version:1.0 Doc. No.: 202206V0 User Manual Blood Pressure Monitor TMB-1597-G Arm Type 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 Model: TMB-1597-G. Please read the user manual carefully and thoroughtly so as to ensure the safe usage of this product,Keep the manual well for further reference in case you have problems. Table of Contents INTRODUCTION..................................................................................................................2 CATALOGUE General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Setting up MEASUREMENT................................................................................................................10 Tie the Cuff Start the Measurement Recall the Records INFORMATION FOR USER...............................................................................................14 Tips for measurement Maintenances 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 ATHORIZED COMPONENT................................................................................................20 CONTACT INFORMATION.................................................................................................20 FCC STATEMENT...............................................................................................................21 EMC GUIDANCE................................................................................................................22 1 INTRODUCTION Safety Information The signs below 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 Symbol for TYPE BF APPLIED PARTS Symbol for MANUFACTURE DATE Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for ENVIRONMENT 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 advice Symbol for DIRECT CURRENT Symbol for RECYCLE For indoor use only Symbol for Class II Equipment Caution: These notes must be observed to prevent any damage to the device. MR Unsafe This device is not intended to operate in Magnetic Resonance environment. Do not take the device into MR environments. INTRODUCTION General Description Thank you for selecting TRANSTEK blood pressure monitor
(TMB-1597-G). 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-1597-G 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:
73mm49 mm Digital LCD display E-MTC wireless communication 3rd technonoly: Measuring during inflation 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 22 cm to 45 cm. It is intended for adult indoor use only. Patient is an intended operator. Contraindications 1.The device should not be used by any person who may be suspected of,or is pregnant . 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. 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 atmosphere 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 self-use in public areas.
* 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.
* Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
* 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.
* Please check that the operation of the device do not result in prolonged impairment of patient blood circulation.
* Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during 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.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
* Warning: Sensor degradation or looseness may reduce performance of device or cause other 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 properly.
* 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 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). Please contact manufacturer or distributor for authorized service personnel.
* 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 choking or strangulation if used improperly.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural detergent. Do not use alcohol, benzene, or other harsh chemicals.
* 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.
* Dispose of accessories, detachable parts, and the device according to the local guidelines.
* The service life of the device is two years or 10000 times measurements, whichever comes first.
* The service life of the AC adaptor (model: BLJ06L060100P-U) is three years.
* In the way of powering the device with 4*AA Kendal Alkaline batteries, the batteries can remain effective for about 70 days considering 3 measurements and 3 history record checks per day in average. problems. 4 5 INTRODUCTION LCD display signal SYMBOL DESCRIPTION EXPLANATION Systolic pressure High blood pressure Diastolic pressure Low blood pressure Pulse display Pulse in beats per minute Memory mmHg Low battery Indicate it is in the memory mode and which group of memory it is. Measurement Unit of the blood pressure Batteries are running low and need to be replaced. Current Time Year/Month/Day, Hour : Minute Irregular heartbeat Blood pressure level indicator Heartbeat 4G network Blood pressure monitor is detecting an irregular heartbeat during measurement. Indicate the blood pressure level. Blood pressure monitor is detecting a heartbeat during measurement. Indicate the current network status. Data transmitting Data pending to transmit The average value The average value of the latest three records INTRODUCTION Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve UP BUTTON DOWN BUTTON START/STOP BUTTON DC POWER SOCKET Monitor Components CUFF AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY List 1.Blood Pressure Monitor
(TMB-1597-G) 2.Cuff (Type BF applied part)
(22cm~45cm) BATTERY COMPARTMENT 3. 4AA batteries 4. AC Adapter
(BLJ06L060100P-U)
(Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) 5.User manual 6.Quick guide 7.Storage pouch 6 7 BEFORE YOU START BEFORE YOU START AC adapter powered mode:
The Choice of Power Supply 1. Battery powered mode:
6V DC 4AA batteries 2. 6V 1A
(Please use the AC adapter which authorized by the manufacturer!). Please unplug the adapter to depart from the using utility power, when you finish the measurement. CAUTION AC adapter In order to get the best effect and protect your monitor,please use the right battery and special power adapter which complies with local safety standard. Installing and Replacing the Batteries Open the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the battery cover. Replace the batteries whenever the below happens The shows The display is dim The display does not light up. CAUTION Do not use new and used batteries together. Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines. Setting up 1. Every time when you insert or replace batteries into the device, it will start network connection, the device will try to connect to the network for 5 minutes. As shown on the right, it indicates that it is looking for a network. 2. If the connection is successful, the LCD will display do nE, and it will turn off after 10 seconds automatically. 3. If the device fails to connect the network within 5 minutes, it will dispaly E6 and then turn off automatically. It will still try to connect to the network next time when it is turned on. 8 9 MEASUREMENT Tie the cuff 1. 2. 3. Remove all jewelry, such as watches and bracelets from your left arm. Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. Hold your arm with your palm facing up and 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. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery. 2~3cm MEASUREMENT Start the Measurement When the monitor is off, press START/STOP button to turn on the monitor, and it will finish the whole measurement automatically. 1. Adjust the zero. Inflating and measuring. 4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first measurement. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. The patient must relax as much as possible and do not move and talk during the measurement procedure. The cuff should maintain at the same level as the right atrium of the heart. Please sit comfortably. Do not cross your legs and keep your feet flat on the ground. Keep your back against the backrest of the chair. 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. 5. 6. 10 Display and save the measurement results.
(The data is pending to be transmitted.) 11 MEASUREMENT MEASUREMENT 2. After finishing the measurement, the data transmission starts. If successful, the symbol and will disappear , and the LCD will display SE nt. Press START/STOP button to turn off the device, otherwise it will power off automatically. Recall the Records 1. When the monitor is off, press the UP or DOWN BUTTON, it will display the latest record first. 2. Press the UP or DOWN BUTTON to get the record you want. Each press the UP BUTTON, it will dispaly the record by one in a cycling manner (MEM 01-02-03-...-AVG). Each press the DOWN BUTTON, it will dispaly the record by one in a cycling manner (MEM 01-AVG-...-03-02). Tips:
1. You can press START/STOP button at any time to stop measuring during the process of measurement. 2. If the measurement result is out of the measurement range (SYS:
60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display E4 + OUt . 3. If an irregular heartbeat was detected during the reading, the regular heartbeat detector indicator will appear on the display. See page 15 for more information on the irregular heartbeat detector feature. 12 The date, time and year of the record will be shown alternately. The corresponding date is April 15th. The corresponding time is A.M. 09:36. The corresponding year is 2022. 3 If there is no record, the LCD will display --
like the right picture. Note:
1. The user can store maximum 60 groups of record. When you pass that limit, every time you take the measurement, the oldest record will be dropped from the list after the measurement. 2. When there are only two records, it will show the average value of these two records. 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. In the case of single patient multiple uses, its recommended to clean the device surface once a month or whenever its necessary. In the case of multiple users multiple uses, its recommended to clean the device every time before and after usage. Maintenance procedures shall be taken as per instruction. Within 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. Within 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 14 Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.
*Clean device surface with a soft, dry cloth only if needed. If necessary use a dampened cloth and neutral detergent. Do not use alcohol, benzene, or other harsh chemicals. 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 Normal Elevated High Blood Pressure
(Hypertension) Stage 1 Systolic mmHg (upper#) less than 120 120-129 130-139 High Blood Pressure
(Hypertension) Stage 2 140 or higher Diastolic mmHg (lower#) less than 80 less than 80 80-89 90 or higher and and or or 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 device is measuring systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. 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%, then the irregular heartbeat symbol will appear on the display with the measurement result. CAUTION 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. 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. 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 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. 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. 16 17 TROUBLE SHOOTING 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 No power Display will not light up. Low batteries Display is dim or show E 1 shows E 2 shows E 3 shows Error message Batteries are exhausted. Replace with new batteries. Batteries are inserted incorrectly. Insert the batteries correctly. Adapter is inserted incorrectly. Insert the AC adapter correctly. Batteries are low. Replace with new batteries The cuff is too tight or too loose. Refasten the cuff and then measure again. The monitor detected motion while measuring. The measurement process does not detect the pulse signal. Movement can affect the measurement.Relax for a moment and then measure again. Loosen the clothing on the arm and then measure again. E 4 + OUt shows Out of measurement range Relax for a moment and then measure again. E 5 shows E 6 shows EEx,shows on the display. Abnormal communication with server or fails to transmit data. Cannot connect to NTP servers Try a place with better signal, or contact customer service. Contact customer service. Hardware error
(x can be some digital symbol, such as 1, 2, 3, etc.) Turn off monitor and measure again. If EEx still appears on the display, please contact the retailer or our customer service. 18 Power supply Display mode Measurement mode Measurement range Accuracy Battery powered mode: 6VDC 4AA batteries AC adapter powered mode: 6V 1A Input: AC 100-240 V; 50/60 Hz; 0,2 A Max.;
Output: DC 6,0 V; 1,0 A
(Please only use the recommended AC adapter model). Blue LCD with white backlight V.A.73mm49mm Oscillographic testing mode Rated cuff pressure:
0mmHg~299mmHg Measurement pressure:
SYS: 60mmHg~230mmHg DIA: 40mmHg~130mmHg Pulse value: (40-199)beat/minute Pressure:
5-40within3mmHg Pulse value:5%
Normal working condition Storage & transportation condition 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 Temperature:-20C to +60C A relative humidity range of 93%, non-condensing, at a water vapour pressure up to 50hPa An atmosphere pressure range of:
700hPa to 1060 hPa Measurement perimeter of the upper arm About 22cm~45cm Weight Approx.255g(Excluding the batteries and cuff) External dimensions Approx.118mm126mm72mm Attachment 4AA batteries, adapter, user manual, quick guidestorage pouch Mode of operation Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Device Classification Battery Powered Mode:
Internally Powered ME Equipment AC Adapter Powered Mode:
Class II ME Equipment Software Version A01 19 ATHORIZED COMPONENT FCC STATEMENT General Environment
- home use, not intended for professional use
- indoor use only
- not for use in shower, bath tub or sink Conditions of visibilit Ambient luminance range: 100 Ix to 1500 Ix Background sound pressure level 50 dB in the range of 100 Hz 8 kHz Frequency of use Once a year to up to 3 times a day Mobility Hand held medical device to be used on a resting patient WARNING: No modification of this equipment is allowed. Athorized Component Please use the TRANSTEK authorized adapter. Adapter Type: BLJ06L060100P-U Input: 100-240V, 50-60Hz, 0.2A max Output:
6V 1000 mA 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. FCC Statement FCC ID: OU9TMB-1597-G 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:
To maintain compliance with FCC's RF Exposure guidelines, this equipment should be installed and operated with minimum distance 20cm between the radiator and your body: Use only the supplied antenna. 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 Website: http://www.transtekcorp.com 20 21 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 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. Table 1 Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance 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 EMC GUIDANCE 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 U T 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 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 800-960 1700-
1990 710 745 780 810 870 930 1720 1845 1970 2450 2400-
2570 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 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 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 5240 5500 5785 Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 Compliance level
(V/m) 27 28 9 2 2 2 0.3 28 28 0.3 28 28 0.3 28 28 0.2 0.3 9 9 24