Andon Health BP5 Spread Spectrum Transmitter User Manual 140100 0614 GB
Andon Health Co., Ltd Spread Spectrum Transmitter 140100 0614 GB
Manual
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| Document ID | 1744561 |
| Application ID | rqrGkynzLs32RlLNBSOAFQ== |
| Document Description | Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 37.96kB (474555 bits) |
| Date Submitted | 2012-07-16 00:00:00 |
| Date Available | 2012-07-23 00:00:00 |
| Creation Date | 2012-06-26 11:17:34 |
| Producing Software | Adobe PDF library 9.90 |
| Document Lastmod | 2012-06-26 11:17:34 |
| Document Title | 140100-0614-GB |
| Document Creator | Adobe Illustrator CS5 |
iHealth TM Wireless Blood Pressure Monitor (BP5) OWNER’S MANUAL Table of Contents INTRODUCTION PACKAGE CONTENTS INTENDED USE BLOOD PRESSURE CLASSIFICATION FOR ADULTS CONTRAINDICATION PARTS AND DISPLAY INDICATORS SET UP REQUIREMENTS SET UP PROCEDURES MEASUREMENT PROCEDURES SPECIFICATIONS GENERAL SAFETY AND PRECAUTIONS BATTERY HANDLING AND USAGE TROUBLESHOOTING CARE AND MAINTENANCE WARRANTY INFORMATION EXPLANATION OF SYMBOLS IMPORTANT INFORMATION REQUIRED BY THE FCC OTHER STANDARDS AND COMPLIANCES ELECTROMAGNETIC COMPATIBILITY INFORMATION 10 11 11 12 13 14 INTRODUCTION BLOOD PRESSURE CLASSIFICATION FOR ADULTS 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 iOS devices to test, track and share vital blood pressure data. 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. Classification of blood pressure for adults PACKAGE CONTENTS Systolic (mmHg) • 1 iHealth Wireless Blood Pressure Monitor • 1 Owner’s Manual • 1 Quick Start Guide • 1 Charging Cable • 1 Travel Bag 180 160 140 130 Severe Hypertension Moderate Hypertension DBP COLOR mmHg INDICATOR <80 GREEN Normal 120-129 80-84 High-normal 130-139 85-89 GREEN Grade 1 Hypertension 140-159 90-99 YELLOW Normal BP Grade 2 Hypertension 160-179 100-109 ORANGE Diastolic (mmHg) 80 INTENDED USE SBP mmHg <120 High-normal BP Mild Hypertension 120 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 cuff circumference is 8.6” to18.9”(22cm-48cm). BLOOD PRESSURE CLASSIFICATION Optimal 85 90 100 Grade 3 Hypertension ≥180 ≥100 GREEN RED WHO/ISH Definitions and Classification of Blood Pressure Levels 110 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. CONTRAINDICATION It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure Monitor. PARTS AND DISPLAY INDICATORS SET UP PROCEDURES Status indicator Bluetooth indicator START/STOP button Download the Free iHealth APP Prior to first use, download and install the iHealth App from the App Store. Use keyword search terms “iHealth”, “BP5” or ”BPM”. Connect to iOS Device Via Bluetooth Cuff • 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) SET UP REQUIREMENTS 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 4S iPhone 4 iPhone 3GS iPad (3rd generation) iPad 2 iPad • 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. • 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. The iOS version of these devices should be V4.0 or higher. Note: Please repeat step 1 when you switch an iOS device. MEASUREMENT PROCEDURES Body Posture Apply the Cuff 1/2”(1-2cm) FF /O lt ea iH 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”(1-2cm) 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. 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. 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. Sitting 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. During measurement, press the “START/STOP” button for 2 seconds to turn off the monitor manually. Monitor Status Bluetooth Indicator During measurement, press the “START/STOP” button to stop the measurement process. Waiting to connect Flashing blue light Measuring Steady blue light Important: Please consult a healthcare professional for interpretation of blood pressure measurements. Measurement completed Gradually extinguishing light Operation Instructions With iOS Device For 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. Note: Please consult a health care professional for interpretation of blood pressure measurements. Measuring without an iOS Device Offline 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 measurement. 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 upon 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. SPECIFICATIONS 1. Product name: Wireless Blood Pressure Monitor 2. Model: BP5 3. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous operation 4. 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 400mAh 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: Bluetooth V3.0 + EDR Class 2 SPP Frequency Band: 2.402-2.480 GHz 13. Environmental temperature for operation: 5°C~40°C(41°F~104°F) 14. Environmental humidity for operation: ≤90%RH 15. Environmental temperature for storage and transport: -20°C~55°C(-4°F~131°F) 16. Environmental humidity for storage and transport: ≤95%RH 17. Environmental pressure: 80kPa-105kPa 18. Battery life: more than 80 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. 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 arteriovenous (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. ! 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 10 result in measurement errors and a biocompatible hazard. ! 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. 10. 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. • 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%, please 11 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. 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 Flashing green light Fully charged Steady green light Low battery Flashing red light (for a few seconds) Abnormal state Steady red light 12 CARE AND MAINTENANCE TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION Low Battery Battery is less than 20% Charge the battery Blood pressure is outside of measurement range Retest, make sure your blood pressure is within measurement range Arm or monitor was moved during test Retest, make sure not to move your arm or the monitor The cuff does not inflate properly or pressure falls quickly during test Review the cuff application instructions and retest Irregular heartbeat (arrhythmia) It is inappropriate for people with serious arrhythmia to use this monitor. Check with physician The cuff was not properly applied Review the cuff application instructions and retest The cuff position was not correct or it was not properly tightened Review the cuff application instructions and retest Display reads an abnormal result 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 Bluetooth connection unstable Bluetooth connection unsuccessful, monitor is abnormal, or strong electromagnetic interference is present Reset 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. No response Incorrect operation or strong electromagnetic interference Press the START/STOP button about 10 seconds to reset the device, relaunch app, and reconnect the iOS device to the monitor Display reads “ERROR” 13 1. 2. 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. 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. 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. 14 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. Symbol for "MANUFACTURER" 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. Symbol for "WARNING" SN Symbol for "SERIAL NUMBER" Symbol for "KEEP DRY" EC REP Symbol for "EUROPEAN REPRESENTATIVE" Symbol for "COMPILES WITH MDD93 /42/EEC REQUIREMENTS" EXPLANATION OF SYMBOLS Symbol for "THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES" 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 "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" 15 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. 16 The 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. Manufactured for iHealth Lab Inc. 719 N. Shoreline Blvd., Mountain View, CA 94043, USA 1-855-816-7705 www.ihealthlabs.com Lotus Global Co., Ltd. 15 Alexandra Road, London UK, NW8 0DP Tel: +0044-20-75868010 Fax: +0044-20-79006187 EC REP ANDON HEALTH CO., LTD. No. 3 Jinping Street, YaAn 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. 17 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 This product is approved in accordance to R&TTE directive transmitter. IC NOTICE 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 undesired operation of the device. 18 OTHER STANDARDS AND COMPLIANCES ELECTROMAGNETIC COMPATIBILITY INFORMATION The 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: Supplementary 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). 19 Table 1 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration - electromagnetic emissions 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. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The 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. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies 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. 20 Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic immunity 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. IMMUNITY test IEC 60601test level 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 %. Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 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 earth Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % 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 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Mains 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. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical 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 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 21 3 A/m NOTE: UT is the a.c. mains voltage prior to application of the test level. Electromagnetic environment - guidance Compliance level 3 A/m IEC 60601test level Compliance level Electromagnetic environment - guidance Portable 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： Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3V d = 1.2 P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 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). 22 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 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. 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 Wireless Blood Pressure Monitor The 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. Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 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. 23 24
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xmp.iid:01801174072068118C14C27F07EBD24F, xmp.iid:04801174072068118C14C27F07EBD24F, xmp.iid:F87F1174072068118083C33E7FEB646D, xmp.iid:FA7F1174072068118083C33E7FEB646D, xmp.iid:FC7F1174072068118083C33E7FEB646D, xmp.iid:05801174072068118C14DCA144FD0965, xmp.iid:FD7F1174072068118083E54413A0D62B History When : 2008:04:17 14:19:15+05:30, 2008:05:15 16:23:06-07:00, 2008:05:15 17:10:45-07:00, 2008:05:15 22:53:33-07:00, 2008:05:15 23:07:07-07:00, 2008:05:16 10:35:43-07:00, 2008:05:16 10:40:59-07:00, 2008:05:16 11:26:55-07:00, 2008:05:16 11:29:01-07:00, 2008:05:16 11:29:20-07:00, 2008:05:16 11:30:54-07:00, 2008:05:16 11:31:22-07:00, 2008:05:16 12:23:46-07:00, 2008:05:16 13:27:54-07:00, 2008:05:16 13:46:13-07:00, 2008:05:16 15:47:57-07:00, 2008:05:16 15:51:06-07:00, 2008:05:16 15:52:22-07:00, 2008:05:22 13:28:01-07:00, 2008:05:22 16:23:53-07:00, 2008:05:28 16:45:26-07:00, 2008:06:02 13:25:25-07:00, 2008:06:09 14:58:36-07:00, 2008:06:11 14:31:27-07:00, 2008:06:11 22:37:35-07:00, 2008:06:18 22:24:01+07:00, 2008:06:19 20:30:34-07:00, 2008:06:24 14:13:53+08:00, 2008:06:24 15:23:44+08:00, 2008:06:26 06:03:48-07:00, 2008:07:02 13:54:27-07:00, 2008:07:21 16:58:31+05:30, 2008:09:05 03:21:29-07:00, 2008:09:05 04:21:56-07:00, 2010:10:13 16:27:48+08:00, 2010:11:10 21:17:14+08:00, 2010:11:21 22:06:38+08:00, 2010:11:23 22:52:09+08:00, 2010:12:20 19:56:58+08:00, 2010:12:21 18:26:55+08:00, 2011:01:05 14:58:59+08:00, 2011:02:12 11:02:53+08:00, 2011:05:13 17:32:59+08:00, 2011:06:24 09:39:39+08:00, 2011:06:24 11:05:14+08:00, 2011:08:18 10:56:39+08:00, 2011:12:17 12:54:32+08:00, 2011:12:23 17:36:29+08:00, 2012:01:06 17:33:51+08:00, 2012:05:23 17:17:18+08:00, 2012:05:23 17:23:39+08:00, 2012:05:24 17:40:47+08:00, 2012:05:24 17:41:39+08:00, 2012:05:25 15:13:04+08:00, 2012:05:25 16:09:01+08:00, 2012:05:28 17:12:54+08:00, 2012:06:01 09:06:06+08:00, 2012:06:01 11:04:35+08:00, 2012:06:05 10:35:23+08:00, 2012:06:05 11:26:25+08:00, 2012:06:05 11:53:41+08:00, 2012:06:14 14:45:56+08:00, 2012:06:26 11:17:25+08:00 History Software Agent : Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator CS4, Adobe Illustrator 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