REKA HEALTH E100 User manual

28 Mar 2011 ASC-MAW-10002-EN
User Manual
EN
FDA approved

2
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.
REKA HEALTH PTE LTD
No. 2 International Business Park
#11-01/02
The Strategy
Singapore 609930
Tel: [phone]
Medical Consult Europe BV
Haagwinde 20
5262 KZ Vught
Netherlands
Tel: [phone]
IT IS IMPORTANT THAT THE USER BE FAMILIAR WITH THIS USER
MANUAL. PLEASE READ THE WARNING, PRECAUTIONS,
INSTRUCTIONS & SAFETY ISSUES BEFORE USING THIS DEVICE.
EN

3
Content
Symbols 4
REKA E100 5
WARNINGS! 6
REKAE100 Overview 8
Product Specification 9
Taking a ECG/EKG Measurement
Lead I Mode 13
Lead II Mode 15
Uploading through PC, Mac®, Linux® & Smartphone 18
Battery & Indication Information 19
Maintenance 20
Reset REKA E100 23
Troubleshooting 24
EN

4
Symbols
Manufacturer
Authorised representative in
the European community
Indicates this device is in
compliance with MDD 93/42/EEC
CAUTION: Federal law (USA)
restricts this device to sale by or
on the order of a physician.
Date of Manufacture
Separate collection for
recovery and recycling
Consult Instructions
for Use
Attention, See
Instructions for Use
Serial Number
Batch Code
EN

5
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.
EN

6
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 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 & 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, external force onto this device.
Do not take measurements where this device will be exposed to strong
DO NOT SHARE THIS DEVICE WITH OTHERS
This device is designed for personal use by one
individual only.
EN

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.
Read instructions for ECG cable and electrodes carefully before taking a
measurement using external electrodes.
Do not plug USB cable in Lead II connector.
EN

8
REKA E100 Overview
Connect to PC / Phone
Start Button
Integrated
Electrode
Indicator
Lead II
Connector
Serial Number
Integrated
Electrode
EN

9
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!
EN

10
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
Input Leads
RA, LA (Integrated Electrodes)
RA, LL (External Electrodes)
Lead Selection
Lead I (Integrated Electrodes)
Lead II (External Electrodes)
Input Dynamic Range
± 3mV
Input Impedance
>100MΩ
CMRR (Common Mode Rejection Ration)
100db
DC Offset
1600mV maximum
Sensitivity
10mm/mV
Sampling Rate
250 Samples/Sec
EN

11
Band Width
0.5 to 40 Hz (Integrated Electrodes)
Measurement Time
32 seconds
Data Transfer
USB interface
ADC Resolution
10 bit
Measurement
Range
Heart Rate
40-240 bpm
QRS interval
80-120 ms
Accuracy of Heart Rate Measurement
40-100bpm: ±1
100-240bpm: ±2
Memory Storage
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
Storage Environment
-20°C to 50°C, 5 to 80%RH

12
Taking Measurement Using Your Thumbs (Lead I)
1a
Press button
2
Place thumbs on
integrated electrode
immediately
1b
You will observe beeping
tone and blinking light
3
After 30 sec, measurement
complete when a long
beep is heard
EN

13
Please ensure that your hands are clean and dry.
Gently place thumbs on the integrated electrodes according to “L”(Left) and
“R”(Right) indication.
Leave a gap between hands.
Take ECG/EKG in sitting position
Feet resting on the ground,
shoulder width apart.
Breathe gently.
ATTENTION! Do not move or talk while taking
measurements.
Gap
EN

14
Taking Measurement Using ECG Cable (Lead II)
1
2
Snap to electrode
Connect to E100
EN

15
4
Press Button
3
Paste electrodes on body
EN

16
5
You will observe
beeping tone and
blinking light
6
After 30 sec, measurement
complete when a long
beep is heard
EN

17
Electrode Placement
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.
IEC (European Standard) AAMI/AHA (American Standard)
Code
Red
Green
Red
White
EN

18
Upload Through PC, Mac®, Smartphone
Note: For details of uploading ECG data through PC, Mac and
Smartphones, please go to www.rekahealth.com
EN

19
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.
Charging the E100 Battery by using USB Cable provided by manufacturer,
Connect E100 to:
1Computer’s USB port or
2Power 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.
EN

20
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.
EN