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Summary of Contents for MODE Re:Balans
- Page 1 Instructions for Use Re:Balans Fluid Status Monitor DOC0085A-IFU-A00...
- Page 2 DOC0085A-IFU-A00 Release date: 27 of January 2023 Device Version ID: PCT005A About Mode Sensors AS Mode Sensors AS develops and markets medical devices to support and improve healthcare and individual lives. www.modesensors.com Versions of this Instructions for Use Versions Changes...
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Page 3: Table Of Contents
Step 2: Prepare skin ..............................10 Step 3: Apply the patch to the body ........................11 Step 4: Connect Re:Balans with Software Application ................... 12 Step 5: Remove and dispose the Re:Balans patch from the body ................ 12 Troubleshooting ............................13 Maintenance ..............................14 Technical Specifications .......................... -
Page 4: Re:balans Introduction
Once activated, Re:Balans continuously collects bioimpedance data from the back of the patient for up to 7 days. • Bioimpedance measurements are transmitted to a Re:Balans API installed device or system for measurement readout and validation by physician. • The bioimpedance data facilitates the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. -
Page 5: Symbol Glossary
2. Symbol Glossary The symbol glossary is useful for safe and effective use of Re:Balans. The symbols below are found on the Re:Balans pouch label, Re:Balans Instructions for Use and the Re:Balans patch. Symbol Title of Symbol Symbol Reference Contact information of the manufacturer Pouch Label –... -
Page 6: Indications For Use
3. Indications for Use The Re:Balans Fluid status Monitor is intended for adult patients: With fluid management problems • Taking diuretic medication • Living with Heart Failure • Living with End-stage Renal Disease • Suffering from Recurrent Dehydration • Recovering from Coronary Artery Disease related event. -
Page 7: General Warnings And Precautions
4.2. Precautions • Remove the device from your body prior to an MRI scan, or any emergency medical procedure. Re:Balans system is not compatible for use with MRI machines. • Re:Balans is an adjunct monitor device not intended to replace existing standard-of-care patient monitoring practices. -
Page 8: Descriptions Of Re:balans
The device has a form-factor of an adhesive patch with four integrated electrodes to be applied on the back of the patient. The Re:Balans applies a low amplitude multi-frequent electrical current and measures the electrical impedance. The impedance signal is obtained by applying a small, safe battery-generated current and measuring the resulting electrical potential. -
Page 9: System Overview
5.4. System Overview Once activated, Re:Balans patch transmits fluid data to a device or third party system for readout and validation by a physician, or under direction of a physician. 5.5. Symbols on Re:Balans Skin contacting side Front side of patch... -
Page 10: Directions For Use
IMPORTANT: The monitoring will be affected if these steps are not followed. Ensure hands are clean and dry before handling the Re:Balans device. When handling the Re:Balans device, do not touch the adhesive. The steps below should minimize the chance of touching the adhesive. -
Page 11: Step 3: Apply The Patch To The Body
Step 3: Apply the patch to the body b) Remove first half #1 of a) Test the device prior to c) Identify the prepared area the release liner. application by pressing and from Step 2. holding the button until (2-4 cm from center patch to blinking yellow light. -
Page 12: Step 4: Connect Re:balans With Software Application
Step 4: Connect Re:Balans with Software Application After applying the Re:Balans to the skin, retain the pouch with the device Patch ID. You will need this information to connect to the Re:Balans to the preferred device or system. Refer to your software application provider’s user manual for more instructions on how to connect to the Re:Balans device. -
Page 13: Troubleshooting
4.Check if Re:Balans is activated. 5.Restart the third-party device. 6.The Re:Balans battery out of battery. For issues related to the third-party user interface application or third-party device or other system and for additional troubleshooting guidance, refer to the separate Instructions for Use for the interface for the respective system. -
Page 14: Maintenance
8. Maintenance Users are not required to perform any maintenance for the Re:Balans patch. 9. Technical Specifications 9.1. Wireless Communication Wireless Data Transmission Bluetooth 5.3 10 meters (30 Feet Line of Sight) Radio Modulation FSK (Frequency Shift Keying) Frequency range 2.4 GHz –... -
Page 15: Compliances
IEC 60601-1-6:2010+A1:2013+A2:2020 • IEC 60601-1-11:2015+A1:2020 10.2. Electromagnetic Compatibility The Re:Balans device is intended for use in the electromagnetic environment specified below. The end user of the device should assure that it is used in such an environment. Emission Test Compliance... - Page 16 • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. FCC Part 15 Clause 15.21: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
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