 2 DIA 85 mm Hg Hypertensive Crisis Higher than 180 or (Emergency care needed) Higher than 110 Avoid intense shaking Avoid dusty and unstable CAUTION and collisions temperature environment 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 Using wet cloths to remove dirt Avoid washing the cuff 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. 14 15

ABOUT BLOOD PRESSURE TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may Why does my blood encounter with your blood pressure monitor. If the pressure fluctuate products not operating as you think it should, check here throughout the day? before arranging for servicing. 1. Individual blood pressure varies multiple times everyday. It PROBLEM SYMPTOM CHECK THIS REMEDY is also affected by the way you tie your cuff and your measurement Batteries are exhausted. Replace with new batteries Display position, so please take the No power Batteries are inserted Insert the batteries will not light up. incorrectly. correctly measurement under the same AC adaptor is inserted Insert the AC adaptor conditions. incorrectly. tightly 2.If the person takes medicine, The display Low the pressure will vary more. indicates the Batteries are low. Replace with new batteries batteries “BAT LO” 3.Wait at least 3 minutes for message, pauses another measurement. for 3 seconds. What you need to pay The battery icon Why do I get a different attention to when you shows empty (does not flash.) measure your blood blood pressure at home Check if both the APP and pressure at home: Bluetooth are on, operate compared to the If the cuff is tied properly. Error Unsuccessful pairing. and send the data again. shows massage hospital? If the cuff is too tight or too Readjust the cuff and loose. The cuff is not secure. relax for a moment The blood pressure is If the cuff is tied on the upper E 01 shows and then measure again. different even throughout the arm. The cuff is too tight or Refasten the cuff and then day due to weather, emotion, If you feel anxious. E 02 shows the inflation is too fast. measure again. exercise etc, Also, there is the Taking 2-3 deep breaths E 03 shows The pressure of the Refasten the cuff and then “white coat” effect, which means before beginning will be better for cuff is excess. measure again. measuring. The monitor detected blood pressure usually E 10 or motion,talking or the Movement can affect the Advice: Relax yourself for 4-5 E 11 shows pluse is too poor measurement.Relax for a increases in clinical settings. minutes until you calm down. moment and then while measuring. measure again. Is the result the same if E 20 shows The measurement Loosen the clothing on process does not detect the arm and then measuring on the right the pulse signal. measure again. arm? E 21 shows Measure incorrectly. Relax for a moment and then measure again. EExx,shows on A calibration error Retake the measurement. the display. occurred. If the problem persists, It is ok for both arms, but contact the retailer or our there will be some different customer service department for further results for different people. We assistance.Refer to the suggest you measure the same warranty for contact information and return 16 arm every time. instructions. 17

SPECIFICATIONS AUTHORIZED COMPONENT Battery powered mode: Power supply 6VDC 4*AA alkaline batteries AC adaptor powered mode: Authorized Component 6V 1A １.please use the TRANSTEK (Can be supplied by AC adaptor model authorized adapter. UE08WCP-060100SPA !) Display mode Digital LCD V.A.68mm*90mm Measurement mode Oscillographic testing mode Rated cuff pressure: 0mmHg-300mmHg Measurement range Measurement pressure: SYS:60mmHg-230mmHg DIA: 40mmHg-130mmHg pulse value:(40-199)beat/minute Pressure: Adapter Accuracy 5℃-40℃ within±3mmHg Type： UE08WCP-060100SPA pulse value:±5% Input：100~240V，50~60Hz,400mA Temperature:5℃ to 40℃ Output：6V 1A Normal working condition ( Conforms to UL certificate ) Relative humidity ≤85%RH Atmospheric pressure: 86kPa to 106kPa Temperature:-20℃to 60℃ Storage & transportation Relative Humidity: 10%RH to 93%RH condition Atmospheric Pressure: 50kPa to 106 kPa Measurement perimeter of the upper arm About 22cm~42cm Ｃｏｎｔａｃｔ Ｉｎｆｏｒｍａｔｉｏｎ Net Weight Approx.300g(Excluding the dry cells) For more information about our products, please visit www.transtek.cn.you External dimensions Approx.92mm*140mm*46mm can get customer service, usual problems and customer download, transtek Attachment 4*AA alkaline batteries,user manual will serve you anytime. Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Mode of operation Continuous operation Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105 ,Dongli Road, Torch Development District, Degree of protection Type BF applied part Zhongshan,528437,Guangdong,China Protection against IP20 ingress of water Software Version V01 18 WARNING: No modification of this equipment is allowed. 19

COMPLIED STANDARDS LIST FCC STATEMENT Complied Standards List FCC Statement FCC ID: OU9TMB1591-B ISO/EN 14971:2012 Medical devices — Application of Risk management risk management to medical devices ISO/EN 15223-1:2012 Medical devices. Symbols to Labeling be used with medical device labels, labelling and This device complies with Part 15 of the FCC Rules. Operation is subject information to be supplied. General requirements to the following two conditions: (1) this device may not cause harmful EN 1041: 2008 Medical equipment manufacturers to interference, and (2) this device must accept any interference received, User manual provide information including interference that may cause undesired operation. IEC 60601-1: 2005+A1：2012 Medical electrical General Requirements equipment - Part 1: General requirements for basic safety Caution: The user is cautioned that changes or modifications not for Safety and essential performance expressly approved by the party responsible for compliance could void the IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential user's authority to operate the equipment. performance - Collateral standard: Requirements for medical electrical equipment and medical electrical NOTE: This equipment has been tested and found to comply with the systems used in the home healthcare environment IEC60601-1-11:2010 limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against Electromagnetic IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and harmful interference in a residential installation. This equipment generates, compatibility essential performance - Collateral uses and can radiate radio frequency energy and, if not installed and used standard:Electromagnetic compatibility - Requirements and tests in accordance with the instructions, may cause harmful interference to IEC 80601-2-30:2009+A1:2013 Medical electrical radio communications. However, there is no guarantee that interference Performance equipment- Part 2-30: Particular requirements for the will not occur in a particular installation. requirements and basic safety and essential performance of automated Clinical investigation non-invasive sphygmomanometers ISO81060-2 Non-invasive sphygmomanometers — If this equipment does cause harmful interference to radio or television Part 2: Clinical validation of automated reception, which can be determined by turning the equipment off and measurement type on,the user is encouraged to try to correct the interference by one or more Software life-cycle IEC/EN 62304:2006+AC: 2008 Medical device of the following measures: software - Software life cycle processes processes -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. IEC 62366 Medical devices - Application of usability Usability engineering to medical devices (IEC 62366:2007) -- Connect the equipment into an outlet on a circuit different from that to IEC 62366:2007+A1:2014 which the receiver is connected. IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1 -6 : General requirements for basic -- Consult the dealer or an experienced radio/TV technician for help. safety and essential performance - collateral standard : FCC Radiation Exposure Statement: Usability 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. 20 21

IC STATEMENT EMC GUIDANCE IC Statement EMC Guidance IC ID：12725A-TMB1591B 1) This equipment needs to be installed and put into service This device complies with Industry Canada license-exempt RSS in accordance with the information provided in the user standard(s). Operation is subject to the following two conditions: (1) this manual; device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 2) Wireless communications equipment such as wireless Le présent appareil est conforme aux CNR d'Industrie Canada applicables home network devices, mobile phones, cordless telephones aux appareils radio exempts de licence. L'exploitation est autorisée aux and their base stations, walkie-talkies can affect this deux conditions suivantes : (1) l'appareil ne doit pas produire de equipment and should be kept at least a distance d=3,3m brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage away from the equipment. radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. (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) 22 23


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Document Modified: 2015-09-07 18:50:00
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