BioTelemetry Braemar ePatch User manual

02-02182 Rev A ePatch ECG Recorder Instructions For Use | 1 OF 36
ePatch
ECG Recorder
Instructions for Use
Product Catalogue Numbers:
REF ePatch 2.0
REF 02-02046
Subject to modification
Copyright © 2022
Braemar Manufacturing LLC
All rights reserved
06/2023
02-02182 Rev. A
UK ENGLISH
2797

02-02182 Rev A ePatch ECG Recorder Instructions For Use | 2 OF 36
Notices
Prescription use only (U.S. Federal Law)
Legal Manufacturer:
Braemar Manufacturing LLC.
1285 Corporate Center Drive
Suite 150
Eagan, MN 55121 USA
Phone: [phone]
Fax : [phone]
E-Mail: [e-mail]
Authorised European Representative:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Electronic Instructions for Use can be found at: www.philips.com/ifu
Read the Instructions for Use before use of the product and keep these instructions for
future reference. Failure to follow the instructions in this document may result in injuries to
the user or the patient and damage to the ECG Recorder and/or the accessories.
Use of the ePatch ECG Recorder and compatible ECG Electrode accessories for purposes other than
those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect
operations, or modifications made to the ePatch ECG Recorder and compatible ECG electrode
accessories may relieve the manufacturer (or his agent) from all or some of the responsibilities for
resultant noncompliance, damage, injury.
Incident Reporting: Any serious incident that has occurred in relation to the ePatch ECG Recorder
and/or its compatible ECG Electrode accessories should be reported to Braemar and the competent
authority of the Member State in which the user and/or patient is established.
IMPORTANT: The ECG Recorder is not provided with physiological-type alarms and the ECG
Recorder does not maintain, nor does it help to maintain the life of the patient. The ECG Recorder is
intended to be used under the direction of a healthcare professional for diagnostic purposesonly. The
patient must therefore be instructed by the healthcare professional to act on any health symptoms
that may arise, as he would do if he was not wearing the ECG Recorder.
The ECG Recorder is MR Unsafe. Do not enter an MRI scanner room or an MR system while
wearing the ECG Recorder. Doing so may result in image artifacts within the MR scan and/or
injury.

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Table of Contents
1Description, indications for use, contraindications, warnings and precautions ..............5
1.1 Description............................................................................................................................................5
1.2 Indications for use...............................................................................................................................5
1.3 Intended Users/Intended Use Environment................................................................................5
1.4 Intended Population...........................................................................................................................5
1.5 Contraindications................................................................................................................................6
1.6 Warnings................................................................................................................................................6
1.7 Precautions...........................................................................................................................................6
2The ECG Recorder interfaces and markings.........................................................................8
3ePatch ECG Recorder Accessories .......................................................................................9
3.1 ECG Electrode Patch.........................................................................................................................9
3.2 Lead Wire Adapter (LWA)................................................................................................................9
3.3 Flex Electrode......................................................................................................................................9
4How to get started..................................................................................................................10
Step 1: Understanding the ePatch ECG Recorder system.................................................................10
Step 2: Prepare and charge the ECG Recorder....................................................................................11
Step 3: Prepare the skin (when using the ECG Electrode Patch)....................................................12
Step 4: Connect the ECG Recorder and the ECG Electrode Patch (when using the ECG
Electrode Patch)...............................................................................................................................................13
Step 5: Apply the ePatch ECG Recorder with ECG Electrode Patch (when using the ECG
Electrode Patch)...............................................................................................................................................14
Step 6: ePatch ECG Recorder with Lead Wire Adapter Set-up (when using the Lead Wire
Adapter)..............................................................................................................................................................15
Prepare the skin...............................................................................................................................................15
Step 7: Connect the ECG Recorder and the LWA (when using the Lead Wire Adapter).........16
Step 8: Attaching the LWA (when using the Lead Wire Adapter).....................................................16
Step 9: ePatch ECG Recorder with Flex Electrode Set-up (when using the Flex Electrode)..17
Prepare the skin...............................................................................................................................................17
Step 10: Connect the ECG Recorder and the Flex Electrode (when using the Flex Electrode)
18
Step 11: Attaching the Flex Electrode (when using the Flex Electrode)........................................18
5What to remember during recording and use.....................................................................19
Showering..........................................................................................................................................................19
After a shower...................................................................................................................................................20
Activities..............................................................................................................................................................20
Skin irritation......................................................................................................................................................20
6Perform an Event marker ......................................................................................................21
How to perform an Event Marker................................................................................................................21

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When to perform an Event Marker.............................................................................................................21
7How to end the recording and transfer the data.................................................................21
Step 1: Remove the ePatch ECG Recorder from the body................................................................21
Step 2: Separate the ECG Recorder from the Patch ...........................................................................22
Step 3: Remove the Lead Wire Adapter (LWA) or Flex Electrode...................................................22
Step 4: Transfer the ECG recording to a computer..............................................................................23
8Troubleshooting.....................................................................................................................24
9Cleaning, maintenance and disposal...................................................................................26
9.1 Cleaning...............................................................................................................................................26
9.2 Maintenance.......................................................................................................................................26
9.2.1 Preventative Maintenance..............................................................................................................27
9.2.2 Corrective Maintenance..................................................................................................................27
9.2.3 Calibration...........................................................................................................................................27
9.2.4 Disposal...............................................................................................................................................27
9.2.5 Disposal of Electrical and Electronic Devices..........................................................................27
10 Specifications, compliance and symbols............................................................................28
10.1 Specifications.....................................................................................................................................28
10.1.1 ePatch ECG Recorder.....................................................................................................................28
10.1.2 Battery (ECG Recorder) ..........................................................................................................28
10.1.3 Dimensions and weight (ECG Recorder)...........................................................................29
10.1.4 Environmental Conditions and Device Life (ECG Recorder).......................................29
10.1.5 System requirements................................................................................................................29
10.2 Compatible accessories and components................................................................................29
10.3 Glossary of Symbols........................................................................................................................30
11 Authorized Representative and Importer Information........................................................31
Annex 1 Electromagnetic compatibility..............................................................................................32
Annex 2 Recording Time......................................................................................................................35
Annex 3 Electrode Configuration ........................................................................................................36

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1 Description, indications for use, contraindications, warnings
and precautions
Please read these instructions carefully before using the ePatch ECG Recorder (later termed ECG
Recorder) or any of the accessories. Contact the healthcare professional or product customer service
in your country with any questions.
1.1 Description
The ePatch ECG Recorder (later termed ECG Recorder) is intended for continuous recording of heart
action potentials (ECG). While in use, the ECG Recorder is connected to a compatible ECG Electrode
accessory (later termed ECG Electrode), such as an ECG Electrode Patch (later termed Patch or
Patch ECG Electrode) and placed on the patient.
The ECG Recorder interfaces with a compatible Charge Adapter. The ECG Recorder is rechargeable
and reusable. The ECG Recorder contains internal non-volatile storage that stores the ECG data until
the file with the ECG data is deleted. The ECG Recorder contains embedded software for recording
ECG, storing ECG and charging. When the ECG Recorder is connected to a PC through the Charge
Adapter, the recorded ECG files are accessible as a USB mass storage device.
There are two (2) models of the ePatch ECG Recorder:
•REF ePatch 2.0
•REF 02-02046
1.2 Indications for use
ePatch ECG Recorder is indicated for use on patients who may be asymptomatic or who may suffer
from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-
syncope, syncope, fatigue, chest pain and/or anxiety.
The ECG Recorder is intended for use by adolescents 18-21 and adults.
1.3 Intended Users/Intended Use Environment
Intended Users: Healthcare professionals (e.g. Physicians, nurses) and lay users (patients and their
respective care givers).
Intended Use Environment: The ECG Recorder is intended for use in hospital/health care facilities
and in a home setting.
1.4 Intended Population
The ePatch ECG Recorder is intended for use by adolescents 18-21 and adults.

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1.5 Contraindications
Please refer to the Instructions for Use associated with the compatible accessories for their specific
Contraindications.
1.6 Warnings
The ECG Recorder has not been evaluated to support its use on infants, or on pregnant and/or
breastfeeding women.
The ECG Recorder is not intended for use on patients with implanted pacemakers.
Do not use the ECG Recorder in an X-ray, computed tomography (CT) or magnetic
resonance imaging (MRI) environment. This may affect the scanning results, may lead to
malfunction of the ECG Recorder and it may injure the patient.
Remove ECG Recorder prior to defibrillation.
Do not tamper with, disassemble or modify ECG Recorder or accessories, as this may
affect functionality or performance. A slight electrical sensation may be experienced.
Use the ECG Recorder with compatible accessories supplied by the manufacturer.
Otherwise, electrical shock or damage to the ECG Recorder may occur. In addition, the
ECG signal quality could be affected.
Use of other equipment or accessories not specified in this Instructions for Use document
might leadto skin irritations, allergy, electrical shock andmalfunction ofthe ECG Recorder.
Use of other chargers may damage the device and/or the accessories.
Keep products out of reach of infants, children and pets, as this could potentially cause a
choking hazard or cause suffocation if placed over face or mouth. There is a danger of
strangulation if the provided USB Cable and/or lead wires are misused.
Please refer to the Instructions for Use associated with the compatible accessory for their
specific Warnings.
1.7 Precautions
Do not use a broken ECG Recorder. This can cause electric discharge or decrease the quality of the
acquired ECG signals.
Do not touch the terminals at the back of the ECG Recorder or let them touch other conductive parts
or earth. This may damage the ECG Recorder.

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If the ECG Recorder is not firmly connected to the ECG Electrode Patch, it is not splash proof
(Protection level IP24). To avoid malfunction, make sure both parts are firmly connected with no
gaps and do not expose to direct jet of water or liquid.
Do not expose the internal parts of the ECG Recorder, the Charge Adapter or the AC Adapter to any
liquids. Do not submerge the ECG Recorder, the Charge Adapter or the AC Adapter in any liquid.
This may cause electric short circuiting or electrical discharge.
Minimise the number of devices connected to the patient. Otherwise, there is a risk of accumulation
of leakage current.
Store and use the ECG Recorder within temperature, pressure and humidity ranges specified in
Section 10.1.4.
Avoid exposing any part of the ECG Recorder to heat sources, heat radiators and fireplaces, direct
exposure to sunlight, nebulisers or electrical steam kettles. Temperature changes cause
condensation and moisture that can lead to malfunction of the ECG Recorder.
Before using the ECG Recorder, allow it to reach ambient temperature. For reference, if the
temperature difference between the ECG Recorder and the environment is above 10ºC, A 20-minute
wait time in an intermediate temperature is recommended.
Mobile phones, transmitters and similar equipment generating radio frequency (RF) emissions
should not be placed next to the ECG Recorder during use. This can affect the ECG Recorder.
Follow the recommendations regarding the separation distance specified in the manufacturer’s
declaration for EMC in this Instruction Manual, see Annex 1.
Do not lie directly on the ECG Recorder.
Do not connect the ECG recorder to external electrical equipment.
Please refer to the Instructions for Use associated with the compatible accessory for their specific
Precautions.

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2 The ECG Recorder interfaces and markings
The ECG Recorder interfaces with the Charge Adapter and is compatible with ECG Electrode Patch,
Flex Electrode or Lead Wire Adapter (LWA) accessories. The front side of the ECG Recorder has a
charging indicator and a status indicator.
The front side of the ECG Recorder:
1 There are three (3) different LED
lights that can appear:
-Charging indicator (one white light)
-Status indicator (one red or green
light)
2 If a constant or flashing red light
appears, consult the Troubleshooting
Guide in Chapter 8
3 When charging, the white LED will
flash. When fully charged, the white
LED will stop flashing and remain
solid (see above)
The back of the ECG Recorder:
Representative example of the back of ePatch ECG Recorder
Connection terminals
Manufacturer’s information
The ECG Recorder’s serial number

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3 ePatch ECG Recorder Accessories
The following accessories are compatible with the ePatch ECG Recorder. Accessories may not be
available in all markets. Refer to the information provided with the accessory for further information.
Accessory
Part Number
Patch ECG Electrode
02-01639
Lead Wire Adapter
02-01560*
Flex Electrode
02-01576*
*Note: The Lead Wire Adapter and Flex Electrode
accessories are marketed in the US only.
3.1 ECG Electrode Patch
The ePatch ECG Recorder can be used with the ECG Electrode Patch
accessory. See Annex 3 for channels and configurations.
3.2 Lead Wire Adapter (LWA)
The ePatch ECG Recorder can be used with the Lead Wire Adapter (LWA)
accessory. See Annex 3 for channels and configurations.
Lead Wire Adapter
3.3 Flex Electrode
The ePatch ECG Recorder can be used with the Flex Electrode accessory.
See Annex 3 for channels and configurations.
Flex Electrode
ECG
Electrode
Patch
ECG Electrode
Patch with
connected ECG
Recorder

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4 How to get started
This chapter describes how to start a recording. The steps must be followed point by point.
Step 1: Understanding the ePatch ECG Recorder system
ePatch ECG Recorder
The ePatch ECG Recorder, also referred to as ECG Recorder,
acquires the patient’s ECG signals and stores them internally. The
ECG Recorder is rechargeable and reusable. The ECG Recorder
must only be used in combination with one of the compatible
accessories as detailed below.
ECG Electrode Patch
The ECG Electrode Patch, also referred to as Patch, is for single use
only and must be disposed of and replaced after 5 days of wear.
Surface Electrodes
LWA
The Lead Wire Adapter (LWA) is for optional
use with the ePatch ECG Recorder. The
surface electrodes are for single use only.
Refer to the information provided with the
surface electrodes for further information.
Surface Electrodes
Flex Electrode
The Flex Electrode isfor optionalusewith the
ePatch ECG Recorder. The surface
electrodes are for single use only. Refer to
the information provided with the surface
electrodes for further information.
ECG Electrode Patch
accessory
LWA accessory
Flex Electrode accessory

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Step 2: Prepare and charge the ECG Recorder
NOTE: The information in this section is for the use of healthcare professionals.
Before each recording, prepare and charge the ECG Recorder as described below.
Charging components
The ECG Recorder can be charged using the
Charge Adapter in two ways (if supplied):
•Using the AC Adapter (fast charging.
Recommended)
•Using a computer’s USB port (will
charge slowly. Not recommended)
Charging components
Part Number
Charge Adapter
02-00109
POWER SUPPLY AC/DC USB 5V 0.55A UK (AC Adapter)
01-02041
POWER SUPPLY AC/DC USB 5V 0.55A EU (AC Adapter)
01-02042
NOTE: Use the ECG Recorder with compatible accessories and components supplied by the
manufacturer. Otherwise, electrical shock or damage to the ECG Recorder may occur. In addition,
the ECG signal quality could be affected.
1
NOTE: Always use an ECG Recorder that is fully charged
and ready to use. Otherwise, the recording time might be
affected.
Use the provided Charge Adapter to connect the ECG
Recorder to a powered-on computer (slow charging), or
to an AC Adapter plugged into an electrical socket (fast
charging).
2
While charging the ECG Recorder, a flashing white light
will appear. When fully charged, a constant white light
will appear indicating it is ready to use. Allow recharge of
the ECG Recorder until the charging indicator shows a
constant white light.
If a red light appears, refer to the Troubleshooting
Section, Chapter 8.
Charge Adapter
Example of
AC Adapter

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3
Ensure that any previously recorded data (with the file
extension .EFS) is copied to a computer and deleted
from the ECG Recorder before the ECG Recorder is re-
used for a new recording, please see Chapter 5 for
further instructions.
Step 3: Prepare the skin (when using the ECG Electrode Patch)
Do not place the Patch on broken, damaged or irritated skin. Apply the Patch ONLY on
clean intact skin and NEVER on open wounds, lesions, infected or inflamed areas.
Expose the chest and prepare the skin according to the steps below (example illustrations for slanted
position):
1. Determine the chest area needing to be prepared by referring to
the diagram. Locate the collarbone on the left side of the body and
measure three (3) finger widths down (when using a slanted
position) or three (3) finger widths below the upper rim of the
sternum (when using a sternum position).
2. If hair is on the chest, wash and shave the area where the Patch
will be placed. Start at the centre of the chest and shave the entire
area marked in the red circle of the diagram.
3. Clean the area with soap and water.
4. Dry skin thoroughly using a towel.
5. Gently rub the skin using the exfoliation pad (if provided) in a
circular motion for 1 minute. This step may help in providing a
better ECG signal.
6. It is important to wait for a minimum of 2-3 minutes until the skin is
completely dry before applying the Patch. While waiting, continue
to the next steps.
RIGHT
LEFT
RIGHT
LEFT
RIGHT
LEFT
RIGHT
LEFT
RIGHT
LEFT
2-3 min

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NOTE: Do not apply oils or lotions in the cleaned area before attaching the Patch to the skin. The
quality of the signals might be decreased if the skin is not properly prepared.
Step 4: Connect the ECG Recorder and the ECG Electrode Patch (when using the
ECG Electrode Patch)
NOTE: Do not connect the ECG Recorder and the Patch until after skin preparation. The ECG
Recorder powers on and starts the recording within five (5) minutes after it has been connected to the
Patch. Premature connection may therefore shorten the length of the recording time.
1. Peel open the packaging and remove the Patch.
2. Always check the use by date on the packaging of the Patch
before use.
3. Do not open the Patch packaging until the Patch is to be used.
Otherwise, the adhesive material might dry.
4. Place the ECG Recorder onto the blue plastic cradle of the Patch.
5. Press down firmly as shown to snap the ECG Recorder in place.
Ensure no gaps are visible between parts. You will hear several
clicks.
6. Once connected, a constant green light will appear followed by a
flashing green light (for about 30 seconds) indicating the ECG
recorder is working. The recording will automatically start when the
flashing green light stops.
Correct- No Gap
7. To avoid malfunction, visually inspect and make sure both parts
are firmly connected with no gaps.
CAUTION: If the ECG Recorder is not firmly connected to the Patch, it
is not splash proof. This may cause ingress of liquids to the internal
parts of the ECG Recorder which may result in electrical short
circuiting and malfunction of the ECG Recorder.
Incorrect- Gap
8. If gaps are visible between the ECG Recorder and the Patch,
press the two items firmly together to close the gaps.

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Step 5: Apply the ePatch ECG Recorder with ECG Electrode Patch (when using
the ECG Electrode Patch)
NOTE: Once the ECG Recorder is connected to the Patch, place on the chest as instructed. Avoid
repositioning the Patch after the first skin contact. Repositioning may result in poor contact between
the Patch and the skin. A poor contact could decrease the quality of the recorded ECG signals and a
new recording might be required. If the Patch is not placed correctly, please start again with a new
Patch.
The ECG Recorder can be placed in two (2) different positions on the chest; a sternum position or a
slanted position. The following diagrams illustrate the areas of the chest where it can be applied.
Follow the steps below to apply the ECG Recorder on the chest in either position:
1. Hold the ECG Recorder with one hand. Peel off the transparent
plastic back liner from the Patch with the other hand. This exposes
the adhesive part of the Patch.
NOTE: Do not touch the adhesive part of the Patch; doing so may
reduce the Patch’s ability to adhere to skin.
Option 1: ePatch ECG Recorder in slanted position
Apply the ECG Recorder to chest on a slight angle as shown in
the illustration, by following these steps:
2. The top edge of the Patch should be three (3) finger widths down
from the collarbone in the centre of the chest.
3. The widest part of the Patch (near the ECG Recorder) should be
closest to the centre of the chest.
4. Press all sides of the Patch so it will adhere to the skin.
NOTE: Wait one (1) minute before proceeding to the next step. This is
important to ensure firm adhesion to the skin.
RIGHT
LEFT
Patient left
Patient right
Upper rim of sternum
Collarbone
Collarbone

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Option 2: ePatch ECG Recorder in sternum position
Apply the ECG Recorder to the chest in a vertical position as
shown in the illustration, by following these steps (stretching the
chest may assist):
2. The top edge of the Patch (near the ECG Recorder) should be
three (3) finger widths down from the collarbone in the centre of
the chest.
3. The widest part of the Patch (near the ECG Recorder) should be
closest to the centre of the chest.
4. Press all sides of the Patch so it will adhere to the skin.
NOTE: Wait one (1) minute before proceeding to the next step. This is
important to ensure firm adhesion to the skin.
5. Gently peel off the top white liner paper of the Patch by starting
with the raised tab.
6. After the top liner is removed, press firmly around all of the edges
of the Patch and on the ECG Recorder so that the Patch will firmly
adhere to the skin.
7. Smooth any wrinkles by pressing around the entire Patch.
8. The ECG Recorder is now correctly placed. The recording will
automatically start when the flashing green light stops. The
recording will stop after the predefined recording time has elapsed
or when the ECG Recorder is removed from the Patch (please see
Chapter 4).
Step 6: ePatch ECG Recorder with Lead Wire Adapter Set-up (when using the
Lead Wire Adapter)
NOTE: Do not connect the ECG Recorder and the LWA until after skin preparation. The ECG
Recorder powers on and starts the recording within five (5) minutes after it has been connected to the
LWA. Premature connection may therefore shorten the length of the recording time.
Prepare the skin
Expose the chest and prepare the skin according to the steps below:
1. Determine the chest area needing to be prepared by referring to
the diagram. If hair is on the chest, wash and shave the area
where the electrodes will be placed.
RIGHT
LEFT

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2. Clean the shaded areas with soap and water.
3. Dry skin thoroughly using a towel.
4. It is important to wait for a minimum of 2-3 minutes until the skin is
completely dry before proceeding to the next step.
NOTE: Do not apply oils or lotions in the cleaned areas before attaching the electrodes to the skin.
The quality of the ECG signals may be decreased if the skin is not properly prepared.
Step 7: Connect the ECG Recorder and the LWA (when using the Lead Wire
Adapter)
1. Push the ECG Recorder through the top of the LWA until it is firmly
in place.
2. After the ECG Recorder has been properly inserted into the LWA,
a constant green light will appear followed by a flashing green light
(for about 30 seconds) indicating the ECG recorder is working. The
recording will automatically start when the flashing green light
stops.
Step 8: Attaching the LWA (when using the Lead Wire Adapter)
1. Connect the lanyard to the LWA (if needed).
2. Place the lanyard over the head and around the neck.
3. Remove a packet of surface electrodes from the pack.
4. Peel open the packet and remove three (3) surface electrodes.
5. Snap each of the three (3) wires into the electrodes.
RIGHT
LEFT
2-3 min

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6. Leave the adhesive liner on the electrodes.
NOTE: Refer to the information provided with the surface electrodes
for replacement instructions.
7. Start with the black lead. Peel the adhesive liner off the back of
the surface electrode and place the black electrode approximately
three (3) fingers below the collarbone on the left side of the chest.
8. Next, attach the white lead. Peel the adhesive liner off the back
of the surface electrode and place the white electrode
approximately three (3) finger widths below the collarbone on
the right side of the chest.
9. Lastly, place the red lead. Peel the adhesive liner off the back of
the surface electrode and place the red electrode on the lower
rib on the left side of the body.
NOTE: When removing the adhesive liner, be careful not to touch the
adhesive.
10. The LWA is nowcorrectly placed. The recording will automatically
start when the flashing green light stops. The recording will stop
after the predefined recording time or when the ECG Recorder is
removed from the LWA.
Step 9: ePatch ECG Recorder with Flex Electrode Set-up (when using the Flex
Electrode)
NOTE: Do not connect the ECG Recorder and the Flex Electrode until after skin preparation. The
ECG Recorder powers on and starts the recording within five (5) minutes after it has been connected
to the Flex Electrode. Premature connection may therefore shorten the length of the recording time.
Prepare the skin
Expose the chest and prepare the skin according to the steps below
1. Determine the chest area needing to be prepared by referring to
the diagram.
2. If hair is on the chest, wash and shave the area where the
electrodes will be placed.
RIGHT
LEFT

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3. Clean the area with soap and water
4. Dry skin thoroughly using a towel
5. It is important to wait for a minimum of 2-3 minutes until the skin
is completely dry before proceeding to the next step.
NOTE: Do not apply oils or lotions in the cleaned areas before attaching the electrodes to the skin.
The quality of the ECG signals may be decreased if the skin is not properly prepared.
Step 10: Connect the ECG Recorder and the Flex Electrode (when using the Flex
Electrode)
1. Slide the ECG Recorder into the Flex Electrode. A green light on the
ECG Recorder will flash briefly when the ECG Recorder is
completely inserted.
2. Once connected, a constant green light will appear followed by a
flashing green light (for about 30 seconds) indicating the ECG
recorder is working.
Step 11: Attaching the Flex Electrode (when using the Flex Electrode)
Attaching the Surface Electrodes:
1. Remove the surface electrode strip from the pouch and use the
perforations to separate two (2) electrodes from the strip. Leave
the adhesive backing on the electrodes.
2. While the electrodes are still on the adhesive backing, snap one
(1) electrode into the connector on the back of the Flex Electrode
and snap the other electrode on the connector on the back of the
Flex Electrode lead.
RIGHT
LEFT
RIGHT
LEFT
2-3 min
Sensor
Flex Electrode

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3. Peel the adhesive backing off the back of the surface electrodes.
When removing the adhesive backing, be careful not to touch the
adhesive.
NOTE: Refer to the information provided with the surface
electrodes for replacement instructions.
Attach Flex Electrode and Flex Electrode Lead:
4. Place the left hand on the left side of the chest so that the index
finger is just below the collarbone.
5. Position the Flex Electrode so that it is lined up below the chin and
three (3) finger widths below the collarbone.
6. Press the Flex Electrode firmly against the chest.
7. Line up the second electrode so that the arm of the Flex Electrode
lies flat against the chest and the button snap is lined up with the
bottom of the Flex Electrode. Be careful not to straighten the arm.
Keep a bend so it looks like a smile.
8. Press the second electrode firmly against the chest.
9. After the electrodes are on the body wait 10-15 minutes to allow
the electrodes to fully adhere to the skin before proceeding to the
next step.
NOTE: Depending on configuration, the ECG Recorder in an LWA or Flex Electrode set-up can
record for up to 14 continuous days on a full charge (1-channel at 256 Hz. See Annex 2). However,
each surface electrode should be changed out in accordance with the information provided with the
surface electrodes.
5 What to remember during recording and use
Showering
If the ePatch ECG Recorder is not firmly connected to the Patch, it is not splash
proof. When the ECG Recorder is properly inserted into the Patch, water splashing
against the enclosure from any direction will have no harmful effect. While
showering, it is recommended to face away from the shower head and deflect any
direct showering water from impinging on the ECG Recorder by shielding it away
from the direct spray of the shower with a hand or a cloth.
Do not swim or submerge the ECG Recorder in water or liquids. The ECG Recorder is water resistant
when combined with the Patch, but it is not waterproof.
RIGHT
LEFT
Collarbone
RIGHT
LEFT
Line up

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For the LWA Set-up: The ECG Recorder is NOT water resistant when worn
with the LWA; therefore, do not shower, bathe or swim while wearing the ECG
Recorder in the LWA Set-up.
Before showering/bathing/swimming, unsnap the leads from the surface
electrodes, remove the surface electrodes from skin, remove LWA with ECG
Recorder and set aside.
For the Flex Electrode Set-up: The ECG Recorder is NOT water resistant when
worn with the Flex Electrode; therefore, do not bathe or swim while wearing the
ECG Recorder in the Flex Electrode Set-up.
Before showering, unsnap the surface electrodes from the Flex Electrode,
remove the surface electrodes from skin and set aside the ECG Recorder and
Flex Electrode.
CAUTION: Do not swim while wearing the ePatch ECG Recorder device and ECG Electrode
Patch/LWA /Flex Electrode. Do not submerge ePatch ECG Recorder in any form of liquid. Fully immersing
may render the ECG Recorder inoperable, may cause recorded ECG data to be unreadable or may affect
proper functionality.
After a shower
Patch Electrode Set-up: After taking a shower, always inspect the ECG Recorder to Patch
connection, and adhesion of the Patch to the skin. If needed, replace Patch. Continued use of a
damaged ECG Electrode Patch may affect quality of ECG measurements. Please follow the
instructions in Chapter 4, steps 3-5.
LWA Set-up: Reapply new surface electrodes and re-attach the lead wire. Please follow the
instructions in Chapter 4, steps 6-8.
Flex Electrode Set-up: Reapply new surface electrodes and re-attach the Flex Electrode. Please
follow the instructions in Chapter 4, steps 9-11.
Activities
Activities that result in excessive sweating might loosen the Patch or cause gel to leak out. If this
occurs, remove and replace the Patch by following instructions in Chapter 7 for removal, and in Chapter
4 for applying a new Patch.
Skin irritation
Minor discomfort, skin irritation, reddening, itching or rash can occur by use of the ePatch ECG
Recorder system. Any sign of severe skin irritation or allergy should be reported to the healthcare
professional and closely monitored to avoid development of more serious reactions.
RIGHT
LEFT
unsnap and
remove LWA
Right Left
Detach and remove electrodes