Transtek Medical Electronics LS802-E02 Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor Users Manual
Users Manual
Version:1.0 User Manual Blood Pressure Monitor LS802-E Arm Type FCC ID:OU9LS802-E02 GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China Thank you very much for selecting TRANSTEK Blood Pressure Monitor LS802-E. To use the monitor correctly and safely, please read the manual thoroughly. please keep well this manual in order to reference in future. CATALOGUE CATALOGUE Table of Contents INTRODUCTION ..............................................................................................................................2 General Description Safety Information LCD Display Signal Monitor Components BEFORE YOU START......................................................................................................................6 The Choice of Power Supply Installing and Replacing the Batteries MEASUREMENT..............................................................................................................................8 Tie the Cuff Start the Measurement INFORMATION FOR USER ...........................................................................................................10 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.........................................................................................................12 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why my blood pressure is varies even in one day? Why the blood pressure I get from the hospital is different from home? If the result is the same if measuring on the right arm? TROUBLESHOOTING ...................................................................................................................14 SPECIFICATIONS..........................................................................................................................15 AUTHORIZED COMPONENTS ....................................................................................................16 CONTACT INFORMATION.............................................................................................................16 FCC STATEMENT...........................................................................................................................17 COMPLIED STANDARDS LIST.....................................................................................................18 EMC GUIDANCE............................................................................................................................19 INTRODUCTION INTRODUCTION CAUTION General Description Thank you for selecting TRANSTEK arm type blood pressure Monitor (LS802-E). The monitor features blood pressure measurement, pulse rate measurement and the the result storage. The design provides you with two years of reliable service. Reading taken by the LS802-E 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 instruction for using the product. Read the manual thoroughly before using the product. Features: 92*78mm Blue LCD display with white backlight Maximum 60 records per each user Measuring during inflation technology Safety Information The below signs 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” Wireless Transmission F1 Symbol for “TYPE BF APPLIED PARTS” Symbol for “MANUFACTURE DATE” Symbol for “MANUFACTURER” Symbol for “DIRECT CURRENT” Symbol for “SERIAL NUMBER” Symbol for “Class II Equipment” For indoor use only Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please follow local guidelines.” T1A/250V Φ3.6*10CCC 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 arm 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 based solely 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. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please consult your physician about the result. 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 armand press the START/STOP button to stop inflation. 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 /adapter and the patient simultaneously. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical 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. This device is contraindicated for any female who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects of this device on the fetus are unknown. 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 patient’s arm 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 been impacted and reduced. During using, the patient will 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 sensization or irritation reaction. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. The device doesn’t need to be calibrated in two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself. Please report to Transtek if any unexpected operation or events occur. Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. The device has been evaluated clinically used manual cuff/stethoscope ausculation 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.” INTRODUCTION INTRODUCTION LCD Display Signal Monitor Components CUFF AIR PIPE AIR CONNECTOR PLUG LCD DISPLAY SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High pressure result DC POWER SOCKET Diastolic blood pressure Low pressure result Pulse Pulse/minute User 1 Provide measurement for user 1, and then save the measure data Guest Provide measurement for guests, but not save the measurement data. User 2 Provide measurement for user 2, and then save the measure data Data storage To remind the users that the measurement data don’t upload to bridge in time Wireless transmitter The blood monitor and Bridge in communication Network connection The bridge not connect the network Shocking remainding Shocking will result in inaccurate Low battery Batteries are low and need to be replaced Unit Measurement Unit of the blood pressure date (hour:minute) Currently time Deflating CUFF air is exhausting of deflating Arrhythmia Irregular heartbeat Heartbeat Heartbeat detection during the measurement User 2 Guest User 1 Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve BATTERY COMPARTMENT List 1.Blood Pressure Monitor (LS802-E) 2.Cuff (Type BF applied part) 3. 4*AA alkaline batteries 4.User manual (22~32cm or 22cm~42cm) 5. AC Adaptor (UE08WCP-060100SPA only!) BEFORE YOU START MEASUREMENT The Choice of Power Supply Tie the Cuff 1.Battery powered mode: 6VDC 4*AA alkaline batteries 1.Tie the cuff on your upper arm, the position the tube off-center toward the inner side of arm in line with the little finger. 2.AC adaptor powered mode: 100-240V~, 50-60HZ,400mA (Can be supplied by AC adaptor model UE08WCP-060100SPA only!) Please unplug the adaptor to depart from the using utility power. Note: The adaptor interface is located on the right side of the monitor. Place NO obstacles on the right for easy pull-off adaptor. AC adaptor CAUTION In order to get the best effect and protect you monitor,please use the right battery and special power adapter which complies with U.S. safety standard. Installing and Replacing the Batteries 1.Slide off the battery cover. 2.Install the batteries by matching the correct polarity, as shown. 3.Replace the cover. Replace the batteries whenever the below 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 battery is harmful to the environment, so please disposal with other daily trash. Remove the old battery from the device and follow your local recycling guidelines. Do not dispose of batteries in fire. Batteries may explode or leak. 2.The cuff should be sung 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. 4.Correct Posture for Patients with Hypertension, especially for Hypertension patient - 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 central of the cuff should maintain at the same level as the right atrium of the heart. 2~3cm Resting 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, on the same arm, or as directed by a physician. MEASUREMENT MEASUREMENT Start the Measurement Press the User 1 button to turn on the monitor and it will finish the whole measurement, and then save the measure data for User 1. The same to the User 2. Press the Guest button to turn on the monitor and it will finish the whole measurement for Guest, but not save the measurement data. In this manual, the measurement of User 1 as an example. 1. When the monitor is off, press the User 1 button to turn on the monitor. Adjust the zero . If the measure data don’t upload to the bridge in time, the icon LCD display When there is will display. no record 3 Please proceed to activate/synchronize before initial use of this equipment or when the measurement unit is changed. When the equipment is OFF, press and hold “GUEST” button to enter Activation / Synchronization Interface. After successful activation/synchronization, the equipment will display and transmit the measuring results after each measurement. Activation /synchroniz ation is proceeding Wireless Transmission AW4431_915 Module No. Frequency Range The measureme -nt data is uploading Supply Voltage 915 - 918.5 MHz Output Power Range The data has been uploaded successfully 3.3V +1 dBm CAUTION Inflating and measuring. Display and save the results will transmit to the bridge through the wireless. Interference may occur in the vicinity of equipment marked with the following symbol . And LS802-E may interfering vicinity electrical equipment. Sensitive people, including pregnant women and those who implanted medical electronic instruments, should avoid using the unit whenever possible. Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement. To enable the data transmission function, this product should be interconnected with Bridge in RF 915 MHz network. How to mitigate possible interference? 2. Press the User 1 to power off , otherwise it will turn off within one minute. Tips: A.when finish the whole measurement, press another button ,the blood monitor will begin measure again. B.If the blood monitor not connect with bridge, the icon of will display. Maximum 60 records are both for User 1 and User 2. 1. The range between the device and the Bridge should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and the Bridge so as to obtain quality connection and to lower the RF output range. 2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. INFORMATION FOR USER INFORMATION FOR USER Tips for measurement It can cause incorrectness if the measurement are taken in the following circumstances. 10 Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine Maintenance In order to get the best performance, please follow the below instructions. Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Avoid the intense shaking and collision Avoid the dusty and unstabletemperature environment Using the wet clothing to remove the dirt Avoid washing the cuff 11 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE 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. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification? This chart reflects blood pressure categories defined by American Heart Association. The chart on the right is the standard blood pressure classification published by American Heart Association (AHA). AHA Home Guideline for Upper Limit of Normal BP SYS 135 mm Hg DIA 85 mm Hg Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#) less than 120 and less than 80 Prehypertension 120-139 or 80-89 High Blood Pressure (Hypertension) Stage 1 140-159 or 90-99 160 or higher or 100 or higher Higher than 180 or Normal High Blood Pressure (Hypertension) Stage 2 Hypertensive Crisis (Emergency care needed) 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. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point. Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. 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, this equipment will light up the IHB symbol on the screen when displaying the measuring result. CAUTION 12 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. Why does my blood pressure fluctuate throughout the day? 1. Individual blood pressure varies every in one day, it also affected by the way you tie your cuff and the your measurement position, so please take the measurement at the same condition. 2.The varies of the pressure is greater if the person take medicine. 3.Waiting at least 3 minutes for another measurement. Why the blood pressure I get from the hospital is different from home? The blood pressure is different even during 24 hour because of the weather,emotion, exercise etc, specially the “white coat” in hospital which makes the results are higher than the ones at home. The attention need to pay when you measure you 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 pressured. You had better take deep breath 2-3 times before beginning. Advice:adjust yourself for 4-5 minutes until you calm down. If the result is the same if measuring on the right arm? It is ok for both arms, but there will be some different results for different arm, so suggest you measure the same arm every time. 13 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 No power Low batteries Display will not light up. AC adaptor is inserted incorrectly. Insert the AC adaptor tightly Display is dim or show Batteries are low. Replace with new batteries E 1 shows Check the database is RF communication failed. power on or not. E 9 shows E10 or E11 shows E20 shows E21 shows Exxx,shows on the display. 14 Batteries are exhausted. Replace with new batteries Insert the batteries correctly E 8 shows Or synchronize the data operation. Refasten the cuff and then The cuff is not secure. measure again. Failure of activating or Check if the newwork is synchronizing the network connected normally or not. Activate or register the The device is not activated or registered. device again. The monitor detected Relax for a moment and then motion,talking or the measure again. pluse is too poor while measuring. The measurement Loosen the clothing on the process does not detect arm and then measure the pulse signal. again The treatment of the measurement failed. A calibration error occurred. Display mode Digital LCD V.A.78*92mm Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure: 0kpa - 40kpa (0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg) pulse value: (40-199) beat/minute REMEDY Batteries are inserted incorrectly. E 3 shows Error massage CHECK THIS Power supply Battery powered mode: 6VDC 4*AA alkaline batteries AC adaptor powered mode: 100-240V~, 50-60HZ,400mA (Can be supplied by AC adaptor model UE08WCP-060100SPA only!) 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. Accuracy Pressure: 5℃-40℃within±0.4kpa(3mmHg) pulse value:±5% Normal working condition Temperature:5℃ to 40℃ Relative humidity ≤85% Atmospheric pressure: 86kPa to 106kPa Storage & transportation condition Temperature:-20℃-60℃ Relative Humidity 10%-93% Atmospheric Pressure: 50-106 kPa Measurement perimeter of the upper arm Net Weight External dimensions Attachment About 22cm~32cm or 22cm~42cm Approx.385g(Excluding the dry cells) Approx.120*160*69mm 4*AA alkaline batteries,user manual Mode of operation Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP21 Device Classification Battery powered mode: Internally powered ME Equipment Software Version V01 AC adaptor powered mode: CLASS II ME Euipment 15 FCC STATEMENT AUTHORIZED COMPONENTS Authorized Components 1.Please use the TRANSTEK authorized adaptor. 2.Storage bag. Adaptor Type:UE08WCP-060100SPA Input:100~240V,50~60Hz,400mA Output:6V 1A (Conforms to UL certificate) 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: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Company: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Address: Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China FCC Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 16 17 EMC GUIDANCE COMPLIED STANDARDS LIST Complied Standards list Risk management ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices Labeling ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements User manual EN 1041: 2008 Medical equipment manufacturers to provide information General Requirements for Safety 18 IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Electromagnetic compatibility 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 Performance requirements and Clinical Investigation 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 Software life-cycle processes IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes EMC Guidance 1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS 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) 19
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