User Manual

FCC ID: 2ABRGBPW4500

Users Manual

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FCCID_3817503

BRAUN iCheck® 7

Braun iCheck® 7 Product description BPW 4500US Wrist blood pressure monitor www.braunhealthcare.com This product is manufactured under licence to the ‘Braun‘ trademark. ‘Braun‘ is a registered trademark of Braun GmbH, Kronberg , Germany. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks is under licence. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Google Play and the Google Play logo are trademarks of Google Inc. iCheck® is a registered trademark of Helen of Troy Limited. Kaz USA, Inc. C € A Helen of Troy Company 0297 Marlborough, MA 01752 e ©2018, All rights reserved. C PAP BPW4500US P/N AAOO2626RO0 O1MAR18 Printed in China

Intended use of the Braun iCheckse 7 A Safety information and important precautions Braun iCheck® 7 is a blood pressure monitor which has been developed for fast, accurate blood People suffering from cardiac arrhythmia, vascular constriction, arteriosclerosis in the extremities, pressure measurements from the wrist. This blood pressure monitor operates as a stand—alone diabetes or users of cardiac pacemakers should consult their doctor before measuring their blood device and automatically records your most recent readings. The recorded readings can be pressure themselves. Deviations in blood pressure values may occur in such cases. downloaded later on your Smartphone for advanced trend interpretation. If you are under medical treatment or taking any medication, please consult your doctor first. What you should know about blood pressure The use of this blood pressure monitor is not intended as a substitute for a consultation with your doctor. Blood pressure constantly changes throughout the day. It rises sharply in the early morning and declines during the late morning. Blood pressure rises again in the afternoon and finally drops to a low level at night. It may also vary over a short period of time. Therefore readings from Key rules for accurate blood pressure measurement successive measurements can fluctuate. Always take readings at the same time of day, under the same conditions. This device will display your blood pressure reading referring to two values: the systolic and the Do not take a measurement within 30 minutes after smoking, drinking coffee or tea or any form diastolic values. The systolic blood pressure (the upper number) indicates how much pressure of exertion. These factors will influence the measurement. your blood is exerting against your artery walls when the heart beats. The diastolic blood pressure (the lower number) indicates how much pressure your blood is exerting against your Always measure on the same wrist. We recommend using left wrist. artery walls while the heart is resting between beats. The pulse value is also displayed after each Take off your wrist watch and jewelry before placing the monitor on the measuring arm. measurement. Remove tight clothing from your arm. The AHA (American Heart Association) have set up the following standard blood pressure values when measured with a resting pulse at home: If you want to take multiple measurements, wait approximately 3 minutes before repeating a measurement. Blood pressure High Blood High Blood Hypertensive (mmHg) Noumal Elevated Pressure Stage 1 Pressure Stage2 Crisis Product description (seePage 1) SYS = systole Less than i [ C t 1 C On/Off button (also used for Bluetooth® pairing, see page 7) [upper value) 120 120—129 30—139 140 or higher higher than 180 (® Graphic display for measurements and indications DIA = diastole Lessthan Less than _ | 4 I (esertalns 80 80 80—89 90 or higher higher than 120 @ Instant read color indicator ) Battery compartment cover For every measurement displayed on the screen, ___SvS the associated color (from green to red) will indicate Green > © Cuff the corresponding blood pressure level. You can use Yellow > 1204129 or < 80 this classification daily to help you understand your Orange> Aeoermpherier ecermghe, blood pressure reading. If you are really concerned l by the classification, you should consult your doctor. Rad> ifeonimiives Uitten. To ensure accurate measuring results, read the complete instructions for use carefully. 2

Inserting/replacing batteries 4. The‘Easy Positioning System‘helps to ensure the arm is in the correct position. Simply move + Remove the battery compartment cover by sliding it your arm up and down until the white dot stays downwards. Insert the two batteries supplied with this product, inside the circle (see Fig. 2). This means that the with polarity as indicated in the battery compartment. When iCheck 7 is now level with your heart. replacing batteries, use alkaline batteries exclusively, type AAA/LRO3, 1.5V. 5. The measurement starts automatically once the correct position has been obtained. Do not + New batteries will provide approximately 300 measurements. move or speak while the measurement is in progress. The basics Note: If it is necessary to interrupt a The On/Off button is located to the right of the display. This is a measurement, press the On/Off button Q) at round button with the power symbol. Simply tap on this touch— any time. The device immediately cancels the sensitive button to turn your iCheck 7 On and Off. measurement, lowers cuff pressure and turns itself off. When turning On, you will see a welcome screen first. When this message disappears the device will be ready to use. The graphic display shows numerical values for measurements, indications for user, guidance system and error notifications, if any. At the conclusion of the measurement the device will show a colored heart. Use the color codes Understanding your reading shown on Page 6 find out what the color means. Once the measurement is complete, the instant read ‘heart‘ symbol will illuminate.The ‘meaning‘ of the color can be found in the table on Page 6. The graphic display will show the numerical Taking a blood pressure measurement values of your blood pressure readings. 1. Sit down, relax, keep still, especially the arm being used for the measurement, do not move SYS: shows the systolic blood pressure in mmHg :D or speak. For greatest accuracy, we recommend using the left wrist for the measurement. DIA: shows the diastolic blood pressure in mmHg snfun _ 2. Fit the monitor on your left wrist, roughly .4 inch PUL: shows the pulse — heart beats per minute %B 4 0 below the palm line (see Fig. 1 for correct placement). DO NOT ATTACH LIKE A WRIST WATCH. The device & This symbol at the right—hand side of pulse reading should be on the inner side of your wrist. Secure the I indicates a regular heartbeat. cuff with the Velcro fastener, so thatit is tight but /\“v/\ comfortable. There should not be a space between N & This symbol at the right—hand side of pulse reading indicates that pulse irregularities were detected during the measurement. This irregular heartbeat can be caused simply by talking, the cuff and the wrist. \ moving or shaking during a measurement. In this case, the result may deviate from your 3. Press the On/Off button (L) to start a measurement. / normal basal blood pressure — repeat the measurement. Normally this is not cause for The graphic display will show the welcome screen concern. However if the symbol appears frequently, and these guidelines are strictly followed by the ‘Easy Positioning System!‘. This is shown followed, you should seek medical advice. as a moving dot within a white circle. Fig. 1

The instant read color indicator follows the AHA recommendations for interpreting readings Connection to Smartphone and Braun Healthy Heart app and is described in the table below. Your iCheck® 7 can be connected by Bluetooth® to your Smartphone (iOS and Android) Green: normal blood Your blood pressure reading is normal, and values are below to download stored readings automatically. When readings are downloaded to your Smartphone, pressure 120 mmHg systolic and below 80 mmHg diastolic. they are deleted from your iCheck® 7 memory. Your blood pressure reading is in the elevated blood pressure range Make sure the ‘Braun Healthy Heart‘ app has been downloaded onto your Smartphone Yellow: Elevated Blood with values between 120—129 mmHg systolic and/or less than and the app is open. Pressure 80 mmHg diastolic. BRH““ CANPERAEREICUIRE GETTON Orange: High Blood Your blood pressure reading is in the hypertension ||||I # App Store » Google Play range with values between 130—179 mmHg systolic and/or Pressure Stage 1 80—119 mmHg diastolic. Your blood pressure reading is in the severe hypertension range Switch on the Bluetooth function on your Smartphone. If you are using the app for the first time, «mm Red: High Blood Pressure it will guide you in pairing your iCheck® 7. If you have already used the app before, go to *\/‘ Stage 2 OR Hypertensive with values of 180 mmHg systolic and above and/or 120 mmHg the "Connect device" function available in the app menu and follow the instructions. diastolic and above. If you constently get readings in this range, — Crisis consult your doctor. During Bluetooth pairing, iCheck® 7 will show a flashing Bluetooth icon 3 on the display. Once pairing is complete, iCheck® 7 will show your name on the display. Blood pressure readings will be automatically saved in the device memory. Results are displayed for approx. 60 seconds, then device will automatically shut—off. You can also shut off your device with On/Off button. Battery life indicator Note: If your iCheck® 7 device is switched on within 60 seconds of powering off, the welcome Batteries are low @_} screen is bypassed. When the batteries are approximately 80% discharged, the low battery symbol will show at power—up for about 6 seconds. The iCheck® 7 device will continue to measure reliably, but new batteries should be obtained. Memory functions Batteries are empty —replacements required B<> Your iCheck® 7 will store up to 100 readings in the internal memory. Readings are stored When the batteries are fully discharged, the empty battery symbol will show at power—up automatically when the measurement is complete. When the 100 readings are reached, for about 6 seconds and then device will automatically shut off. You cannot take any readings the new readings automatically replace the oldest ones. We suggest you regularly transfer and must replace the batteries. your stored readings onto the Braun Healthy Heart app on your Smartphone in order to follow the evolution of your blood pressure easily over a long period of time. The memory is non—volatile. Stored readings will not be lost when the batteries are replaced. Storage and cleaning + Do not place/leave the item in direct sunlight, at high temperatures or in damp and dusty places. + Do not store at extremely low (less than —4 °F) or high (more than 131 °F) temperatures. + Use a wet cloth or one impregnated with a mild cleansing agent to clean the case and then use a dry cloth to wipe it dry. +« Do not use any strong cleansers to clean it.

+ When the unit is not going to be used for a long time, remove the batteries. (Batteries may leak Troubleshooting or cause damage). + Do not modify the device. NEVER open the device! This will void the manufacturer‘s guarantee. Low battery warning Be ready to replace batteries with new ones soon. Calibration Insert new batteries or check that batteries are correctly This device was calibrated at the time of manufacture. If used according to the instructions for Empty battery warning inserted. use, periodic recalibration is not required. Device does not turn on, Change batteries for new ones and make sure to insert them Problem with batteries screen is black correctly. If problem persists, contact consumer support Guarantee Stay away from radio interference such as microwave ovens, WiFi routers, laptop computers, etc. Make sure Bluetooth Please read all instructions before attempting to use this device. Please retain the receipt as is enabled on your Smartphone before starting the pairing proof/date of purchase. "ERROR $ " Cannot connect to sequence. The receipt must be presented when making any claim within the relevant guarantee period. Smartphone Follow the instructions for Bluetooth pairing in the Braun Any claim under the guarantee will not be valid without a proof of purchase. APP and re—initiate the Bluetooth pairing sequence using the Braun APP. Your device is guaranteed for Two Years (2 Years) from date of purchase. Measuring error This guarantee covers defects in materials or workmanship that occur under normal use, "ERROR 0" The pulse signals on the cuff Reposition the cuff and repeat the measurement. defective devices meeting these criteria will be replaced free of charge. are too weak. The guarantee DOES NOT cover defects or damage resulting from abuse or failure to follow Pumping error Reposition the cuff, close it tighter then repeat the the user instructions. "ERROR 1" The cuff is not fastened measurement. The guarantee becomes void if the device is opened, tampered with, or used with non properly. Braun branded parts or accessories, or if repairs are undertaken by unauthorized persons. Relax for a while and repeat the measurement. "ERROR 2" Out of Range Results Error Make sure the cuff is correctly positioned on your arm. Accessories and consumables are excluded from any warranty. Pump time error For support requests, please visit www.braunhealthcare.com or find service contact information "ERROR 3" The cuff is not fastened Re—fit the cuff, and take a measurement again. at the end of this owner manual. properly. This guarantee is applicable to US only. User could not find the Position the wrist at heart level as indicated by the ‘Easy "ERROR 4" correct wrist position (angle) The LOT and SN of your device are printed on the rating label located inside the battery in less than 60 seconds Positioning System!. compartment. Remove and then reinsert the batteries. If the problem "ERROR 254" Device internal error persists, contact consumer support. Remove and then reinsert the batteries. If the problem "ERROR 255" Calibration error persists, contact consumer support. Device will automatically restart using the original Bluetooth An error occurred during the "ERROR 256" firmware. Re—initiate the firmware download process or follow Bluetooth Firmware update the on—screen instruction from Braun APP.

Specifications Subject to change without notice. This device conforms to the following standards: Model BPW4500US EN 60601—1:2006/A1:2013 — General requirements for basic safety and essential performance. Measurement method Oscillometric EN 60601—1—2:2015 — Medical Electrical Equipment — Electromagnetic compatibility — Requirements and tests. Display OLED display EN 60601—1—11:2010 — Medical Electrical Equipment — Requirements for medical electrical equipment and medical electrical Blood pressure measurement range 40 ~ 255 mmHg systems used in the home healthcare environment. Pulse measurement range 40 ~ 199 beats/minute EN 1060—3:1997 + A2:2009 — Non—invasive sphygmomanometers — Supplementary requirements for electromechanical blood Calibration accuracy Blood pressure: +/— 3 mmHg pressure measuring systems. Pulse rate: +/— 4% of reading EN 1060—4:2004 — Non—invasive sphygmomanometers — Test procedures to determine the overall system accuracy of Inflation/Deflation Automatic automated non—invasive sphygmomanometers. Sets of memory Up to 100 readings Cuff size Fits wrist circumference: 12.5 — 21 cm (4.9 — 8.3 inch) min/max This product conforms to the provisions of the EC Directive 93/42/EEC (Medical Device Directive and Operating temperature +50 °F ~+ 104 °F, less than 85 % R.H. non—condensing pag7 superseding regulations). Storage temperature ~4°F ~ +131 °F, less than 85 % R.H. non—condensing This product carries the CE mark and is manufactured in conformity with the RoHS Directive 2011/65/EU. Unit weight Approximately 1259 (exluding batteries) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. Power source Alkaline battery: 2 x AAA (LR3) 1.5V For a detailed description of EMC requirements please contact an authorized local Service Center (see guarantee) Auto power off Approx. 60 seconds or visit www.braunhealthcare.com Service life 5 years Portable and mobile RF communications equipment can affect medical electrical equipment. Wireless communication Bluetooth® Smart Frequency Range: 2.4GHz ISM Band (2400 — 2483.5 MHz) Modulation: GFSK i:‘\’ This product contains batteries and recyclable electronic waste. To protect the environment, do not dispose Effective radiated power: <20dBm «\ of it in household waste, but take it to an appropriate local collection center. mm A fanmt /\ Important Read the operating instructions. If the device is not used within the specified temperature, humidity and atmospheric pressure ranges, @ Id: 2ABRGBPW4500 the technical accuracy of the measurement cannot be guaranteed. Classification: s Internally powered equipment W Type BF applied parts i P22 Protected against solid foreign objects of 49 in diameter and larger. Protected against water drops falling vertically when the device is tilted up to 15°. Not suitable for use in the presence of flammable anaesthetic mixtures with air, oxygen or nitrous oxide. Continuous operation with short—time loading. o # 85 su"r/g/ Operating temperature wvflfm * Storage temperature Storage humidity 10 11

FCC statement THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES. 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. FCC Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment. ‘ Note: This equipment 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 equipment 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 equipment 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 equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co—located or operating in conjunction with any other antenna or transmitter. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption ratio (SAR). Support contact numbers USA B +1 XXX XXX XX XX


Document Created: 2018-04-11 10:59:11
Document Modified: 2018-04-11 10:59:11
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