Andon Health 557BT Blood Pressure Monitor User Manual KD 557BT

Andon Health Co., Ltd Blood Pressure Monitor KD 557BT

User Manual

iHealth® Wireless Blood Pressure Monitor (KD-557BT) OWNER’S MANUAL Table of Contents INTRODUCTION ................................................................................................................. 1 PACKAGE CONTENTS ...................................................................................................... 1 INTENDED USE .................................................................................................................. 1 CONTRAINDICATION ......................................................................................................... 1 PARTS AND DISPLAY INDICATORS ................................................................................ 2 SET UP REQUIREMENTS .................................................................................................. 2 SET UP PROCEDURES ...................................................................................................... 3 BATTERY LOADING .......................................................................................................... 3 MEASUREMENT PROCEDURES ...................................................................................... 4 TAKING YOUR BLOOD PRESSURE READING ................................................................ 5 DISPLAYING STORED RESULTS ..................................................................................... 6 DELETING MEASUREMENTS FROM THE MEMORY ....................................................... 6 SPECIFICATIONS ............................................................................................................... 7 GENERAL SAFETY AND PRECAUTIONS ........................................................................ 8 TROUBLESHOOTING ........................................................................................................ 9 CARE AND MAINTENANCE ............................................................................................ 11 WARRANTY INFORMATION ............................................................................................ 11 EXPLANATION OF SYMBOLS ........................................................................................ 12 CONTACT AND CUSTOMER SERVICE .......................................................................... 13 IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................. 13 OTHER STANDARDS AND COMPLIANCES ................................................................... 14 ELECTROMAGNETIC COMPATIBILITY INFORMATION ................................................ 16
第 1 页 共 16 页INTRODUCTION Thank you for selecting the iHealth Wireless Blood Pressure Monitor. The iHealth Wireless Blood Pressure Monitor is a fully automatic arm cuff blood pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your mobile device or is alone to test, track and share vital blood pressure data. PACKAGE CONTENTS  1 iHealth Wireless Blood Pressure Monitor  1 Owner’s Manual  1 Travel Bag  1 Arm Cuff INTENDED USE The iHealth Wireless Blood Pressure Monitor (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the standard cuff circumference is 8 21/32”~11 13/16”(22cm~30cm). Note: Consult your physician for proper interpretation of blood pressure results. CONTRAINDICATION It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure Monitor.
第 2 页 共 16 页 PARTS AND DISPLAY INDICATORS SET UP REQUIREMENTS The iHealth Wireless Blood Pressure Monitor is designed to be used with the following iPod touch, iPhone and iPad models: iPhone 4+ iPad mini + iPad Air iPad 2+ iPod touch (5th generation)+ The iOS version of these devices should be V6.0 or higher. The iHealth Wireless Blood Pressure Monitor is also compatible with a number of Android devices, the Android version should be V4.0 or higher, and RAM should be 1.0G or more. For a complete list of compatible devices, please visit the support page on www.ihealthlabs.com CufLCD START MEM button Blood Pressure Level Classification Irregular Heartbeat Low Battery Diastolic Pressure/ Pulse Rate Ready to inflate Systolic PressureMemory
第 3 页 共 16 页 SET UP PROCEDURES Download the Free iHealth MyVitals App For iOS device: Prior to first use, download and install “iHealth MyVitals” from the App Store. For Android device: Prior to first use, download and install “iHealth MyVitals” from the Google Play. Follow the on-screen instructions to register and set up your personal account. Access the iHealth Cloud Account Your iHealth account also gives you access to the free and secure iHealth cloud service. Go to www.ihealthlabs.com and click “Sign In” for access once your account has been created. BATTERY LOADING a. Open battery cover at the back of the monitor. b. Load four “AA” size batteries. Please pay attention to polarity. c. Close the battery cover. When LCD shows battery symbol , replace all batteries with new ones. Rechargeable batteries are not suitable for this monitor. Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of battery leakage. Avoid the battery fluid to get in your eyes. If it should get in your eyes, immediately rinse with plenty of clean water and contact a physician. The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage. Connect to iOS Device via Bluetooth  Apply the cuff and press the START button to test.  Turn Bluetooth "On" under the "Settings" menu on the iOS device.  Wait until the model name printed on the monitor, (i.e. "KD-557BT xxxxxx") and "Not Paired" appear in the Bluetooth menu, and select the model name "KD-557BT xxxxxx" to pair and connect. The Bluetooth indicator will remain steady upon successful connection. When using the monitor for the first time, it may take up to 30 seconds for your iOS device to detect the Bluetooth signal.  Each subsequent time you use the monitor, "Not Connected" will be displayed next to "KD-557BT xxxxxx" in the Bluetooth Menu.  Launch the “iHealth MyVitals” app to start using your monitor.  Please repeat these steps when you switch to another iOS device with the Monitor.
第 4 页 共 16 页Connect to Android Device via Bluetooth  Apply the cuff and press the START button to test.  In the setting menu, turn the Bluetooth on.  When using the monitor for the first time, you should pair the monitor to the Android device. Wait until the model name printed on the monitor, (i.e. "KD-557BT xxxxxx") appears in the Bluetooth menu, and select the model name "KD-557BT xxxxxx" to pair. it may take up to 30 seconds for your Android device to detect the Bluetooth signal.  Launch the “iHealth MyVitals” app to start using your monitor.  Please repeat these steps when you switch to another Android device with the monitor. MEASUREMENT PROCEDURES Blood pressure can be affected by the position of the cuff and your physiologic condition. It is very important that the cuff is positioned at your heart level during blood pressure measurements. Body Posture Sitting Comfortably During Measurement a. Sit with your feet flat on the floor without crossing your legs. b. Place your hand palm-side up in front of you on a flat surface such as a desk or a table c. The center of the cuff should be at your heart level. Lying Down During Measurement a. Lie on your back. b. Place your arm straight along your side with your hand palm-side up. c. The cuff should be level with your heart. Note: Blood pressure can be affected by the position of the cuff and your physiologic condition, so it is important that you always measure your blood pressure in the same position. Apply the Cuff a. Pulling the cuff end through the medal loop (the cuff is packaged like this already), turn it outward (away from your body) and tighten it and close the Velcro fastener. b. Place the cuff around a bare arm 1-2cm above the elbow joint. c. While seated, place palm upside in front of you on a flat surface such as a desk or table. Position the air tube in the middle of your arm in line with your middle finger. d. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger between your arm and the cuff.
第 5 页 共 16 页Note: a.Please refer to the cuff circumference range in “SPECIFICATIONS” to make sure that the appropriate cuff is used. b.Measure on the same arm each time. c.Do not move your arm, body, or the monitor and do not move the rubber tube during measurement. d.Stay still, calm for 5 minutes before blood pressure measurement. e.Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clear it by hand in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it. Clean the cuff after the usage of every 200 times is recommended. TAKING YOUR BLOOD PRESSURE READING a. Press the START button to start off-line measurement when disconnected with iOS device. If connected with iOS device.your monitor can be controlled by ios device b. A beep is heard and all display characters are shown for self-test. See picture 6. Please contact the service center if segment is missing. Picture 6 Picture 6-1 Picture 6-2 c. Then the current memory bank (U1 or U2) is blinking. See picture 6-1. Press “MEM” button to change over to other bank. See picture 6-2. Confirm your selection by pressing “START” button. The current bank can also be confirmed automatically after 5 seconds with no operation. d. After selecting the memory bank, the monitor starts to seek zero pressure. See picture 6-3. Picture 6-3 Picture 6-4 Picture 6-5 e. The monitor inflates the cuff until sufficient pressure has built up for a measurement. Then the monitor slowly releases air from the cuff and carries out the measurement. Finally the blood pressure and pulse rate will be calculated and displayed on the LCD screen separately. Irregular heartbeat symbol (if any) will blink. See picture 6-4&6-5. The result will be automatically stored in the current memory bank. f. After measurement, the monitor will turn off automatically after 1 minute of no operation. Alternatively, you can press the “START” button to turn off the monitor manually or control your monitor to test again by your app. g. During measurement, you can press the “START” button to turn off the monitor manually. Note: Please consult a health care professional for interpretation of pressure measurements.
第 6 页 共 16 页DISPLAYING STORED RESULTS a. After the measurement, you can review the measurements in the current memory bank by pressing button “MEM”. b. Press “START” button to change over to other bank. See picture 7. Confirm your selection by pressing “MEM” button. The current bank can also be confirmed automatically after 3 seconds with no operation. Picture 7 Picture 7-1 Picture 7-2 picture 7-3 c. After selecting the memory bank, the LCD will display the most recent result in this bank, See picture 7-1 &7-2. If no result stored, LCD will show dashes as picture 7-3. d. Followed by, the blood pressure and pulse rate will be shown separately. Irregular heartbeat symbol (if any) will blink. Press “MEM” button again to review the next result. In this way, repeatedly pressing the “MEM” button displays the respective results measured previously. e. When displaying the stored results, the monitor will turn off automatically after 1 minute of no operation. You can also press the button “START” to turn off the monitor manually. DELETING MEASUREMENTS FROM THE MEMORY When any result is displaying, keeping on pressing button “MEM” for three seconds, all results in the current memory bank will be deleted after three “beep”. LCD will show picture 8, Press the button “MEM” or “START”, the monitor will turn off. Picture 8 Remember to: 1.Make sure that the appropriate cuff size is used; refer to the cuff circumference range in the Specifications section of this manual. 2. Stay still during measurement. Do not move your arm, body or the monitor. 3. Stay still and calm for one to one and half minutes before taking a blood pressure measurement. Prolonged over-inflation of the bladder may cause bruises of your arm. 4. Keep the cuff clean. Cleaning the cuff after every 200 measurements is recommended.If the cuff becomes dirty, clean it with a moistened cloth. Do not rinse the monitor or cuff with running water. Press the “START” button at any time to turn off the monitor. Note: Physical activity, eating, drinking, smoking, excitement, stress, and many other factors influence blood pressure results.
第 7 页 共 16 页Auto Connect Option The auto connect option allows the monitor to find the last used iOS device and re-establish the connection automatically. The auto connect option can be enabled in the App. Taking Measurements with Multiple iOS Devices Turn off the Bluetooth of the last used iOS device if the Auto Connect option is enabled in your App, then follow the Set Up Instructions in the Quick Start Guide. Measuring Without an iOS Device Enable the Offline Measurement function on the App. Apply the cuff, follow the “Measurement Procedures”, and then press the “START” button to begin measurement. All offline measurements will be uploaded to the App automatically upon the next successful Bluetooth connection. For answers to frequently asked questions, please visit www.ihealthlabs.com SPECIFICATIONS 1. Product name: Wireless Blood Pressure Monitor 2. Model: KD-557BT 3. Classification: Internally powered, Type BF applied part,IPX0,No AP or APG, Continuous operation 4. Machine size: 136 mm ×100 mm × 65mm(5 11/32” x 3 15/16” x 2 9/16”) 5. Cuff circumference: 22cm~30cm(8 21/32”~11 13/16”) 6. Weight: about 236g (8 5/16 oz.) (exclude batteries and cuff) 7. Measuring method: oscillometric method, automatic air inflation and measurement 8. Memory volume: 2x60 times with time and date stamp 9. Power source: batteries: 4 ×1.5V SIZE AA 10. Measurement range: Cuff pressure: 0-300mmHg Systolic: 60-260mmHg Diastolic: 40-199mmHg Pulse rate: 40-180 beats/minute 11. Accuracy: Pressure: ±3mmHg Pulse rate: ±5% 12.Environmental temperature for operation: 10℃～40 (℃50℉～104 )℉ 13.Environmental humidity for operation: 15%～85% RH 14.Environmental temperature for storage and transport: -20℃～55 (℃-4℉～131 )℉ 15.Environmental humidity for storage and transport: ≤90% RH 16.Environmental pressure: 80kPa-105kPa 17.Battery life: Approx.360 times. 18.All components belonging to the pressure measuring system, including accessories: Pump,Valve, LCD, Cuff, Sensor
第 8 页 共 16 页 Note: These specifications are subject to change without notice. GENERAL SAFETY AND PRECAUTIONS 1. Read all of the information in the Owner’s Manual and other provided instructions before operating the unit. 2. Consult your physician for any of the following situations: a)The application of the cuff over a wound or inflamed area. b)The application of the cuff on any limb with intravascular access or therapy, or an arterio-venous (A-V) shunt. c)The application of the cuff on the arm on the side of a mastectomy. d)Simultaneous use with other medical monitoring equipment on the same limb. e)The blood circulation of the user needs to be checked. 3. Do not use this product in a moving vehicle as this may result in inaccurate measurements. 4. Blood pressure measurements determined by this product are equivalent to those obtained by professional healthcare practitioners using the cuff/stethoscope auscultation method within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometer. This device is also clinically validated according to the 2010 Protocol of the European Society of Hypertension(ESH 2010). 5. If you are using a smart phone to operate the device and a phone call comes in during the measurement, the measurement process will be terminated automatically. It is thus recommended that the phone be set in Airplane mode during measurement to avoid interrupting the measurement. 6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed. Under this condition, the Wireless Blood Pressure Monitor can keep functioning, but the results may be inaccurate. Please consult your physician for accurate assessment. The IHB symbol will be displayed under 2 sets of circumstances: 1) The coefficient of variation (CV) of pulse period >25%. 2) The difference of adjacent pulse period is ≥0.14s and more than 53 percent of the total number of pulses readings falls within this definition. 7. Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate measurements. 8. For information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference,please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor should be operated at least 10 metres away from electric or wireless devices (e.g. routers, microwave oven, etc.) 9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in part SPECIFICATIONS, the app will immediately display a technical alarm on the screen. In this case, repeat the measurement ensuring that the proper measurement procedures are followed and/or consult with your medical
第 9 页 共 16 页 professional.The technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical alarm is assigned as low priority according to IEC 60601-1-8. The technical alarm does not need to be reset. This Wireless Blood Pressure Monitor is designed for adults and should never be used on infants, young children, pregnant or pre-eclamptic patients. Consult your physician before use on Children. This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges. Please do not share the cuff with any infectious person to avoid cross-infection. TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION LCD shows low battery symbol Low Battery Change the battery LCD shows “Er 0” or APP display reads “ERROR” Pressure system is unstable before measurement Don’t move and try again. LCD shows “Er 1”or APP display reads “ERROR” Fail to detect systolic pressure LCD shows “Er 2”or APP display reads “ERROR” Fail to detect diastolic pressure LCD shows “Er 3”or APP display reads “ERROR” Pneumatic system blocked or cuff is too tight during inflation Apply the cuff correctly and try again LCD shows “Er 4”or APP display reads “ERROR” Pneumatic system leakage or cuff is too loose during inflation LCD shows “Er 5””or APP display reads “ERROR” Cuff pressure above 300mmHg Measure again after five minutes. If the monitor is still abnormal, please contact the local distributor or the factory. LCD shows “Er 6””or APP display reads “ERROR” More than 3 minutes with cuff pressure above 15 mmHg LCD shows “Er 7””or APP display reads “ERROR” EEPROM accessing error LCD shows “Er 8””or APP display reads “ERROR” Device parameter checking errorLCD shows “Er A””or APP display reads “ERROR” Pressure sensor parameter error Bluetooth connection unstable Bluetooth connection unsuccessful, monitor is abnormal, or strong electromagnetic interference is present Reset iOS/Android device and take out batteries for five minutes, and then reinstall all batteries.. Make sure the monitor and iOS/Android device are away from other electrical equipment. Please see GENERAL SAFETY
第 10 页 共 16 页ANDPRECAUTIONS No response Incorrect operation or strong electromagnetic interference Take out batteries for five minutes, and then reinstall all batteries.
第 11 页 共 16 页 CARE AND MAINTENANCE 1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use. 2. It is recommended that product performance be checked every 2 years or after each repair. Please contact the iHealth Customer Service Center to do so. 3. No monitor component needs to be maintained by the user. The circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of the equipment which are designated for repair can be supplied by the iHealth technical department. 4. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water, diluted disinfectant alcohol, or diluted detergent. 5. The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years of usage, and the cuff integrity is maintained after 1,000 open-close cycles. 6. It is recommended that if the cuff is used in a hospital or a clinic, it be disinfected twice a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff. Do not drop this monitor or subject it to strong impact. Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this will result in damage to the monitor. Do not attempt to disassemble this monitor. Battery replacement should only be performed by a qualified iHealth technician. To do otherwise will void your warranty and possibly damage your unit. Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise will possibly damage your unit. WARRANTY INFORMATION The iHealth Wireless Blood Pressure Monitor is warranted to be free from defects in materials and workmanship within one year from the date of purchase when used in accordance with the provided instructions. The warranty extends only to the end user. We will, at our option, repair or replace without charge the iHealth Wireless Blood Pressure Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty.
第 12 页 共 16 页EXPLANATION OF SYMBOLS Symbol for “TYPE BF APPLIED PARTS” (Cuff only) Symbol for ”THE OPERATION GUIDE MUST BE READ” The sign background color: blue The sign graphical symbol: White Symbol for “ENVIRONMENTAL PROTECTION – Electrical products should not be disposed of with household waste. Please recycle at appropriate facilities exist. Check with your local authority or retailer for recycling advice”. Symbol for “KEEP DRY” Symbol for “WARNING” Symbol for “MANUFACTURER” Symbol for “SERIAL NUMBER” Symbol for “EUROPEAN REPRESENTATIVE” Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS” iHealth is a trademark of iHealth Lab Inc. “Made for iPod”, “Made for iPhone”, and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. EC REP
第 13 页 共 16 页EC REP CONTACT AND CUSTOMER SERVICE Manufactured for iHealth Lab Inc. iHealth Lab Inc. 719N . Shoreline Blvd.,Mountain View, CA 94043, USA Tel:+1-855-816-7705 www.ihealthlabs.com iHealthlabs Europe 3 Rue Tronchet,75008,Paris,France Tel:+33-144-940-488 www.ihealthlabs.com ANDON HEALTH CO., LTD. No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China Tel: 86-22-60526161 IMPORTANT INFORMATION REQUIRED BY THE FCC This device complies with Part 15 of the FCC Rules. Its 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. Changes or modifications not expressly approved by iHealth Lab Inc. would void the user’s authority to operate the product. Note: This product 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 product 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 product 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. This product complies with Industry Canada. IC: RSS-210 IC NOTICE This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. This product is approved in accordance to R&TTE directive transmitter.
第 14 页 共 16 页OTHER STANDARDS AND COMPLIANCES The Wireless Blood Pressure Wrist Monitor corresponds to the following standards: IEC 60601-1:2005+C1:2006+C2:2007(Medical electrical equipment – Part 1: General requirements for safety); IEC 60601-1-2:2007 (Medical electrical equipment – Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility - Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems); AAMI/ANSI 80601-2-30：2009/IEC 80601-2-30：2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers). ELECTROMAGNETIC COMPATIBILITY INFORMATION Table 1 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration - electromagnetic emissions The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or the user of the KD-557BT should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The KD-557BT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The KD-557BT is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic immunity The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or the user of the KD-557BT should assure that it is used in such an environment. IMMUNITY test IEC 60601test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency (50/60 Hz) magnetic field 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
第 15 页 共 16 页IEC 61000-4-8 commercial or hospital environment. Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration - electromagnetic immunity The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or the user of the KD-557BT should assure that it is used in such an environment. IMMUNITY test IEC 60601test level Compliance level Electromagnetic environment - guidance Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the KD-557BT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance： 80 MHz to 800 MHz 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KD-557BT is used exceeds the applicable RF compliance level above, the KD-557BT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, Pd 2.1Pd 3.2
第 16 页 共 16 页such as re-orienting or relocating the KD-557BT. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the KD-557BT The KD-557BT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KD-557BT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KD-557BT as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0,01 0.12 0.12 0.23 0,1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Pd 2.1Pd 2.1Pd 3.2

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