Transtek Medical Electronics TMB1490-B Blood Pressure Monitor User Manual TMB 1490 BT
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor TMB 1490 BT
TMB-1490-BT User Manual
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 2797358 |
| Application ID | CeNWoHZpu6ThUsQMuo4Ktw== |
| Document Description | TMB-1490-BT User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 106.34kB (1329258 bits) |
| Date Submitted | 2015-10-29 00:00:00 |
| Date Available | 2016-02-16 00:00:00 |
| Creation Date | 2015-10-29 15:14:48 |
| Producing Software | GPL Ghostscript 9.0 |
| Document Lastmod | 2015-10-29 15:14:48 |
| Document Title | TMB-1490-BT User Manual.pdf |
| Document Creator | PDFCreator Version 1.2.0 |
| Document Author: | ferry-al |
Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Arm Type TMB-1490-BT Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1490-BT. Blood Pressure Monitor User Manual version:1.0 TROUBLESHOOTING.......................................................................................................21 SPECIFICATIONS..............................................................................................................22 AUTHORIZED COMPONENT ...........................................................................................23 CONTACT INFORMATION.................................................................................................23 COMPLIED STANDARDS LIST..........................................................................................24 FCC STATEMENT...............................................................................................................25 EMC GUIDANCE................................................................................................................26 ABOUT BLOOD PRESSURE.............................................................................................19 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? INFORMATION FOR USER...............................................................................................17 Tips for measurement Maintenances DATA MANAGEMENT........................................................................................................15 Recall the Records Delete the Records MEASUREMENT................................................................................................................12 Tie the Cuff Start the Measurement BEFORE YOU START..........................................................................................................6 The Choice of Power Supply Installing and Replacing the Batteries Measurement Principle Setting Date, Time and Measurement Unit Pair-up the Blood Pressure Monitor with Your Device INTRODUCTION..................................................................................................................2 General Description Indications for Use Safety Information LCD Display Signal Monitor Components Table of Contents CATALOGUE F1 For indoor use only Symbol for âClass II Equipmentâ Symbol for âIncluding RF transmitterâ 7$9Ä &&& The Bluetooth Combination Mark Symbol for âENVIRONMENT 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 adviceâ Symbol for âTYPE BF APPLIED PARTSâ Symbol for âMANUFACTURE DATEâ Symbol for âDIRECT CURRENTâ Symbol for âSERIAL NUMBERâ Symbol for âMANUFACTURERâ Symbol for âTHE OPERATION GUIDE MUST BE READâ The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Safety Information The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging IURPFPWRFP DERXWĂ´Ăòà RUFPWRFP DERXWĂ´Ăòà It is intended for adult indoor use only. Indications for Use Features: 60.5 mmĂ92.5 mm Digital LCD display Maximum 60 records per each user 3rd technonoly: Measuring during inflation (The updated technology in the world) Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1490-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-1490-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. General Description INTRODUCTION 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 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 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. 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. 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 arm and 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/AC adaptor 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 patientâs 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 be 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. 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.â The patient is an intended operator. The patient can measure under normal circumstances and maintain the device and its accessories according to the user manual. The blood pressure monitor, and the cuff are suitable for use within the patient environment. If you are allergic to dacron or plastic, please donât use this device. Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fata. If Luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel. The device is not suitable for public use. The device is not intended for PATIENT transport outside a healthcare facility. This device cannot be used with HF surgical equipment at the same time. Be careful to strangulation due to cables and hoses, particularly due to excessive length. INTRODUCTION mmHg kPa Pul/min SYMBOL CUFF air is exhausting of deflating The displayed measurement values is from the memory. Deflating Memory The grade of the blood pressure Grade Bluetooth icon The average value The average value of the latest three records The bluetooth icon blinks when the bluetooth is working Heartbeat detection during the measurement Start measurement,save and transmit the measuring results for User B User B Heartbeat Start measurement,save and transmit the measuring results for User A User A Month/Day/Year, Hour/Minute Irregular heartbeat Arrhythmia Current Time Batteries are low and need to be replaced Low battery mmHg Measurement Unit of the blood pressure (1kPa=7.5mmHg) Measurement Unit of the blood pressure (1mmHg=0.133kPa) Beats per minute, BPM Pulse per minute kPa Low pressure result Diastolic blood pressure EXPLANATION STOP High pressure result Pul/min START Systolic blood pressure DESCRIPTION TIME/DATE MEMORY LCD display signal INTRODUCTION 3. 4ĂAAA batteries 1.Blood Pressure Monitor (TMB-1490-BT) List LCD DISPLAY AIR CONNECTOR PLUG AIR HOSE CUFF 67$57Â6723%87721 SET BUTTON BATTERY COMPARTMENT USER SWITCH MEM BUTTON 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve 4.User manual 5. AC Adaptor (Model: KH0601000UW) Component list of pressure measuring system 2.Cuff (Type BF applied part) (22cm~32cm or 22cm~42cm) Monitor Components INTRODUCTION AC adaptor shows 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. The old batteries are harmful to the environment, do not dispose with other daily trash. Remove batteries if the device is not likely to be used for some time. CAUTION The display does not light up The display dims The Replace the batteries whenever the below happen  Open the battery cover.  Install the batteries by matching the correct polarity, as shown.  Replace the cover. Installing and Replacing the Batteries In order to get the best effect and protect your monitor,please use the the right batteries and special power adaptor which complies with U.S. safety standard. CAUTION the using utility power. Please unplug the adaptor to depart from 6V 1A (Please only use the recommended AC adaptor model). 2.AC adaptor powered mode: 6VDC 4ĂAAA batteries 1.Battery powered mode: The Choice of Power Supply BEFORE YOU START 1: 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 arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the upper arm on the side of a mastectomy. 2. Do not apply the cuff over a wound, otherwise it can cause further injury. 3. 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. 4. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT. 5: Donât kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. CAUTION when the difference of the time intervals is over 25%. displays a warning signal with the reading to indicate the detection of irregular heartbeat pulse waves to mean time interval then calculates standard deviation. The device will oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. The device also compares the longest and the shortest time intervals of detected pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure Before every measurement, the unit establishes a âzero pressureâ equivalent to the air This product uses the Oscillometric Measuring method to detect blood pressure. Measurement Principle BEFORE YOU START 2.Press the âMEMâ to change the [YEAR]. Each press will increase the numeral by one in a cycling manner. 1.When the monitor is off, hold pressing âSETâ for 3 seconds to enter the mode for year setting. TIME/DATE MEMORY TIME/DATE MEMORY Pul/min Pul/min STOP START STOP START It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :2000â2050 time format:12 H/24H) Setting Date, Time and Measurement Unit BEFORE YOU START Pul/min STOP START TIME/DATE MEMORY Pul/min START STOP START STOP Pul/min TIME/DATE Pul/min Pul/min MEMORY TIME/DATE MEMORY TIME/DATE MEMORY 5.Repeat steps 2 and 3 to set the [TIME FORMAT] between 12h and 24h. TIME/DATE MEMORY 4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. 3.When you get the right year, press âSETâ to set down and turn to next step. STOP START STOP START BEFORE YOU START Pul/min STOP START Pul/min STOP STOP TIME/DATE Pul/min START START MEMORY Pul/min STOP TIME/DATE Pul/min START MEMORY TIME/DATE MEMORY 8.After the unit is set,the LCD will display âdOnEâfirst,then display all the settings you have done and then it will turn off. TIME/DATE MEMORY 7.Repeat steps 2 and 3 to set the [UNIT]. TIME/DATE MEMORY 6.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. BEFORE YOU START STOP START Bluetooth Module No.: AW2540MV1 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -1 dBm Supply Voltage: 2V-3.6 V Transmitting Distance: 10 meters 3.The monitor will shut off after Pair-up process is complete. will be shown on the LCD. If FAIL, only bluetooth symbol If SUCCEED, symbol will be shown on the LCD. 2.When the monitor is OFF, press and hold the START/STOP button to start pair-up. The bluetooth symbol will blink, indicating pair-up is proceeding. 1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. Pair-up the Blood Pressure Monitor with Your Device BEFORE YOU START Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician. 4.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 arm supported. 3.Sit comfortably with your tested arm resting on a flat surface. 2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 1.Tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Tie the cuff MEASUREMENT 2~3cm Pul/min STOP START TIME/DATE MEMORY Pul/min STOP START Inflating and measuring. TIME/DATE MEMORY LCD display Pul/min STOP START TIME/DATE MEMORY Pul/min STOP START Display and save the measurement result. TIME/DATE MEMORY Adjust to zero. 1.Before you start the measurement, switch the User button to select the user between User A and User B. Switch to right to select User A, switch to left to VHOHFW8VHU%:KHQWKHPRQLWRULVRIISUHVVWKHÂł67$57Â6723EXWWRQWRWXUQ on the monitor, and it will finish the whole measurement,save and transmit the measurement data for the desired user. (Take User A for example.) Start the Measurement MEASUREMENT TIME/DATE MEMORY TIME/DATE MEMORY TIME/DATE MEMORY STOP START Pul/min Pul/min Pul/min Tips: Maximum 60 records are both for User A and User B. 43UHVVWKHÂł67$57Â6723´WRSRZHU off, otherwise it will turn off within 1 minute. If the data transmission fails, the LCD will display â Err â instead. 3.If the data is successfully transmitted, the LCD will then display âdOnEâ. 2.This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting. MEASUREMENT STOP START STOP START STOP START Pul/min The current No. is No 2. STOP START The corresponding date is January 6th. TIME/DATE MEMORY TIME/DATE MEMORY STOP START STOP The corresponding time is P.M. 10:08. Pul/min Pul/min START 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. CAUTION 3. If you want to look over another userâs data, switch the User button to select the desired user. Then you can look over its historical records. The date and time of the record will be shown alternately. TIME/DATE MEMORY 2. Press the âMEMâ or âSETâ to get the record you want. 1. When the monitor is off, please press the âMEMâ,it will display the latest record first when the records are less than three groups. When there are three or more than three groups ,it will display the average value of the latest three records first. Recall the Records DATA MANAGEMENT 4. If there is no record. Press âMEMâ button, the right display will show. 3.If you donât want to delete the records, press âSTART/STOPâ to escape. 2.Press âSETâ to confirm deleting and the monitor will turn off. 1.Hold pressing âMEMâ for 3 seconds when the monitor is in the memory recall mode ,the flash display âdEL ALLâ will show. TIME/DATE MEMORY STOP START TIME/DATE MEMORY TIME/DATE MEMORY Pul/min Pul/min Pul/min STOP START STOP START STOP START If you did not get the correct measurement, you can delete all results for the selected user by following steps below. Delete the Records DATA MANAGEMENT In a very cold environment Within 20 minutes after taking a bath Within 1 hour after dinner or drinking When you want to discharge urine When talking or moving your fingers Immediate measurement after tea, coffee, smoking Measurements may be inaccurate if taken in the following circumstances. Tips for Measurement INFORMATION FOR USER CAUTION 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 doesnât need to be calibrated within the 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 the SERVICE PERSONNEL of Transtek. Donât 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. Donât use any abrasive or volatile cleaners. Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. Avoid dusty and unstable temperature environment Avoid intense shaking and collisions Using wet cloths to remove dirt Avoid touching water, clean it with a dry cloth in case. Put in a dry place and avoid the sunshine In order to get the best performance, please follow the instructions below. Maintenance INFORMATION FOR USER Diastolic blood entering vein relax Systolic blood discharging artery press 140-159 160 or higher High Blood Pressure (Hypertension) Stage 1 High Blood Pressure (Hypertension) Stage 2 Hypertensive Crisis (Emergency care needed) Higher than 180 or 120-139 or or or and less than 120 Normal Prehypertension Systolic mmHg (upper#) Higher than 110 100 or higher 90-99 80-89 less than 80 Diastolic mmHg (lower#) This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. CAUTION 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. Irregular Heartbeat Detector 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. CAUTION SYS 135 mm Hg DIA 85 mm Hg AHA Home Guideline for Upper Limit of Normal BP The chart on the right is the standard blood pressure classification published by American Heart Association (AHA). What is the standard blood pressure classification? When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. What are systolic pressure and diastolic pressure? ABOUT BLOOD PRESSURE It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. Is the result the same if measuring on the right arm? The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the âwhite coatâ effect, which means blood pressure usually increases in clinical settings. Why do I get a different blood pressure at home compared to the hospital? 3.Wait at least 3 minutes for another measurement. 1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. 2.If the person takes medicine, the pressure will vary more. If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down. What you need to pay attention to when you measure your blood pressure at home: Why does my blood pressure fluctuate throughout the day? ABOUT BLOOD PRESSURE Error massage Display is dim or shows Low batteries EExx,shows on the display. Err 21 shows Err 20 shows Err 10 or Err 11 shows Err 3 shows Err 2 shows Err 1 shows Err shows Display will not light up. No power PROBLEM SYMPTOM REMEDY Replace with new batteries Insert the batteries correctly Insert the AC adaptor tightly A calibration error occurred. The pressure of the cuff is excess. The monitor detected motion,talking or the pulse is too poor while measuring. The measurement process does not detect the pulse signal. The treatment of the measurement failed. The cuff is very tight Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions. Relax for a moment and then measure again. Relax for a moment and then measure again. Loosen the clothing on the arm and then measure again. Relax for a moment and then measure again. Refasten the cuff and then measure again. Data communication has Check if the App/Bluetooth is on or not,try data failed. transmission again. Refasten the cuff and then The cuff is not secure. measure again. Batteries are low. Batteries are inserted incorrectly. AC adaptor is inserted incorrectly. Batteries are exhausted. Replace with new batteries CHECK THIS 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. TROUBLESHOOTING IP21 V01 Protection against ingress of water Software Version WARNING: No modification of this equipment is allowed. Type BF applied part Continuous operation 4ĂAAA batteries,user manual Approx.140mmĂ130mmĂ49.7mm Approx.248g(Excluding the dry cells and cuff) Mode of operation Degree of protection Attachment External dimensions Net Weight About 22cm~32cm or 22cm~42cm Storage & transportation condition Measurement perimeter of the upper arm Temperature:-20â-60â Relative Humidity: 10%RH-93%RH Atmospheric Pressure: 50kPa-106 kPa Normal working condition Pressure: 5Ä-40ÄwithinÂą0.4kPa(3mmHg) pulse value:Âą5% Rated cuff pressure: 0kPa - 40kPa (0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg) pulse value: (40-199) beat/minute Oscillographic testing mode Battery powered mode: 6VDC 4ĂAAA batteries AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model). Digital LCD V.A.60.5 mmĂ92.5 mm Temperature:5Ä to 40Ä 5HODWLYHKXPLGLW\ Â5+ Atmospheric pressure: 86kPa to 106kPa Accuracy Measurement range Measurement mode Display mode Power supply SPECIFICATIONS Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China 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. Contact Information &RQIRUPVWR8/FHUWLILFDWH $GDSWHU 7\SHËKH0601000UW ,QSXWË100~240VAC, 50/60Hz, 0.3A Max 2XWSXWË6V 1A authorized adapter. 1please use the TRANSTEK Authorized Component AUTHORIZED COMPONENT 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 Software life-cycle processes 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 Electromagnetic compatibility IEC 60601-1: 2005+A1ďź2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 1041: 2008 Medical equipment manufacturers to provide information User manual General Requirements for Safety ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements ISO/EN 14971:2012 Medical devices â Application of risk management to medical devices Labeling Risk management Complied Standards List COMPLIED STANDARDS LIST 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. 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. 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. FCC ID:OU9TMB1490-B 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 (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) 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. 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 EMC Guidance EMC GUIDANCE
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.4 Linearized : No Page Count : 15 XMP Toolkit : XMP toolkit 2.9.1-13, framework 1.6 About : 59570405-80ab-11e5-0000-62a93c7c4aa0 Producer : GPL Ghostscript 9.0 Keywords : () Modify Date : 2015:10:29 15:14:48+00:00 Create Date : 2015:10:29 15:14:48+00:00 Creator Tool : PDFCreator Version 1.2.0 Document ID : 59570405-80ab-11e5-0000-62a93c7c4aa0 Format : application/pdf Title : TMB-1490-BT User Manual.pdf Creator : ferry-al Description : () Author : ferry-al Subject :EXIF Metadata provided by EXIF.tools