BEWELL CONNECT BW-X07HD HANDHELD VITALSIGNS MONITORING SYSTEM User Manual

BEWELL CONNECT CORP HANDHELD VITALSIGNS MONITORING SYSTEM

User Manual

1 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 BewellConnect Logo Picture cover REF PRODUCT+CE+pictos VisioCheck By Visiomed DIAGRAMS Diagram A 1) LED (Flash) 2) HD Camera 3) Indicating light 4) Display screen 5) Home button 6) Infrared probe 7) Earphone port 8) SIM card tray 9) SpO2 port 10) BPM port
2 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 11) Speaker 12) On/Off button 13) Up/down wheel (OK Button) 14) ECG port 15) USB port Diagram B Diagram C Diagram D Diagram E Diagram F Accessories picture ECG Connexion Diagram Thermometer Diagram
3 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 + rating label SpO2 Connexion Diagram BPM Connexion Diagram
4 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
5 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 TECHNICAL DEFINITIONS ECG or EKG : Electrocardiogram SpO2: Blood oxygen saturation MRI: Magnetic resonance imaging RF: Radio Frequency EMC: Electromagnetic Compatibility PVC: Polyvinyl chloride ABS: Acrylonitrile Butadiene Styrene TPU: Thermoplastic Polyurethane ISM device: Industrial, scientific and medical device CISPR 11: International Standard for electromagnetic emissions (disturbances) from industrial, scientific and medical (ISM) equipment MAM: Mean Arterial Measurement MAP: Mean arterial pressure SBP: Systolic Blood Pressure DBP: Diastolic Blood Pressure PI : Perfusion index
6 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Language Logo BewellConnect COVER VisioCheck Picture of product CE + Pictos + Ref product By Visiomed This product is a medical device, class IIa, compliant with European directive and part 15 of the FCC rules. TABLE OF CONTENTS 1. Notes on safety (general + each device) 1.1 ECG cable/Lead wires and SpO2 adapter cable 1.2 Reusable blood pressure cuff 1.3 Finger clip SpO2 sensor for adult 1.4 FCC statement 2. Information 3. Features 4. Description 5. Precautions before use 5.1 ECG 5.2 Oximeter 5.3 Blood pressure monitor 5.4 Thermometer 6. User guide 6.1 General functions 6.2 Taking a measurement 6.2.1 ECG 6.2.2 Oximeter 6.2.3 Blood pressure monitor 6.2.4 Thermometer
7 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 7. HD Camera 8. Storage and maintenance 9. Specifications 9.1 Technical specifications 9.2 Blood pressure 9.3 SpO2 9.4 ECG 9.5 Temperature 9.6 Wireless communication 9.7 Key and interface 9.8 Power parameter 9.9 Appearance 9.10 Accessories included 9.11 Other Accessories 10. Troubleshooting Log onto our website to find out how to use VisioCheck www.bewell-connect.com/install The manufacturer reserves the right to change the product’s technical specifications without prior notice. Dear customer, Thank you for purchasing the HandHeld VitalSigns Monitoring System VisioCheck. Please read this guide prior to device use. This device is not intended for use as a conventional diagnostic tool, but it is a healthcare tool which can provide a doctor the recorded data as a reference to help evaluate the patient’s health. It must be used in conjunction with other devices to evaluate symptoms and clinical signs. For further information about the health or specific measurements, PLEASE CONTACT A DOCTOR.
8 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 1. Notes on safety - The equipment must be used per the requirements of this manual. Failure to properly use the equipment may result in degraded performance, loss of functionality, measurement abnormalities and equipment damage. The manufacturer assumes no responsibility for personal injury or device damage sustained by or through the use of this product. - This device is intended to monitor patient’s physical index at home, hospital, hospital facility or other outdoor situation. Do not use for any other purpose. - This product should not encourage self-medication or adaptation of the treatment. - Always consult the doctor if the patient has any questions or he believes he has abnormal measurements. The measurement results are given for information - Do not take measurements in a moving vehicle. - Stop use of the device in case of anomalies or malfunction. Visiomed and Bewell Connect Corp are not held liable for any problems resulting from failure to observe the installation and operating rules stated in these directions for use. Visiomed and Bewell Connect Corp are not held liable of the use with incompatible components which can result in degraded performance. Warning - This device must always be placed in a clean and dry place. - This device is not designed for use by people (including children) with reduced physical, emotional or mental abilities or those lacking experience or knowledge unless used in the presence of someone responsible for their security, under supervision or following instructions about how to use the device. - Do not use the ECG function while charging the device because of the risk of electric shock. - Do not use the ECG with a cardiac pacemaker or defibrillator. - The protective glass over the lens is the most fragile part of the thermometer. Do not touch the glass of the infrared lens with your fingers. - Do not insert other objects into any holes. - Do not use accessories, detachable parts and materials not described in the instructions for use - Do not use sharp tools to operate any of the buttons. - Do not interconnect this device with other equipment not described in the instructions for use - Do not open, disassemble, repair or modify the device. In case of problems, contact customer service. - Do not expose the device to static electricity. Disperse static electricity from your body before handling the device. - Do not use near flammable anesthetics, or near pressurized oxygen such as in a hyperbaric chamber, ultraviolet sterilizer or oxygen tent. - Do not expose the device to strong shocks, vibrations, electric shocks, sunlight or water. Never drop the device. - Do not operate the device if it has been immersed in liquid - Follow the maintenance instructions specified in this manual.
9 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - This electrical medical equipment requires specific precautions regarding electromagnetic compatibility. It must be installed and used in accordance with EMC (Electromagnetic Compatibility) Information. - Mobile and portable RF communications equipment may affect the equipment. The equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended below, according to the maximum output power of the communications equipment. - The received signal may be interfered/disrupted by other equipment operating in this frequency band (i.e. Bluetooth, other non-associated access points, microwave ovens, ISM devices, etc) even if the other equipment complies with its applicable regulations such as CISPR 11. - Use this device in an ambient temperature range of 5 to 40°C / 41 to 104°F. - Avoid using the device immediately after a significant change in temperature or humidity. - Do not expose this device to extreme temperature conditions > 50°C (122°F) or < -10°C (14°F). - Do not use this device at a relative humidity of more than 95%. - Do not use the device out of the required condition to avoid inaccurate measurement. - The values displayed by the device are the ones obtained at the time of measurement. Medical conditions can change suddenly. If you notice any change in your condition, consult a doctor, regardless of the measured results. - Do not use the device for measurements when the battery power is lower than 15% or 3.5V. - Be careful about the small parts broken off the device, as children may swallow and it could lead to suffocation. - When the screen displays the battery symbol , this indicates that the battery is low and you should charge the product through our adapter as soon as possible. 1.1. ECG cable/lead-wires and SpO2 adapter cable - As with all medical equipment, carefully place cables to reduce the possibility of patient entanglement or strangulation. - Do not use the cables during MRI scanning. Conducted current could cause burns. - Do not use the ECG function during charge of the device. Risk of electric shock - Do not use the ECG with a cardiac pacemaker or defibrillator. - Do not use lotion or oil prior to the test. Skin must be clean and dry. - This product is not suitable for PVC, TPU and ABS plastic allergy patients and users. - The ECG cable/lead-wires and SpO2 adapter cable are designed for use with VisioCheck - Do not use the ECG cable/lead-wires and SpO2 adapter cable if the cable, wires and connector are broken or damaged. 1.2. Reusable Blood Pressure Cuff for adults - When the cuff is not connected to monitor, always fit cap to tubing to prevent accidental entry of liquid. - Periodically inspect and replace damaged or deteriorated cuffs.
10 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - Only use the appropriate size cuff when the artery index marker falls within the printed range, Otherwise erroneous readings may result. Principle of operation This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value. 1.3. Finger Clip SpO2 Sensor for Adult - Probes are designed for use with VisioCheck. Do not use them with other device. - Using the sensor in the presence of direct sunlight may result in inaccurate measurements. In such cases, put the receiving surface of the sensor back to ambient light sources (such as fluorescent lamps) or cover the sensor with a black cloth after removing the sensor from the patient's body in order for the monitor to displaySpO2 value, pulse rate value and their waveforms. - Reusable sensors must be moved to a new site on the patient at least every 4 hours. Because individual skin condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some patients. If skin integrity changes, move the sensor to another site. - Intravascular dyes may lead to inaccurate measurements. - The performance of the sensor is compromised by motion. - Do not apply tape to secure the sensor in place or to tape it shut; venous pulsations may lead to inaccurate saturation measurements. - As with all medical equipment, carefully place cables to reduce the possibility of patient entanglement or strangulation. - Do not use the sensor or other oximeter sensors during MRI scanning. Conducted current may cause burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of oximeter measurements. - Do not alter or modify the sensor. Alterations or modifications may affect the performance or accuracy. - Do not use if the wire or the shell of connector is broken or damaged. - Sterilize using ethylene oxide only. - The MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided at the end of this user manual. - Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. - The equipment is without a manual sensitivity adjustment. The minimum amplitude or value of patient physiological signal is 70% SpO2. Operation of the EQUIPMENT or SYSTEM below this amplitude or value may cause inaccurate results. - The use of accessories, transducer and cables other than those specified, with the exception of those sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased EMISSION or decreased IMMUNITY of the EQUIPMENT or SYSTEM.
11 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - Be aware that following removal of the sensor from the patient, it is possible that environmental light may cause the monitor to continue to display a waveform or data values but these are not a basis for a clinical diagnosis. - Make sure the application site for the sensor is not deeply pigmented, or deeply colored. For example, nail polish, artificial nails, dye or pigmented cream may cause inaccurate measurements. In any of these cases reposition the sensor or choose an alternative sensor for use at a different site. - Protect the sensor and connector from becoming soaked with any liquid. Do not immerse the sensor or connector in any cleaning solution, disinfectant, or other liquid (the sensor and connector may be wiped with cleaner and disinfectant but never immersed). - Where possible, the application site for the sensor should be an extremity free of arterial catheters, blood pressure cuffs, or intra-vascular infusion lines. - At elevated ambient temperatures, patient skin could become severely burned after prolonged sensor application on sites with poor blood circulation. To prevent this condition, be sure to check patient application sites frequently. All listed sensors operate without risk of exceeding 41℃ /105.8°F on the skin if the initial skin temperature does not exceed 35℃/95°F. - The waste of the pulse oximeter probe must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative for information concerning the disposal of your equipment - A warning to the effect that misapplication of a pulse oximeter probe with excessive pressure for prolonged periods can induce pressure injury. 1.4. FCC statement changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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. 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.
12 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 – 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 user 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. The device is designed to meet the requirements for exposure to radio waves established by the Federal Communications Commission (USA). These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body is 1.250W/kg. For body operation, this device has been tested and meets FCC RF exposure guidelines when used with any accessory that contains no metal and that positions a minimum of 5mm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. 2. Information VisioCheck® is a four in one handheld, smart and connected medical device, designed for the remote monitoring of vitalsigns and telemedicine, by health professionals and patients. The product combines a blood pressure monitor, a pulse oximeter, an electrocardiograph (5 electrodes, 7 leads), and a non-contact infrared thermometer. VisioCheck software is an embedded software which provides multiple services. It is applicable for home care, hospital and other remote and mobile situations. The software can be used by healthcare professional providers or patients, to monitor vitals. Medical data can be stored locally and a reports can be sent through WiFi, 3G or 4G. It is designed to be easy to use to take measurements and share results accross long distances. VisioCheck allows the user to communicate with their health professional through an HD video conferencing system but cannot be used as a phone (no voice-only IP connection, only M2M sim cards) 3. Features The devices used with the application include: -> Non-Contact Thermometer based on a miniature version of Visiomed’s ThermoFlash® technology -> Blood Pressure Monitor (and pulse rate) -> 5 electrodes and 7 leads ECG (and pulse rate) -> Pulse Oximeter (and pulse rate) 4. Description View diagram A page 2 Accessories View diagram B page 2 1) BPM Cuff *1 2) SpO2 Adapter Cable *1
13 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 3) SpO2 universal sensor connector *1 4) ECG 5-Electrode Cable*1 5) Infrared Probe Cover*1 6) USB Cable*1 7) Adapter*1 5. Precautions before use Before using the VisioCheck, - Do not confuse self-monitoring with self-diagnosis. Measurement should only be interpreted by a health professional who is familiar with your medical history. - If you are taking medication, consult with your physician to determine the most appropriate time to measure your vital signs. - This device should not encourage self-medication or adaptation of your treatment. NEVER change a prescribed medication without first consulting with your physician - This device is designed for use by adults only. If using the device on a child, toddler or elderly patient, please consult with your physician first. - Check that the accessories are intact and clean. - Always consult your doctor with any medical questions. Adhere to the temperature ranges and humidity levels shown in the specifications. 5.1. Precaution before use ECG - Low battery may affect the accuracy of heart rate measurements. - Do not use this device near an Electrosurgical Unit (ESU), since it may function incorrectly as a result. - Do not use the ECG while charging VisioCheck because of the risk of electric shock. - The electrodes pads are disposable and for single use only Duration of use: it is recommended to replace the ECG cable every 6 months. If it is necessary to use, please evaluate the period of use, it should be regularly inspected. 5.2. Precaution before use Oximeter - Do not use this device near an Electrosurgical Unit (ESU), since it may function incorrectly as a result. - The pulse oximeter must be placed so that the pulse can be recorded correctly and the main objective is to evaluate the oxygen saturation (SpO2) level. Check that nothing is interfering with the readings. - Do not use the device in an MRI (Magnetic Resonance Imaging). - Do not use the device in an explosive atmosphere. - Frequently check (every 30 minutes) on the application zone of the device sensor (checking for signs of skin sensitivity, change in position, etc.). - The device must not be used near or on top of another device. - Inaccurate readings may result from:
14 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 -> Nail-polish (colorimetric interference) or artificial nails -> High levels of dysfunctional hemoglobin (carboxyhemoglobin or methemoglobin) -> Intravascular dyes (indocyanine green or methylene blue) -> Bright light. If necessary, protect the sensor positioning area -> Excessive movement of the patient -> Defibrillators and interference from high-frequency electrosurgical devices -> Venous pulse -> Placing the sensor on a patient with a blood-pressure cuff, an arterial or intravascular catheter -> High blood pressure, severe vasoconstriction, acute anemia or hypothermia -> Heart failure or stress -> Poor pulse quality (low blood flow) -> Low levels of hemoglobin. Duration of use: It is recommended to replace the SpO2 adapter cable every 6 months. If it is necessary to use, please evaluate, and the period of use should be thoroughly inspected. 5.3. Precaution before use Blood pressure monitor Blood pressure measurements determined by this monitor are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard Institute, electronic or automated sphygmomanometers. Reference: Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002. The followings texts are adapted for a personal use of the VisioCheck Choice of the arm for the blood pressure measurement: For the first use, it’s recommended to take the measurement in both arms. If one arm consistently has higher blood pressure than the other (> 10 mmHg in US or > 20mmHg in Europe), that arm should be used to measure your blood pressure except in the event of contraindications (e.g. fistula, ganglion) in this arm. If there is no difference in readings, the readings are often more easily taken in the non-dominant arm (left for right-handed, right for left-handed). Reference: American Heart Association. How to Monitor and Record Your Blood Pressure. Haute Autorité de Santé. « Prise en charge des patients adultes atteints d’hypertension artérielle essentielle » - Recommandations pour la pratique clinique - juillet 2005 Self-measurement of blood pressure -Repetition is essential in self-monitoring blood pressure as single measurements are often unreliable for a number of reasons due to huge variations in blood pressure and its susceptibility to factors such as: recent activity, stress and even breathing. Taking 3 consecutive measurements in a row and averaging them provides a more reliable home measurement by a non-professional. This method comes recommended by the American Heart Association and the European Society of Hypertension.
15 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - The rule of three: 3 measurements recommended while seated, at rest, 3 days in a row: In the morning before taking medications, 3 consecutives measurements in a row (MAM); In the evening after taking medications, 3 measurements in a row (MAM). A single measurement may not be significant especially in terms of blood pressure self-monitoring. - Blood pressure self-measurement: the ideal targets for a person with high blood pressure when self-measuring at home are different and lower than those of the American Heart Association (AHA) or European Society of Hypertension (ESH) ). These targets depend on age and can vary depending on your health. General case: SBP* < 135 mmHg and DBP* < 85 mmHg * SBP: Systolic Blood Pressure - DBP: Diastolic Blood Pressure The aforementioned targets are provided for reference only and need to be rechecked by a doctor. It is important to check your targets in the event of serious disease or pregnancy. Before taking measurements, - Avoid eating, smoking or exercising for 30 minutes prior. Relax for 15 minutes before taking blood pressure. - Stress increases blood pressure. Avoid taking measurements during a stressful period - You must take a blood pressure measurement in a calm environment and you must be relaxed and seated with your arm on a table. - Remain stationary and do not speak while taking your measurement. Note: For more reliable results, take measurements on the same arm. Speak to your doctor if you have any questions about using the blood pressure monitor Duration of use: The Blood pressure cuff is reusable for 1 year. 5.4. Precaution before using of Thermometer This device is pre-set at the factory. It is not necessary to calibrate it when starting it up. - In order to obtain reliable and stable results: Each time there is a significant change in the ambient temperature (due to a change in environment), you are advised to allow the VisioCheck thermometer to acclimate to this ambient temperature for 15 to 20 minutes before using it. It is important to allow a one-minute interval between two measurements. Practical considerations when taking a temperature: - In order to ensure that precise and accurate temperature measurements are obtained, it is essential that each user has received adequate information and training in the temperature measurement technique when using such a device. - It is essential to remember that although procedures such as taking a temperature may be simple, they must be followd correctly. - The patient must not have undertaken vigorous physical activity prior to taking his/her temperature and the room temperature must be moderate.
16 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - Be aware of physiological variations in temperature which must be taken into consideration when evaluating the results: temperature increases by 0.5C° /1.6°F between 6am and 3pm. Women have a temperature that is higher, on average, by around 0.2C°/ 0.4°F. Their temperature also varies in accordance with their ovarian cycle. It rises by 0.5C°/ 1.6°F in the second half of the cycle and at the early stages of pregnancy. - When sitting, temperature is lower by about 0.3° to 0.4°C/ 0.5 to 0.7 °F than when standing. Reference: Haut Conseil de Santé Publique : Recommandations sanitaires du Plan national canicule 2014. P123 (French Public Health Council: Sanitary recommendations of the National Heatwave Plan 2014) 6. User guide 6.1. General functions 6.1.1. Start/Shutdown the Device: Start: Long press the On/Off button until the display screen is on. Shutdown: Long press the On/Off button until the display screen is off 6.1.2. Modules inspection After turning on the device, it performs a module inspection which allow to verify each module functioning before launching the application.  The status Failed means that the module doesn’t functions properly, you should not use it. Please contact the customer service.  The status Succeeded means that the module functions properly, it can be used. 1.1.1. Connect the device to internet You can connect the device to the internet using a M2M sim card or a WiFi connection.
17 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Note: Connect the device to internet is required for data sharing (see page 20) 1.1.1.1. Sim card Installation Insert a small paper clip or the sim card eject tool provided into the opening of the SIM tray, located on the side of VisioCheck®. See Diagram A, page 2. Press lightly to bring out the SIM tray and place the sim card as indicated. Close carefully. Note: M2M sim card provided by your retailer. 6.1.2.2 Wifi Connection Go to the settings parameters of the system. In wireless and networks > WLAN, turn the button ON. The list of available networks will be displayed. Select your secured network and enter the password. Go back to the Application, the device is now connected. 6.1.3. VisioCheck Settings The VisioCheck settings are defined for all accounts (admin, user) 6.1.3.1. General In the general settings, you can choose the units in which you want to display your measurements. The Admin can also erase all the previous data saved in the application by clicking on “Erase app data button”.
18 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 6.1.3.2. Measures In the Measures setting, you can select the mode you want to use for the measurements. For personal use, we advise you to consult your physician prior choosing the measurements modes.  For the Blood Pressure Monitor, you can choose between a simple standard measurement or a triple measurement (Mean Arterial Measurement). You can also set a static mode to simulate a range of normal, hypertensive and hypotensive dynamic noninvasive BP in order to verify if the VisioCheck’s blood pressure monitor functions correctly and that the blood pressures values measured are reliable. You’ll need a blood pressure simulator and tester for that (not provided).
19 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017  For the ECG, you can select the duration of the measurement by choosing manual (control the recording time is controlled during the measurement) or timer mode (the recording time is preset for 30 seconds). You can also set the filters in three different positions to control the interference of electric current during the tracing ECG: Off, 50Hz (mostly for France and Europe) or 60Hz (mostly for US)  For the Oximeter, you can choose between three different modes: Single (the measurement is instantaneous), Manual (you can control the recording time during the measurement) or Timer (the recording time is preset for 30 seconds).
20 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 6.1.4. Accounts The professional use allows you to create and manage several accounts (organization, admin and users accounts) 6.1.4.1. Organization At the first use you need to provide your organization’s informations. 6.1.4.2. Admin account
21 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 You need to create an admin account which allow you to create, modify or delete other user accounts. To be connected to your admin account, you will need to provide your email and password. 6.1.4.3. User accounts As Admin, you can add new user accounts To connect to his account, the user will need his login and password. As admin, you can also modify or delete patient’s files related to other user accounts. 6.1.5. Patient’s file and patient’s profile The Admin or any user account can create a patient’s file.
22 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 The patient’s file include profile, dashboard, history and share options. You can also have an unidentified patient file, allowing the user to make measurement without assigning the result to a specified profile. It allows to use the medical device directly and simply. To switch to unidentified patient or another patient’s file you can click on the top bar. 6.1.5.1. Patient’s profile Before starting to monitor a patient, you can create his patient file, and complete his profile with his personal data (medical history, allergy, contact) and choose the visibility of the file. Don’t forget to save all the information to have a complete file. Thereby all the measurements can be saved in the patient’s file.
23 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 6.1.5.2. Dashboard The dashboard is the last measurements, done for the patient. It also allows to view oximeter and ECG recordings simultaneously 6.1.5.3. View history The data history can be viewed by day, week, month or year, by selecting the specific date and the specific device (ECG, BPM, OXI or TEMP) 6.1.5.4. Data sharing
24 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 You can share the data of a patient with another health professional, a family member, caregiver. For that, the contact information should be pre-saved in the patient profile. 6.2. Taking a measurement To take a measurement, go to the main screen of your account and click on the stethoscope icon. Then select the icon of the device you want to use. 6.2.1. ECG See diagram C page 2 Before taking a measurement
25 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 It is recommended to be in a comfortable position (lying flat or sitting), your back straight and in a relaxed position for the full duration of the measurement. Make sure that your chest is free of tension. Prepare the skin by cleansing and drying the areas where the electrodes will be placed. Typically, 70% alcohol is used for this purpose. Be sure to dry the skin. If necessary, shave the skin before placing the electrodes. Avoid skin with scars, wounds, lesions, folds or swelling. It is recommended placing the electrodes facing a visible bone structure. The electrodes pads are disposable and for single use only WARNING: It is strictly prohibited to attach the lead cable electrodes on the patient’s body if the lead cable is not connected with the device. Before you begin a measurement, first connect the lead cable with the device, next attach the lead cable electrodes to your body. After taking a measurement, first remove the lead cable electrode from the body, second disconnect the lead cable from the device. 1) Connect the ECG cable to VisioCheck 2) Stick the electrodes pads to the correct positions (see picture below). 3) Connect the lead-wires set to the electrodes pads. -> Red electrode: Right shoulder or right wrist -> Yellow electrode: Left shoulder or left wrist -> Green electrode: Left ankle or left spine iliac -> White electrode: Two fingers under the nipple (for the woman, if the breast is voluminous, under the fold of the breast opposite the left nipple) -> Black electrode: right ankle or right spine iliac
26 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Taking a Measurement Follow the steps to properly measure and record your data 1) Press “start measure” on the screen of VisioCheck to launch the measurement 2) Click on “stop measure” to stop the measurement and then “save measure”, to save the measurement. Remain still, and do not flex or move until the recording is complete. If the device senses poor contact or the measurement is interrupted by a hand adjustment, you will need to repeat the recording. After a measurement, you should first remove the lead-wires from the body, second the cable should be disconnected to the device. You can take ECG and SpO2 measurements simultaneously, and view them in real-time from the Dashboard. WARNING: When disconnecting the cable, pull on the plug itself not on the cable. Scale: Calibration of ECG Signal: 1 mV=10 mm ± 1.0 (in ordinates) Graph paper unwinding speed: 1s = 25 mm (in abscissas)
27 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Notes about the results The values for Pulse given by VisioCheck are between 40-180mmHg. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. 6.2.2. SpO2 See diagram D page 2 Before taking a measurement Avoid eating, smoking or exercising for 30 minutes before measuring your oxygen saturation. Remain calm for 15 minutes before the measurement 1) Plug the adapter cable into VisioCheck SpO2 port 2) Connect the SpO2 adapter cable to the SpO2 Sensor connector. 3) Insert an index finger over the sensor window with the fingernail facing upwards and the fingertip against the end. 4) Spread open the rear tabs of the sensor to provide even force over the length of the pads. 5) Check the position of the sensor. If an index finger cannot be positioned correctly or is not available, a smaller finger can be used. Do not use on the thumb, toe, or across a child’s hand or foot. Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. The sensor should be oriented in such a way that the cable is positioned along the top of the hand. See picture below.
28 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Taking a Measurement Follow the steps to properly measure and record your data 1) Press “start measure” on the screen of VisioCheck to launch the measurement. 2) Click on “stop measure” to stop the measurement and then on “save measure”, to save the measurement. Remain still, and do not speak, flex or move until the recording is complete. If the device senses poor contact or the measurement is interrupted by a hand adjustment, you will need to repeat the recording. For the value to be reliable, the blood supply index (signal strength of the arterial pulse) must be superior to 0.3%. You can take ECG and SpO2 measurements simultaneously, and view them in real-time from the Dashboard. WARNING: When disconnecting the cable, pull on the plug itself not on the cable. Note: If the sensor does not track the pulse reliably, the blood flow may be too thick, thin, or deeply pigmented to permit appropriate light transmission. If any of these situations occur, reposition the sensor or choose an alternate sensor.
29 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Notes about results: Many factors can modify hemoglobin’s affinity for oxygen and reduce oxygen saturation in the blood. Measuring oxygen saturation is vital for individuals who may be at risk of desaturation, a condition that could result in the need for medical treatment to address the deficiency. Warning: This table DOES NOT apply to individuals already suffering from certain illnesses (e.g. asthma, heart disease, respiratory diseases) or who are at altitudes above 1500 meters. If you are already suffering from a disease, always consult your doctor to analyze your results.
30 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 The values for oxygen saturation given by VisioCheck are between 70-99 mmHg. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. The values for Pulse given by VisioCheck are between 40-180mmHg. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. 6.2.3. Blood pressure See diagram E page 2 Before taking a measurement - Sit down on a chair with your feet flat on the floor (do not cross your legs). - Apply cuff to arm so that the orange mark on the cuff is over branchial artery. The cuff must be 0.4 – 0.8 inches / 1-2 cm from elbow crease. - Wrap cuff around arm. Make sure the white side line folds within the arrow box, if it does not, change to a bigger or smaller cuff that fits better. - Close the cuff with the Velcro (not too tight). - Put your arm on the table, palm up so that the blood pressure cuff is level with the heart. - Remain seated and calm for 5 to 15 minutes before taking measurement - Do not take measurements over clothing. Remove jewelry from the arm you are measuring before taking measurement (watch, ring, bracelet etc.). - Avoid eating, smoking or exercising 30 minutes before taking measurements. Relax for 15 minutes before taking blood pressure
31 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Taking a Measurement in real time 1) Press “start measure” on the screen of VisioCheck to launch the measurement. The armband inflates automatically. Do not remove the armband before the end of the measurement. 2) At the end of the measurement, click on “save measure”, to save the measurement. Notes: - For more reliable results, always take measurements on the same arm for the same patient - Only use the appropriate size cuff when the artery index marker falls within the printed range. Otherwise erroneous readings may result -The measurement will be too low if the armband is higher than the heart or too high if it is lower than the heart. Notes about results:
32 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 In 2013, the American Heart Association (AHA) defined a blood pressure classification shown in the table below. Nevertheless, this classification is just a general guide, as blood pressure varies from one person to another, based on age, weight, and health. This blood pressure chart reflects categories defined by the American Heart Association The values for Blood Pressure given by VisioCheck are between 0-297 mmHg. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. The values for Pulse given by VisioCheck are between 40-180mmHg. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. 6.2.4. Body temperature See diagram F page 2 Before taking a measurement
33 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Please take the following precautions before any measurement to ensure a stable and reliable result: - Push back hair from the forehead. - Wipe away any perspiration from the forehead. - Avoid any drafts (e.g. from nasal specs, air conditioning, etc.). - Each time there is a significant change in the ambient temperature due to a change in environment, allow the thermometer to acclimate to this ambient temperature for at least 15 minutes before using it. - Do not put the thermometer in contact with an open wound - Do not drink hot or cold drinks, or exercise while taking a temperature measurement Taking a Measurement 1) Aim at the forehead, over the region center, from a distance of about 2-5cm / 1-2 inches, see picture below 2) Press and release the “OK” button on the right side of VisioCheck. 3) Wait for the BEEP sonore without moving. The temperature is instantly displayed on the screen. 4) Click on “save measure” to save the measurement. The reliability of the measurement cannot be guaranteed if the temperature is measured over another part of the body (e.g. arm, torso…). Note about results Diagnostic of temperature readings
34 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 The values for temperature given by VisioCheck are between 32°-43°C /89.6 -109.4 °F. Outside this interval, the device display OUT OF RANGE and the measurement should be retake. 7. HD Camera To be defined 8. Storage and maintenance Do not pour or spray any liquid on the surface of the device or its accessories; Make sure that liquid does not come into contact with any of the device openings. Do not sterilize the device or its accessories in an autoclave, with ethylene oxide, by radiation, by steam, by high pressure or by immersing it in a liquid. The device or its accessories must not be sterilized. Protect the device or its accessories from UV radiation WARNING: Never immerse the device or its accessories in any liquid. VisioCheck - Avoid extreme changes in temperature and humidity. Do not use this device in locations subject to high or low temperatures or humidity. - Do not store the device in ambient conditions such as exposed to direct sunlight, with high temperatures and/or high humidity, that are wet or damp or where water may get on the device, that are dusty near fires or open flames or exposed to strong vibration, or strong electromagnetic fields.
35 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 - Dispose of the device in accordance with applicable local regulations. - This device is designed to be compliant with the rules and regulations in locations which it is sold and will be labeled as required. - Any changes or modifications to this device, not expressly approved by the manufacturer, will void the user’s authority to operate the equipment Storage Conditions -10°C~+50°C (14°F ~122°F), 10～95%RH, 50kPa～106kPa（Non condensing) Working conditions 5°C~+40°C (41°F~104°F), 15%～95%, 70kPa～106kPa（Non condensing） - Clean the device using a medical disinfectant wipe only. - Do not use water, or substances such as benzene, gasoline, paint thinner, concentrated alcohol, or detergents. Do not clean other parts of the device with any liquid. - Do not drop or hit this device. - Do not disassemble the device. ECG cable/lead-wires, SpO2 adapter cable Cleaning 1) Disconnect the cables from the monitoring device. WARNING: When disconnecting pull on the plug itself not on the cable. 2) Dampen a clean cloth or gauze pad with an appropriate cleaning solution and wipe all exposed surfaces. 3) Dampen a clean cloth or gauze pad with sterile or distilled water and again wipe all exposed surfaces. 4) Dry all exposed surfaces with a clean, dry cloth or gauze pad. NOTES: Do not treat the cables with oils (e.g. household or lubricating) or aggressive fluids or solvents (e.g. acetone). The cable is not made with natural rubber latex. Disinfection Disinfect with a chemical disinfectant, such as ethanol, propanol, phenolic disinfectant. Pulse oximeter probe Cleaning The sensor may be surface cleaned by wiping it with a solution such as 70% isopropyl alcohol. To clean or care for the sensor: 1) Disconnect the pulse oximeter probe from the SpO2 adapter cable 2) Soak a clean, dry gauze pad with the cleaning solution. Wipe all surfaces of the sensor and cable with this gauze pad. 3) Soak another clean, dry gauze pad with the sterile or distilled water. Wipe all surfaces of the sensor and cable with this gauze pad. 4) Dry the sensor and cable by wiping all surfaces with a clean, dry gauze pad
36 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Disinfecting If low level disinfection is required, use a 1:10 bleach solution. Do not use undiluted bleach (5%-5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to the sensor could occur. Blood Pressure cuff Cleaning 1) Disconnect the BP cuff from the monitoring device 2) Clean the cuff by wiping a damp cloth with mild soapy and water Warnings: Do not sterilize cuffs. Do not use bleach. Wash and rinse; temperatures should not exceed 104 F/ 40°C Disinfecting The cuff can be disinfected by 70% isopropyl alcohol. After disinfection, the cuff cover should be left out to air dry. Warnings: 1) When cuff is not connected to monitor, always fit the cap to the tubing to prevent accidental entry of liquid. 2) Periodically inspect and replace damaged or deteriorated cuffs. Thermometer Cleaning - Clean the surface of the glass over the lens with a cotton ball lightly moistened with 70% isopropyl alcohol. 9. Specifications 1.1. Technical specifications Vital Signs Temperature (Non-contact), SpO2 (Probe type-internal), BP (Inflation), ECG (5 leads-internal) Model BW-XO7HD Brand Bewell Connect Classification Class IIa (for Europe) / Class II (for US) CPU Chipset Qualcomm MSM8909 Type Cortex A7 Number of cores Quad Core Frequency 1.1GHz GPU Chipset Adreno 304 Number of cores Quad Core Frequency 400MHz
37 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 RAM Capacity 1GB ROM Capacity 8GB Operating system OS Version Android 5.1 Language Multi-language LCD Type HFFS Screen size 10“/ 3.97inch Color 16M Brightness 400cd/m² Screen resolution 480*800 Touch panel Type 5 Points capacitive touch screen Material G+F+F Camera Front Camera 5.0MP AF Rear Camera No Flash light Yes Speaker Built-in 8Ω/0.5W×1 MIC Built-in Yes Receiver Built-in No G-sensor Built-in Yes Gyro-Sensor Built-in No Light-Sensor Built-in No Proximity Sensor Built-in No Grade of Waterproofing IP22 1.2. Blood Pressure Measuring Mode Upper arm type Measuring Method Inflation+MAP (Mean arterial pressure) Measurement Range Pressure: 0-295mmHg (0-39.3kPa) Pulse Rate: 40-180 times/min Measurement Accuracy Pressure: ±3mmHg (±0.4kPa) Pulse Rate: ±5% 1.3. SpO2 Measuring Mode Finger type (Internal) Measuring Method Infrared & Absorption Spectrometry Measurement Range Oxygen Saturation: 0%～100% Pulse Rate:25～250 times/min PI: 0.05%～20% Measurement Accuracy Oxygen Saturation: 70%-100%: ±2% 0%-69%: Accuracy is not defined Pulse Rate: ±3 times/min PI: Accuracy is not defined 1.4. ECG Measuring Mode 5 Electrodes,7-Lead ECG ECG Lead Ⅰ、Ⅱ、Ⅲ、 aVR、aVL、aVF、V DC offset Voltage Range ±300mV Differential Voltage Measurement Range ±5mV Voltage Measurement Accuracy ±5%
38 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 Anti-electrosurgical Capability No Defibrillation Protection No PACE No 1.5. Temperature Measurement range Body temperature：32.0°C~43.0°C / 89°F ~109.4°F Room temperature： 0°C~50°C / 32°F~122°F Surface temperature： 0°C~90°C / 32°F~194°F Measurement speed 1s-2s Measurement site Forehead Measurement distance 2-5 cm / 1-2 inches Display resolution 0.1°C / 0.1°F Measurement Accuracy +/- 0.2°C (35°C-42°C) / +/- 0.2°F (95°F-107.6°F) in body temperature +/-0.3°C (32°C -34.9°C, 42.1°C-43°C) / +/- 0.3°F (89.6°F-93.2°F, 107.6°F-109.4°F) in body temperature. +/- 0.2°C (22°C -40°C ) / +/- 0.2°F (71,6°F-104°F); others +/-2°C / +/-2°F in surface temperature. Unit °C/°F 1.6. Wireless Communication Wi-Fi Built-in Yes Cryptographic algorithms WFA, WPA/WPA2 Version 802.11b/g/n Bluetooth Built-in Yes Version 4.0 GPS Built-in Yes A-GPS Yes 3G(WCDMA) Frequency band B1, B2 LTE-FDD Frequency band B1, B2, B3, B4, B7, B12, B20 Data transmission speed Upload 50Mbps (4G mode) Download 150Mbps (4G mode) Phone feature Phone calls & message No FM Radio No NFC No 1.7. Key and Interface Earphone 3.5mm CTIA standard headphone jack Buttons Home Key; Power key; Up/Down Wheel (Up/Down, one click confirm) Micro USB Charge BP port Yes
39 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 SpO2 probe port Yes ECG cable port Yes Non-contact temperature sensor Yes Micro Sim Card Yes Micro SD No 1.8. Power Parameter Battery Type Li-ion battery Capacity 3.7V/2500mAh Time on stand by 3 days Performance capacity 4 hours Charge lamp Blue/Green Adapter Information Temperature Operating: The adapter is capable to operate from 32° to 104° Fahrenheit / 0°C to 40°C. Non- Operating: The adapter is capable to store from -4° F - 140°F / -20°C to 60°C Humidity Operating: The adapter is capable to operate from 10% to 90% RH. Non- Operating: The adapter is capable to store from 5% to 90% RH. INPUT: 100-240V~50/60Hz,500mA OUTPUT: 5.0V 2.0A 1.9. Appearance Body Material PC+ABS Color White Size 172*87*30 mm (length*width*height) About 6.77in*3.43in*1.16 inches Weight 298g / 10.5oz (without accessories) 1.10. Life time Life time of button 50 000 times pressed Life time of BPM Bump and Valve 30 000 times Battery life 500 times of full Charging (The capacity will decrease 10% each year) Continuous usage With Battery 100% Charged, BPM: 50 times; SPO2: 5 hours; ECG: 5.5 housrs. Period of 5 years 1.11. Accessories included - Carrying pouch, including: o VisioCheck BW-XO7HD o Cable and cuff for BPM (22~42 cm / 8.5~16.5 in) o Pulse oximeter SpO2 probe o SpO2 adapter cable (50cm / 20 inches) o ECG cable 5 electrodes / 7 leads
40 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 o AC Adaptor 5V 2A with EU/US/UK plug, USB cable 1 m / 3.3 ft - Pouch of 10 disposable adhesive electrodes for ECG - PP bag including: o Quickstep o User manual o Warranty card with serial number o Sim card removal tool o Earphone with microphone 1.12. Other Accessories (not included) Item NO. DESIGNATION BW-XA8-13 cuff for BPM-infant (8cm-13cm) BW-XA12-19 cuff for BPM- Children (12cm-19cm) BW-XA17-25 cuff for BPM-Medium (17cm-25cm) BW-XA22-36 cuff for BPM-standard(22cm-36cm) BW-XA22-42 cuff for BPM-large(22-42cm) BW-XA32-52 cuff for BPM-X-large(32cm-52cm) BW-XSPOP Pediatric Pulse oxymeter SpO2 probe with extension cable (50cm / 20 inches) BW-XSPOS Pulse oxymeter SpO2 probe BW-XSPOC SpO2 adapter cable (50cm / 20 inches) BW-XDC2A AC Adaptor 5V 2A with EU/US/UK plug, USB cable 1 m BW-ECG5/7 ECG cable 5 electrodes / 7 leads BW-XTM1 Professionnal table stand for VisioCheck BW-XCASE Silicone Protection holster with lanyard and cart stand BW-XTP1 Table stand for VisioCheck BW-XTCART VisioCheck professional cart with wheel BW-XT001 Telescopic mobil stand with 2 International AC adaptor, 1 USB - power cord 2 m, wheel with security lock BW-XT002 Basket for cart BW-XT003 Handle for cart BW-XT004 Tray for cart BW-XT005 Cart stand for VisioCheck No part of this manual may be copied, reproduced or translated into another language without prior written consent of Visiomed. Visiomed reserves the right to revise this guide at any time without prior notice.
41 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 2. Troubleshooting Main device 1. Device can’t be turned on. System is abnormal. Battery has low power. Device is damaged. Restart the device. Charge the device. Contact customer service. 2. Module Inspection Failed The module concerned has a problem Device malfunction Restart the device If restarting can’t solve the problem, contact customer service. 3. After turning on the device, 4G/Wi-Fi signal is abnormal. Network signal is weak. Wi-Fi hotspot is configured incorrectly. Device malfunction. Be patient and wait. If there is still no signal, try to restart the device. If restarting can’t solve the problem, contact customer service. If the communication mode is Wi-Fi, check whether the Wi-Fi hotspot (router) is configured correctly. 4. Device crash Device malfunction Stop measuring and unplug the BPM cuff, SpO2 cable and ECG cable. Long press the on/off button to shut down. If the device can’t be shutdown normally, try to press the on/off button for 15s to force restart. Contact customer service. 5. Device doesn’t recognize SIM card. SIM card is connected poorly. Device malfunction. Check if SIM card is plugged in correctly Take out the SIM card and plug in again. Contact customer service. 6. Speaker has no sound. The setting of volume is too low. Device malfunction. Reset the volume in system setting. Contact customer service. 7. Earphone is abnormal (no Earphone has a poor connection Plug the earphone correctly.
42 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 sound/ with noise/ abnormal recording) Using earphones that are not in match with the device. Use the earphone matching to the device. Contact customer service. Oximeter module 8. SpO2 probe malfunction Probe is not entirely plug in the device. Probe has a problem. Device malfunction Take out the probe and plug in again, then re-measure. Change with a new probe and re-measure If the problem persists, restart the device. If problem can’t be solved, contact customer service. 9. No pulse rate found The measured site has novital signs. Measuring in wrong operation. Device malfunction Re-measure according to the user manual If still no vital signs after several tries, contact customer service. 10. Weak perfusion index PI of the measured site is low, lower than 0.3% may cause inaccuracy. Change measuring site, and re-measure according to the user manual. 11. Light interference The test environment has strong light Re-measuring in weak light environment. 12. Oximeter module fails to start. Firmware malfunction. Restart the device. If the problem persists, contact customer service BPM module 13. Measure overtime cuff being worn the wrong way. Device malfunction. Remeasure according to the user manual. If the problem persists, contact customer service 14. Measured result is low Device malfunction Remeasuring according to the user manual. If the problem persists, contact customer service 15. Pressurize overtime Cuff dropping, loose or deflating Restart the device If the problem persists, contact customer service 16. Deflate overtime Valve damage Restart the device If the problem persists, contact customer service 17. Pulse detecting overtime Wearing the cuff the wrong way. The measured person is wearing thick clothing. Device malfunction. Wear the cuff according to the user manual. Undress the thick clothes and do the measure a second time. If the problem persists, contact
43 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 customer service 18. Interference in measuring process The measured person moves or talks. Do again the measuring according to the user manual. 19. BPM module fails to start Firmware malfunction Restart the device If the problem persists, contact customer service ECG monitor 20. ECG malfunction Hardware malfunction (chip does not respond for 5s) Chip error of ECG Data frames lost Restart the device If the problem persists, contact customer service 21. Weak ECG signal Electrodes stuck in the wrong position. Re-connect the cable with device according to the user manual, and restart the device for measurement. 22. Measuring result of heart over the limit Measuring result of heart over the limit To measure again according to user manual If still not normal, please contact your doctor. 23. ECG interference Interference signal exist. Be quite and breath smoothly during measurement. Check and remove the interference signal around the cable and electrodes. Re-connect the cable with device and measure again. 24. ECG fails to start Hardware malfunction Restart the device If the problem persists, contact customer service Body temperature module 25. Temperature module malfunction Open circuit or bad connect on the cable of infrared sensor. Infrared sensor is abnormal. Battery voltage lower than 3.2V. Communication protocol is wrong. Reading data overtime Restart the device Please charge the device and restart. If the problem persists, contact customer service 26. Abnormal body temperature measurement. Big temperature difference between room temperature and device temperature. Room temperature beyond the range of 41 – 104 Fahrenheit / 5℃-40℃ Please allow the device to acclimatize the room temperature for at least 30min before using it. Please measure the body temperature within 41-104
44 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017 during body temperature measuring, Fahrenheit / 5℃- 40℃ of room temperature. 27. Temperature module fails to start Hardware malfunction Restart the device If the problem persists, contact customer service
45 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
46 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017

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