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Summary of Contents for BioTelemetry Braemar ePatch
- Page 1 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 | 1...
- Page 2 Notices Prescription use only (U.S. Federal Law) Legal Manufacturer: Braemar Manufacturing LLC. 1285 Corporate Center Drive Suite 150 Eagan, MN 55121 USA Phone: +1.800.328.2719 Fax : +1.651.286.8630 E-Mail: sales-braemar@gobio.com 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.
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Page 3: Table Of Contents
Table of Contents Description, indications for use, contraindications, warnings and precautions ....5 Description ............................5 Indications for use ..........................5 Intended Users/Intended Use Environment ................5 Intended Population ...........................5 Contraindications ..........................6 Warnings ..............................6 Precautions ............................6 The ECG Recorder interfaces and markings ................. 8 ePatch ECG Recorder Accessories .................. - Page 4 When to perform an Event Marker ......................21 How 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 Troubleshooting ........................
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Page 5: Description, Indications For Use, Contraindications, Warnings And Precautions
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). -
Page 6: Contraindications
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 use on infants, or on pregnant and/or has not been evaluated to support its 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. - Page 7 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.
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Page 8: The Ecg Recorder Interfaces And Markings
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 2 If a constant or flashing red light... -
Page 9: Epatch Ecg Recorder Accessories
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*... -
Page 10: How To Get Started
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 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. -
Page 11: Step 2: Prepare And Charge The Ecg Recorder
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): Charge Adapter Example of... -
Page 12: Step 3: Prepare The Skin (When Using The Ecg Electrode Patch)
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. -
Page 13: Step 4: Connect The Ecg Recorder And The Ecg Electrode Patch (When Using The Ecg Electrode Patch)
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. -
Page 14: Step 5: Apply The Epatch Ecg Recorder With Ecg Electrode Patch (When Using The Ecg Electrode Patch)
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. -
Page 15: Step 6: Epatch Ecg Recorder With Lead Wire Adapter Set-Up (When Using The Lead Wire Adapter)
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. -
Page 16: Step 7: Connect The Ecg Recorder And The Lwa (When Using The Lead Wire Adapter)
2. Clean the shaded areas with soap and water. RIGHT LEFT 3. Dry skin thoroughly using a towel. 4. It is important to wait for a minimum of 2-3 minutes until the skin is 2-3 min 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. -
Page 17: Step 9: Epatch Ecg Recorder With Flex Electrode Set-Up (When Using The Flex Electrode)
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. -
Page 18: Step 10: Connect The Ecg Recorder And The Flex Electrode (When Using The Flex Electrode)
3. Clean the area with soap and water RIGHT LEFT RIGHT LEFT 4. Dry skin thoroughly using a towel It is important to wait for a minimum of 2-3 minutes until the skin 2-3 min 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. -
Page 19: What To Remember During Recording And Use
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: Collarbone LEFT RIGHT... -
Page 20: After A Shower
unsnap and For the LWA Set-up: The ECG Recorder is NOT water resistant when worn remove LWA RIGHT LEFT 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. -
Page 21: Perform An Event Marker
6 Perform an Event marker The healthcare professional may ask you to perform a digital event marker in the recorded ECG data file (if enabled). The digital event marker is an optional functionality that provides a means to mark an event with a timestamp if a health-related symptom is felt. -
Page 22: Step 2: Separate The Ecg Recorder From The Patch
Step 2: Separate the ECG Recorder from the Patch 1. Hold Patch as shown. Fold the clear adhesive out of the way to locate the tab on the blue plastic cradle of the Patch. Note: Do not use a tool to separate the ECG Recorder from the Patch. This might damage the ECG Recorder. -
Page 23: Step 4: Transfer The Ecg Recording To A Computer
Detach and remove electrodes Flex Electrode (If used) Right Left 2. Unsnap both the Flex Electrode and the Flex Electrode lead from the surface electrodes and gently remove the electrodes from the body. 3. Slide out the ECG Recorder from the Flex Electrode. ECG Recorder Flex Electrode Step 4: Transfer the ECG recording to a computer... -
Page 24: Troubleshooting
5. When initially connected, the computer’s operating system may need to install drivers to access the ECG Recorder as a USB Mass Storage Device. Please allow up to 5 minutes for the installation of the drivers. If after waiting 5 minutes the ECG Recorder remains inaccessible as a USB Mass Storage Device, follow instructions in Troubleshooting, Chapter 8. - Page 25 reconnect to the electrode (see Chapter 2). If red light persists, contact Customer Service, the distributor or manufacturer. The ECG Recorder shows a If you are a patient experiencing this issue, call Customer flashing red light when it is Service. connected to an electrode If you are a healthcare professional, follow these steps: Connect the ECG Recorder to a computer using a...
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Page 26: Cleaning, Maintenance And Disposal
connected to the Patch with no gaps. If using a LWA, ensure that the ECG Recorder is firmly in place. If using a Flex Electrode, ensure that the ECG Recorder is completely inserted. If it is still not possible to mark an event, the ECG Recorder may have stopped recording due to the predefined recording time having elapsed, or the event marker function may have been disabled in the ECG... -
Page 27: Preventative Maintenance
9.2.1 Preventative Maintenance Check periodically that the ECG Recorder and its compatible accessories and components are not broken, have no external damage and that the performance is acceptable (i.e. length of recording has not diminished from a fully charged battery). If issues are detected that cannot be solved, please contact Customer Support or your distributor. -
Page 28: Specifications, Compliance And Symbols
10 Specifications, compliance and symbols 10.1 Specifications 10.1.1 ePatch ECG Recorder Device classification (EN 60601-1) Internally Powered, Type BF applied parts, not protected against Class: defibrillator, no functional earth terminal Data acquisition: 1, 2, or 3 channels ECG, Event Marker Recording time: Up to 14 days (the recording time is configurable by... -
Page 29: Dimensions And Weight (Ecg Recorder)
10.1.3 Dimensions and weight (ECG Recorder) Packaging: Dimensions (W x H x D): 100 x 100 x 100 mm Weight (empty): 183 g Weight (complete): 270 g The ECG Recorder: Dimensions (W x H x D): 40 x 49 x 12 mm Weight: 20 g 10.1.4... -
Page 30: Glossary Of Symbols
• ECG Electrode Patch • Lead Wire Adapter • Flex Electrode ▪ Components: • Charge Adapter • AC Adapter (USB 5.0 V , minimum 500 mA) 10.3 Glossary of Symbols Symbol Description CE mark Indicates that the product conforms with standards for products sold within the European Union 2797 WEEE (Waste Electrical and Electronic Equipment) -
Page 31: Authorized Representative And Importer Information
11 Authorized Representative and Importer Information MDSS GmbH Schiffgraben 41 30175 Hannover European Germany Authorized Representative Philips Medical Systems Nederland B.V. High Tech Campus 52 5656 AG Eindhoven European Union The Netherlands Importer UK Responsible Person Philips Electronics UK Limited Ascent 1, Aerospace Boulevard Farnborough, GU14 6XW United Kingdom... -
Page 32: Annex 1 Electromagnetic Compatibility
Annex 1 Electromagnetic compatibility Table 1 – Guidance and Manufacturer’s declaration – electromagnetic emissions – for all Medical Electrical equipment and Medical Electrical systems. Guidance and manufacturer’s declaration - electromagnetic emissions The ECG Recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG Recorder should assure that it is used in such an environment. - Page 33 61000-4-8 typical home, commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level Table 3 – Guidance and manufacturer’s declaration – electromagnetic immunity – for all Medical Electrical equipment and Medical Electrical systems that are not life-supporting. Guidance and manufacturer’s declaration - electromagnetic immunity The ECG Recorder is intended for use within the limits of the electromagnetic environment described below.
- Page 34 Table 4 – Recommended separation distances between portable and mobile RF communications equipment and the Medical Electrical equipment or the Medical Electrical system – for Medical Electrical equipment and Medical Electrical systems that are not life supporting. Recommended separation distances between portable and mobile RF communications equipment and the Medical Electrical equipment or the Medical Electrical system The ECG Recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 35: Annex 2 Recording Time
Annex 2 Recording Time Maximum possible recording time at different ECG Recorder configurations The maximum possible recording time is a function of battery life and storage capacity. Recording time is increased when the number of recorded ECG channels and/or the sampling frequency is decreased. Likewise, the maximum possible recording time is decreased when the number of recorded ECG channels and/or the sampling frequency is increased. -
Page 36: Annex 3 Electrode Configuration
Annex 3 Electrode Configuration ECG Electrode Patch Configuration Channel 3 Channel 1 Electrode 2 Electrode 1 Electrode 3 Unused in ePatch Channel 2 Example configuration for a 3-channel recording The Patch has three (3) active electrodes and channels can be created between electrodes 1, 2 or 3 in any combination.
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