User Manual - REKA Health
Contents
1. 100 User Manual FDA approved Rx Only 28 Mar 2011 ASC MAW 10002 EN REKA HEALTH PTE LTD No 2 International Business Park 11 01 02 The Strategy Singapore 609930 Tel 65 6777 1588 0482 EC REP Medical Consult Europe BV Haagwinde 20 5262 KZ Vught Netherlands Tel 31 736 576976 IT IS IMPORTANT THAT THE USER BE FAMILIAR WITH THIS USER MANUAL PLEASE READ THE WARNING PRECAUTIONS INSTRUCTIONS amp SAFETY ISSUES BEFORE USING THIS DEVICE The information contained in this document was accurate at time of publication REKA HEALTH PTE LTD reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold Content Symbols REKA E100 WARNINGS REKA E100 Overview Product Specification Taking a ECG EKG Measurement Lead Mode Lead II Mode Uploading through PC Mac Linux amp Smartphone Battery amp Indication Information Maintenance Reset REKA E100 Troubleshooting oO Ooo uo A 15 18 19 20 23 24 Symbols Manufacturer Date of Manufacture mi Consult Instructions for Use BE Authorised representative in the European community EC REP Separate collection for recovery and recycling X Attention See Instructions for Use Indicates this device is in compliance with MDD 93 42 EEC CE 0482 CAUTION Federal law USA restricts this device to sale by or2. on the order of a physician Rx Only Serial Number Batch Code A REKA E100 The E100 ECG Cardiac Rhythm Monitor is for self recording of ECG by patients outside the hospital and for long term remote monitoring by medical professionals The device is intended for patients who may have cardiac arrhythmia The E100 records an Electrocardiogram ECG EKG and the ECG data is uploaded to REKA Cloud online health record portal at www rekahealth com by connecting the device to a computer or a smart phone Visit www rekahealth com for registration WARNINGS CAUTION Federal law USA restricts this device by a physician or on the order of a physician Do not self diagnose Do not use this device during electro magnetic scanning like MRI scan Do not use this device with the electrodes if you have sensitive skin or allergies DO NOT SHARE THIS DEVICE WITH OTHERS This device is designed for personal use by one individual only Do not measure ECG when this device is charging Do not plug ECG cable in this device when it is connected to computer or adaptor Do not disassemble repair or modify this device Only use power adaptor amp cables provided by the manufacturer Do not sterilize this device in an autoclave ultraviolet sterilizer or gas sterilizer Do not wash this device with water Do not use this device for any purpose other than obtaining an ECG Do not induce excessive shock vibration exte
3. Battery Orange Blinking Shown after measuring Short Beep 5 sec Continues Very Low Battery Unable to upload Red Blinking Shown after measuring Short Beep 5 sec Continues Unable to measure Red Blinking While pressing button Short Beep 5 sec Continues During Data Transfer Connected to Phone Status Light Indication Sound Data Transferring Steady Orange Transfer Completed Steady Blue Short Beep Please Unplug Connected to Computer Status Light Indication Sound Charging Steady Green 00000 Fully Charged No Light 2 Reset REKA E100 1 Use a small wire to poke reset hole SEE TROUBLESHOOTING BELOW FOR WHEN TO USE Reset Hole 2 Reset is successful when beep sound is heard 23 Troubleshooting Problem Solution No response when Start Battery is low Charge the device eUHONUSPreseee System crash Reset the device Excessive movement Check instructions and repeat during measurement measurement Thumbs are greasy Clean hands Moisten hands with a damp towel or Thumbs are dry ECG gel Integrated electrodes are dirt Refer to maintenance irty Thumb press on integrated Place thumbs on the integrated electrode IS too strong electrodes gently Noisy ECG Signal Replace ECG cable following its ECG cable is worn out Instruction Check instructions and repeat The ECG signal is too measuremen
4. USB Cable provided by manufacturer Connect E100 to 1 Computer s USB port or 2 Power Adapter To charge the battery using your computer the computer must be turned on and not be in sleep mode Understanding Battery Status The battery status only will show after measuring More detail refer to indication information You should charge the E100 when the Start button is Orange Blinking You can disconnect and use E100 before it s fully charged Note The Rechargeable battery has a limited number of charge cycles and might eventually need to be replaced Battery life varies based on use 19 Maintenance Cleaning and disinfection Wipe the integrated electrodes using a cloth dampened with disinfectant alcohol If you do not disinfect the electrodes there is a risk of skin disease Do not wipe the device with volatile detergents Maintenance and Storage Clean the device with a cotton cloth This unit does not require calibration during its expected life cycle Do not store the unit in the following ambient conditions Exposed to direct sunlight vibration or electromagnetic fields Subject to high temperatures or high humidity Wet damp or dusty environments Near fires or open flames 20 Indication Information During Measuring Status Light Indication Sound Measuring Light Pink Blinking Short Beep 30 sec Measurement Steady Light Pink Long Beep 5 Sec Complete Low
5. mbs Lead 1 You will observe beeping tone and blinking light Place thumbs on After 30 sec measurement integrated electrode complete when a long immediately beep is heard 12 ATTENTION Do not move or talk while taking measurements Please ensure that your hands are clean and dry Gently place thumbs on the integrated electrodes according to L Left and R Right indication Take ECG EKG in sitting position Feet resting on the ground shoulder width apart Breathe gently Leave a gap between hands 13 Taking Measurement Using ECG Cable Lead Il Connect to E100 14 15 You will observe After 30 sec measurement beeping tone and complete when a long blinking light beep is heard 16 Electrode Placement IEC European Standard AAMI AHA American Standard ATTENTION To improve accuracy choose an area with little to no hair or shave the skin where the electrodes will be attached Do not move or talk while taking measurements 17 Upload Through PC Mac Smartphone Note For details of uploading ECG data through PC Mac and Smartphones please go to www rekahealth com 18 Battery amp Indication Information About the E100 Battery E100 has an internal non user replaceable battery For best results the first time you use E100 let it charge for 4 hours The E100 battery is fully charged in 4 hours Charging the E100 Battery by using
6. rnal force onto this device Do not take measurements where this device will be exposed to strong electromagnetic forces Do not use in the presence of flammable anesthetics drugs or pressurized oxygen Keep out of reach of infants small children and compromised people Important note for correct measurement Do not measure if integrated electrodes are dirty Wipe any dirt off with a soft cloth or a cotton swab moistened with disinfectant alcohol Read instructions for ECG cable and electrodes carefully before taking a measurement using external electrodes Do not plug USB cable in Lead II connector REKA E100 Overview Connect to PC Phone Integrated Electrode Integrated Electrode fed ce x co 110 S ASC1011100000001Y J Indicator Serial Number Lead Il Connector Packing list 1 REKA E100 5 ECG Cable 2 REKA USB Cable 6 Power Adapter 3 Micro USB Cable 7 Pouch 4 30 pin Cable 8 Quick Start Guide and Warnings een Product Specification 02 Input Leads Lead Selection Measurement Heart Rate 40 100bpm 1 100 240bpm 2 Accuracy of Heart Rate Measurement Up to 4000 ECG records with the built in 256MB NAND flash memory Battery Charge Cycles Up to 360 times Operating Environment 10 C to 40 C 25 to 80 RH Memory Storage Storage Environment 20 C to 50 C 5 to 80 RH 11 Taking Measurement Using Your Thu
7. t weak Measure using external electrodes Refer to electrode placement External electrodes do not stick tightly on skin 24 Problem Noisy ECG Signal Environmental noise Device is not recognized ER The connection is improper or the USB port power supply is too low when plugged into computer Device is not charged when USB port is low power or plugged 10 computer computer is in sleep mode Device red blink and beep when plugged in mobile Battery level is low phone Solution Take measurements in an environment not exposed to strong vibration or electromagnetic force Plug in your device properly and ensure plug is securely inserted into the USB port Plug Into main direct USB port amp ENSURE the computer IS not in sleep mode Use the provided power adapter Charge the device If the problem persists or other problems occur contact your dealer or visit REKA HEALTH website www rekahealth com 25
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