REKA HEALTH E100 User Manual

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User Manual

FDA approved

28 Mar 2011

ASC-MAW-10002-EN

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Summary of Contents for REKA HEALTH E100

Page 1: User Manual
User Manual FDA approved 28 Mar 2011 ASC-MAW-10002-EN...
Page 2 INSTRUCTIONS & 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...
Page 3: Table Of Contents
Content Symbols REKA E100 WARNINGS! REKA E100 Overview Product Specification Taking a ECG/EKG Measurement Lead I Mode Lead II Mode ® ® Uploading through PC, Mac , Linux & Smartphone Battery & Indication Information Maintenance Reset REKA E100 Troubleshooting...
Page 4: Symbols
Symbols Authorised representative in Indicates this device Manufacturer the European community compliance with MDD 93/42/EEC Date of Manufacture Separate collection for CAUTION: Federal law (USA) recovery and recycling restricts this device to sale by or on the order of a physician. Consult Instructions Attention, See Serial Number...
Page 5: Reka E100
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...
Page 6: Warnings
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.
Page 7 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.
Page 8: Reka E100 Overview
REKA E100 Overview Connect to PC / Phone Start Button Integrated Integrated Electrode Electrode Indicator Serial Number Lead II Connector...
Page 9 1. REKA E100 5. ECG Cable Packing list: 2. REKA USB Cable 6. Power Adapter 3. Micro USB Cable 7. Pouch 4. 30 pin Cable 8. Quick Start Guide and Warnings!
Page 10: Product Specification
Product Specification Size (mm) 70H x 81W x 17.4D Weight 105g (Device Only) Battery & Power Built-in 250mAh rechargeable lithium-ion battery Stand by Up to 6 weeks, measure up to 200 times Buzzer Level 70 dB RA, LA (Integrated Electrodes) Input Leads RA, LL (External Electrodes) Lead I (Integrated Electrodes)
Page 11 Band Width 0.5 to 40 Hz (Integrated Electrodes) Measurement Time 32 seconds Data Transfer USB interface ADC Resolution 10 bit Heart Rate 40-240 bpm Measurement Range QRS interval 80-120 ms 40-100bpm: ±1 Accuracy of Heart Rate Measurement 100-240bpm: ±2 Up to 4000 ECG records with the built-in 256MB Memory Storage NAND flash memory Battery Charge Cycles...
Page 12 Taking Measurement Using Your Thumbs (Lead I) Press button 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...
Page 13 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  Leave a gap between hands. ...
Page 14 Taking Measurement Using ECG Cable (Lead II) Snap to electrode Connect to E100...
Page 15: Lead Ii Mode
Paste electrodes on body Press Button...
Page 16 After 30 sec, measurement You will observe complete when a long beeping tone and beep is heard blinking light...
Page 17: Electrode Placement
Electrode Placement White Green IEC (European Standard) AAMI/AHA (American Standard) Code 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.
Page 18: Uploading Through Pc, Mac ® , Linux ® & Smartphone
® Upload Through PC, Mac , Smartphone Note: For details of uploading ECG data through PC, Mac and Smartphones, please go to www.rekahealth.com...
Page 19: Battery & Indication Information
Battery & 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.
Page 20: Maintenance
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 ...
Page 21 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 Orange (Blinking) Short Beep (5 sec) Low Battery Shown after Continues measuring Very Low Battery Red (Blinking) Short Beep (5 sec) Unable to upload...
Page 22 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 -------- Fully Charged No Light --------...
Page 23: Reset Reka E100
Reset REKA E100 Use a small wire to poke reset hole. SEE TROUBLESHOOTING BELOW FOR WHEN TO USE. Reset is successful when “beep” sound is heard.
Page 24: Troubleshooting
Troubleshooting Problem Cause Solution Battery is low Charge the device. No response when Start button is pressed 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.
Page 25 Use the provided power adapter. Device red blink and beep when plugged in mobile Battery level is low Charge the device phone If the problem persists or other problems occur, contact your dealer or visit REKA HEALTH website www.rekahealth.com...