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Summary of Contents for DMS 3000sl-b
- Page 1 Page 1 of 24 3 Channel ECG Recorder Model: 3000sl-b Version: DRAFT ENGLISH LD0006 Rev. 10 Proprietary & Confidential - Page 1 of 22 - Uncontrolled if Printed...
- Page 2 During intended use, the myPatch®sl-b ECG Recorder is connected to the myPatch®sl ECG electrode and placed on the patient. The myPatch®sl-b Ambulatory ECG Recorder has a 2- year warranty from date of purchase. Manufactured By: dms-service llc HVIN: RC7611 11845 W. Olympic Blvd, Ste 880W...
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Page 3: Copyright
applicable regulations All repairs, revisions, or modifications, both in and out of the warranty period, are made by technical staff of dms-service llc. The equipment is used by qualified staff in accordance with the recommendations stated in this Instruction Manual ... -
Page 4: Table Of Contents
Page 4 of 24 Copyright Disclaimer Trademark FCC Statement Package Contents Description 2.1. Top Side of myPatch®sl-b ECG Recorder 2.2. Bottom Side of myPatch®sl-b ECG Recorder 2.3. Side of myPatch®sl-b ECG Recorder 2.4. myPatch4sl-b Light State Diagram 2.5. Top Side of myPatch®sl Electrode (myPatch®sl 3-Channel ECG Electrode) Important Safety Information 3.1. -
Page 5: Package Contents
Package Contents The package contains: myPatch®sl-b ECG Recorder Note: The operator manual for the myPatch®sl-b Ambulatory ECG recorder is available digitally and can be accessed at www.dms-service.com Accessories Include: myPatch®sl Electrodes Wireless Battery Charger Note: All accessories are packaged and sold separately. -
Page 6: Description
Page 6 of 24 Description 2.1. Top Side of myPatch®sl-b ECG Recorder The light on the top/side of the recorder flashes different colors that indicate the state the recorder is in. Please see Page 7, myPatch®sl-b Light Sequence State Diagram, for a the different states with the associated color flashes and required button pushes 2.2. -
Page 7: Mypatch4Sl-B Light State Diagram
Page 7 of 24 2.4. myPatch®sl-b Light State LD0006 Rev. 10 Proprietary & Confidential - Page 7 of 22 - Uncontrolled if Printed... -
Page 8: Top Side Of Mypatch®Sl Electrode (Mypatch®Sl 3-Channel Ecg Electrode)
Page 8 of 24 2.5. Top Side of myPatch®sl Electrode (bottom of myPatch®sl-b ECG Recorder) Snaps to connect myPatch®s-b Ambulatory ECG recorder to myPatch®sl 3 channel electrode LD0006 Rev. 10 Proprietary & Confidential - Page 8 of 22 - Uncontrolled if Printed... -
Page 9: Important Safety Information
The 3 channel myPatch®sl-b ECG Recorder has been designed and developed for dms-service llc. The myPatch®sl-b ECG Recorder is designed and manufactured in accordance with the Quality Management System of dms- service llc which is in consistency with the quality standard EN 13485 and Regulation (EU) 2017/745 (EU MDR) . The myPatch®sl-b Ambulatory ECG Recorder also complies with the EN 60601-1 Electrical Safety and Electromagnetic Compatibility EN 60601-1-2 standards, as specified in the Electromagnetic Compatibility Clause. - Page 10 Page 10 of Once the study period is complete, all of the ECG data can be compiled and analyzed using software packages, for the purposes of assisting physicians and other clinicians, in the diagnosis of cardiac rhythm abnormalities or ruling out such findings.
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Page 11: Indications For Use
Do not place the myPatch®sl-bECG Recorder and Electrode on skin that is torn or has a rash. 3.5. Warnings and Precautions In case of doubts, unexpected events, or complaints, contact your distributor OR you can contact dms-service llc. Contact information can be found on page 2 of this instruction manual. - Page 12 Page 12 of on the electrodes may potentially cause an allergic reaction such as skin irritation, etc. This risk is unavoidable when using electrodes in general. The patient should stop use and contact their physician should irritation or other allergies occur. The medical professional should ask the patient if they have had any reactions to electrodes.
- Page 13 ECG Recorder. WARNING: It may be unsafe to use accessories (myPatch®sl ECG electrode) other than those that are provided by dms-service llc. Keep the myPatch®sl-b ECG Recorder and the myPatch®sl ECG electrode out of reach of children and pets.
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Page 14: Operating Instructions
Please instruct the patient to refrain from pulling, tugging or peeling the electrode. Notice: In the event that any serious incident has occurred in relation to the device, it should be reported immediately to dms- service llc and the competent authority of the Member State in which the user and/or patient is established. -
Page 15: End Of Recording
Page 15 of 24 Channel Descriptions Channel 1: LA-RA=LEAD I modified Channel 2: LA-V1=V1 modified Channel 3 RA- V2=V2 modified The myPatch®sl electrode placement versus the standard placement for a 12 lead ECG will result in the leads being similar in nature and appearance but lower in amplitude. -
Page 16: Cleaning, Maintenance, And Disposal
The myPatch®s-bl recorder should be fully charged and discharged at least every two months to help maintain battery health. If you detect any problems that you cannot solve, please get in contact with your distributor or dms-service at the contact information on page 2 of this manual. -
Page 17: Service
Page 17 of 24 (if applicable), and specify the type of problem OR contact dms-service llc. See page 2 of this Instruction Manual for dms- service llc contact details. 5.4. Service The myPatch®sl-b ECG Recorder has no user-serviceable parts. The myPatch®sl-b ECG Recorder requires no calibration. -
Page 18: Specifications
Page 18 of 24 Specifications 7.1. Type and Model Type: myPatch®3000sl-b Model: Internally Powered, Type BF applied parts, no functional earth terminal Device classification (EN 60601-1): Class: Internally Powered, Type BF applied parts, no functional earth terminal Data acquisition:Placement: 1, 2 or 3 channels ECG Upper Sternum... -
Page 19: Environment
The myPatch®sl-b ECG Recorder requires 7.6. Validated Accessories The myPatch®sl ECG Recorder is used in combination with other medical accessories manufactured by dms-service llc or by other manufacturers. The replacement parts should be requested from dms-service llc or an authorized dealer only. -
Page 20: Reference To Standards
Page 20 of 24 Reference to Standards LD0006 Rev. 10 Proprietary & Confidential - Page 20 of 22 - Uncontrolled if Printed... -
Page 21: Symbols
Recyclable Materials Stacking Limitation This way Up Fragile, Handle with Care QR-Code (Quick Response Code linking towww.dms-service.com) Authorised European Representative Humidity Range: To indicate the upper and lower limits of relative humidity for transportation and storage. Pressure Range: To indicate the acceptable upper and lower limits for atmospheric pressure for storage and transportation. - Page 22 Proprietary & Confidential - Page 22 of 22 - Uncontrolled if Printed Proprietary & Confidential - Page 1 of 1 - Uncontrolled if Printed...
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