BEWELL CONNECT BW X07HD User Manual

BewellConnect - VisioCheck - BW-X07HD – User manual – 022017

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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

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

BewellConnect - VisioCheck - BW-X07HD – User manual – 022017

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SpO2 Connexion

Diagram

BPM Connexion

Diagram

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

BewellConnect - VisioCheck - BW-X07HD – User manual – 022017

Language

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VisioCheck

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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.

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.

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.

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.

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 con nected.

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

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:

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.

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BEWELL CONNECT BW X07HD User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual