EVOLT EV360 User Manual

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EV360 USER MANUAL

Version 2.0

THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC

SELVAS Healthcare, Inc.

155, Shinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea

TEL: 82-42-879-3000, FAX: 82-42-864-4462

Obelis s.a.

Bd. General Wahis 53.

B-1030 Brussels, Belgium

Evolt IOH Pty Ltd

1/ 24 Leda Drive, Burleigh Heads, QLD

Australia 4220

V20 20211025

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Page 1 EV360 USER MANUAL Version 2.0 THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC SELVAS Healthcare, Inc. 155, Shinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea TEL: 82-42-879-3000, FAX: 82-42-864-4462 Obelis s.a. Bd. General Wahis 53. B-1030 Brussels, Belgium...
Page 2: Table Of Contents
SAFETY PRECAUTIONS……………………………………………………………6, 7 & 8 CORRECT HANDLING TECHNIQUE………………………………………………………33 & 34 SAFETY SYMBOLS AND INFORMATION …………………………………………..9 CORRECT USE OF THE EVOLT 360………………………………………………………35 & 36 TERM AND FUNCTION OF EACH PART ………………………………………10 & 11 SCANNING PRECAUTIONS FOR THE EVOLT 360…………………………………….37 & 38 SYSTEM SET UP………………………………….………………………12, 13, 14 &...
Page 3: Introduction
INTRODUCTION We highly appreciate that you have chosen our company’s product. You are kindly requested to be familiar with these directions before using this product and always keep it together with the product. In case you are not sure about any directions or problems arising while using the product, please contact our service center and we will provide you with detailed instructions.
Page 4: Intended Use
INTRODUCTION 1. INTENDED USE This device measures impedance by bioelectrical impedance analysis method and provides lots of informa6on using measured impedance and inpu8ed personal data (height, age, gender, weight). It shows body composi6on of MBF, LBM, SLM, SMM, TBW, protein mass, mineral mass, etc. and informa6on regarding BMI, PBF, BMR, abdominal analysis, Target to control, segmental analysis, Body composi6on change, etc.
Page 5: Classification And Compliance
CLASSIFICATION AND COMPLIANCE 1) This device is classified as; - Class 1 type-BF against electric shock - Ordinary equipment without protection against ingress of water - Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of IEC 60601-1: 2005+A1:2012(Basic safety and essential performance of Medical Electrical Equipment) 2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of IEC 60601-1-2:2014(Electromagnetic Compatibility Requirements).
Page 6 CAUTION Avoid the following environments for storage; - Where the ambient temperature falls below -25°C or exceeds 70°C. - Where the atmospheric pressure falls below 70kPa (700mbar) or exceed 106kPa (1060mbar). Where the humidity is over 93% non-condensing. - Where the unit is exposed to spray or splashing water Where the unit is exposed to dust.
Page 7 PROHIBITION Do not disassemble or alter the device under any circumstances, as this could This equipment has been tested and found to comply with the limits for medical devices according to NOTE result in electric shock or injury as well as adversely affect the precision of IEC 60601-1-2:2014.
Page 8 NOTE In case of patients who have certain diseases, the estimates might be different WARNING Do not modify this equipment without authorization of the manufacturer. PROHIBITION Connect the earth placed on the backside of this device to terminal plate to prevent any electric shock from leakage current or a potential difference.
Page 9: Safety Symbols And Information
5. SAFETY SYMBOLS AND INFORMATION The International Electro-technical Commission (IEC) has established a set of symbols for medical electrical equipment which classify a connection or warning of any potential hazard. The classifications and symbols are shown below. Save these instructions for your safety.
Page 10 6. Guidance for Electromagne4c compa4bility (EMC) Details about the electromagne2c compa2bility (EMC) of the EV 360 are given below. Before using the EV 360, be sure to read and understand the following informa2on. 1) Guidance and manufacturer’s declara4on – electromagne4c emissions The EV 360 is intended for use in the electromagne2c environment speciﬁed IEC 60601-1-2:2014 (Fourth Edi2on).
Page 11: Term And Function Of Each Part
TERM & FUNCTION OF EACH PART COLOUR LCD FRONT PART HANDLE ELECTRODE Color LCD panel as touch screen. -Displays the procedure and results. Handle Electrode Handle Electrode measure the impedance by sending harmless electric current to the body. Hold them with the hands during measurement...
Page 12 REAR PART BASE ▪ Power switch (POWER): It can be used to turn on/oﬀ the power. PART ▪ WIFI port: Conneckng the Wi-Fi Dongle. (OPTION) Plate electrode (Applied Part) ▪ Bluetooth port: Conneckng the Bluetooth. (OPTION) ▪ Printer port: Conneckng the printer oﬀered with this device. Cau$on Weight scale (Applied Part) Do not touch the pakent while operakng the rear panel.
Page 13: System Set Up
SYSTEM SET UP CONTROL PANEL • Enter your Operator Email and Password • Click “Operator Panel” • Click “Save”...
Page 14 SYSTEM SET UP SCALE CONFIGURATION OPERATOR CONFIGURATION • Ensure Abdominal Circumference is in the “ON” • Click the location drop down box and click the position desired location. • Ensure Abdominal Obesity over 18 is in the “ON” • Click “Unattended” position •...
Page 15 SYSTEM SET UP • Ensure Abdominal Circumference is in the “ON” position • Ensure Abdominal Obesity over 18 is in the “ON” position • Set the Measurement mode to “Precision” • Set the Weight of Clothes at “0.3kg” • Click “Save”...
Page 16 • Click the Wi-Fi in the “ON” position • Ensure your printer is connected to the same Wi- • Click “New Connection” Fi connection as the EV360 • Find your desired Wi-Fi location and Click “Quick • Click “Printer" Connect” to insert your password details •...
Page 17: User Experience
USER EXPERIENCE Voice activated instructions �� Enter new Member details Access the Kiosk as a new Member via ”sign up Enter new Member details and scan” or an existing Member via “login and scan” Enter new Member Goal details Enter new Member Body Type details Enter new Member details...
Page 18 USER EXPERIENCE Voice activated instructions �� Enter new Member activity level details Enter new Member activity type details Accept Member terms and conditions to continue Member weighed Member prompted to make contact with tactile Member prompted to stand on device points...
Page 19 USER EXPERIENCE Voice activated instructions �� Progression shown during scanning Once completed, print out shown...
Page 20: Installation
INSTALLATION • Power Supply Connect the power cable to the ‘ADAPTER INPUT’ placed on the lower back panel of the device. Connect the cable. Turn on the power switch placed next to Power input, then after moment initial screen animation is displayed automatically. Caution 1.
Page 21: Measurement Analysis
MEASUREMENT ANALYSIS Precaution for measurement • The reliability of the results can be assessed by its accuracy. The “Accuracy” of the device is determined by comparing the actual body composition and the results from Body Composition Analyzer. The “Reproducibility” is determined when the device gives the identical results under the same conditions. In order to maintain the accuracy of the results, the following guidelines should be kept.
Page 22: Measurement Analysis
MEASUREMENT ANALYSIS • In order to keep one’s health and the balance of body composition, check the changes of body composition through continuous analysis and compare the results. Make sure that the body composition should are measured under the same physical and environmental conditions.
Page 23 MEASUREMENT ANALYSIS 2) How to grip handle electrodes • Ensure contact with all fingers including thumbs and palms as shown in the image • Ensure palms have full contact with electrodes at all times. • Stretch out arms enough to ensure that arms are not touching the body •...
Page 24: Measurement
MEASUREMENT • Enter your first name, last name, • Enter your date of birth, gender and mobile phone number and email twice height and click ”Next” • Click ”Sign up and Scan” then click “Next” • Confirm that you are not pregnant or •...
Page 25 MEASUREMENT • Remove shoes, sock and/or stockings • The screen shows a completion tab to • Terms & Conditions continued or any other foot wear show the progress of the scan • Once scanning process is complete, the system will produce a pdf image of the result sheet.
Page 26 RESULTS EXPLAINED...
Page 28: Storage And Maintenance
STORAGE & MAINTENANCE 1. Pay attention to the allowable value to electric current 2. Avoid direct sunlight, humidity, dust, thick oil and salty or extreme changes in temperature. 3. Do not install or store the device in a place where any chemicals or gas is stored. 4.
Page 29 STORAGE & MAINTENANCE Users must wipe with safety equipment such as gloves in disinfecting electrode. Our company doesn’t take any responsibility for safety accidents caused by carelessness or incorrect use of the product. WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) The device could be sent back to the manufacturer for recycling or proper disposal a@er their useful lives.
Page 30: Error And Repair
ERROR & REPAIR Error Cause Repair • Clean the measuring parts (the electrodes, palms, and soles) and try again. When the subject’s body impedance deviates from • Measure again with correct posture. the limit - Insufficient touch to electrodes • Do not move during measurement. Out of range of - Impedance is out of range impedance...
Page 31 ERROR & REPAIR ERROR CAUSE REPAIR to Ankle When the subject’s height is deviated Can’t input • Input height correctly. If the subject’s height from the limit the height is out of range, height can’t be entered. - Incorrect input of height •...
Page 32 ERROR & REPAIR Error code Cause Repair • Try to measure again after cleaning the electrode holders with soft gauze. • Try again after cleaning the hands and soles. • Electrode and measuring parts are not detected or dirty • Check if foreign materials are between electrodes and measuring parts. •...
Page 33: Service
• Our company or local distributor will make available on-request circuit diagrams, component part list, descriptions, calibration or other information which will assist your appropriately qualified technical personnel to repair those parts of the unit which are designated by our company as repairable. How to contact our company EVOLT IoH Pty Ltd 1/24 Leda Drive, Burleigh Heads Queensland, Australia 4220 Ph: +617 5535 6227 Email: info@evolt360.com...
Page 34: Correct Handling Technique
Correct Handling Technique Ensure that your back is kept in a straight position at all times, keeping your feet, shoulder width apart, use your legs to lift the machine up as shown in the figures above. DO NOT round your back.
Page 35 Correct Handling Technique When the unit is folded, firmly grasp the base of the neck as shown in figure A with one hand and grasp the other side of the unit by grasping under the scale between to two feet as shown in figure B.
Page 36: Correct Use Of The Evolt 360
Correct use of the Evolt 360 Correct position to measure 1) How to touch electrodes • Make sure that the plate electrodes are clean. Use antiseptic wipes on all silver plate electrodes after each use to ensure cleanliness and hygiene.
Page 37 Correct use of the Evolt 360 2) How to grip handle electrodes • Ensure contact with all fingers including thumbs and palms as shown in the image • Ensure palms have full contact with electrodes at all times. • Stretch out arms enough to ensure that arms are not touching the body •...
Page 38 WARRANTY Name of product Body Composition Analyzer Name of model EV360 Serial number Period of warranty Within 1 year from the date of purchase Date of purchase Customer Add. Name Tel. Dealer (market) Add. Name Tel. Note When you receive this warranty, make sure that the name of the dealer and the month, day and year of purchase are all completed.
Page 39: Checklist
CHECKLISTS...
Page 40 CHECKLISTS...
Page 41: Specification
Storage ambient Ambient temperature range -25 to +70 °C Relative humidity range lower than 93 % RH Software name and version EV360 .AP.1.0.19 & BCA-CE3F/V5.26.G & VNBCA-360/v0.19.2. NOTE. For purpose of improvement, specifications and design are subject to change without notice.
Page 42 EVOLT’S MISSION STATEMENT “Educating people with the knowledge of their body composition, providing inspiration from information.” - EVOLT. "To be the most trusted company for peoples wellness journey, by evolving body composition intelligence and providing a complete ecosystem for personal measurement."...