Summary of Contents for MEDCHECK VITAL SIGNS MONITOR
- Page 1 VITAL SIGNS MONITOR THE COMPLETE MANUAL TO MEDCHECK’S VITAL SIGNS MONITOR VITAL SIGNS MONITOR MANUAL BY SMARTFUTURE PTE LTD CONSISTING OF DEVICE MANUAL APPLICATION MANUAL...
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Page 2: Intended Use
INTENDED USE The Vital Signs Monitor is intended to be used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate, temperature and blood pressure variation in home or healthcare facilities environment. - Page 3 Warnings and Cautionary Advices We recommend not to use this device if you have a pacemaker or other implanted devices. Follow the advice given by your doctor, if applicable. Do not use this device with a defibrillator. Do not use this device during MRI examination. Do not use the device in a combustible environment (i.e., oxygen-enriched environment).
- Page 4 DEVICE OVERVIEW 1. Touch Screen 2. Infrared temperature sensor 3. Internal SpO2 sensor 4. LED indicator Off: the monitor is turned off or working in Standby Mode; Green: the monitor is turned on, and working normally; or when the battery is fully charged; Blue: the battery is being charged;...
- Page 5 DEVICE OVERVIEW 8. Speaker 9. ECG left electrode Put it to your left palm, left abdomen or left knee. 10. Neck stripe hole 11. ECG back electrode Use right forefinger or middle finger to press on it. Main Screen The Main Screen is shown as below. Slipping your finger from right to left can switch to the second page, and vice versa.
- Page 6 DEVICE OVERVIEW Calendar Screen / Standby Mode The device will enter Calendar Screen / Standby Mode when: No operation is detected for 120 seconds in other screen interface, the device will automatically switch to the Calendar Screen. Pressing the Home button in the Main Screen. 1.
- Page 7 DEVICE OVERVIEW Result Screen For each measurement, a Result report will be provided after the measurement is finished. An example is shown as below. 1. Measured parameters and readings 2. A summary of this measurement 3. A graphic indicator about the health status : All measured parameters are within the reference range;...
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Page 8: Prior To Use
SYMBOLS DEFINITIONS DEFINITIONS SYMBOLS Application part type BF Manufacturer CE0197 In conformity with Directive 93/42/EEC European Representative Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”. - Page 9 DAILY CHECK Daily Check measurement is a function that combines the measuring of ECG (Electrocardiograph), SpO2 (blood oxygenation) and systolic blood pressure. It takes only 20 seconds to collect your vital signs before giving you vital signs readings and your health evaluation. Using Daily Check To start a Daily Check, follow the steps as below.
- Page 10 1. Select the <Settings> icon, select <BP Calibration>, and then choose the right user. 2. Ensure that the cuff and the Vital Signs Monitor are at the same level as your heart. Then start the blood pressure measurement from the cuff BP meter.
- Page 11 Method A and B offer maximum comfort, than method C and D, but no ST segment value. No matter which method you choose to measure ECG, please keep stable posture and stay calm during the measurement. Measuring without Cable To start an ECG Recorder measurement without cable, 1.
- Page 12 Measuring with Cable To start an ECG Recorder measurement with cable, 1. Choose the method C or D. 2. Follow the instructions to connect the ECG cable and place the ECG electrodes. Sit down or stand, / stay calm; Palms facing up, place an electrode in the middle of right wrist; For method C, place another electrode in the middle of left wrist;...
- Page 13 Temperature About thermometer Warnings and Cautionary Advices The thermometer is only designed for the measuring area on the human body stated in this manual. The device needs to be in the room which the measurement is taken for at least 10 minutes before use. Physical activity, increased perspiration on the forehead, taking vasoconstictive medication and skin irritations can distort the result.
- Page 14 Oximeter The Vital Signs Monitor measures the amount of oxygen in your blood, your pulse rate and pulse index. The oxygen saturation (SpO2) is measured and displayed as a percentage of full capacity. Measuring without Cable To start a Oximeter measurement without cable, 1.
- Page 15 Sleep Monitor Vital Signs Monitor offers a non-invasive method to monitor sleep status for adult users who have sleep problem, sleep related breathing disorders and obstructive sleep apnea. To start a sleep monitor measurement, 1. Tie the wristband on one of your left hand.
- Page 16 Pedometer To start a Pedometer measurement, 1. In the Main Screen, select <Pedometer> icon. If you have not created user, then please add your user account. 2. Select a user to enter the screen as below. 3. Tap the button to set your target, if needed. 4.
- Page 17 Settings Changing Sound Volume In the Settings menu, tap the <Volume> area to change volume directly. “X” means the volume is turned off. Enabling/Disabling Voice Guide In the Settings menu, tap the <Voice Guide> to enable or disable this function. User Management To use the Daily Check measurement, you must create your account.
- Page 18 Setting Date & Time 1. In the Settings menu, choose <Date & Time> 2. Tap “+” or “-” button to change the date, then tap 3. Tap “+” or “-” button to change the time. 4. Tap to finish the setting. Choosing Language 1.
- Page 19 Erasing Data In the Setting menu, Tap <Erase All Data>, and then <Yes>. All measurements saved in the device will be deleted. Factory Reset In the Setting menu, tap <Factory Reset>, then tap <Yes>. All measurements, user information and other settings saved in the device will be deleted, and the device will be restored to the factory default settings.
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Page 20: Care And Cleaning
Maintenance Care and Cleaning Clean the device per week, carefully swabbing the device surface with a soft cloth or cotton swab with rubbing alcohol. Trouble Shooting Problem Possible Cause Solution The device does 1. The battery may be low. 1. Charge the battery and not turn on. - Page 21 Accessories Warnings and Cautionary Advices Use accessories specified in this chapter. Using other accessories may cause damage to the device or not meet the claimed specifications. Depending on the configuration, May not all the accessories are included in your package. Part Number Description 540-00192-00...
- Page 22 Integrated ECG electrodes Lead type External ECG cable and electrodes Lead set Lead I, lead II Measurement mode Episode, continuous Sampling rate 500 Hz Sampling accuracy 16 bit 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV Display Gain 10 mm/mV, 20 mm/mV Sweep speed 25 mm/s Bandwidth*...
- Page 23 PI range 0.5-15 , PR, PI, Summary (Normal Blood Oxygen, Low Blood Oxygen, Unable Measurement summary to analyze) Blood Pressure Variation Measurement method Cuff-free non-invasive technology Measurement summary Systolic pressure based on individual calibration coefficient Thermometer Technique Infrared body temperature Environment temperature 16.0 to 40.0 °C Measurement site...
- Page 24 Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. All the accessories also meet the requirements of EN 60601-1-2 when in use with this device. Warnings and Cautionary Advices Using accessories other than those specified in this manual may result increased electromagnetic...
- Page 25 Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. All the accessories also meet the requirements of EN 60601-1-2 when in use with this device. Warnings and Cautionary Advices Using accessories other than those specified in this manual may result increased electromagnetic...
- Page 26 Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete (ESD) IEC 61000-4-2 ± 8 kV air ± 8 kV air or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
- Page 27 3 V/m 80 MHz 3 V/m 80 MHz Recommended separation distances: Radiated RF 80 MHz〜800 MHz: IEC61000-4-3 2.5 GHz 2.5 GHz 800MHz-2.5GHz: Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
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