BewellConnect Logo Picture cover REF PRODUCT+CE+pictos VisioCheck By Visiomed DIAGRAMS Diagram A 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) LED (Flash) HD Camera Indicating light Display screen Home button Infrared probe Earphone port SIM card tray SpO2 port BPM port 1 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
11) 12) 13) 14) 15) Speaker On/Off button Up/down wheel (OK Button) ECG port USB port Diagram B Accessories picture Diagram C Diagram F Diagram D ECG Connexion Diagram Diagram E Thermometer Diagram 2 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
SpO2 Connexion Diagram BPM Connexion Diagram + rating label 3 BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
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 SB
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 1.2 1.3 1.4 ECG cable/Lead wires and SpO2 adapter cable Reusable blood pressure cuff Finger clip SpO2 sensor for adult FCC statement 2. Information 3. Features 4. Description 5. Precautions before use 5.1 ECG 5.2 Oximeter 5.
. 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.
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.
- - - - - 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.
- 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.
- - - - - - 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.
– 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).
3) 4) 5) 6) 7) SpO2 universal sensor connector *1 ECG 5-Electrode Cable*1 Infrared Probe Cover*1 USB Cable*1 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.
-> Nail-polish (colorimetric interference) or artificial nails -> High levels of dysfunctional hemoglobin (carboxyhemoglobin or methemoglobin) -> Intravascular dyes (indocyanine green or methylene blue) -> Bright light.
- 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.
- 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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
- 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.
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.
RAM ROM Operating system LCD Touch panel Camera Speaker MIC Receiver G-sensor Gyro-Sensor Light-Sensor Proximity Sensor Grade of Waterproofing 1.2. Blood Pressure Measuring Mode Measuring Method Measurement Range Measurement Accuracy 1.3. SpO2 Measuring Mode Measuring Method Capacity Capacity OS Version Language Type Screen size Color Brightness Screen resolution Type Material Front Camera Rear Camera Flash light Built-in Built-in Built-in Built-in Built-in Built-in Built-in IP22 1GB 8GB Android 5.
Anti-electrosurgical Capability Defibrillation Protection PACE 1.5. Temperature No No No Body temperature:32.0°C~43.0°C / 89°F ~109.4°F Measurement range 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 +/- 0.2°C (35°C-42°C) / +/- 0.2°F (95°F-107.6°F) in body temperature Measurement Accuracy +/-0.3°C (32°C-34.9°C, 42.1°C-43°C) / +/- 0.
SpO2 probe port ECG cable port Non-contact temperature sensor Micro Sim Card Micro SD 1.8. Power Parameter Battery Charge lamp Adapter Information Yes Yes Yes Yes No Type Li-ion battery Capacity 3.7V/2500mAh Time on stand by 3 days Performance capacity 4 hours Blue/Green Operating: The adapter is capable to operate from 32° to 104° Fahrenheit / 0°C to 40°C.
- 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.
2. Troubleshooting Main device 1. Device can’t be turned on. System is abnormal. Battery has low power. Device is damaged. 2. Module Inspection Failed The module concerned has a problem Device malfunction 3. After turning on the device, 4G/Wi-Fi signal is abnormal. 4. Device crash 5. Device doesn’t recognize SIM card. 6. Speaker has no sound. 7. Earphone is abnormal (no Network signal is weak. Wi-Fi hotspot is configured incorrectly. Device malfunction.
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. 9. SpO2 probe malfunction No pulse rate found Weak 10. perfusion index Light 11. interference Oximeter 12. module fails to start. BPM module Take out the probe and plug in again, then re-measure. Change with a new probe and remeasure If the problem persists, restart the device.
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 21. Weak ECG signal Electrodes stuck in the wrong position. 22.
during body temperature measuring, 27. Temperature module fails to start Hardware malfunction Fahrenheit / 5℃- 40℃ of room temperature.
BewellConnect - VisioCheck - BW-X07HD – User manual – 022017
BewellConnect - VisioCheck - BW-X07HD – User manual – 022017