Andon Health BP5 Spread Spectrum Transmitter User Manual 140100 0614 GB

Andon Health Co., Ltd Spread Spectrum Transmitter 140100 0614 GB

Manual

Wireless Blood Pressure Monitor (BP5)OWNER’S MANUALiHealthTMTable of ContentsINTRODUCTIONPACKAGE CONTENTSINTENDED USEBLOOD PRESSURE CLASSIFICATION FOR ADULTSCONTRAINDICATIONPARTS AND DISPLAY INDICATORSSET UP REQUIREMENTSSET UP PROCEDURESMEASUREMENT PROCEDURESSPECIFICATIONSGENERAL SAFETY AND PRECAUTIONSBATTERY HANDLING AND USAGETROUBLESHOOTING1111222346789CARE AND MAINTENANCEWARRANTY INFORMATIONEXPLANATION OF SYMBOLSIMPORTANT INFORMATION REQUIRED BY THE FCCOTHER STANDARDS AND COMPLIANCESELECTROMAGNETIC COMPATIBILITY INFORMATION101111121314
INTRODUCTIONThank 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 iOS devices to test, track and share vital blood pressure data. • 1 iHealth Wireless Blood Pressure Monitor• 1 Owner’s Manual• 1 Quick Start Guide• 1 Charging Cable• 1 Travel BagPACKAGE CONTENTSINTENDED USE It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure Monitor.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 only depicts different classifications of blood pressure. Consult your physician for proper interpretation of blood pressure results.CONTRAINDICATIONThe 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 cuff circumference is 8.6” to18.9”(22cm-48cm).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.BLOOD PRESSURE CLASSIFICATION FOR ADULTS160180Systolic(mmHg)Diastolic(mmHg)14013012080 85 90 100 110Severe HypertensionModerate HypertensionMild HypertensionHigh-normal BPNormal BPClassification of blood pressure for adultsBLOOD PRESSURECLASSIFICATIONSBPmmHgDBPmmHgCOLORINDICATOROptimal <120 <80 GREENNormal 120-129 80-84 GREENHigh-normal 130-139 85-89Grade 1 Hypertension 140-159 90-99GREENGrade 2 Hypertension 160-179 100-109YELLOWGrade 3 Hypertension REDORANGE≥180 ≥100WHO/ISH Definitions and Classification of Blood Pressure Levels1 2!
The iHealth Wireless Blood Pressure Monitor is designed to be used with the following iPod touch, iPhone and iPad models:iPod touch (4th generation)iPod touch (3rd generation)iPhone 4SiPhone 4iPhone 3GSiPad (3rd generation)iPad 2iPadThe iOS version of these devices should be V4.0 or higher.SET UP REQUIREMENTSPARTS AND DISPLAY INDICATORS3 4Bluetooth indicator Status indicatorSTART/STOP buttonCuffSET UP PROCEDURESNote: Please repeat step 1 when you switch an iOS device. Download the Free iHealth APPPrior to first use, download and install the iHealth App from the App Store. Use keyword search terms “iHealth”, “BP5” or ”BPM”.• Apply the cuff or press the START/STOP button, the Bluetooth Indicator Light will begin flashing.• Turn Bluetooth “On” under the “Settings” Menu (Settings->General->Bluetooth->On)• Wait until the model name printed on the monitor, (i.e. "BP5 xxxxxx") and "Not Paired" appear in the Bluetooth Menu, and select the model name “BP5 xxxxxx” to pair and connect. The Bluetooth Indicator Light 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.Connect to iOS Device Via Bluetooth• Each subsequent time you use the monitor "Not Connected" will be displayed next to “BP5 xxxxxx” in the Bluetooth Menu. Tap to re-establish the connection.
Apply the Cuffa. Pull the cuff end through the metal loop, positioning it outward (away from your body).Body PostureSitting During Measurementa. 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.MEASUREMENT PROCEDURES5 6b. Place a bare arm through the cuff and position the cuff 1/2”(1-2cm) 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 monitor in the middle of your arm aligned with your middle finger.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.4. 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. Lying Down During Measurementa. 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.During measurement, press the “START/STOP” button for 2 seconds to turn off the monitor manually.1/2”(1-2cm)ON/OFFiHealthe. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger between your arm and the cuff.
Note: Please consult a health care professional for interpretation of blood pressure measurements.Important: Please consult a healthcare professional for interpretation of blood pressure measurements.1. Product name: Wireless Blood Pressure Monitor2. Model: BP53. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous operation4. Machine size: approx. 5.7” x 2.3” x 1.2”(145mm × 58mm × 30mm)5. Cuff circumference: 8.6”-16.5”(22cm-42cm), 16.5”-18.9”(42cm-48cm) (XL size sold separately) 6. Weight: approx. 4.8oz (135g) (excluding cuff) 7. Measuring method: Oscillometric method, automatic inflation and measurement 8. Memory volume: 120 times with time and date stamp (off-line measurement only) 9. Power: DC: 5V 1.0A, Battery: 1*3.7V Li-ion 400mAh10. Measurement range: Cuff pressure: 0-300 mmHg Systolic: 60-260 mmHg Diastolic: 40-199 mmHg Pulse rate: 40-180 beats/minuteSPECIFICATIONSOperation Instructions With iOS DeviceFor detailed operating instructions, please visit http://www.ihealthlabs.com.During measurement, press the “START/STOP” button to stop measurement, press the “START/STOP” button for 2 seconds to turn off the monitor manually.Measuring without an iOS DeviceOffline measurement is enabled automatically at your first online measurement. To start offline measurement when disconnected from the iOS device, turn on the monitor by pressing the “START/STOP” button. The status indicator light will be green and the monitor will begin measure-ment. If measured successfully, the measurement will be stored in the iHealth Wireless Blood Pressure Monitor and the status indicator light will flash green. The reading is not visible until the next iOS connection. The measurement will be uploaded to the device automatically 7 8Monitor Status Bluetooth IndicatorWaiting to connect Flashing blue lightMeasuring Steady blue lightMeasurement completed Gradually extinguishing lightupon the next iOS connection. Otherwise the status indicator will be red for a moment then change to flashing green. The monitor will turn off automatically after 2 minutes of non-operation. Alternatively, you can keep on pressing the “START/STOP” button for 2 seconds to turn off the monitor manually.During measurement, press the “START/STOP” button to stop the measurement process.
Note: These specifications are subject to change without notice.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 inflamedarea. b) The application of the cuff on any limb with intravas cular 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.GENERAL SAFETY AND PRECAUTIONS9 103. 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.4. Do not use this product in a moving vehicle as this may result in inaccurate measurements.5. 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.6. 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.7. It is recommended that the iOS device be set in Airplane mode during measurement to avoid strong magnetism interference. If a call comes in during the measurement, the measurement process will be terminated automatically.8. If 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. There are 2 conditions under which the signal of IHB will be displayed: a) The coefficient of variation (CV) of pulse period >25%. b) 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. 9. Please do not use any other cuff other than that supplied by the manufacturer as this may! 18. Battery life: more than 80 measurements on a full charge19. The blood pressure measurement system includes accessories: pump, valve, cuff, and sensor11. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%12. Wireless communication: Bluetooth V3.0 + EDR Class 2 SPP Frequency Band: 2.402-2.480 GHz13. Environmental temperature for operation: 5°C~40°C(41°F~104°F)14. Environmental humidity for operation: ≤90%RH15. Environmental temperature for storage and transport: -20°C~55°C(-4°F~131°F)16. Environmental humidity for storage and transport: ≤95%RH17. Environmental pressure: 80kPa-105kPa
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.• When the monitor is connected to an iPod touch, iPhone, or iPad, the battery volume will be displayed on the iPod touch, iPhone, or iPad screen. If the power is less than 25%, pleaseBATTERY HANDLING AND USAGE1110. This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges.11. Please do not share the cuff with any infectious person to avoid cross-infection.12. This product should not be used as a USB device.13. This product is verified by auscultatory method. It is recommended that you check Annex B of ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed.14. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in 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. 15. 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, such as ASP5-05010002JU (input: 100-240V, 50/60Hz, 200mA; output: DC 5V, 1.0A). Please note that the monitor jack size is USB mini B.! ! ! result in measurement errors and a biocompatible hazard. 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.12 the battery. The monitor will not work until the battery has enough power.• When you charge the monitor, the LED will display with different colors 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.The monitor, cable, battery and cuff must be disposed of according to local regulations at the end of their usage.Monitor Status Status IndicatorCharging Flashing green lightFully charged Steady green light Low battery Flashing red light (for a few seconds)Abnormal state Steady red light
13 14 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 Customer Service. CARE AND MAINTENANCETROUBLESHOOTING! ! ! PROBLEM POSSIBLE CAUSE SOLUTIONBattery is less than 20% Charge the batteryLow BatteryBlood pressure is outside of measurement range Retest, make sure your blood pressure is within measurement rangeArm or monitor was moved during test Retest, make sure not to move your arm or the monitorThe cuff does not inflate properly or pressure falls quickly during testReview the cuff application instructions and retestIrregular heartbeat (arrhythmia) It is inappropriate for people with serious arrhythmia to use this monitor. Check with physicianThe cuff was not properly applied Review the cuff application instructions and retestDisplay reads “ERROR”The cuff position was not correct or it was not properly tightenedReview the cuff application instructions and retestIncorrect operation or strong electromagnetic interferencePress the START/STOP button about 10 seconds to reset the device, relaunch app, and reconnect the iOS device to the monitorNo responseBody posture was not correct during testing Review body posture instructions and retestSpeaking, moving arm or body, being angry, excited or nervous during testRetest when calm; avoid speaking or movement during the testBluetooth connection unsuccessful, monitor is abnormal, or strong electromagnetic interference is presentReset iOS device. Reset monitor by pressing the START/STOP button about 10s. Make sure the monitor and iOS device are away from other electrical equipment. Please see GENERAL SAFETY AND PRECAUTIONS.Display reads an abnormal resultBluetooth connection unstable 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.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 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.
15 16The 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. WARRANTY INFORMATIONEXPLANATION OF SYMBOLSiHealth 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. Symbol for "WARNING"! Symbol for "EUROPEAN REPRESENTATIVE"EC REPSymbol for "COMPILES WITH MDD93/42/EEC REQUIREMENTS"Symbol for "MANUFACTURER"Symbol for "SERIAL NUMBER"SNSymbol 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 "THE OPERATION GUIDE MUST BE READ"The sign background color: blue The sign graphical symbol: whiteSymbol for "KEEP DRY"Symbol for "TYPE BF APPLIED PARTS" (cuff only)Symbol for "THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES"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.iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
17 18IMPORTANT INFORMATION REQUIRED BY THE FCCThis 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.Lotus Global Co., Ltd. 15 Alexandra Road, London UK, NW8 0DPTel: +0044-20-75868010 Fax: +0044-20-79006187EC REPANDON HEALTH CO., LTD.No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China. Tel: 86-22-60526161Manufactured for iHealth Lab Inc.719 N. Shoreline Blvd., Mountain View, CA 94043, USA 1-855-816-7705www.ihealthlabs.comThe Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by iHealth Lab Inc. is under license. Other trademarks and trade names are those of their respective owners.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-210This product is approved in accordance to R&TTE directive transmitter.IC NOTICEThis 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 undesired operation of the device.
19 20OTHER STANDARDS AND COMPLIANCES ELECTROMAGNETIC COMPATIBILITY INFORMATIONThe Wireless Blood Pressure Monitor corresponds to the following standards: IEC 60601-1:2006 (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: Supplemen-tary requirements for electro-mechanical blood pressure measuring systems); ANSI/AAMI SP-10:2002+A1:2003+A2:2006;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).For all ME EQUIPMENT and ME SYSTEMSEmissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11RF emissionsCISPR 11Harmonic emissionsIEC 61000-3-2Voltage fluctuations/flicker emissionsIEC 61000-3-3Group 1Class BClass ACompliesThe Wireless Blood Pressure Monitor 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.The Wireless Blood Pressure Monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below.The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.Guidance and manufacture’s declaration - electromagnetic emissionsTable 1
21 22Guidance and manufacturer’s declaration - electromagnetic immunityThe Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTINGIMMUNITY test IEC 60601test level Compliance level Electromagnetic environment - guidanceConducted RFIEC 61000-4-63 Vrms 150 kHz to 80 MHz3 V3 V/mPortable and mobile RF communications equipment should be used no closer to any part of the BP5, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance：Radiated RFIEC 61000-4-33 V/m 80 MHz to 2.5 GHzPd 2.1=Pd 2.1=80 MHz to 800 MHzPd 3.2=800 MHz to 2.5 GHzWhere 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). Guidance and manufacturer’s declaration - electromagnetic immunityThe Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.IMMUNITY test Electromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-2± 6 kV contact± 8 kV air± 6 kV contact± 8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.Electrical fasttransient/burstIEC 61000-4-4± 2 kV for power supply lines± 2 kV for power supply linesMains power quality should be that of a typical commercial or hospital environment. SurgeIEC 61000-4-5± 1 kV line(s) to line(s)± 2 kV line(s) to earth± 1 kV line(s) to line(s)± 2 kV line(s) to earthMains power quality should be that of a typical commercial or hospital environment.Voltage dips, shortinterruptions andvoltage variationson power supplyinput linesIEC 61000-4-11<5 % UT(>95 % dip in UT)for 0.5 cycle40 % UT(60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT(>95 % dip in UT) for 5 s<5 % UT(>95 % dip in UT)for 0.5 cycle40 % UT(60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT(>95 % dip in UT) for 5 sMains power quality should be that of a typical commercial or hospital environment. If the user of theBP5 requires continued operation during power mains interruptions, it is recommended that theBP5 be powered from an uninterruptible power supply or a battery.NOTE: UT is the a.c. mains voltage prior to application of the test level.Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.IEC 60601test level Compliance levelFor all ME EQUIPMENT and ME SYSTEMSTable 2Table 3
23 24Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipmentmarked 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 BP5 is used exceeds the applicable RF compliance level above, the BP5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the BP5.b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTINGPd 2.1=Pd 2.1=Pd 3.2=Recommended separation distances betweenportable and mobile RF communications equipment and the Wireless Blood Pressure MonitorThe Wireless Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Wireless Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Wireless Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment.Rated maximum outputpower of transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz0.12 0.230.120.010.38 0.730.380.1For 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.1.2 2.31.213.8 7.33.81012 2312100Table 4

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