version:1.0 User Manual Blood Pressure Monitor TMB-1591-BS Arm Type FCC ID:OU9TMB1591B2 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1591-BS. To use the monitor correctly and safely, please read the manual thoroughly. Please keep this manual well in order to reference in future. CATALOGUE Table of Contents INTRODUCTION........................................................................................2 General Description Safety Information Indications for Use Contraindications Measurement Principle LCD Display Signal Monitor Components Pairing Tie the Cuff Start the Measurement Tips for measurement Maintenances BEFORE YOU START................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries MEASUREMENT.......................................................................................9 INFORMATION FOR USER......................................................................14 ABOUT BLOOD PRESSURE....................................................................16 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector 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..............................................................................18 SPECIFICATIONS.....................................................................................19 AUTHORIZED COMPONENT ..................................................................20 CONTACT INFORMATION........................................................................20 FCC STATEMENT......................................................................................21 EMC GUIDANCE.......................................................................................22 1 INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1591-BS). 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-1591-BS are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using the product. Read the manual thoroughly before using the product. Features:
68mm*90mm Digital LCD display with White backlight Maximum 99 records Measuring during inflation technology Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read. Symbol for Type BF applied part Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm(about 8-16). It is intended for adult indoor use only. Symbol for Recycle SN Symbol for Serial Number Symbol for Direct Current Symbol for Manufacturer Contraindications 1.The device is not suitable for use on may be pregnant women or pregnant women. 2.The device is not suitable for use on patients with implanted,electrical devices,such as cardiac pacemakers, defibrillators. Symbol for Date and Country of manufacture For indoor use only Symbol for Class II Equipment Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a zero pressure equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. 2 3 INTRODUCTION CAUTION
* This device is intended for indoor, home use.
* This device is not intended for public use.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* 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 any purpose other than obtaining a blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.
* Do not use on the women in pregnant, including pre-eclamptic, patients.
* The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.
* The effectiveness of this device has not been established for use:
-on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
-on users with peripheral arterial disease,
-on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
* If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.
* Report any unexpected operation or events to the manufacturer.
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
* Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries. frequently for irritation.
* Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site
* Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
* Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time. INTRODUCTION CAUTION
* Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
* The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
* You can use this device to take your own measurement, no third-party operator is required.
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
* The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.
* Warning: Excessive cuff tube lengths could cause strangulation if you don't manage them
* Warning: Do not touch output of the batteries/adapter and the user simultaneously.
* Adapter is specified as a part of ME EQUIPMENT.
* Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient properly. environment.
* Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
* Warning: Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
* Warning: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.
* No calibration is required within two years of reliable service.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
* At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
* It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
* Warning: Do not use the device while under maintenance, or being serviced.
* Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of
* Please check that the operation of the device do not result in prolonged impairment of patient choking or strangulation if used improperly. blood circulation.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural
* Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during detergent. Do not use alcohol, benzene, or other harsh chemicals. measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
* Dispose of accessories, detachable parts, and the device according to the local guidelines. 4 5 INTRODUCTION INTRODUCTION LCD Display Signal Monitor Components SYS mmHg DIA mmHg PULSE
/MIN SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result Pulse mmHg Pulse/minute Measurement Unit of the blood pressure Irregular heartbeat Irregular heartbeat detection Battery Indicator Indicate the current battery Grade The grade of the blood pressure Shocking reminder Shocking will result in inaccurate Data transmission error Data transmission error Heartbeat Heartbeat dectetion during measurement CUFF AIR HOSE AIR CONNECTOR PLUG ON/STANDBY BUTTON Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve List LCD DISPLAY DC POWER SOCKET BATTERY COMPARTMENT 1. Blood Pressure Monitor
(TMB-1591-BS) 2. Cuff (about 22cm~42cm)
(Type BF applied part) 3. 4*AA alkaline batteries 4. User manual 6 5. AC adaptor (UE08WCP-060100SPA) 7 BEFORE YOU START MEASUREMENT Pairing Turn on Bluetooth and APP. Make sure both are ON when pairing is proceeding. When the blood pressure monitor is off, press On/Standby button for 2 full seconds to enter bluetooth pairing mode. The symbol flashes, indicating the pairing is proceeding. The Choice of Power Supply 1.Battery powered mode:
6VDC 4*AA alkaline batteries 2.AC adaptor powered mode:
6V 1A
(Can be supplied by AC adaptor model UE08WCP-060100SPA !) Right picture is the hole in for power adaptor. CAUTION In order to get the best effect and protect your monitor,please use the right 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 the supply mains. 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. The shows The display dims The display does not light up CAUTION Replace the batteries whenever the below happen If succeed, symbol will be shown. Then blood pressure monitor will turn off. Then please select the user ID you want to connect with your smartphone on the app to continute the pair-up. 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 Remove the old batteries from the device and follow your local recycling daily trash. 8 guidelines. If fail, symbol will flash all the time until the blood pressure turns off. Bluetooth Module No.: LS51802 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -3.21 dbm Supply Voltage: 2V-3.6 V Transmitting Distance: 10 meters 9 MEASUREMENT Start Measurement When the blood pressure monitor is off, press On/Standby button to turn it on, it will finish the whole measurement. LCD display Adjust to zero. 2~3cm Inflating and Measuring Display and save the result. MEASUREMENT Tie the Cuff 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. 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. 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 the same level as the right atrium of the heart. 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, on the same upper arm, or as directed by a physician. 10 11 MEASUREMENT MEASUREMENT The blood pressure monitor will proceed to data transmission after measurement. The bluetooth symbol flashes on the LCD indicates data is transmitting. During the measurement, if you press the On/Standby button to stop the measurement, the numerics are cleared. It will display as below:
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. 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 users 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 2 3 4
>= 0
>= 40
>= 80
>= 120 5 6 7 8
>= 140
>= 160
>= 180
>= 200 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. Or if there is no operation, after a 10 seconds of inactivity, the device 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 dropped from the list. 12 13 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Maintenance In order to get the best performance, please follow the instructions below. wait at least 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Wait at least 20 minutes after taking a bath When talking or moving your fingers Avoid intense shaking and collisions Avoid dusty and unstable temperature environment In a very cold environment When you want to discharge urine Using wet cloths to remove dirt Avoid washing the cuff 14 15 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
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. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classifi-
cation published by American Heart Association (AHA). This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#) Normal Elevated High Blood Pressure
(Hypertension) Stage 1 High Blood Pressure
(Hypertension) Stage 2 less than 120 120-129 130-139 less than 80 less than 80 80-89 and and or or 140 or higher 90 or higher Hypertensive Crisis
(Consult your doctor immediately) Higher than 180 and/or Higher than 120 CAUTION Please consult a physician if your measuring result falls outside 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, the monitor records all the pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference between each interval and the average is more than the average value of 25% , or there are four or more pulse intervals ,the difference between each interval and the average is more than the average value of 15%,the irregular heartbeat symbol appears on the display when the measurement results are appear. 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. Why does my blood pressure fluctuate throughout the day?
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. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the white coat effect, which means blood pressure usually increases in clinical settings. Is the result the same if measuring on the right arm?
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. What you need to pay attention to when you measure your blood pressure at home:
If the cuff is tied properly. If the cuff is too tight or too If the cuff is tied on the upper loose. 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. 16 17 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 CHECK THIS REMEDY Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly AC adaptor is inserted incorrectly. Insert the AC adaptor tightly Batteries are low. Replace with new batteries No power Display will not light up. Low batteries The display indicates the BAT LO message, pauses for 3 seconds. The battery icon shows empty
(does not flash.) Battery powered mode:
6VDC 4*AA alkaline batteries Power supply AC adaptor powered mode:6V 1A Display mode Measurement mode Measurement range Accuracy Normal working condition
(Can be supplied by AC adaptor model UE08WCP-060100SPA !) Digital LCD V.A.68mm*90mm Oscillographic testing mode Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Pressure:
5-40 within3mmHg pulse value:5%
A temperature range of :+5C to +40C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of :
700 hPa to 1060 hPa Error message Unsuccessful pairing. shows E 1 shows The cuff is not secure. Warning message out shows Out of measurement range Check if both the APP and Bluetooth are on, operate and send the data again. Readjust the cuff and relax for a moment and then measure again. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician. Storage & transportation condition A relative humidity range of 93%, non-condensing, at a water vapour pressure up to 50hPa Temperature:-20C to +60C Measurement perimeter of the upper arm About 22cm~42cm Net Weight Approx.300g(Excluding the dry cells) External dimensions Approx.92mm*140mm*46mm Attachment 4*AA alkaline batteries,user manual,AC adapter Mode of operation Continuous operation Degree of protection Type BF applied part Protection against ingress of water Software Version IP22 V01 18 WARNING: No modification of this equipment is allowed. 19 AUTHORIZED COMPONENT FCC STATEMENT Authorized Component 1.please use the TRANSTEK authorized adapter. Adapter Type UE08WCP-060100SPA Input100~240V50~60Hz,400mA Output6V 1A
( Conforms to UL certificate ) Contact Information For more information about our products, please visit www.transtekcorp.com.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China FCC Statement FCC ID:OU9TMB1591B2 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. 20 21 EMC GUIDANCE EMC GUIDANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Dont be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-1591-BS including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2. Guidance and manufacturers declaration-electromagnetic emissions and Immunity. Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance Table 1 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /
flicker emissions IEC 61000-3-3 22 Group 1 Class [ B ]
Class A Comply Table 2 Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 2 kV for power supply lines Not Applicable 100 kHz repetition frequency Surge IEC61000-4-5 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV, 2 kV common mode 0.5 kV, 1 kV differential mode Not Applicable Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle Power frequency magnetic field IEC 61000-4-8 30 A/m 50 Hz / 60 Hz 30 A/m 50 Hz / 60 Hz Conduced RF IEC61000-4-6 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz Radiated RF IEC61000-4-3 10 V/m 80 MHz 2,7 GHz 80% AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80% AM at 1 kHz NOTE UT is the a.c. mains voltage prior to application of the test level. 23 EMC GUIDANCE EMC GUIDANCE Table 3 Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicati-
ons equipment) Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency
(MHz) Band
(MHz) Service Modulation Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) Compliance level
(V/m) 1.8 0.3 27 0.3 28 0.2 0.3 9 27 28 9 0.3 28 28 0.3 28 28 Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 2 2 2 2 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 800-960 1700-
1990 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4,25;
UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 710 745 780 810 870 930 1720 1845 1970 5240 5500 5785 2450 2400-
2570 0.3 28 28 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 9 24