Users Manual

FCC ID: OU9LS802-E02

Users Manual

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FCCID_2413119

Version:1.0 User Manual Blood Pressure Monitor LS802-E Arm Type FCC ID:OU9LS802-E02 Thank you very much for selecting TRANSTEK Blood Pressure Monitor GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD LS802-E. Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China 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 1

INTRODUCTION INTRODUCTION CAUTION General Description 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 Thank you for selecting TRANSTEK arm type blood pressure Monitor (LS802-E). blood pressure measurement. The monitor features blood pressure measurement, pulse rate measurement and the Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood the result storage. The design provides you with two years of reliable service. pressure.Do not begin or end medical treatment based solely physician for treatment advice. Reading taken by the LS802-E are equivalent to those obtained by a trained 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 observer using the cuff and stethoscope auscultation method. Physician. This manual contains important safety and care information, and provides step When the device was used to measure patients who have common arrhythmias such as atrial or by step instruction for using the product. ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please Read the manual thoroughly before using the product. 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 Features: 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 92*78mm Blue LCD display with white backlight anesthetic mixture with air of with oxygen or nitrous oxide. Maximum 60 records per each user The operator shall not touch output of batteries /adapter and the patient simultaneously. Measuring during inflation technology 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. Safety Information 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. The below signs might be in the user manual, labeling or other component. 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. they are the requirement of standard and using. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED 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. GUIDE MUST BE READ” PARTS” During using, the patient will contact with the cuff. The materials of the cuff have been tested and Symbol for “MANUFACTURE found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not Wireless Transmission DATE” cause any potential sensization or irritation reaction. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Symbol for “MANUFACTURER” Symbol for “DIRECT CURRENT” 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. Symbol for “SERIAL NUMBER” Symbol for “Class II Equipment” Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. For indoor use only Symbol for “ENVIRONMENT If you have any problems with this device, such as setting up, maintaining or using, please PROTECTION – Waste electrical contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself. products should not be disposed of Please report to Transtek if any unexpected operation or events occur. with household waste. Please follow Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. F1 T1A/250V Φ3.6*10CCC local guidelines.” 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.” 2 3

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 2 Guest User 1 Provide measurement for user 1, and User 1 then save the measure data Provide measurement for guests, Guest Component list of but not save the measurement data. pressure measuring system Provide measurement for user 2, and 1 Cuff User 2 then save the measure data 2 Air pipe BATTERY COMPARTMENT To remind the users that the measurement 3 PCBA Data storage 4 Pump data don’t upload to bridge in time 5 Valve Wireless transmitter The blood monitor and Bridge in communication Network connection The bridge not connect the network List Shocking remainding Shocking will result in inaccurate 1.Blood Pressure Monitor 2.Cuff (Type BF applied part) (LS802-E) (22~32cm or 22cm~42cm) 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 3. 4*AA alkaline batteries 4.User manual 5. AC Adaptor (UE08WCP-060100SPA only!) Arrhythmia Irregular heartbeat 4 Heartbeat Heartbeat detection during the measurement 5

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, 2.AC adaptor powered mode: the position the tube off-center 100-240V~, 50-60HZ,400mA toward the inner side of arm in (Can be supplied by AC adaptor model line with the little finger. UE08WCP-060100SPA only!) 2.The cuff should be sung but not Please unplug the adaptor to depart from too tight. You should be able to the using utility power. AC adaptor insert one finger between the Note: cuff and your arm. The adaptor interface is located on the right side of the monitor. Place NO obstacles on the right for easy pull-off adaptor. 3.Sit comfortably with your tested CAUTION arm resting on a flat surface. 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. 4.Correct Posture for Patients with Hypertension, especially for Installing and Replacing the Batteries Hypertension patient 2~3cm - Bare your arm or wear tights only １.Slide off the battery cover. when starting measurement. ２.Install the batteries by matching - Sit comfortably with legs the correct polarity, as shown. uncrossed, feet flat on the floor, ３.Replace the cover. back and arm supported. The central of the cuff should maintain at the same level as the right atrium of the heart. Replace the batteries whenever the below happen Resting for 5 minutes before The + shows measuring. The display dims Wait at least 3 minutes between measurements. This allows your The display does not light up blood circulation to recover. For a meaningful comparison, CAUTION try to measure under similar Remove batteries if the device is not likely to be used for some time. conditions. For example, take daily measurements at approximately The old battery is harmful to the environment, so please disposal with other daily trash. the same time, on the same arm, Remove the old battery from the device and follow your local recycling guidelines. or as directed by a physician. Do not dispose of batteries in fire. Batteries may explode or leak. 6 7

MEASUREMENT MEASUREMENT Start the Measurement Press the User 1 button to turn on the monitor and it will finish the 3 Please proceed to activate/synchronize before initial use of this equipment or when whole measurement, and then save the measure data for User 1. The the measurement unit is changed. When the equipment is OFF, press and hold same to the User 2. “GUEST” button to enter Activation / Synchronization Interface. After successful activation/synchronization, the equipment will display and transmit the measuring Press the Guest button to turn on the monitor and it will finish the whole results after each measurement. measurement for Guest, but not save the measurement data. Activation The The data In this manual, the measurement of User 1 as an example. /synchroniz measureme has been ation is -nt data is uploaded 1. When the monitor is off, proceeding uploading successfully press the User 1 button to turn on the monitor. Adjust the zero . If the measure data don’t upload to LCD display When there is the bridge in time, the icon no record will display. Wireless Transmission AW4431_915 Supply Voltage 3.3V Module No. Frequency Range 915 - 918.5 MHz Output Power Range +1 dBm CAUTION Interference may occur in the vicinity of equipment marked with the following symbol Inflating and measuring. Display and save the results will . And LS802-E may interfering vicinity electrical equipment. transmit to the bridge through the Sensitive people, including pregnant women and those who implanted medical elec- wireless. tronic 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? 1. The range between the device and the Bridge should be reasonably close, from 1 2. Press the User 1 to power off , otherwise it meter to 10 meters. Please ensure no obstacles between the device and the Bridge will turn off within one minute. so as to obtain quality connection and to lower the RF output range. 2. To avoid interference, other electronic devices (particularly those with wireless Tips: transmission / Transmitter) should be kept at least 1 meter away from the monitor. 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. 8 9

INFORMATION FOR USER INFORMATION FOR USER Tips for measurement Maintenance It can cause incorrectness if the measurement are taken in the In order to get the best performance, please follow the below following circumstances. instructions. Within 1 hour Immediate measurement Avoid touching water, after dinner or drinking after tea, coffee, smoking Put in a dry place and avoid the sunshine clean it with a dry cloth in case. Within 20 minutes after taking a bath When talking or moving your fingers Avoid the intense shaking Avoid the dusty and unstable- and collision temperature environment In a very cold environment When you want to discharge urine Using the wet clothing to remove the dirt Avoid washing the cuff 10 11

ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? Why does my blood When ventricles contract and pump blood Systolic Diastolic pressure fluctuate blood discharging blood entering out of the heart, blood pressure reaches its artery vein throughout the day? maximum value, the highest pressure in the 1. Individual blood pressure varies cycle is known as systolic pressure. When press relax every in one day, it also affected by the the heart relaxes between heartbeats, the way you tie your cuff and the your lowest blood pressure is diastolic pressure. measurement position, so please take What is the standard blood pressure the measurement at the same condition. 2.The varies of the pressure is classification? This chart reflects blood pressure categories defined by American Heart Association. greater if the person take medicine. The chart on the right is the standard Blood Pressure Category Systolic Diastolic 3.Waiting at least 3 minutes for blood pressure classification published mmHg (upper#) mmHg (lower#) another measurement. by American Heart Association (AHA). Normal and less than 80 less than 120 Prehypertension 120-139 or 80-89 Why the blood pressure The attention need to pay AHA Home Guideline for I get from the hospital when you measure you blood Upper Limit of Normal BP High Blood Pressure 140-159 or 90-99 (Hypertension) Stage 1 pressure at home: SYS 135 mm Hg High Blood Pressure 160 or higher or 100 or higher is different from home? If the cuff is tied properly. (Hypertension) Stage 2 The blood pressure is different even If the cuff is too tight or too loose. DIA 85 mm Hg Hypertensive Crisis (Emergency care needed) Higher than 180 or Higher than 110 during 24 hour because of the If the cuff is tied on the upper arm. If you feel anxious pressured. weather,emotion, exercise etc, You had better take deep breath 2-3 CAUTION specially the “white coat” in hospital times before beginning. which makes the results are higher Advice:adjust yourself for 4-5 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 than the ones at home. minutes until you calm down. your blood pressure value has reached a dangerous point. If the result is the same Irregular Heartbeat Detector if measuring on the 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 right arm? 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. It is ok for both arms, but there will be some different results for CAUTION different arm, so suggest you The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular measure the same arm every time. 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. 12 13

TROUBLESHOOTING SPECIFICATIONS This section includes a list of error messages and frequently Battery powered mode: asked questions for problems you may encounter with your blood 6VDC 4*AA alkaline batteries pressure monitor. If the products not operating as you think it AC adaptor powered mode: should, check here before arranging for servicing. Power supply 100-240V~, 50-60HZ,400mA (Can be supplied by AC adaptor model PROBLEM SYMPTOM CHECK THIS REMEDY UE08WCP-060100SPA only!) Batteries are exhausted. Replace with new batteries Display mode Digital LCD V.A.78*92mm Display will not No power Batteries are inserted Insert the batteries Measurement mode Oscillographic testing mode light up. incorrectly. correctly Rated cuff pressure: AC adaptor is inserted Insert the AC adaptor 0kpa - 40kpa (0mmHg~300mmHg) incorrectly. tightly Measurement range Measurement pressure: 5.3kPa-30.7kPa Low Display is dim (40mmHg-230mmHg) Batteries are low. Replace with new batteries pulse value: (40-199) beat/minute batteries or show Check the database is Pressure: E 1 shows RF communication failed. power on or not. Accuracy 5℃-40℃within±0.4kpa(3mmHg) Or synchronize the data pulse value:±5% operation. E 3 shows The cuff is not secure. Refasten the cuff and then Normal working condition Temperature:5℃ to 40℃ Relative humidity ≤85% measure again. Atmospheric pressure: 86kPa to 106kPa E 8 shows Failure of activating or Check if the newwork is synchronizing the network connected normally or not. Storage & transportation Temperature:-20℃-60℃ Relative Humidity 10%-93% Error The device is not Activate or register the condition E 9 shows Atmospheric Pressure: 50-106 kPa activated or registered. device again. massage Measurement perimeter The monitor detected Relax for a About 22cm~32cm or 22cm~42cm motion,talking or the moment and then of the upper arm E10 or E11 measure again. pluse is too poor shows while measuring. Net Weight Approx.385g(Excluding the dry cells) The measurement Loosen the clothing on the External dimensions Approx.120*160*69mm E20 shows process does not detect arm and then measure the pulse signal. again Attachment 4*AA alkaline batteries,user manual The treatment of the Relax for a moment and E21 shows measurement failed. Mode of operation Continuous operation then measure again. Retake the measurement. Degree of protection Type BF applied part If the problem persists, contact the retailer or our Protection against IP21 Exxx,shows on A calibration error customer service the display. occurred. department for further ingress of water assistance.Refer to the Battery powered mode: Internally powered ME Equipment warranty for contact Device Classification AC adaptor powered mode: CLASS II ME Euipment information and return instructions. Software Version V01 14 15

AUTHORIZED COMPONENTS FCC STATEMENT Authorized Components FCC Statement １.Please use the TRANSTEK 2.Storage bag. authorized adaptor. 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 Adaptor to operate the equipment. Type：UE08WCP-060100SPA Input：100~240V，50~60Hz,400mA NOTE: This equipment has been tested and found to comply with the limits for Output：6V 1A a Class B digital device, pursuant to Part 15 of the FCC Rules. (Conforms to UL certificate) 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 Contact Information 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 For more information about our products, please visit www.transtek.cn.you can get to try to correct the interference by one or more of the following measures: customer service, usual problems and customer download, transtek will serve you anytime. -- Reorient or relocate the receiving antenna. Manufactured by: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD -- Increase the separation between the equipment and receiver. Company: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD -- Connect the equipment into an outlet on a circuit different from that to which the Address: Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch receiver is connected. Development District, Zhongshan, Guangdong, 528437, China -- 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

COMPLIED STANDARDS LIST EMC GUIDANCE Complied Standards list EMC Guidance 1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions ISO/EN 14971:2012 Medical devices — Application of risk regarding EMC and needs to be installed and put into service according to Risk management management to medical devices the EMC information provided in the ACCOMPANYING DOCUMENTS ISO/EN 15223-1:2012 Medical devices. Symbols to be Labeling used with medical device labels, labelling and information to be supplied. General requirements 2. Wireless communications equipment such as wireless home network User manual EN 1041: 2008 Medical equipment manufacturers to devices, mobile phones, cordless telephones and their base stations, provide information walkie-talkies can affect this equipment and should be kept at least a General IEC 60601-1: 2005+A1：2012 Medical electrical distance d=3, 3m away from the equipment. equipment - Part 1: General requirements for basic safety and Requirements for essential performance Safety (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 Electromagnetic IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential yields d=3, 3m at an IMMUNITY LEVEL of 3V/m) compatibility performance - Collateral standard:Electromagnetic compatibility - Requirements and tests Performance IEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and requirements and essential performance of automated non-invasive sphygmomanometers Clinical Investigation ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers Software life-cycle IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes processes 18 19


Document Created: 2014-07-15 17:18:43
Document Modified: 2014-07-15 17:18:43
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