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1 | Users Manual | Users Manual | 336.89 KiB |
iHealth CardioMed Ambulatory Blood Pressure Monitor (ABP100) USER GUIDE Table of Contents Introduction to Ambulatory Blood Pressure Monitoring ............................................................ 2 Indication ......................................................................................................................................... 2 Package Contents .......................................................................................................................... 2 Intended Use ................................................................................................................................... 2 Contraindication .............................................................................................................................. 3 Warning ............................................................................................................................................ 3 Caution .............................................................................................................................................. 4 PARTS AND DISPLAY INDICATORS ......................................................................................... 5 SPECIFICATIONS .......................................................................................................................... 5 SET UP REQUIREMENTS ........................................................................................................... 6 BATTERY HANDLING AND USAGE ........................................................................................... 6 SET UP PROCEDURES ............................................................................................................... 7 ABPM SYNC AND SETUP ........................................................................................................... 7 MEASUREMENT PROCEDURES .............................................................................................. 8 TAKING YOUR BLOOD PRESSURE READING ...................................................................... 9 TAKING YOUR BLOOD PRESSURE READING MANUALLY ................................................ 9 TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY ................................... 10 BLOOD PRESSURE CLASSIFICATION FOR ADULTS ........................................................ 10 TROUBLESHOOTING ................................................................................................................ 10 CARE AND MAINTENANCE ...................................................................................................... 12 WARRANTY INFORMATION ..................................................................................................... 12 EXPLANATION OF SYMBOLS .................................................................................................. 12 IMPORTANT INFORMATION REQUIRED BY THE FCC ...................................................... 13 OTHER STANDARDS AND COMPLIANCES .......................................................................... 14 ELECTROMAGNETIC COMPATIBILITY INFORMATION ..................................................... 15 1/16 Introduction to Ambulatory Blood Pressure Monitoring Thank you for selecting the iHealth CardioMed Ambulatory Blood Pressure Monitoring. Ambulatory blood pressure monitoring (ABPM) is to allow subjects to wear an ambulatory blood pressure recording device for normal daily activities and sleep, the instrument will automatically set blood pressure measurements at intervals, recording 24h. Within the blood pressure data to provide valuable information to understand the level and trend of the patient's blood pressure fluctuations throughout the day. Indication The data obtained from ambulatory blood pressure monitors is accurate and useful for managing a wide variety of hypertensive situations including:
Siesta dipping / post-prandial hypotension Identifying white-coat hypertension phenomena Identifying masked hypertension phenomena Identifying abnormal 24-h BP patterns
Daytime hypertension
Nocturnal hypertension
Dipping status/isolated nocturnal hypertension Assessment of treatment
Assessing morning hypertension and morning BP surge Screening and follow up of obstructive sleep apnoea Assessing increased BP variability Assessing hypertension in the elderly Assessing hypertension in high-risk patients Identifying ambulatory hypotension Identifying BP patterns in Parkinsons disease Assessing endocrine hypertension Assessing 24-h BP control Identifying true resistant hypertension Package Contents
* 1 iHealth CardioMed Ambulatory Blood Pressure Monitoring
* 2 Cuffs
* 1 User Guide
* 1 Quick Start Guide
* 1 Charging Cable Intended Use The iHealth CardioMed Ambulatory Blood Pressure Monitor is a non-invasive blood pressure measurement system that is intended to be worked with your mobile devices for the recording and displaying of up to 500 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult (> 12yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses. 2/16
Contraindication
Measurements are not possible in patients with a high frequency of arrhythmias
Do not apply the device to patients with sickle cell disease or patients who have or are expected to develop skin lesions. The device is not intended for use on pregnant women, neonates and children. The security and effectiveness of the device has not been validated on pregnant women, neonates and children. Do not apply the device to patients with coagulation disturbances. 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). Warning Read all of the information in the User Guide and other provided instructions before operating the unit. Consult your physician for any of the following situations:
a)The application of the cuff on any limb with intravascular access or therapy, or an arteriovenous(A-V) shunt. b) The application of the cuff on the arm on the side of a mastectomy. c) Simultaneous use with other medical monitoring equipment on the same limb.
Do not use this product in a moving vehicle as this may result in inaccurate measurements.
If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed in the iHealth APP. Under this condition, the Blood Pressure Monitor can keep functioning, but the results may be inaccurate. Please consult your physician for accurate assessment. The IHB symbol will be displayed under 2 conditions:
(1)The coefficient of variation (CV) of pulse period >25%.
(2)The difference of adjacent pulse period is 0.14s and more than 53 percent of the total number of pulses readings falls within this definition. This product should not be used as a USB device. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified inpart SPECIFICATIONS, the monitor will immediately display a technical alarm on the LED screen. In this case, repeat the measurement ensuring that the proper measurement procedures are followed and/or consult with your medical professional. The technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical alarm is assigned as low priority according to IEC 60601-1-8. The technical alarm does not need to be reset. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC60601-1/UL 60601-1 and IEC 60601-1-2/EN 60601-1-2 such as FJ-SW328U0502000N(input:100-240V~, 50/60Hz, 0.4A Max; output: DC 5V, 2.0A). Please note that the monitor jack size is USB micro B. The USB jack should be used for charging only. 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. Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate measurements. The device would not apply to the patients who use an artificial heart and lung (there will be no pulse) 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, renal diseases, secondary hypertension caused by other diseases.
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Whether applying the device to confused, dazed, unconscious or otherwise incapable patients need to consult a physician. The device should be used only under supervision if the physician agrees.
Whether applying the device to the patients with serious mobility impairments need to consult a physician. The
device should be used only under supervision if the physician agrees. The device should not be exposed to strong electromagnetic fields, otherwise they may cause inaccurate results or malfunction. Do not use the device in combination with high-frequency(HF) surgical equipment. Do not use the device in the presence of flammable anaesthetics due to risk of explosion. The physician must be certain that, according to the health of the patient, the use of the device will not damage blood circulation in the arm. Do not attach the cuff to a limb being used for intravenous infusions. This may cause the infusion to be blocked and cause the patient harm. The cuff must not be placed on the area with dermatitis, open wounds and other contraindications. Please consult a physician for specific situation. Caution
Motion, trembling, shivering may affect the measurement reading.
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. For information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor be kept 10 meters away from other wireless devices, such as WLAN unit, microwave oven, etc. The results of blood pressure measurements may be influenced by: the patient's physical condition, cuff wrapping method, measuring posture, measuring environment etc. Strictly in accordance with product instructions to operate the device, otherwise it may lead to inaccurate results. It is recommended to apply the cuff to non-dominant arm. Choose the arm of the other side if there are blood pressure measurement contraindications(e.g. there are open wounds or amputation on the area where the cuff is wrapped) on the arm of one side. Please consult a physician for specific situation. Choose the appropriate cuff according to the arm circumference. The arm circumference outside the applicable scope of the cuff may lead to inaccurate results. Cuff wrapping method should be strictly in accordance with product instructions. Inappropriate cuff wrapping location, cuff wrapping too loose or too tight, and other factors may lead to inaccurate results.
When the cuff is placed over thick clothing may result in inaccurate readings.
Relax and be quiet during measurement, avoid talking and movement. Avoid flexing the muscles or moving the hand and fingers of the cuffed arm during the measurement. Do not use the device when it is exposed to mechanical vibration (e.g. in vehicles). Advise patient not to drive but if this is necessary to stop if possible during measurement. Please check measurement values by other methods (e.g. auscultation), if you suspect an value. To prevent electric shock hazard due to leakage current, only use the power supplies which are compliant with the technical specifications of the device. The equipment must never be connected to a printer, computer or other external equipment while still fitted to the patient.
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The physician should make the patient understand the whole measurement procedure and how to cope with the device. Instruct patient how to switch off the device and take off the cuff, in case of malfunctioning and other emergencies, such as repeated inflation. If the patient experience arm numbness or pain during the measurement, they should switch off the device immediately and take off the cuff. In some patients petechiae, haemorrhages or subcutaneous haematomas may occur. Please consult a physician for specific situation. Some patients may be allergic caused by the material of the cuff. Please consult a physician for specific situation. It is recommended that the patient record important events, such as take medicine(taking time, drug name, drug dose etc.), awake and asleep periods, any symptoms(pain, dizziness etc.), any events which may influence blood pressure values(after meals, taking a nap, smoking, watching matches, taking a car etc.). This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges. Please do not share the cuff with any infectious person to avoid cross-infection. PARTS AND DISPLAY INDICATORS SPECIFICATIONS 1. Product name: iHealth CardioMed 2. Model: ABP100 3. Classification: Internally powered; Defibrillation-proof Type BF applied part; IP22, No AP or APG; Continuous operation 5/16 Li-ion 950mAh 2.0A, Battery: 1*3.7V 4. Machine size: approx. 5.57x 2.38x 0.75 (141.5mm60.5mm19mm) 5. Cuff circumference: 8.66 to 11.81(22cm-30cm) and 11.81 to 16.54(30cm-42cm) 6. Weight: approx.3.54 oz(110g)(excluding cuff) 7.Measuring method: Oscillometric method, automatic inflation and measurement 8.Memory volume: 500 times with time and date stamp 9. Power: DC:5.0V 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 V4.0 Frequency Band: 2.400-2.4835 GHz 13. Environmental temperature for operation: 5C-40C(41F -104F) 14. Environmental humidity for operation: 85%RH 15. Environmental temperature for storage and transport:-20C-55C(-4F-131F) 16. Environmental humidity for storage and transport: 90%RH 17. Environmental pressure: 80kPa-105kPa 18. Battery life: approx. 120 measurements on a full charge 19. The blood pressure measurement system includes accessories: pump, valve, cuff, LED screen and sensor. Note: These specifications are subject to change without notice. SET UP REQUIREMENTS The iHealth CardioMed Ambulatory Blood Pressure Monitor is designed to be used with the following iPad models:
iPad Air+
iPad mini+
iPad 3+
Please note that the compatible devices are subject to change. For the latest compatibility list, visitwww.ihealthlabs.com/support BATTERY HANDLING AND USAGE
Charge Battery before First Use Connect the monitor to a USB port(Power: DC:5.0V charging indicator steady. The battery charge will be displayed on the LED screen after each measurement. And when the monitor is connected to the iHealth APP, the battery charge will be displayed in the APP. The monitor will not work until the battery has enough power. 2.0A) using the charging cable provided until the
When the monitor needs charging, please connect the monitor to a power source.
You should charge the battery when the battery is less than 25% charged. Overcharging the battery may reduce its lifetime. 6/16
When in charging mode, the charging status will be displayed on the LED screen. See the table below for details. Monitor Status Charging Fully charged Battery charge <25%
Battery low Status Indicator battery/charge symbol flashing slow battery/charge symbol steady battery/charge symbol flashing fast battery/charge symbol flashing fast Do not change the battery. If the battery can no longer be charged, please contact Customer Service. 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 use the monitor while charging. 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. SET UP PROCEDURES Download the Free iHealth App Prior to first use, scan QR code and download the iHealth App. Follow the on-screen instructions to register and set up your personal account. Access the iHealth Cloud Account Your iHealth account also gives you access to the secure iHealth cloud service. Power on the Monitor Connect the monitor to a USB port using the charging cable provided or press LED screen displays all characters to power on the monitor at the first use. button at least 2 seconds until the ABPM SYNC AND SETUP Bluetooth Function The Bluetooth function is always on if the monitor has enough power. Only if the monitor is in low power status(not enough power to take blood pressure readings), the Bluetooth function will be turned off until the monitor has charged and have enough power. Connect to iOS Device via Bluetooth a. Enable Bluetooth on your iOS device. b. Launch the iHealth App from your iOS device. c. When a successful connection has been established, the Bluetooth indicator light will light up. d. When sync is processing, the sync indicator will flash , when sync is finished, the sync indicator lights up for 2 seconds and then light off. 7/16 Bluetooth connected Syncing Syncing Sync finished SYNC TIME AND SETTINGS Automatic mode is disabled before automatic test parameters are set. Using APP to configuration automatic mode parameters. Time and date on the device will be automatically sync with your smart device when the Bluetooth connection is established. MEASUREMENT PROCEDURES Blood pressure can be affected by the position of the cuff and your physiologic condition. It is very important that the cuff should be placed at the same level as your heart. Body Posture Sitting Comfortably During Measurement a. Relax and be quiet during measurement, avoid talking and movement. b. c. d. Avoid flexing the muscles or moving the hand and fingers of the cuffed arm during the measurement 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. When measuring in the standing position, let the cuffed arm hang relaxed, slightly away from the body. When measuring in the sitting position, the arm should be supported at heart level. Pull the cuff end through the metal loop, positioning it outward (away from your patient body). Place a bare arm through the cuff and position the cuff 1/2"(1-2cm) above the elbow joint. Tighten the cuff by pulling it towards your body, securing it closed with the Velcro fastener. Fitting a Patient with the ABPM Cuff a. b. c. d. While seated, place your hand, palm-side up, in front of you on a flat surface such as a desk or table. When the left arm is measured, position the monitor in the middle of your arm so that it is aligned with your middle finger. When the right arm is measured, position the monitor in the middle of your arm so that it is aligned with your middle finger, the up and down position is opposite. 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. 8/16 Remember to:
1. Make sure that the appropriate cuff size is used; refer to the cuff circumference range in the Specifications section of this manual. 2. 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. Prolonged over-inflation of the bladder may cause ecchymoma of your arm. 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. Left arm measurement Right arm measurement TAKING YOUR BLOOD PRESSURE READING The iHealth CardioMed Ambulatory Blood Pressure Monitor has two measurement modes. Preparing your patient for the ABPM study is the most important step to achieving a successful test. TAKING YOUR BLOOD PRESSURE READING MANUALLY a. Long press the button, the monitor will activate and all display characters are shown for self-test. You can check the LED screen display according to the right picture. Please contact the service center if symbol is missing. 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 be automatically stored in the memory, and all results will be uploaded to the App automatically upon the next successful Bluetooth connection. b. c. During measurement, you can press the button or button to turn off the monitor manually. After measurement, the monitor will display SYS and DIA in first screen, and then display pulse rate in 2 seconds or press any button, and turn off display in 2 seconds or press any button. Note: Manual test readings taken before automatic mode is configured cannot be stored in memory. 9/16 TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY a. b. c. d. Long press the for at least 2 seconds to switch on or off the "Automatic Mode", the monitor shows current automatic mode on the LED screen. If the monitor has no automatic mode parameters, the monitor shows "- -" on the LED monitor. If the monitor has finished the automatic test, the monitor shows "END" on the LED monitor. In the automatic mode, the LED screen is turned off by default. During the test, short press any button to turn on the LED screen and it will last to the end of this measurement. When "Auto Mode" on ,while not in a measurement, short press any button to turn on the LED screen and the LED screen shows the last measurement result. When "Auto Mode" on, the monitor will continue take measurements in the scheduled time, and after the monitor get enough readings, the monitor automatic stop taking readings. Note: Please consult a health care professional for interpretation of pressure measurements. 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: Consult your physician for proper interpretation of blood pressure results. TROUBLESHOOTING PROBLEM Low Battery LED display reads Er0 POSSIBLE CAUSE Battery do not have enough power Charge the battery Pressure system before measurement is unstable SOLUTION Retest, make sure not to move your arm or the monitor 10/16 LED display reads Er1 LED display reads Er2 LED display reads Er3 LED display reads Er4 LED display reads Er5 LED display reads Er6 LED display reads Er7 LED display reads Er8 LED display reads ErA Fail to detect systolic pressure Fail to detect diastolic pressure Pneumatic system blocked or cuff is too tight during inflation Pneumatic system leakage or cuff is too loose during inflation Cuff pressure above 300mmHg More than 160 seconds with cuff pressure above 15 mmHg memory accessing error Device parameter checking error Pressure sensor parameter error LED display reads Er Bluetooth communicate error LED display reads an abnormal result Bluetooth connection unstable The cuff position was not correct or it was not properly tightened Body posture was not correct during testing Speaking, moving arm or body, being angry, excited or nervous during test Bluetooth unsuccessful, monitor is abnormal, electromagnetic interference is present or connection strong No response when you press button Incorrect operation or strong electromagneticinterference 11/16 Apply the cuff correctly and try again after again Measure five minutes. If the monitor is still abnormal, please contact the local distributor or the factory. Reset monitor by pressing button and holding for the about 10 seconds, then connect the mobile device correctly and try again, If the monitor is still abnormal, please contact the local distributor or the factory. the cuff application Review instructions and retest body posture Review instructions and retest Retest when avoid speaking or movement during the test Reset iOS device. Reset monitor calm;
by pressing the button and holding for about 10 seconds. Make sure the monitor and iOS device are away from other electrical equipment. Please see Warning Press the button and hold for about 10seconds to reset the device. CARE AND MAINTENANCE
Strictly in accordance with product instructions to maintain and clean the device. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use. If the monitor is not used for a long time, please be sure to fully charge it every month. 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 users appropriately qualified technical personnel to repair those parts of the equipment which are designated for repair can be supplied. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water, diluted disinfectant alcohol, or diluted detergent. The monitor can maintain the safety and performance characteristics for a minimum of 30,000measurements or three years of usage, and the cuff integrity is maintained after 1,000 open-close cycles. The battery can maintain the performance characteristics for a minimum of 300 charge cycles. It is recommended that if the cuff is used in a hospital or a clinic, it be disinfected twice a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff. It is recommended that product performance be checked every 2 years or after each repair. Please contact the customer service. Do not use the device if you think it is damaged or if anything appears unusual. Please refer your device to qualified service personnel of the manufacturers. The monitor requires 6 hours to warm or cool from the minimum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 C. It may lead to inaccurate results or equipment failure if the device is stored or used outside the specified temperature and humidity ranges.
Do not drop this monitor or subject it to strong impact. Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this will result in damage to the monitor. Do not attempt to disassemble this monitor. Battery replacement should only be performed by a qualified iHealth technician. To do otherwise will void your warranty and possibly damage your unit. Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise will possibly damage your unit. WARRANTY INFORMATION The iHealth CardioMed 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 Next Blood Pressure Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty. EXPLANATION OF SYMBOLS Symbol for "DEFIBRILLATION-PROOF TYPE BF APPLIED PARTS" (cuff only) 12/16 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". Symbol for "WARNING"
Symbol for "MANUFACTURER"
Symbol for "EUROPEAN REPRESENTATIVE"
Symbol for "COMPILES WITH MDD93/42/EEC REQUIREMENTS"
IP22 The first characteristic numeral symbol for Degrees of protection against access to hazardous parts and against solid foreign objects .The second characteristic numeral symbol for Degrees of protection against ingress of water iHealth is a trademark of iHealth Lab Inc. iPad,iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. Manufactured for iHealth Lab Inc. 120 San Lucar Ct.,Sunnyvale, CA 94086, USA Tel:+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, 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 this device must accept any interference received, including interference that may cause undesired operation.
(2) Changes or modifications not expressly approved by iHealth Lab Inc. would void the users 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 13/16 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. Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This product complies with Industry Canada. IC: RSS-210 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. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radioexempts de licence. L'exploitation est autorise aux deux conditions suivantes :
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum
(or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformment la rglementation d'Industrie Canada, le prsent metteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablissement d'une communication satisfaisante. Hereby, [ANDON HEALTH CO., LTD.] declares that the equipment type [ABP100] is incompliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.ihealthlabs.eu OTHER STANDARDS AND COMPLIANCES The iHealth CardioMed Ambulatory Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance);
IEC 60601-1-2:2014/EN 60601-1-2:2007/AC:2010(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+AMD12013/EN 80601-2-30:2010/A12015(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);
14/16 ISO81060-2 2013,(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type). 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, Bluetooth receive bandwidth 2M. This product can also be used to include RF transmitter equipment and system requirements and emission frequency of 2.4GHz ISM band, Bluetooth modulation types:GFSK, effective radiated power: <4dBm. Table 1 - Emission Phenomenon RF emissions Harmonic distortion Voltage fluctuations and flicker Phenomenon Electrostatic Discharge Radiated RF EM field Proximity fields from RF wireless communications equipment Rated power frequency magnetic fields Compliance CISPR 11 Group 1, Class B IEC 61000-3-2 Class A IEC 61000-3-3 Compliance Electromagnetic environment Home healthcare environment Home healthcare environment Home healthcare environment Table 2 - Enclosure Port EMC Basic standard IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-3 Immunity test levels Home Healthcare Environment 8 kV contact 2kV, 4kV, 8kV, 15kV air 10V/m 80MHz-2.7GHz 80% AM at 1kHz Refer to table 3 IEC 61000-4-8 30A/m 50Hz or 60Hz Table 3 Proximity fields from RF wireless communications equipment Test frequency
(MHz) 385 450 710 745 780 810 Band
(MHz) 380-390 430-470 704-787 Immunity test levels Professional healthcare facility environment Pulse modulation 18Hz, 27V/m FM, 5kHz deviation, 1kHz sine, 28V/m Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 15/16 870 930 1720 1845 1970 2450 5240 5500 5785 1700-1990 Pulse modulation 217Hz, 28V/m 2400-2570 5100-5800 Pulse modulation 217Hz, 28V/m Pulse modulation 217Hz, 9V/m Phenomenon fast Electrical transients/burst Surges Line-to-line Surges Line-to-ground Conducted disturbances induced by RF fields EMC Table 4 Input a.c. power Port Basic standard IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-5 IEC 61000-4-6 Immunity test levels Home Healthcare Environment 2 kV 100kHz repetition frequency 0.5 kV, 1 kV 0.5 kV, 1 kV, 2 kV 3V, 0.15MHz-80MHz 6V in ISM and amateur radio bands between 0.15MHz and 80MHz 80%AM at 1kHz 0% UT; 0.5 cycle At 0, 45, 90, 135, 180, 225, 270 and 315 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0 0% UT; 250/300 cycles Voltage dips IEC 61000-4-11 Voltage interruptions IEC 61000-4-11 Date of issue:Sep25,2017 ABP100-SMSY01 V1.0 16/16
frequency | equipment class | purpose | ||
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1 | 2018-03-22 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2018-03-22
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1 | Applicant's complete, legal business name |
iHealth Labs, Inc.
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1 | FCC Registration Number (FRN) |
0022414882
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1 | Physical Address |
120 San Lucar Ct., Sunnyvale, CA 94086, USA
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1 |
Sunnyvale, California 94086
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1 |
United States
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app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
SLR
|
||||
1 | Equipment Product Code |
ABP100
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
M****** C****
|
||||
1 | Telephone Number |
650-9********
|
||||
1 | Fax Number |
650-2********
|
||||
1 |
M******@ihealthlabs.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
K**** X******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section, Science & Tec
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
0755-********
|
||||
1 | Fax Number |
0755-********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
J**** s****
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section, Science & Tec
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
0755-********
|
||||
1 | Fax Number |
0755-********
|
||||
1 |
J******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | iHealth CardioMed | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
K**** X******
|
||||
1 | Telephone Number |
+86 (********
|
||||
1 |
K******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0008000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC