iHealth Labs BPM1 Blood Pressure Monitor User Manual BPM1AE REV

iHealth Labs Inc. Blood Pressure Monitor BPM1AE REV

Users Manual

 1iHealth® Blood Pressure Monitor (BPM1AE) OWNER’S MANUAL  Table of Contents INTRODUCTION ................................................................................................................... 2PACKAGE CONTENTS .......................................................................................................... 2INTENDED USE ................................................................................................................... 2BLOOD PRESSURE CLASSIFICATION FOR ADULTS ....................................................... 2CONTRAINDICATION .......................................................................................................... 3PARTS AND DISPLAY INDICATORS ................................................................................. 3SETUP AND OPERATING PROCEDURES ............................................................................ 3Download The Free iHealth App ....................................................................................... 3Set Wi-Fi ............................................................................................................................. 3OPERATING PROCEDURES .................................................................................................. 4Connecting The Cuff To The Monitor .................................................................... 4Apply The Cuff ............................................................................................................... 4Body Posture ................................................................................................................... 5OPERATION INSTRUCTIONS ............................................................................................. 5SPECIFICATIONS ............................................................................................................... 6GENERAL SAFETY AND PRECAUTIONS ............................................................................ 7BATTERY HANDLING AND USAGE ..................................................................................... 9TECHNICAL ALARM DESCRIPTION ................................................................................. 10TROUBLESHOOTING .......................................................................................................... 10CARE AND MAINTENANCE ................................................................................................ 12WARRANTY INFORMATION ................................................................................................ 12EXPLANATION OF SYMBOLS ........................................................................................... 13IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................... 14OTHER STANDARDS AND COMPLIANCES ........................................................................ 15ELECTROMAGNETIC COMPATIBILITY INFORMATION ................................................... 15
 2 INTRODUCTION  Thank you for selecting the BPM1AE. The BPM1AE is a fully automatic arm cuff blood pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor can transmit your measurements to iHealth cloud when it connected with wifi.    PACKAGE CONTENTS • 1 Blood Pressure Monitor • 1 Owner’s Manual • 1 Cuff • 1 Charging Cable   INTENDED USE The BPM1AE(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 cuff circumference is 8.6” to18.9’ (22cm-48cm)  BLOOD PRESSURE CLASSIFICATION FOR ADULTS The World Health Organization (WHO) has created the following guide for assessing high blood pressure (without regard to age or gender). Please note that other factors (e.g. diabetes, obesity, smoking, etc.) also need to be considered. Consult with your physician for accurate assessment.  Note: This chart is not intended to provide a basis for any type of emergency condition or diagnosis based on the color scheme; this chart
 3only depicts different classifications of blood pressure. Consult your physician for proper interpretation of blood pressure results.  CONTRAINDICATION It is not recommended for people with serious arrhythmia to use this Blood Pressure Monitor.   PARTS AND DISPLAY INDICATORS    SETUP AND OPERATING PROCEDURES  Download The Free iHealth App         Prior to first use, download and install the iHealth App from the App Store(iOS device) or Google Play(Android device). Use keyword search terms ”iHealth” , ”BPM1AE” or ”Blood Pressure Monitor”.  Set Wi-Fi Step 1: Press and hold the user2 key for 10s, the monitor will display “Open MyVitals App, ready to connect”. Step 2: Launch the App and set the Wi-Fi linking of BPM1AE with App guidance. Step 3: If the monitor connects with router, the monitor will display ”Success at once, just a moment… ”.  Step 4: If the monitor connects to cloud, the monitor will display “Wi-Fi setting is success, if the App reminder over time, please reopen the App”. Then Wi-Fi set done.
 4If Wi-FI set done, the monitor will connect to cloud at 2 hour intervals. If new version software release the monitor will updata automatic when it connect to cloud.  The monitor can sync clock with cloud automatic when it connect to cloud.  OPERATING PROCEDURES  Connecting The Cuff To The Monitor  Insert the cuff tubing connector into the air port in the side of the monitor. Make sure that the connector is completely inserted to avoid air leakage during blood pressure measurements.  Avoid compression or restriction of the connection tubing during measurement,which may cause inflation error, or harmful injury due to continuous cuff pressure.  When the monitor in turn off mode, insert the cuff tubing connector the monitor will turn on.  Apply The Cuff a.  Pull the cuff end through the metal loop, positioning it outward (away from your body). b.  Place a bare arm through the cuff and position the cuff 1/2“(1-2 cm) above the elbow joint. c.  Tighten the cuff and close it by pulling it towards your body, securing it closed with the Velcro fastener. d.  While seated, place your hand palm-side up in front of you on a flat surface such as a desk or table. Position the rubber tube in the middle of your arm aligned with your middle finger. e.  The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger between your arm and the cuff.   Remember to: 1. Make sure that the appropriate cuff size is used; refer to the cuff circumference range in “SPECIFICATIONS”. 2. Measure on the same arm each time. 3. Stay still during measurement. Do not move your arm, body, or the monitor.
 54. Stay still and calm for one to one and half minutes before taking a blood pressure measurement. 5. Keep the cuff clean. Cleaning the cuff after every 200 times of usage is recommended. If the cuff becomes dirty, clean it with a moistened cloth. Do not rinse the monitor or cuff with running water.   Body Posture Sitting Comfortably During Measurement a.  Be seated 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 table. c.  The middle of the cuff should be at the level of the right atrium of your heart.  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 placed at the same level as your heart.  Note: Blood pressure can be affected by the position of the cuff and your physiologic condition.  OPERATION INSTRUCTIONS  a.  After applying the cuff and your body is in a comfortable position, press user1 key or user2 key the the monitor will turn on and display “While measuring, please relax”. Then the monitor starts to seek zero pressure. If the cuff doesn’t connect with the monitor, press any key the door temperature, outdoor tempetature(if Wi-Fi set done) ,the battery valume and clock(if Wi-Fi set done) will display on monitor for 3 seconds, Then the monitor will turn off automatically. b.  Then the cuff will be slowly inflated. The blood pressure and pulse will be measured during inflation. Inflation will stop as soon as the blood pressure and pulse rate have been calculated and displayed on the screen. The result will automatically be stored in the Memory bank of the monitor. If memory is stored
 6in the current memory group, the machine will show the difference between the current measurement results and the latest measurement. If the monitor connect to cloud, the measurements will be transmit to cloud automatically. c.  If the monitor connect to cloud and download the outdoor remind, press any key the monitor will display the outdoor remind, otherwise press any key the monitor will turn off. d.  After measurement, the monitor will turn off automatically after 1 minute of no operation. e.  During measurement, you can press the any key to turn off the monitor manually.  Important: Please consult a healthcare professional for interpretation of blood pressure measurements   SPECIFICATIONS  1. Product name: Blood Pressure Monitor 2. Model: BPM1AE 3. Classification: Internally powered, Type BF applied part, IP20, No AP or APG, Continuous operation 4. Machine size: approx. 4.7” x 4.6” x 2.0”(119mm × 118mm × 51mm) 5. Cuff circumference: 8.6’’-11.8’’(22cm-30cm), 11.8’’-16.5’’(30cm-42cm) (Optional), 16.5’’-18.9’’(42cm-48cm) (Optional)) 6. Weight: approx. 12.3oz (350g) (excluding cuff) 7. Measuring method: Oscillometric method, automatic inflation and measurement 8. Memory volume: 2*1000 times with time and date stamp 9. Power: DC:5V  1.0A,  Battery: 1*3.7V Li-ion 2200mAh 10. Measurement range: Cuff pressure: 0-300 mmHg Systolic:     60-260 mmHg Diastolic:    40-199 mmHg Pulse rate:   40-180 beats/minute 11. Accuracy:  Pressure:    ±3 mmHg Pulse rate:   ±5%  12. Wireless communication: Wi-Fi: IEEE802.b/g/n  13. Environmental temperature for operation:    10Ԩ~40Ԩ(50Ԭ~104Ԭ) 14. Environmental humidity for operation: ≤85%RH
 715. Environmental temperature for storage and transport: -20Ԩ~50Ԩ(-4Ԭ~122Ԭ) 16. Environmental humidity for storage and transport: ≤85%RH 17. Environmental pressure: 80kPa-105kPa 18. Battery life: more than 180 measurements on a full charge 19. The blood pressure measurement system includes accessories, pump, valve, cuff, and sensor.  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. Stay still, calm and rest for 5 minutes before blood pressure measurement. 3. The cuff should be placed at the same level as your heart. 4. During measurement, neither speak nor move your body and arm. 5. Measuring on same arm for each measurement. 6. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300 mmHg or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your arm. 7. 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  8. This 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. 9. Do not use this product in a moving vehicle as this may result in inaccurate measurements. 10. 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.
 811. 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 be kept 10 meters away from other wireless devices, such as WLAN unit, cell phone, microwave oven, etc. 12. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed. Under this condition, the Blood Pressure Monitor can keep functioning, but the results may be inaccurate. Please consult your physician for accurate assessment.    There are 2 conditions under which the signal of IHB will be displayed: 1) The coefficient of variation (CV) of pulse period >25%. 2) The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than 53 percent of the total number of pulses.  13. Please do not use any other cuff other than that supplied by the manufacturer as this may result in measurement errors and a biocompatible hazard.  14. This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges. 15. Please do not share the cuff with any infectious person to avoid cross-infection. 16. This product should not be used as a USB device. 17. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this case, consult a physician or ensure that proper measurement procedures are followed. 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 is non-latching and does not need to be reset.  18. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1 and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor. Please note that the monitor jack size is USB micro-B. 19. Use of Charging Cable 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. 20. Measurements are not possible in patients with a high frequency of arrhythmias. 21. The device is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or pregnant women.) 22. Motion, trembling, shivering may affect the measurement reading.
 923. The device would not apply to the patients with poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood flow to the measurement position). 24. The device would not apply to the patients who use an artificial heart and lung (there will be no pulse) 25. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, enal diseases. 26. The patient can be an intended operator.    BATTERY HANDLING AND USAGE Do not change the battery. If the battery can no longer be charged, please contact Customer Service.  • When charging is needed, please connect the monitor to a power source. The monitor can work normally while charging. • If the cuff doesn’t connect with the monitor, press any key the door temperature, outdoor tempetature(if Wi-Fi set done) ,the battery valume and clock(if Wi-Fi set done) will display on monitor. If the power is less than 20%(the battery valume indication only display a battery symbol ), please charge the battery. The monitor will not work until the battery has enough power. • When you charge the monitor, the monitor will display with different indicator indicating the charging status. See the table below for details. • It is suggested that you charge the battery when the battery is less than 25%. Overcharging the battery may reduce its lifetime.   Lithium battery replacement by inadequately trained personnel could result in a hazard such as a fire or explosion.  Do not plug or unplug the power cord into the electrical outlet with wet hands.  If the AC adapter is abnormal, please change the adapter.   Do not pull out the adapter when you are using the monitor.   Do not use any other type of AC adapter as it may harm the monitor.
 10The monitor, cable, battery and cuff must be disposed of according to local regulations at the end of their usage.  Note:The battery has limited charge cycles and may eventually need to replaced by an iHealth service provider. Battery life and charge cycles vary by use and settings.  Monitor Status Status Indicator Charging  dynamical battery symbol Fully charged full battery symbol Low battery  empty battery symbol and reminder”Low battery unable to perform measurement, please recharge”  TECHNICAL ALARM DESCRIPTION The monitor will show 'SYS or DIA beyond measurement range' or ' SYS or DIA below measurement range'' as technical alarm on screen with no delay if the determined blood pressure (systolic or diastolic) is outside the rated range specified in part SPECIFICACIONS. In this case, you should consult a physician or check if your operation violated the instructions. The technical alarm condition (outside the rated range) is preset in the factory and cannot be adjusted or inactivated. This alarm condition is assigned as low priority according to IEC 60601-1-8. The technical alarm is non-latching and need no reset. The signal displayed on screen will disappear automatically after about 8 seconds.  TROUBLESHOOTING  PROBLEM POSSIBLE CAUSE  SOLUTION Low Battery  Battery is less than 20%  Charge the battery Display reads “ERR xxx” Blood pressure is outside of measurement rangeRetest, make sure your blood pressure is within measurement range Arm or monitor was moved during testRetest, make sure not to move your arm or the monitor The cuff does not inflate properly or pressure fallsquickly during test Review the cuff applizcation instructions and retest
 11The cuff was not properly applied or the rubber tube was bent or pressed Review the cuff application instructions and retest Display reads an abnormal result The cuff position was not correct or it was not properly tightened. Review the cuff supplication instructions and retest. Body posture was not correct during testing Review body posture instructions and retest Speaking, moving arm or body, being angry, excited or nervous during test Retest when calm; avoid speaking or movement during the test No response  Incorrect operation or strong electromagnetic interference Press the user2 key about 10 seconds to reset the device, relaunch app, and reconnect the iOS device to the monitor
 12CARE AND MAINTENANCE  1. Do not drop this monitor or subject it to strong impact. 2. Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this will result in damage to the monitor. 3. If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature before use. 4. Do not attempt to disassemble this monitor. 5. If the monitor is not used for a long time, please sure to fully charge it every month. 6. It is recommended that product performance be checked every 2 years or after each repair. Please contact the service center. 7. 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. 8. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water, diluted disinfectant alcohol, or diluted detergent 9. 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 of the closure. 10. The battery can maintain the performance characteristics for a minimum of 300 charge cycles. Battery replacement should only be performed by a qualified iHealth technician. To do otherwise will void your warranty and possibly damage your unit. 11. Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise will possibly damage your unit. 12. It is recommended that if the cuff is used, for example, 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.   WARRANTY INFORMATION The 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 Blood Pressure Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty.
 13EC REP   EXPLANATION OF SYMBOLS    Symbol for ”THE OPERATION GUIDE MUST BE READ” The sign background color:  blue. The sign graphical symbol:  white.  Symbol for “WARNING” Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)   Symbol for “ENVIRONMENT PROTECTION – Waste electrical 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 “MANUFACTURER”  Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”  Symbol for“ DATE OF MANUFACTURE”  Symbol for “SERIAL NUMBER”       Symbol for “EUROPEAN REPRESENTATIVE”    Symbol for “KEEP DRY”    iHealth is a trademark of iHealth Labs Inc.   Manufactured for iHealth Labs Inc. 719 N. Shoreline Blvd., Mountain View, CA 94043, USA  1-855-816-7705 www.ihealthlabs.com  iHealthLabs Europe SARL  3 rue Tronchet, 75008, Paris, France support@ihealthlabs.eu   www.ihealthlabs.eu   ANDON HEALTH CO., LTD. No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China EC REP
 14Tel: 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 Labs 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.  The SAR limit of USA (FCC) is 1.6 W/kg averaged over one gram of tissue. Device has also been tested against this SAR limit.  IC NOTICE  The SAR limit of Canada (IC) is 1.6 W/kg averaged over one gram of tissue. Device has also been tested against this SAR limit.  This Class B digital apparatus complies with Canadian ICES-003.   Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.  This product complies with Industry Canada. IC: RSS-247  This device complies with Industry Canada licence-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
 15undesired operation of the device. This product is approved in accordance to R&TTE directive transmitter. Hereby, [iHealth Labs Inc],declares that this BPM1AE is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Directive 1999/5/EC declaration of conformity can be downloaded on the following link: https://www.ihealthlabs.eu/support/certifications  Ce produit est conforme à l'Industry Canada. IC: RSS-247 DECLARATION IC Le présent appareil est conforme aux CNR d'Industrie Canada applicablesaux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes :  (1) l'appareil ne doit pas produire de brouillage, et  (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre lefonctionnement. Ce produit a été approuvé conformément au directives R&TTE de l'émetteur.  Par la présente, [iHealth Labs Inc.] déclare que l’appareil [BPM1AE] est conforme aux exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE. La déclaration de conformité, les documents réglementaires et certifications iHealth peuvent être consultés via ce lien : https://www.ihealthlabs.eu/support/certifications   OTHER STANDARDS AND COMPLIANCES  The Blood Pressure Monitor corresponds to the following standards:   IEC 60601-1:2005 +A1:2012(E)/EN 60601-1:2006/A11: 2011 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance), IEC 60601-1-2:2014(Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015(Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)EN 1060-1: 1995 +  A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems).  ELECTROMAGNETIC COMPATIBILITY INFORMATION  This product is applicable to the equipment and system requirements for the purpose of receiving radio frequency energy for the purpose of the work, Wi-Fi receive bandwidth 22M. This product can also be used to include RF transmitter equipment and system requirements and
 16emission frequency of 2.4GHz ISM band, Wi-Fi modulation types: DBPSK/DQPSK/CCK (DSSS) BPSK/QPSK/16QAM/64QAM (OFDM) , effective radiated power: < 20dBm Table 1 - Emission Phenomenon Compliance  Electromagnetic environment RF emissions  CISPR 11 Group 1, Class B Home healthcare environment Harmonic distortion  IEC 61000-3-2 Class A  Home healthcare environment Voltage fluctuations and flicker IEC 61000-3-3 Compliance  Home healthcare environment    Table 2 - Enclosure Port Phenomenon Basic EMC standard  Immunity test levels Home Healthcare Environment Electrostatic Discharge  IEC 61000-4-2  ±8 kV contact ±2kV, ±4kV, ±8kV, ±15kV air Radiated RF EM field  IEC 61000-4-3  10V/m 80MHz-2.7GHz 80% AM at 1kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3  Refer to table 3 Rated power frequency magnetic fields   IEC 61000-4-8  30A/m 50Hz or 60Hz   Table 3 –    Proximity fields from RF wireless communications equipment  Test frequency   (MHz)  Band (MHz)  Immunity test levels Professional healthcare facility environment 385  380-390  Pulse modulation 18Hz, 27V/m 450 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 710  704-787  Pulse modulation 217Hz, 9V/m 745 780 810  800-960  Pulse modulation 18Hz, 28V/m 870
 17930 1720  1700-1990  Pulse modulation 217Hz, 28V/m 1845 1970 2450  2400-2570  Pulse modulation 217Hz, 28V/m 5240  5100-5800  Pulse modulation 217Hz, 9V/m 5500 5785  Table 4 – Input a.c. power Port Phenomenon Basic EMC standard  Immunity test levels Home Healthcare Environment Electrical fast transients/burst  IEC 61000-4-4  ±2 kV 100kHz repetition frequency Surges Line-to-line  IEC 61000-4-5  ±0.5 kV, ±1 kV  Surges Line-to-ground  IEC 61000-4-5  ±0.5 kV, ±1 kV, ±2 kV  Conducted disturbances induced by RF fields IEC 61000-4-6  3V, 0.15MHz-80MHz 6V in ISM and amateur radio bands between 0.15MHz and 80MHz 80%AM at 1kHz Voltage dips  IEC 61000-4-11 0%    UT; 0.5 cycle At 0º, 45º,    90º, 135º, 180º, 225º, 270º and 315º 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0º Voltage interruptions  IEC 61000-4-11 0% UT; 250/300 cycles                                                      Date of issue:Jul 15,2016                                                     BPM1AE-SMSY01 V1.0

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