EPI Mobile Health Solutions W518 User Guide

EPI Mobile Health EPI Mini W518
Portable ECG Recording User Manual

User Assistance Information

Company Contact Details

EPI Mobile Health Solutions (S) Pte Ltd
8 Ubi View, Serial System Building, #03-01
Singapore 408554
Tel: [phone]
Fax: [phone]
Email: [e-mail]

www.epi.com.sg

Inside this box you will find

1. EPI Mini W518 X 1

2. Charger (Model No: AU1050501e) X 1

3. USB cable X 1

4. User Manual X 1

© 2012 EPI Mobile Health Solutions (S) Pte Ltd

Document number LPI-0001-04 Page 1 of 17

Table of Contents

Symbols ................................................................................................................................................... 3

Indications for Use .................................................................................................................................. 5

Warnings and Cautions ........................................................................................................................... 6

Description of Device ............................................................................................................................. 8

Environmental conditions that affect use............................................................................................... 9

Classification of degree of protection/Type BF ...................................................................................... 9

Getting Started ....................................................................................................................................... 9

Charging the device ............................................................................................................................ 9

Pairing the device with your phone .................................................................................................... 9

Download Application ......................................................................................................................... 9

Set-up and Connection (For Android) ............................................................................................... 10

Operating Instructions ......................................................................................................................... 12

Recording your ECG .......................................................................................................................... 12

ECG Manager .................................................................................................................................... 13

Date/Time ......................................................................................................................................... 13

Language ........................................................................................................................................... 14

User Settings ..................................................................................................................................... 14

System Information .......................................................................................................................... 15

Cleaning and Maintenance ................................................................................................................... 15

Storage and Transport .......................................................................................................................... 15

Troubleshooting Guide ......................................................................................................................... 16

Specifications ........................................................................................................................................ 17

Document number LPI-0001-04 Page 2 of 17

Symbols

Symbols Meaning

Follow Instructions for Use

Caution. Please refer to safety-related notes
accompanying this instrument

Temperature limitation (Store at)

Humidity limitation (Store at)

Type BF applied part

Serial Number

Document number LPI-0001-04 Page 3 of 17

IP20

Indicates separate collection for electrical and
electronic equipment (WEEE).

Protected against ingress of solid foreign objects
greater than or equal to 12.5 mm diameter per IEC

60529. Not protected against ingress of water

CE Marking indicating conformance to EC Directive
No. 93/42/EEC concerning medical devices.

Authorized Representative in the European
Community

Manufacturer name and address

Document number LPI-0001-04 Page 4 of 17

For your safety, please follow all operating and safety instructions in this user guide

Indications for Use

EPI Mini W518 is a portable single lead electrocardiogram (ECG) recording device. It is capable of

recording, storing and sending several leads using different configurations allowing mobile recording,

storing and sending of ECGs on-the-go. This provides the user with instant access to information

about their heart, within the limitations of a traditional 12 lead ECG. It serves the purpose of a mobile

and highly portable ECG recording device. The device is used for ad-hoc recording of ECGs when

cardiac symptoms are present to allow the detection of abnormal heart activity. The target patient

population includes but it is not limited to users who are at risk of heart disease, have existing heart

conditions and/or users who show symptoms suggestive of heart disease. The device is not meant to

entirely replace the clinical 12 lead ECG machine.

ECG data is recorded for 30 seconds each time by the user. Recorded ECG data is stored on the EPI

Mini and can be sent to a Smartphone via Bluetooth. ECG data sent from the EPI Mini is received and

stored for viewing on the Smartphone using the EPI Mini mobile software application (mobile app).

Users are able to view their ECGs using the mobile app, as well as resend or delete any of these data

via the app to allow the doctor to monitor their conditions.

Document number LPI-0001-04 Page 5 of 17

Warnings and Cautions

Contraindications

Users who have pacemakers implanted should not use this device to record any modified pre­cordial leads and should strictly be limited to using the modified limb leads for ECG recording
(device should be kept at a minimal distance of 9 inches away from the implanted pacemaker)

For your safety, please take note of the following warnings.

Warnings

 Do not use this device in places with flammable substances like anaesthetic gas or

pressurized oxygen.

 Do not self-diagnose ECG. Always consult your doctor. Self-diagnosis or self-treatment

may lead to deterioration in your condition.

 Do not use this device around electromagnetic scanning like MRI scans.

 Do not use this device on people with sensitive skin or allergies.

 Do not attempt to use the device over or through clothing.

 Use only the original charger and the original USB data cable for charging. Use of other

chargers and USB cable may expose to unwanted electrical risk.

 Do not measure ECG when this device is charging

 Do not operate the device during charging.

 Keep out of reach of infants and small children.

For your safety, please take note of the following cautions

Cautions

 Do not use this device for any purpose other than obtaining an ECG.

 Do not take record ECG where this device will be exposed to strong electromagnetic

forces.

 Do not expose the unit to strong shocks or vibrations. Do not drop or step on the unit.

 Do not use for any purpose other than obtaining an electrocardiograph.

 Do not take measurements in a moving vehicle.

 If electrodes are dirty, please wipe with dry soft cloth before recording ECG

 Only use this device in accordance with instructions provided from the manufacturer

 The device will automatically shut down after 2 minutes of non-use.

 Do not induce excessive shock, vibration, external force onto this device

 Do not disassemble, repair, or modify the unit.

 Charger input voltage is 100V – 220V. Do not disassemble the charger.

Document number LPI-0001-04 Page 6 of 17