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BC 54 ENGLISH Wrist Blood Pressure Monitor Instructions for use .............. 3 ESPAOL Tensimetro para mueca Manual de instrucciones ... 22 Distributed by/Distribuido por:
Beurer North America LP 1 Oakwood Boulevard, Suite 255 Hollywood, FL 33020, USA www.shop-beurer.com Questions or comments?
Call our US-based customer service toll free at 1-800-536-0366. Preguntas o comentarios? Llame a nuestro servicio al cliente en Estados Unidos gratis al telfono 1-800-536-0366. READ THIS MANUAL COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT Keep this manual in a safe location for future reference LEA TODO ESTE MANUAL CON ATENCIN ANTES DE USAR ESTE PRODUCTO Conserve este manual en un lugar seguro para consultarlo en el futuro ENGLISH Contents 1. IMPORTANT SAFETY NOTES ......................................... 4 2. Indications for Use .......................................................... 8 3. Package Contents ........................................................... 8 4. Parts and Controls ........................................................... 9 5. Preparing for Measurement ........................................... 10 6. Measuring Blood Pressure ............................................ 11 7. Evaluating Results ......................................................... 12 SAVE THESE INSTRUCTIONS FOR FUTURE REFERENCE If the instruction manual is damaged or if you no longer have the instruction manual in your possession, please contact customer service. See warranty for service contact. Dear Valued Customer, Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for application in the areas of heating, weight management, blood pressure, body temperature, pulse, gentle therapy, massage, and beauty. 8. Displaying and Deleting Measurements ...................... 14 9. Care and Maintenance ................................................ 15 10. Troubleshooting Guide ................................................ 16 11. Technical Specifications .............................................. 17 12. FCC Compliance Information ...................................... 18 13. Warranty ...................................................................... 19 Register your product today to receive further benefits:
added protection for your purchase health and wellness tips new product information continual outstanding customer service and support. Visit www.registerbeurer.com or contact customer service at 1-800-536-0366. Please read these instructions for use carefully and keep them for later use. Make them accessible to other users and observe the information they contain. With kind regards, Your Beurer team 3 1. IMPORTANT SAFETY NOTES Signs and symbols Whenever used, the following signs identify safety and property damage messages and designate a level of hazard or seriousness. READ THIS ENTIRE MANUAL, THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT. This is the safety alert symbol. It alerts you to potential personal injury hazards. Obey all safety messages that follow this symbol to avoid possible injury or death. Indicates a hazardous situation which, if not avoided, could result in death or serious injury. Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury WARNING CAUTION 4 NOTICE Addresses practices not related to personal injury, such as product and/or property damage. Isolation of applied parts Type BF Galvanically isolated applied part
(F stands for floating); meets the requirements for leakage currents for type B Observe the instructions Read the instructions before starting work and/or operating devices or machines Direct current The device is suitable for use with direct current only Product information Note on important information Temperature limit The temperature limit values to which the medical device can safely be exposed are indicated. Humidity, limit Indicates the humidity range to which the medical device can safely be exposed. Atmospheric pressure, limit Indicates the range of atmospheric pressures to which the medical device can be safely exposed IP class Device protected against foreign objects 12.5 mm and against water dripping at an angle Serial number Data transfer via Bluetooth low energy technology IP22 SN WARNING To reduce the risk of re, electric shock, or serious personal injury:
For consistency, always measure your blood pressure at the same time each day. Before each measurement, relax for about ve minutes. When performing multiple measurements on an individual, wait at least 5 minute between each measurement. Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising. The time (30 min) required for the ME EQUIPMENT to warm from the minimum storage temperature -20C between uses until the ME EQUIPMENT is ready for its INTENDED USE when the ambient temperature is 20 C . 5 The time (30 min) required for the ME EQUIPMENT to cool from the maximum storage temperature +60C between uses until the ME EQUIPMENT is ready for its INTENDED USE when the ambient temperature is 20 C. Repeat the measurement if you are unsure of the results. Measurements are for your information only they are no substitute for a medical examination. Discuss the measurements with your doctor and never base any medical decisions on them (e.g. medicines and their administration). Do not use the blood pressure monitor on newborns or patients with pre-eclampsia. Consult your doctor before using the blood pressure monitor during pregnancy. This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Supervise children around the device to ensure they do not play with it. Cardiovascular diseases may lead to incorrect or have a detrimental eect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders, and arrhythmias as well as chills or shaking. The blood pressure monitor must not be used in connection with a high-frequency surgical unit. The blood pressure monitor is made from precision and electronic components. The accuracy of the measured values and service life of the device depend on its careful handling:
- Protect the device from impacts, humidity, dirt, Make sure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular or therapy, or an arteriovenous (AV) shunt. Please note that when inflating, the functions of the marked temperature fluctuations and direct sunlight. limb in question may be impaired.
- Do not drop the device.
- Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.
- Only use the cuff included with the delivery or original replacement cuffs. Otherwise incorrect measured values will be recorded. Using the blood pressure monitor outside your home environment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physical activity such as playing sport) can influence the measurement accuracy and cause incorrect measurements. People with pacemakers or other electrical implants should consult their doctor before using the device. Do not use the cuff on people who have undergone a mastectomy. Do not place the cuff over wounds as this may cause further injury. 6 During the blood pressure measurement, the blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm. Do not perform measurements more frequently than necessary. The resulting restriction of the blood flow may cause injury. Place the cuff on your wrist only. Do not place the cuff on other parts of the body. The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or careless use. CAUTION To reduce the risk of personal injury or product/ property damage:
Do not use the device at the same time as other medical electrical devices (ME equipment). This could lead to a malfunction of the device and/or an inaccurate measurement. We recommend that the batteries be removed if the device is not to be used for a prolonged period. Do not use the device outside of the specified storage and operating conditions. This could lead to incorrect measurements. NOTICE:
Do not wash the unit in a washing machine, dish washer or tumble dryer. Never immerse and or spill water or any other liquid onto the monitor or any components, otherwise liquid will enter it and cause damage. Never attempt to repair, open and/or disassemble the unit (including wrist cuff and optional accessory) or adjust it yourself. This may damage the unit and impair the functions. If you need to have the unit repaired, please contact our customer service. Please see warranty for service contact. Before submitting any complaint, first check the batteries and replace them if necessary. Battery Handling Safety Precautions Use only the size and type of batteries specified. Be sure to follow the correct polarity when installing the batteries. Reversed batteries may cause damage to the device. Do not mix different types of batteries together (e.g. Alkaline and Carbon-zinc or rechargeable batteries) or old batteries with fresh ones. Always replace batteries as a simultaneous set. If the batteries in the device are depleted or the device will not be used for a long period of time, remove the batteries to prevent damage or injury from possible battery leakage. Do not try to recharge batteries not intended to be recharged; they can overheat and rupture (follow battery manufacturers directions.) Do not dispose of batteries in fire, batteries may Changes or modifications to the device will nullify the explode or leak. user warranty. Clean the battery contacts and also those of the device Do not press the buttons with excessive force or with prior to battery installation. pointed objects. Only use the device on people who have the specified wrist measurement for the device. Remove discharged batteries from the product and dispose/recycle in compliance with all applicable laws. Keep batteries away from children and pets. Batteries may be harmful if swallowed. Should a child or 7 pet swallow a battery, seek medical assistance immediately. If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance. Do not disassemble, open or crush the batteries. If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth. Notes on electromagnetic compatibility The device is suitable for use in all environments listed in these instructions for use, including domestic environments. The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device. Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly. The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease 8 in the devices electromagnetic immunity; this can result in faulty operation. Failure to comply with the above can impair the performance of the device. 2. INDICATIONS FOR USE This blood pressure monitor performs non-invasive measurement and monitoring of arterial blood pressure and heartbeat rate in adults with a wrist circumference raging from 5.3 - 8.5 in. You can use it to measure your blood pressure quickly and easily, store the results, and display stored readings and their average. This device also features an irregular heartbeat indicator and average blood pressure results classified and compared to industry guidelines. 3. PACKAGE CONTENTS 1 x Wrist blood pressure monitor with cuff 1 x Storage box 2 x 1.5 V Unnecessary AAA batteries 1 x Quick start guide 1 x Instruction manual 4. PARTS AND CONTROLS 1 1 2 LCD Display Information 1 2 7 6 5 3 2 4 11 10 9 8 7 6 3 4 5 11 10 9 8 7 6 3 4 5 1. LCD Display 2. START/STOP Button 3. M1 Button 4. M2 Button 5. Wrist Cuff 6. Battery Compartment (on rear) 7. Blood Pressure Classification Scale 1. Blood Pressure Classification Indicator 2. Bluetooth Indicator 3. Time and Date 4. Systolic Pressure 5. Diastolic Pressure 6. Pulse Rate 7. Irregular Heartbeat Indicator/Pulse Rate Icon 8. Low Battery Indicator 9. Deflation Indicator 10. User Number Indicators 11. Memory Space Number/Memory Display of Average
(A), Morning (M), or Evening (E) 9 5. PREPARING FOR MEASUREMENT Inserting/changing batteries:
1. Remove the Battery Compartment Cover from the rear of the device. 2. Insert two AAA alkaline batteries (included) according to the polarity markings inside the compartment. NOTE: Do not use rechargeable batteries. 3. Reattach the Battery Compartment Cover. 4. Before first use, remove the clear plastic film from the LCD Display. All LCD Display elements will briefly appear and 24h will flash. Set the date and time as described below. Any saved measurements will be retained. Setting the hour format, date, and time:
If date and time are not set, stored measurements will not have a valid timestamp associated with them. NOTE: Press and hold the M1 or M2 Buttons to advance values rapidly. 10 1. If 24h is not flashing in the LCD Display, press and hold the START/
STOP Button for five seconds. 2. Select an hour format (12 or 24 hour display) with the M1 or M2 Button and press the START/STOP Button to confirm. 3. The year flashes on the LCD Display. Set the year with the M1 or M2 Button and press the START/STOP Button to confirm. 4. The month flashes on the LCD Display. Set the month with the M1 or M2 Button and press the START/STOP Button to confirm. 5. The day flashes on the LCD Display. Set the day with the M1 or M2 Button and press the START/STOP Button to confirm. NOTE: If the hour format is set to 12h, the day/month display sequence is reversed. 6. The hour flashes on the LCD Display. Set the hour with the M1 or M2 Button and press the START/STOP Button to confirm. 7. The minutes flash on the LCD Display. Set the minutes with the M1/M2 Buttons and press the START/STOP Button to confirm. Attaching the Cuff:
1 2 0.4 in / 1 c m 3 8. "bt" will appear on the LCD Display.Turn Bluetooth on or off using the M1/M2 Buttons; the Bluetooth symbol will appear in the upper left corner of the LCD Display when it is activated. NOTE: Battery drain is increased slightly when Bluetooth is on. 9. Press the START/STOP Button to confirm and exit;
the LCD Display will shut off. 6. MEASURING BLOOD PRESSURE The blood pressure monitor needs to be at room temperature when measuring. Measurements can be performed on the left or right wrist. 1. With your palm up, place the cuff around your left wrist. 2. Position the cuff about half an inch (0.4 in) below the bottom of your hand. 3. Secure the cuff with the hook and loop strip so that it fits snugly but does not affect blood circulation. Correct Posture:
1. Rest for at least five minutes before each measurement. 2. Perform the measurement either sitting or lying down. Always make sure that the cuff is level with your heart. 11 3. To perform a measurement, sit comfortably with your arms and back supported. Do not cross your legs and place your feet flat on the floor. 4. Keep still during the measurement and do not talk. Performing a Measurement:
1. With the device shut off, press M1 or M2 to select a User Number and confirm by pressing the START/
STOP Button. 2. With the cuff attached properly and in a correct posture, press the START/STOP Button. All LCD Display elements will briefly display and measurement will begin after about five seconds. To cancel a measurement at any time, press the START/
STOP Button again. 3. As the measurement concludes, the cuff will deflate. will display, along with systolic The pulse symbol and diastolic pressure. 4. "Er_" will appear if the measurement was not performed properly. Refer to the "Troubleshooting Guide" section for details about specific error message numbers. 12 5. Press the START/STOP Button to shut off the blood pressure monitor. The measurement is now stored in the selected user memory. The device will also shut off automatically after about three minutes. 6. If the Bluetooth function is on, data will transfer after pressing the START/STOP Button; the Bluetooth icon will flash in the LCD Display and the unit will try to connect to the HealthManager app on your Bluetooth device for about 30 seconds. 7. When Bluetooth pairing is successful, the icon will display steadily and all measurement data is transferred. The unit will then shut off. 8. If a Bluetooth pairing is not found, the icon will disappear from the LCD Display and the unit will shut off after about three minutes. 9. Wait at least five minutes before taking another measurement. 7. EVALUATING RESULTS Irregular Heartbeat:
This device can detect irregular heartbeat patterns during measurement and will indicate them by displaying the Irregular Heartbeat Indicator for arrhythmia, a condition where the heart rhythm is
. This may be an indicator abnormal. These symptoms (omitted or premature heartbeats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress, or lack of sleep. Only your doctor can determine if you do have arrhythmia. Repeat the measurement if the Irregular Heartbeat Indicator displays after a measurement. Rest for at least five minutes between measurements and do not talk or move during measurement. If the Indicator appears often, contact your doctor, since self-diagnosis and treatment based solely on the test results may be dangerous. It is vital to follow your doctors instructions. Risk Classification Measurements can be classified and assessed by the table below. However, these standard values are only a general guideline, since individual blood pressure varies in different people and different age groups, etc. Hypertension Category Grade 3: Severe hypertension Systolic
(in mmHg) Diastolic
(in mmHg) LED Risk Indicator 180 110 Red Hypertension Category Grade 2:
Moderate hypertension Grade 1: Mild hypertension High Normal Normal Optimal Systolic
(in mmHg) Diastolic
(in mmHg) LED Risk Indicator 160 179 100 109 Orange 140 159 90 99 130 139 120 129
< 120 85 89 80 84
< 80 Yellow Green Green Green Source: WHO, 1999 It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous. The classification on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the systolic and diastolic values fall into two different categories, the Risk Classification Indicator on the device always shows the higher category. 13 8. DISPLAYING AND DELETING MEASUREMENTS User Memory:
Every successful measurement is stored along with its date and time. If there are more than 60 measurements, the oldest measurement is deleted. With the unit shut off, press the M1 or M2 Button to select a user memory and then confirm by pressing the Start/Stop Button. If Bluetooth is activated, the device will attempt to connect to the mobile app. If a connection is achieved, the buttons are deactivated, the Bluetooth icon disappears from the LCD Display, and data is transferred. To cancel Bluetooth transfer, press the M1 or M2 Button. Average Values:
AA flashes on the display. The average of all saved measurements in the selected user memory is displayed. Press the M1 Button again. AMAM flashes on the display. The average value of the morning measurements for the last seven days is displayed (morning: 5:00 AM 9:00 AM). Press the M1 Button a third time. PMPM flashes on the display. The average value of the evening measurements for the last seven days is displayed (evening: 6:00 PM 8:00 PM). Individual Measured Values:
Press the M1 Button again and the last individual measurement is displayed. Keep pressing the M Button to cycle through all the stored individual measurements. To shut the device off, press the START/STOP Button. You can exit the menu at any time by pressing the START/
STOP Button. 14 Clearing Memory:
For a list of compatible devices, scan the QR Code below:
To clear one of the user memories, you must first select it. Start individual measurement access as described above and select a user memory. Press and hold the M1 and M2 Buttons for five seconds. All values in the selected user memory will be deleted. Transfer via Bluetooth In addition to displaying and saving measurements locally on the blood pressure monitor itself, you can also transfer measurements to your mobile device via Bluetooth. To do so, you will need to install the "beurer HealthManager Pro" app. The app is freely available in either the Apple App Store or Google Play Store. System requirements:
iOS 14.0, Android 8.0 Bluetooth 4.0 15 To transfer the measured values, proceed as follows:
Start the app and follow the instructions. Select the blood pressure monitor in the app. Confirm the pairing request on your smartphone. Make sure the "beurer HealthManager Pro" app on your smartphone is always activated and open before you start data transfer from the blood pressure monitor. Data transfer is in progress when the Bluetooth symbol flashes on the LCD Display. 9. CARE AND MAINTENANCE Clean the device and cuff with a slightly moistened cloth. Do not use detergents or solvents. Never immerse the device in water or other liquids. When storing the device, make sure no heavy objects are placed on top of it. Remove the batteries. Disposal Observe the local regulations for material disposal. Dispose of the device in accordance with local regulations. If you have any questions, please contact the local authorities responsible for waste disposal. 10. TROUBLESHOOTING GUIDE In case of faults, "Er_" appears in the LCD Display, where
"_" is a number from 1-8. Error messages may appear if:
Error message Possible cause Solution Please wait five minute and repeat the measurement. Ensure that you do not speak or move during the measurement. Unable to record a pulse. You have moved or spoken during the measurement. Error message Possible cause Solution Please observe the notes in chapter "Measuring Blood Pressure" under the section
"Attaching the cuff". During a new measurement, check whether the cuff can now be inflated properly. Please wait five minutes and repeat the measurement. Ensure that you do not speak or move during the measurement. The cuff was not attached correctly. An error occurred during measurement. The inflation pressure is higher than 300 mmHg or the measured blood pressure is outside the measuring range. 4 4 16 Error message Possible cause Solution The batteries are almost empty. The data could not be sent via Bluetooth. A device error has occurred. Insert new batteries into the device. Proceed as described in chapter "Displaying and Deleting Measurements"
under the section
"Transfer via Bluetooth" into the manual memory mode and try to restart the data transfer. Please repeat the measurement after a pause of five minutes. 4 7 8 11. TECHNICAL SPECIFICATIONS Type BC 54 Measurement Method Measurement Range Oscillometric, non-invasive blood pressure measurement on the wrist Cuff pressure 0-299 mmHg, Systolic 60-230 mmHg, Diastolic 40-130 mmHg, Pulse 40-199 beats/minute Display Accuracy Pressure 3 mmHg, Pulse 5%
Dimensions Weight Cuff Size Operating Range 3.16 in L x 2.73 in W x 0.98 in H
(80.5 mm L x 69.5 mm W x 25 mm H) 4 oz (116 g) without batteries 5.3 in - 8.5 in (135 - 215 mm) 41 F - 104 F (5 C - 40 C), 90% relative humidity
(non-condensing) 17 Storage Range Power Supply Battery Life Amount of user Measurements per user
-4 F - 140 F (-20 C - 60 C), 93% relative humidity at a water vapour pressure up to 50 hPa An atmospheric pressure range of 500 hPa to 1060 hPa Two AAA Batteries Approx. 150 measurements up to 2 users 60 memory spaces per user The serial number is located on the device or in the battery compartment. 12. FCC COMPLIANCE INFORMATION Wrist Blood Pressure Monitor BC 54 Responsible Party U.S. Contact Information Beurer North America LP 1 Oakwood Boulevard, Suite 255 Hollywood, FL 33020 United States 1-800-536-0366 info@beurer.com FCC ID: OU9-TMB-BC54 FCC Compliance 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. Changes or modications not expressly approved by the party responsible for compliance could void the users 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 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. 18 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. 13. WARRANTY Limited Lifetime Warranty For Original Purchaser Your Beurer Wrist Blood Pressure Monitor, BC 54, is warranted to be free from defects in materials and workmanship for the life of the product under normal conditions of intended use and service. This warranty extends only to the original retail purchaser and does not extend to retailers or subsequent owners. We will, at our option, repair or replace the Beurer Wrist Blood Pressure Monitor, BC 54, without additional charge, for any part or parts covered by these written warranties. No refunds will be given. Repair or replacement is our only responsibility and your only remedy under this written warranty. If replacement parts for defective materials are not available, Beurer reserves the right to make product substitutions in lieu of repair or replacement. For warranty service contact our customer service department at 1-800-536-0366 or at info@beurer.com to provide a description of the problem. If the problem is deemed to be within the scope of the limited lifetime warranty, you will be asked to mail the product at your costs in its original package with proof of purchase, your name, address and phone number. If the problem is not deemed to be within the scope of the limited lifetime warranty, we will provide a quotation for repair respectively replacement and return shipping fee. This warranty does not cover damage caused by misuse or abuse; accident; the attachment of unauthorized accessory; alteration to the product; improper installation;
misapplication; lack of reasonable care with respect to the product; unauthorized repairs or modifications; improper use of electrical/power supply; old worn batteries; normal wear; loss of power; dropped product; malfunction or damage of an operating part as a result of failure to comply with instructions for use or to provide manufacturers recommended maintenance; transit damage; theft; neglect;
vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of Beurer. This warranty is void if the product is ever used in a commercial or business 19 environment. The maximum liability of Beurer under this warranty is limited to the purchase price actually paid by the customer for the product covered by the warranty, as confirmed by proof of purchase, regardless of the amount of any other direct or indirect damage suffered by the customer. This warranty is effective only if the product is purchased and operated in the country in which the product is purchased. A product that requires modifications or adaptation to enable it to operate in any other country than the country for which it was designed, manufactured, approved and/or authorized, or repair of products damaged by these modifications is not covered under this warranty. THE WARRANTY PROVIDED HEREIN SHALL BE THE SOLE AND EXCLUSIVE WARRANTY. ANY IMPLIED WARRANTIES, OBLIGATIONS, OR LIABILITES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE DURATION OF THIS APPLICABLE WRITTEN WARRANTY. Some states do not allow limitations on how long an implied warranty lasts, so the above limitations may not apply to you. IN NO EVENT SHALL BEURER BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES FOR BREACH OF THIS OR ANY OTHER WARRANTY, EXPRESS, IMPLIED OR ANY OTHER THEORY OF LIABILITY, WHATSOEVER. Some states do not allow the exclusion or limitation of special, incidental, or consequential damages, so the above limitation may not apply to you. Beurer does not authorize anyone, including, but not limited to, retailers, the subsequent consumer purchaser of the product from a retailer or remote purchaser, to obligate Beurer in any way beyond the terms set forth herein. This warranty does not extend to the purchase of opened, used, repaired, repackaged and/or resealed products, including but not limited to sale of such products on Internet auction sites and/or products by surplus or bulk resellers. Any and all warranties or guarantees shall immediately cease and terminate in connection with any products or parts thereof which are repaired, replaced, altered, or modified, without the prior explicitly written consent of Beurer. This warranty gives you specific legal rights, and you may also have other rights which may vary from state to state. 20 For more information regarding our product line in the USA, please visit: www.shop-beurer.com Distributed by:
Beurer North America LP 1 Oakwood Boulevard, Suite 255 Hollywood, FL 33020, USA www.shop-beurer.com Questions or comments? Call our US-based customer service toll free at 1-800-536-0366. Assembled in China e g n a h c d n a r o r r e o t j t c e b u S 21 ESPAOL ndice 1. NOTAS IMPORTANTES DE SEGURIDAD ...................... 23 2. Indicaciones de uso ...................................................... 28 3. Contenido del paquete .................................................. 28 4. Partes y controles .......................................................... 28 5. Preparacin de la medicin ........................................... 29 6. Medicin de la presin arterial ...................................... 31 7. Evaluacin de los resultados ......................................... 32 CONSERVE ESTAS INSTRUCCIONES PARA PODER CONSULTARLAS EN EL FUTURO Si el manual de instrucciones est daado o si ya no lo tiene, llame al servicio al cliente. En la garanta encontrar la informacin de contacto del servicio. 8. Visualizacin y eliminacin de lecturas ....................... 34 9. Cuidado y mantenimiento ........................................... 36 10. Gua de solucin de problemas................................... 36 11. Especificaciones tcnicas ........................................... 38 12. Informacin de conformidad con la FCC .................... 39 13. Garanta ....................................................................... 40 Registre su producto hoy para disfrutar de ms beneficios:
mayor proteccin por su compra consejos sobre salud y bienestar informacin sobre nuevos productos servicio al cliente continuo y de gran calidad. Estimado cliente:
Gracias por elegir uno de nuestros productos. Nuestro nombre es sinnimo de productos de alta calidad, minuciosamente probados, que se utilizan en las reas de calefaccin, control de peso, presin arterial, temperatura corporal, pulso, terapia moderada, masajes y belleza. Visite www.registerbeurer.com o pngase en contacto con el servicio al cliente llamando al 1-800-536-0366. Lea atentamente estas instrucciones de uso y consrvelas para poder consultarlas en el futuro. Asegrese de que estn disponibles para los dems usuarios y tenga en cuenta la informacin que contienen. Saludos cordiales, Su equipo de Beurer 22 1. NOTAS IMPORTANTES DE SEGURIDAD Signos y smbolos Siempre que se usan, estos signos identifican mensajes de seguridad y de daos materiales, e indican el nivel de gravedad del peligro. LEA CON ATENCIN TODO ESTE MANUAL, LA SECCIN DE SEGURIDAD Y TODAS LAS INSTRUCCIONES Y ADVERTENCIAS ANTES DE USAR ESTE PRODUCTO. SIGA TODAS LAS INSTRUCCIONES Y ADVERTENCIAS DE SEGURIDAD PARA EVITAR SITUACIONES PELIGROSAS Y PARA USAR CORRECTAMENTE ESTE PRODUCTO. Este es el smbolo de alerta de seguridad. Le advierte sobre los posibles riesgos de lesiones personales. Obedezca todos los mensajes de seguridad que siguen a este smbolo para evitar posibles lesiones o la muerte. 23 ADVERTENCIA PRECAUCIN AVISO Indica una situacin peligrosa que, si no se evita, podra causar la muerte o una lesin grave. Indica una situacin peligrosa que, si no se evita, puede causar una lesin menor o moderada. Se refiere a prcticas que no estn relacionadas con lesiones, como es el caso de daos al producto o daos materiales. Aislamiento de las partes aplicadas tipo BF Parte aplicada con aislamiento galvnico (F significa flotante);
cumple los requisitos relativos a corrientes de fuga para los productos de tipoB. Consultar las instrucciones Lea las instrucciones antes de empezar el trabajo o utilizar dispositivos o mquinas. Corriente directa El dispositivo solamente es apto para uso con corriente directa Informacin sobre el producto Nota sobre informacin importante Lmite de temperatura Se indican los valores lmite de temperatura a los que el producto mdico puede estar expuesto de forma segura. Lmite de humedad Indica el rango de humedad al que el dispositivo mdico puede ser expuesto con seguridad. Lmite de presin atmosfrica Indica el rango de presiones atmosfricas al que se puede exponer el dispositivo mdico de forma segura. Clase IP Este dispositivo est protegido contra la penetracin de objetos extraos con un tamao mayor o igual a 12.5mm de dimetro y contra la cada de gotas de agua con inclinacin. Nmero de serie 24 Transferencia de datos va tecnologa Bluetooth de bajo consumo energtico. ADVERTENCIA. Para reducir el riesgo de incendio, descarga elctrica o lesiones personales graves:
Por razones de uniformidad, mida siempre su presin arterial a la misma hora cadada. Antes de cada lectura, reljese durante unos cinco minutos. Cuando tome varias lecturas a una misma persona, espere 5 minutos entre cada una. No realice ninguna lectura dentro de 30minutos despus de haber comido, bebido, fumado o hecho ejercicio. Repita la lectura si no est seguro de los resultados. Las lecturas son nicamente para informacin: no son un sustituto de los exmenes mdicos. Hable acerca de dichas mediciones con su mdico y nunca base ninguna decisin mdica exclusivamente en ellas (por ejemplo, sobre medicamentos y su administracin). No utilice el tensimetro en recin nacidos ni en pacientes con preeclampsia. Consulte a su mdico antes de usar el tensimetro durante el embarazo. IP22 SN Este dispositivo no debe ser usado por personas
- No utilice el dispositivo cerca de campos
(incluyendo nios) con capacidades fsicas, sensoriales o mentales limitadas o que carezcan de experiencia o conocimientos, a menos que estn bajo la supervisin de una persona que sea responsable de su seguridad o que dicha persona los instruya sobre cmo usar el dispositivo. Supervise a los nios que estn cerca del dispositivo para asegurarse de que no jueguen con este. Las enfermedades cardiovasculares pueden provocar mediciones incorrectas o presentar un efecto perjudicial sobre la precisin de las mediciones. Lo mismo ocurre con la presin sangunea muy baja, la diabetes, los problemas circulatorios, las arritmias y los escalofros o temblores. electromagnticos fuertes y mantngalo alejado de los sistemas de radio y los telfonos celulares.
- Utilice nicamente el brazalete incluido en el envo o brazaletes de reemplazo originales. En caso contrario, se obtendrn lecturas incorrectas. El uso del tensimetro fuera de casa o cuando est viajando (por ejemplo, cuando viaje en automvil, ambulancia o helicptero, o cuando est realizando alguna actividad fsica, como un deporte) puede influir en la precisin de las mediciones y provocar mediciones incorrectas. Las personas con marcapasos u otros implantes elctricos deben consultar a su mdico antes de utilizar el dispositivo. El tensimetro no debe usarse junto con una unidad No use el brazalete en personas que han sido quirrgica de alta frecuencia. sometidas a mastectoma. Este tensimetro est fabricado con componentes No coloque el brazalete sobre heridas, ya que esto electrnicos de precisin. La precisin de las lecturas y la vida de servicio del dispositivo dependen del manejo cuidadoso del mismo:
- Proteja el dispositivo contra golpes, humedad, suciedad, cambios drsticos de temperatura y de la luz solar directa.
- Evite que el dispositivo se caiga. puede causar otras lesiones. Asegrese de que el brazalete no se coloque en un brazo en el que las arterias o venas estn siendo sometidas a un tratamiento mdico; por ejemplo, accesos o terapias intravasculares o una derivacin arteriovenosa (AV). Observe que al inflar, las funciones de la extremidad en cuestin pueden afectarse. 25 Durante la medicin de la presin sangunea, no debe interrumpirse la circulacin de la sangre durante un periodo de tiempo innecesariamente largo. Si el dispositivo funciona incorrectamente, retire el brazalete del brazo. No realice mediciones con ms frecuencia de la necesaria, ya que la reduccin del flujo sanguneo resultante podra provocar lesiones. Coloque el brazalete nicamente en la mueca. No lo coloque en otras partes del cuerpo. El dispositivo solamente es para el uso descrito en estas instrucciones. El fabricante no se hace responsable por los daos que cause el uso indebido o imprudente del mismo. PRECAUCIN. Para reducir el riesgo de lesiones personales o daos en el producto o en otros objetos:
No utilice el dispositivo al mismo tiempo que otros dispositivos electromdicos (equipos EM). Esto podra provocar funcionamiento incorrecto del dispositivo o medicin imprecisa. No utilice el dispositivo en condiciones de almacenamiento y funcionamiento distintas de las especificadas. Esto podra dar lugar a mediciones incorrectas. 26 AVISO:
No lave esta unidad en una lavadora de ropa, mquina lavaplatos o secadora de ropa. Nunca sumerja la unidad en agua u otros lquidos ni derrame agua o lquidos sobre el tensimetro, ya que stos entrarn en l y lo daarn. Nunca trate de reparar, abrir o desarmar esta unidad
(incluyendo el brazalete para mueca y el accesorio opcional) ni de ajustarla usted mismo. Podra daar la unidad e impedir su funcionamiento correcto. Si la unidad requiere reparacin, llame a nuestro servicio al cliente. En la garanta encontrar la informacin de contacto del servicio. Antes de presentar cualquier queja, revise las bateras y reemplcelas si es necesario. Los cambios o modificaciones en el dispositivo anularn la garanta del usuario. No presione los botones con fuerza excesiva o con objetos punzantes. Use el dispositivo solo en personas que tengan la medida de la circunferencia especificada para este aparato. Si no va a utilizar el dispositivo durante un periodo de tiempo prolongado, le recomendamos que retire las bateras. Precauciones de seguridad en el manejo de las bateras Use solo el tamao y tipo de bateras que se especifican. Asegrese de utilizar la polaridad correcta cuando instale las bateras. Las bateras colocadas con la polaridad invertida pueden daar el dispositivo. No combine tipos distintos de bateras (por ejemplo, alcalinas, carbono-zinc o recargables) ni bateras usadas con bateras nuevas. Cuando cambie las bateras, sustityalas todas al mismo tiempo. Si las bateras del dispositivo estn agotadas o el dispositivo no se va a utilizar durante un tiempo prolongado, retire las bateras para evitar daos o lesiones por posible derrame de estas. No intente recargar bateras que no estn diseadas para recargarse: se pueden sobrecalentar y romper
(siga las instrucciones del fabricante de la batera). No arroje las bateras al fuego, ya que podran explotar o podra producirse un derrame. Limpie los contactos de las bateras y tambin los del dispositivo antes de instalar las bateras. Retire las bateras descargadas del producto y deseche o recicle de acuerdo con la legislacin aplicable. Mantenga las bateras lejos del alcance de nios y mascotas. Las bateras pueden ser dainas en caso de ingestin. Si un nio o una mascota llega a ingerir una batera, busque atencin mdica de inmediato. Si la piel o los ojos entran en contacto con el fluido de las bateras, enjuague con agua el rea afectada y solicite ayuda mdica. No desarme, abra ni aplaste las bateras. Si se derrama lquido de una pila, pngase guantes protectores y limpie el compartimiento para las bateras con un trapo seco. Notas sobre compatibilidad electromagntica El dispositivo es adecuado para usarse en todos los ambientes indicados en estas instrucciones de uso, incluidos ambientes domsticos. El uso del dispositivo puede ser limitado en presencia de interferencias electromagnticas. Esto podra resultar en problemas como mensajes de error o falla de la pantalla o del dispositivo. Evite usar este dispositivo cerca de otros dispositivos, o colocarlo encima de otros dispositivos, ya que esto podra causar un funcionamiento incorrecto. Sin embargo, si es necesario usar el dispositivo en la forma mencionada, este y los dems dispositivos debern vigilarse para asegurar que funcionen correctamente. 27 El uso de accesorios que no sean los especificados o los que proporciona el fabricante de este dispositivo puede causar aumento de las emisiones electromagnticas o disminucin de la inmunidad electromagntica del dispositivo; esto puede resultar en funcionamiento incorrecto. El incumplimiento de lo anterior puede perjudicar el desempeo del dispositivo. 2. INDICACIONES DE USO Este tensimetro realiza mediciones no invasivas y monitoriza la presin arterial y la frecuencia cardaca en adultos con un permetro de mueca de 5.3 a 8.5 pulgadas. Usted puede usarlo para medir su presin arterial rpida y fcilmente, guardar los resultados y mostrar las lecturas almacenadas y sus valores promedio. Este dispositivo tambin cuenta con un indicador de latidos irregulares y resultados promedio de presin arterial clasificados y comparados con los lineamientos de la industria. 3. CONTENIDO DEL PAQUETE 1 tensimetro para mueca con brazalete 1 caja de almacenamiento 2 bateras AAA de 1.5 V innecesarias 1 gua de inicio rpido 1 manual de instrucciones 28 4. PARTES Y CONTROLES 1 7 6 5 3 2 4 1. Pantalla LCD 2. Botn INICIO/FIN 3. Botn M1 4. Botn M2 5. Brazalete 6. Compartimiento de las bateras (en la parte posterior) 7. Escala de clasificacin de la presin arterial 1 2 1 2 Informacin de la pantallaLCD 11 10 9 8 7 6 3 4 5 11 10 9 8 7 6 3 4 5 1. Indicador de clasificacin de la presin arterial 2. Indicador de Bluetooth 3. Hora y fecha 4. Presin sistlica 5. Presin diastlica 6. Pulso 7. Indicador de ritmo cardaco/icono de ritmo cardaco irregular 8. Indicador de batera baja 9. Indicador de desinflado 10. Indicadores de nmero de usuario 11. Nmero de espacio de memoria / Visualizacin de memoria de promedio (A), maana (M) o tarde (E) 29 5. PREPARACIN DE LA MEDICIN Insercin/cambio de las bateras 1. Retire la tapa del compartimiento de las bateras de la parte posterior del dispositivo. 2. Coloque dos bateras AAA alcalinas (incluidas) de acuerdo con las marcas de polaridad que hay dentro del compartimiento. NOTA: No use bateras recargables. 3. Cierre el compartimento. 4. Antes del primer uso, retire la pelcula de plstico transparente de la pantalla LCD. Todos los elementos de la pantalla LCD aparecern brevemente y parpadear un 24h. Ajuste la fecha y hora segn se describe a continuacin. Todas las mediciones guardadas se conservarn. Configuracin del formato de hora y ajuste de la fecha y la hora:
Si no se ajustan la fecha y la hora, las mediciones guardadas no llevarn asociado un sello de tiempo vlido. NOTA: Mantenga presionados los botones M1 o M2 para avanzar valores rpidamente. 1. Si 24h no parpadea en la pantalla LCD, mantenga presionado el botn INICIO/FIN durante cincosegundos. 2. Seleccione un formato de hora
(visualizacin de 12 o 24horas) con los botones M1 o M2 y presione el botn INICIO/FIN para confirmar. 3. El ao parpadear en la pantallaLCD. Ajuste el ao con los botones M1 o M2 y presione el botn INICIO/FIN para confirmar. 4. El mes parpadear en la pantalla LCD. Ajuste el mes con los botones M1 o M2 y presione el botn INICIO/FIN para confirmar. 5. El da parpadear en la pantallaLCD. Ajuste el da con los botones M1 o M2 y presione el botn INICIO/FIN para confirmar. NOTA: Si el formato de hora est configurado como 12h, se invertir la secuencia en la que se muestran el da y el mes. 6. La hora parpadear en la pantallaLCD. Ajuste la hora con los botones M1 o M2 y presione el botn INICIO/FIN para confirmar. 7. Los minutos parpadearn en la pantallaLCD. Ajuste los minutos con los botones M1/M2 y presione el botn INICIO/FIN para confirmar. 8. Aparecer bt en la pantalla LCD. Active o desactive Bluetooth con los botones M1/M2; el smbolo de Bluetooth aparecer en la esquina superior izquierda de la pantalla LCD cuando se active. NOTA: El agotamiento de la batera se incrementa levemente cuando el Bluetooth est encendido. 9. Presione el botn INICIO/FIN para confirmar y salir, la pantalla LCD se apagar. 30 6. MEDICIN DE LA PRESIN ARTERIAL El tensimetro debe estar a temperatura ambiente durante las mediciones. Las lecturas se pueden llevar a cabo en la mueca izquierda o en el derecha. Colocacin del brazalete:
1 2 0.4 in / 1 c m 3 1. Con la palma hacia arriba, coloque el brazalete alrededor de la mueca izquierda. 2. Coloque el brazalete aproximadamente media pulgada (0.4 in) por debajo de la parte inferior de la mano. 3. Fije el brazalete con la tira de velcro de modo que quede bien ajustado, pero que no afecte a la circulacin sangunea. Postura correcta:
1. Descanse al menos cincominutos antes de cada medicin. 2. Realice la medicin sentado o acostado. Asegrese siempre de que el brazalete est al mismo nivel que el corazn. 3. Para realizar la medicin sentado, sintese cmodamente con sus brazos y espalda apoyados. No cruce las piernas y coloque sus pies en el piso. 4. Mantngase quieto durante la medicin y no hable. Cmo realizar una medicin:
1. Con el dispositivo apagado, presione M1 o M2 para seleccionar un nmero de usuario y confirme presionando el botn INICIO/FIN. 2. Una vez que haya colocado correctamente el brazalete y la postura sea adecuada, presione el botn INICIO/FIN. Todos los elementos de la pantalla LCD se mostrarn brevemente y la medicin comenzar despus de unos cinco segundos. Para cancelar una medicin en cualquier momento, presione el botn INICIO/FIN otra vez. 31 3. Al finalizar la medicin, el brazalete se desinflar. El 8. Si no se encuentra un emparejamiento Bluetooth, el smbolo del pulso y diastlica se mostrarn en la pantalla. y los valores de presin sistlica 4. Si la lectura no se realiz correctamente, aparecer Er_. Consulte la seccin Gua para la resolucin de problemas para obtener informacin ms detallada acerca de los diferentes nmeros de mensaje de error, y repita la medicin. 5. Presione el botn INICIO/FIN para apagar el tensimetro. La lectura se guardar en la memoria de usuario seleccionada. El dispositivo se apagar automticamente despus de aproximadamente tres minutos. 6. Si la funcin Bluetooth est activada, los datos se transferirn tras presionar el botn INICIO/FIN; el icono de Bluetooth parpadear en la pantalla LCD y la unidad intentar conectarse a la aplicacin HealthManager en su dispositivo Bluetooth durante unos 30 segundos. 7. Cuando el emparejamiento Bluetooth se realice correctamente, el icono se mostrar de forma constante y se transferirn todos los datos de medicin. La unidad se apagar. icono desaparecer de la pantalla LCD y la unidad se apagar despus de aproximadamente tres minutos. 9. Espere al menos cinco minutos antes de tomar otra lectura. 7. EVALUACIN DE LOS RESULTADOS Ritmo cardaco irregular:
Este dispositivo puede detectar irregularidades del ritmo cardaco durante la medicin y las indicar mostrando el indicador de ritmo cardaco irregular
. Esto podra ser un indicio de arritmia, que es una enfermedad en la que el ritmo cardaco es anmalo. Estos sntomas (palpitaciones o extrasstoles, o pulso demasiado lento o demasiado rpido) pueden ser provocados por factores como las cardiopatas, la edad, la predisposicin fsica, el exceso de estimulantes, el estrs o la falta de sueo. Solo un mdico puede determinar si realmente tiene arritmia. Repita la medicin si, despus de efectuarla, aparece en la pantalla el indicador de ritmo cardaco irregular. Descanse durante al menos cinco minutos entre mediciones y no 32 Categora de hipertensin ptima Sistlica
(en mm de Hg)
< 120 Diastlica
(en mm de Hg)
< 80 Indicador LED del riesgo Verde Fuente: OMS, 1999 Es importante consultar a su mdico peridicamente. Su mdico le informar de sus valores personales de presin sangunea normal, as como del valor por encima del cual su presin sangunea se puede clasificar como peligrosa. La clasificacin de la pantalla y la escala de la unidad muestran la categora a la que pertenecen los valores de presin sangunea registrados. Si los valores de presin sistlica y diastlica pertenecen a dos categoras diferentes, el indicador de clasificacin del riesgo del dispositivo mostrar siempre la categora ms alta. hable ni se mueva durante las mismas. Si aparece el indicador con frecuencia, consulte a su mdico, ya que el autodiagnstico y tratamiento basados nicamente en los resultados de estas pruebas pueden resultar peligrosos. Es imprescindible seguir las indicaciones de su mdico. Clasificacin del riesgo Las lecturas se pueden clasificar y evaluar mediante la tabla que se muestra a continuacin. Sin embargo, estos valores estndar solamente sirven como pauta general, ya que la presin arterial individual vara entre diferentes personas, grupos de edad,etc. Categora de hipertensin Grado 3:
Hipertensin grave Grado 2:
Hipertensin moderada Grado 1:
Hipertensin leve Normal alta Normal Sistlica
(en mm de Hg) Diastlica
(en mm de Hg) Indicador LED del riesgo 180 110 Rojo 160 179 100 109 Naranja 140 159 90 99 Amarillo 130 139 120 129 85 89 80 84 Verde Verde 33 8. VISUALIZACIN Y ELIMINACIN DE LECTURAS Memoria de usuario:
Cada lectura correcta se guarda junto con la fecha y la hora. Si hay ms de 60lecturas, se elimina la lectura ms antigua. Con la unidad apagada, presione el botn M1 o M2 para seleccionar una memoria de usuario y luego confirme presionando el botn INICIO/FIN. Si Bluetooth est activado, el dispositivo intentar conectarse a la aplicacin mvil. Si se logra una conexin, los botones se desactivan, el icono de Bluetooth desaparece de la pantalla LCD y se transfieren los datos. Para cancelar la transferencia por Bluetooth, presione el botn M1 o M2 Valores promedio:
AA parpadea en la pantalla. Se mostrar el valor promedio de todas las lecturas guardadas en la memoria de usuario seleccionada. Presione el botn M1 nuevamente. AMAM parpadear en la pantalla. Se mostrar el valor promedio de las lecturas matinales de los ltimos siete das (5:00 a. m. - 9:00 a. m.). Presione el botn M1 por tercera vez. PMPM parpadear en la pantalla. Se mostrar el valor promedio de las lecturas vespertinas de los ltimos siete das (tarde: 6:00 p. m. -
8:00 p. m.). Valores de las lecturas individuales:
Presione nuevamente el botn M1: se mostrar la ltima lectura individual. Mantenga presionado el botn M para recorrer todas las mediciones individuales almacenadas. Para apagar el dispositivo, presione el botn INICIO/
FIN. Puede salir del men en cualquier momento presionando el botn INICIO/FIN. 34 Borrado de la memoria:
Requisitos del sistema:
Para vaciar el contenido de una determinada memoria de usuario, primero debe seleccionarla. Ingrese a las lecturas individuales como se indic anteriormente y seleccione una memoria de usuario. Mantenga presionados los botones M1 y M2 durante cinco segundos. Se eliminarn todos los valores almacenados en la memoria de usuario seleccionada. Transmisin de datos va Bluetooth Adems de visualizar y guardar las mediciones en el propio tensimetro, tambin puede transferir las mediciones a su dispositivo mvil a travs de Bluetooth. Para esto, deber instalar la aplicacin beurer HealthManager Pro. La aplicacin est disponible de forma gratuita en Apple App Store o Google Play Store. iOS a partir de la versin14.0, Android a partir de la versin8.0 Bluetooth 4.0 Para ver la lista de dispositivos compatibles, escanee este cdigo QR:
Para transferir los valores medidos, siga estos pasos:
Inicie la aplicacin y siga las instrucciones. Seleccione el tensimetro en la aplicacin. Confirme la solicitud de emparejamiento en su smartphone. Antes de iniciar la transferencia de datos desde el tensimetro, asegrese siempre de que la aplicacin beurer HealthManager Pro est activada y abierta en su smartphone. La transferencia de datos est en curso cuando parpadee el smbolo de Bluetooth en la pantalla LCD. 35 9. CUIDADO Y MANTENIMIENTO Limpie el dispositivo y el brazalete con un pao Mensaje de error Causa posible Solucin ligeramente hmedo. No use detergentes ni solventes. Nunca sumerja el dispositivo en agua ni en otros lquidos. Cuando almacene el dispositivo, asegrese de que no se pongan objetos pesados sobre l. Retire las bateras. Desecho Respete las normas locales para el desecho de materiales. Deseche el aparato de acuerdo con las normas locales. Si tiene alguna pregunta, consulte a las autoridades locales responsables del desecho de residuos. 10. GUA DE SOLUCIN DE PROBLEMAS En caso de fallas, aparecer Er_ en la pantalla LCD, donde _ es un nmero del 1 al 8. Los mensajes de error pueden aparecer si:
36 No se puede registrar el pulso. Se ha movido o ha hablado durante la medicin. El brazalete no estaba bien colocado. Espere cinco minutos y repita la medicin. Asegrese de no hablar o moverse durante la medicin. Siga las indicaciones del captulo Medicin de la presin arterial del captulo Colocacin del brazalete. Durante una nueva medicin, compruebe si el brazalete se puede inflar correctamente. Mensaje de error Causa posible Solucin Mensaje de error Causa posible Solucin Se ha producido un error durante la medicin. La presin de inflado es superior a 300mmHg o la presin arterial medida est fuera del rango de medicin. Las bateras estn casi agotadas. 4 4 4 Espere cinco minutos y repita la medicin. Asegrese de no hablar o moverse durante la medicin. Coloque bateras nuevas en el dispositivo. No se han podido transmitir los datos va Bluetooth. Se produjo un error en el dispositivo. Proceda como se describe en el captulo Visualizacin y eliminacin de lecturas en la seccin Transferencia de datos va Bluetooth al modo de memoria manual e intentar reiniciar la transferencia de datos. Repita la medicin despus de una pausa de cinco minutos. 7 8 37 Rango de almacenamiento
-4 a 140 F (-20 a 60 C), 93 % de humedad relativa Alimentacin Dos bateras AAA Duracin de la batera Cantidad de usuarios Aprox. 150 lecturas hasta 2 usuarios Lecturas por usuario 60 posiciones de memoria por usuario El nmero de serie se encuentra en el propio dispositivo o en el compartimiento de bateras. 11. ESPECIFICACIONES TCNICAS Tipo BC 54 Mtodo de medicin Medicin de presin arterial Rango de medicin Exactitud de la pantalla Dimensiones oscilomtrica, no invasiva en la mueca Presin del brazalete: 0-299mmHg Presin sistlica: 60-230mmHg Presin diastlica: 40-130mmHg Pulso 40-199latidos por minuto Presin 3mm de Hg Pulso 5%
3.16 pulgadas L x 2.73 pulgadas A x 0.98 pulgadas H (80.5 mm L x 69.5mm A x 25 mm H) Peso 116 g (4 oz) sin bateras Tamao de brazalete 5.3 - 8.5 pulgadas (135 - 215mm) Rango de operacin: 41 F 104 F (5 C 40 C) 90% de humedad relativa
(no condensante) 38 12. INFORMACIN DE CONFORMIDAD CON LA FCC Tensimetro para mueca BC54 Parte responsable Informacin de contacto en Estados Unidos Beurer North America LP 1 Oakwood Boulevard, Suite 255 Hollywood, FL 33020 Estados Unidos 1-800-536-0366 info@beurer.com Declaracin de conformidad de la FCC Este dispositivo cumple con la parte15 de las Reglas de la FCC. El funcionamiento correcto est sujeto a las dos condiciones siguientes:
(1) este dispositivo no podr causar interferencias dainas, y (2) este dispositivo debe aceptar cualquier interferencia recibida, incluyendo las interferencias que podran causar funcionamiento no deseado. Los cambios o modificaciones que la parte responsable del cumplimiento no apruebe expresamente podran anular la autoridad del usuario para operar el equipo. 39 NOTA: Este equipo ha sido probado y se determin que cumple con los lmites para los dispositivos digitales Clase B, de acuerdo con la parte 15 de las reglas de la FCC. Estos lmites sirven para proporcionar proteccin razonable contra la interferencia daina en instalaciones residenciales. Este equipo genera, usa y puede emitir energa de radiofrecuencia y, si no se instala de acuerdo con las instrucciones, puede causar interferencias dainas a las comunicaciones de radio. Sin embargo, no hay garanta de que no se producirn interferencias en una instalacin en particular. Si este equipo causa interferencias dainas a la recepcin de radio o televisin, lo cual puede determinarse al apagar y encender el equipo, se recomienda al usuario que intente corregir las interferencias mediante una o ms de las siguientes medidas:
Reorientar o cambiar de lugar la antena receptora. Aumentar la distancia entre el equipo y el receptor. Conectar el equipo en una toma o circuito diferente al que est conectado el receptor. Consultar al distribuidor o a un tcnico con experiencia en radio y televisin. 13. GARANTA Garanta limitada de por vida para el comprador original Se garantiza que su tensimetro para mueca Beurer, modelo BC54, est libre de defectos en los materiales y la mano de obra durante la vida til del producto en las condiciones normales del uso y servicio previstas. Esta garanta se aplica solamente al comprador original y no se extiende a vendedores minoristas o propietarios subsecuentes. A nuestra discrecin, repararemos o reemplazaremos el tensimetro para mueca Beurer, BC54, sin cargo adicional, por cualquier parte o partes cubiertas por esta garanta escrita. No se harn reembolsos. La reparacin o reemplazo es nuestra nica responsabilidad y el nico recurso con que usted cuenta segn esta garanta escrita. Si no hay partes de repuesto disponibles para los materiales defectuosos, Beurer se reserva el derecho de hacer sustituciones del producto en lugar de la reparacin o reemplazo. Para obtener servicio de garanta, llame a nuestro departamento de servicio al cliente al telfono 40 1-800-536-0366 o escriba a info@beurer.com para proporcionar una descripcin del problema. Si se considera que el problema est dentro del alcance de la garanta limitada de por vida, se le pedir que enve el producto, a su cargo, en su empaque original con el comprobante de compra, su nombre, domicilio y nmero telefnico. Si se considera que el problema no est cubierto por la garanta limitada de por vida, le enviaremos una cotizacin para la reparacin o remplazo, as como el costo del transporte. Esta garanta no cubre daos causados por mal uso o abuso; accidente; conexin de accesorios no autorizados;
alteracin del producto; instalacin incorrecta; aplicacin errnea; falta de cuidado razonable con respecto al producto; reparaciones o modificaciones no autorizadas;
uso indebido de alimentacin o energa elctrica; bateras usadas y gastadas; desgaste normal; falta de potencia;
producto que sufri una cada; mal funcionamiento o dao de una parte operativa por no cumplir con las instrucciones de uso o no proporcionar el mantenimiento recomendado por el fabricante; dao en el transporte;
robo; negligencia; vandalismo; condiciones ambientales;
prdida del uso durante el periodo en que el producto est en una instalacin de reparacin o en espera de partes o reparacin por otra causa; o cualquier condicin de otro tipo que est fuera del control de Beurer. Esta garanta se anula si el producto se usa alguna vez en un ambiente comercial o empresarial. La mxima responsabilidad de Beurer segn esta garanta se limita al precio de compra que el cliente haya pagado realmente por el producto cubierto por la garanta, segn se confirme mediante prueba de compra, independientemente del monto de cualquier otro dao directo o indirecto que sufra el cliente. Esta garanta es efectiva solamente si el producto se usa en el pas en el que se compr. Un producto que requiera modificaciones o adaptaciones para que pueda funcionar en cualquier otro pas que no sea el pas para el cual fue diseado, fabricado, aprobado y/o autorizado, as como la reparacin de productos daados debido a esas modificaciones, no est cubierto por esta garanta. LA GARANTA AQU PROPORCIONADA SER LA GARANTA NICA Y EXCLUSIVA. CUALESQUIERA GARANTAS, OBLIGACIONES O RESPONSABILIDADES IMPLCITAS, INCLUIDAS, PERO NO LIMITADAS A, LA GARANTA IMPLCITA DE COMERCIABILIDAD E IDONEIDAD PARA UN PROPSITO EN PARTICULAR, ESTN LIMITADAS EN CUANTO A DURACIN A LA DURACIN DE ESTA GARANTA ESCRITA APLICABLE. Algunas jurisdicciones no permiten limitaciones acerca de la duracin de las garantas implcitas, de manera que las limitaciones anteriores podran no ser aplicables para usted. EN NINGN CASO BEURER SER RESPONSABLE DE NINGN DAO ESPECIAL, INCIDENTAL, INDIRECTO O CONSECUENTE POR INCUMPLIMIENTO DE ESTA O DE CUALQUIER OTRA GARANTA, EXPRESA, IMPLCITA O DERIVADA DE CUALQUIER OTRA TEORA DE LA RESPONSABILIDAD. Algunas jurisdicciones no permiten la exclusin o la limitacin de daos especiales, incidentales o consecuentes, de manera que la limitacin anterior podra no ser aplicable para usted. Beurer no autoriza a ninguna persona, incluyendo, entre otros, vendedores minoristas, el comprador consumidor posterior del producto de un vendedor minorista o comprador remoto, a responsabilizar a Beurer de cualquier forma ms all de los trminos establecidos en la presente. Esta garanta no se extiende a la compra de productos abiertos, usados, reparados, reempacados o resellados, incluyendo, entre otros, la venta de dichos productos en sitios de subasta de Internet o de productos de revendedores de excedentes o en volumen. Cualesquiera garantas cesarn y terminarn inmediatamente en relacin con los productos o partes de los mismos que sean 41 reparadas, reemplazadas, alteradas o modificadas sin el consentimiento explcito por escrito de parte de Beurer. Esta garanta le da derechos legales especficos, y usted puede tambin tener otros derechos que pueden variar de una jurisdiccin a otra. Para ms informacin respecto de nuestra lnea de productos en los Estados Unidos de Amrica, visite:
www.shop-beurer.com Distribuido por:
Beurer North America LP 1 Oakwood Boulevard, Suite 255 Hollywood, FL 33020, Estados Unidos www.shop-beurer.com Preguntas o comentarios? Llame a nuestro servicio al cliente en Estados Unidos gratis al telfono 1-800-536-0366 Ensamblado en China 42 i s o b m a c y s e r o r r e a o t e u S j EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments Warning: Dont use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specfied 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. Warning: Portable RF communications equipment
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specfied 43 by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description:
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2. Guidance and manufacturers declaration
-electromagnetic emissions and Immunity Table 1 Guidance and manufacturers declaration -
electromagnetic emissions Emissions test RF emissions, CISPR 11 RF emissions, CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions, IEC 61000-3-3 Compliance Group 1, Class B Not applicable Not applicable Immunity Test Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 IEC 60601-1-2 Test level Not applicable Compliance level Not applicable 10 V/m 10 V/m 80 MHz 2,7 GHz 80 MHz 2,7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz NOTE UT is the a.c. mians voltage prior to application of the test level. Table 2 Guidance and manufacturers declaration -
electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency magnetic field IEC 61000-4-8 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz 44 Table 3 Guidance and manufacturers declaration -
electromagnetic Immunity Test frequency
(MHz) Band
(MHz) Service Modulation Maximum Power (W) Distance
(m) Test Level
(V/m) Compliance level
(V/m) Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment) 385 380-390 TETRA 400 450 710 745 780 810 870 930 430-470 GMRS 460, FRS 460 704-787 LTE Band 13, 17 900-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz 1,8 2 0.3 0.3 27 27 28 28 0.2 0.3 9 9 2 0.3 28 28 45 1720 1845 1970 1700-1990 2450 2400-2570 GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 5240 5500 5785 5100-5800 WLAN 802.11 a/n Pulse modulation 217 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 2 2 0.3 28 28 0.3 28 28 0.2 0.3 9 9 46 47 The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Beurer North America LP is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. 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 LLC. Android is a trademark of Google LLC. 48 A S U
U E B _ M I _ 1 0 _ 2 1
9 0
2 2 0 2 _ 4 5 C B _ 3 1
. 7 5 6
1 | Internal Photos | Internal Photos | 550.88 KiB | March 13 2023 / September 10 2023 | delayed release |
1 | External Photos | External Photos | 461.96 KiB | March 13 2023 / September 10 2023 | delayed release |
1 | Label | ID Label/Location Info | 197.22 KiB | March 13 2023 |
Distributed by: Beurer North America LP, 1 Oakwood, Boulevard, Suite bosteers). FL 83020, USA Linie nur fiir GrBe und Position Measuring ran 40-230 mmHg FOC ID: OUS-TMB-BO54 Line only for size and position Power: 3V (2 x 1.5V AAA) Assembled in China
(En) Definition rating label: 657.13_BC54_2022-08-15_01_RP-T1_BEU-USA GrdBe / size: 45 mm x 15 mm Druckfarbe / printcolour: Pantone 428 C Folienfarbe / foilcolour: schwarz / black NOTICE: This device complies with Part 15 of the FCC Rules. Linie nur fiir GroBe und Position Operation is subject to the following two conditions: 1) this devios may not cause harmful interference, and (2) this device must accept Line only for size and position any interference received, including interference that may cause undesired operation. Definition rating label: 657.13_BC54_2022-08-15_01_RP-T2_BEU-USA GrdBe/ size: 65 mm x 26 mm Druckfarbe / printcolour: Pantone 428 C Folienfarbe / foilcolour: schwarz/black
1 | Authorization Letter | Cover Letter(s) | 121.11 KiB | March 13 2023 |
TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID:OU9-TMB-BC54 To whom it may concern:
Date: 2023-1-14 We, the undersigned, hereby authorize Compliance Certification Services (Kunshan) Inc and Winkey Wang in Compliance Certification Services (Kunshan) Inc to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Guangdong Transtek Medical Electronics Co.,Ltd. This authorization is valid until further written notice from the applicant. Print Name:
Jerry Fan Signature:
Title: RA Manager On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | Confidentiality Letter | Cover Letter(s) | 123.63 KiB | March 13 2023 |
TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding:
Confidentiality Request regarding application for FCC ID: OU9-TMB-BC54 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Jerry Fan Signature:
Title: RA Manager On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | Declaration Letter | Attestation Statements | 150.63 KiB | March 13 2023 |
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name Guangdong Transtek Medical Electronics Co., Ltd. Address Grantee Code FCC ID Zone A, No 105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China OU9 OU9-TMB-BC54 Authorized Contact Name Jerry Fan Contact Email Contact Phone gt-rateam@transtekcorp.com 86-760-85166220 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;
a) b) c) d) e) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
(1)
(2)
(3) labeling the equipment with the exact FCC ID as specified in this application, compliance statement labeling pursuant to the applicable rules, compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1)
(2)
(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) g) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List
[Guangdong Transtek Medical Electronics Co., Ltd. covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules.
] (the applicant) certifies that the equipment for which authorization is sought is not
[Guangdong Transtek Medical Electronics Co., Ltd. applicant is not identified on the Covered list, established pursuant to 1.50002, as an entity producing covered equipment.
] (the applicant) certifies that, as of the date of the filing of the application, the Applicant Signature:
Date: 2023/2/14 Print Name:
Jerry Fan Title:
RA Manager
*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 1 Original Issue: Jan. 4, 2021
1 | Test Setup Photos | Test Setup Photos | 315.86 KiB | March 13 2023 / September 10 2023 | delayed release |
1 | US Agent | Attestation Statements | 165.46 KiB | March 13 2023 |
Section 2.911(d)(7) USA Agent for Service of Process Company name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No 105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China Product Name: Wrist Blood Pressure Monitor FCC ID: OU9-TMB-BC54 Model(s): BC 54 2.911(d)(7) USA Designated Agent for Service of Process We, Guangdong Transtek Medical Electronics Co., Ltd. (the applicant) designate Beurer North America LP NOTE1 for the purpose of accepting service of process on behalf of the applicant. Applicant consent: We Acknowledge our consent to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and email address of the designated agent and acknowledge our acceptance of our obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Agent obligation: We Acknowledge our obligation to accept service of process in the United States for matters related to the applicable equipment at our physical U.S. address and email address for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. 2.911 (d)(7)USA Agent v1.2 USA Agent Company name: Beurer North America LP Address: 1 Oakwood Boulevard, Suite 255, Hollywood, FL 33020,United States Applicant Company name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No 105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China FRN: 0033460726 Contact Name: Luis Isturiz Telephone No: 1-800-536-0366 Email: info@beurer.com FCC Grantee Code: OU9 Contact Name: Jerry Fan Telephone No: 86-760-85166220 Email: gt-rateam@transtekcorp.com Signature:
Title: Quality Assurance Manager Date: 2023/2/22 Signature:
Title: RA Manager Date: 2023/2/22 NOTE 1: An applicant located in the United States may designate itself as the agent for service of process. Reference; Federal Register document 2022-28263 published on 02/06/23 https://www.federalregister.gov/documents/2023/02/06/2022-28263/protecting-against-
national-security-threats-to-the-communications-supply-chain-through-the 2.911 (d)(7)USA Agent v1.2
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-03-13 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-03-13
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
||||
1 | FCC Registration Number (FRN) |
0021999248
|
||||
1 | Physical Address |
Zone A, No.105,Dongli Road
|
||||
1 |
Zhongshan, Guangdong, N/A 528437
|
|||||
1 |
China
|
|||||
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 |
OU9
|
||||
1 | Equipment Product Code |
TMB-BC54
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J******** F******
|
||||
1 | Title |
RA Manager
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
g******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
W**** W****
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8613********
|
||||
1 | Fax Number |
N/A********
|
||||
1 |
w******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
W******** W******
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8613********
|
||||
1 | Fax Number |
N/A********
|
||||
1 |
w******@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?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 09/10/2023 | ||||
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) | Wrist Blood Pressure Monitor | ||||
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 | Output Power 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 |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
A**** Z********
|
||||
1 | Telephone Number |
+86 7********
|
||||
1 |
A******@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 | 0.0025000 |
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