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Koya Dayspring Directions For Use Manual

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Summary of Contents for Koya Dayspring

  • Page 1 ® Directions for Use...

  • Page 2: Table Of Contents

    Table of Contents GETTING STARTED WITH DAYSPRING ................CONTACT KOYA MEDICAL ....................INDICATIONS FOR USE ......................4 CONTRAINDICATIONS & WARNINGS ................5-6 INTRODUCTION ......................... CONTROLLER ........................8-9 Charging the Controller ....................Controller Summary....................LOWER EXTREMITY CARE..................10-20 Preparing the Liner ....................Full Leg Garment ......................11 Lower Leg Garment ....................12...

  • Page 3: Getting Started With Dayspring

    Getting Started with Dayspring Read this entire guide before using your device. Contact Koya Medical • • By phone: 1-833-999-KOYA (5692) Monday–Friday, 9AM-5PM CST • • By email: support@koyamedical.com...

  • Page 4: Indications For Use

    • • Reducing wound healing time • • Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers • • Lipedema • • Phlebolymphedema Dayspring delivers active compression, designed to provide mobility and movement.

  • Page 5: Contraindications & Warnings

    Contraindications & Warnings Dayspring should not be used if you have one or more of the following conditions: • • Pulmonary edema • • Thrombophlebitis • • Congestive heart failure • • Deep vein thrombosis • • Episodes of pulmonary embolism •...
  • Page 6 CAUTION: Risk of Device Damage • • Do not use devices that can generate high heat such as irons or blow dryers near the Dayspring system. • • Do not attempt to wash the Garment.

  • Page 7: Introduction

    The system consists of a mobile Controller and a Garment with programmable compression segments. When properly used, Dayspring creates a calibrated pressure gradient that compresses distally to proximally. Dayspring comes with the following: •...

  • Page 8: Controller

    Controller Charging the Controller Before using Dayspring for the first time, fully charge the Controller. Plug the Charging Cable into a wall outlet and into the Controller. A full charge takes approximately three (3) hours. The battery indicator light on the Controller will flash orange when charging and turn to solid green when fully charged. Unplug the Charging Cable from the Controller after it has fully charged.

  • Page 9: Controller Summary

    • E ach light represents 6 minutes • • Light ring flashes when Play/Pause Button treatment is paused • • Single blue light means Dayspring is ready to pair to Intensity Button the mobile app via Bluetooth • • Single flashing orange light appears when the Garment is not connected...

  • Page 10: Lower Extremity Care

    The liner is intended to provide a fabric barrier between the Garment and your skin and can be left off if wearing Dayspring over lightweight pants. If a footwrap is determined to be necessary by your healthcare provider, one will be provided. Follow the instructions packaged with the footwrap.

  • Page 11: Full Leg Garment

    Full Leg Garment Ready the Garment by placing it on the front of your leg with the oval positioned at your knee and facing outward. The tag indicating “R” (right leg) or “L” (left leg) should be at your thigh. Figure 4.

  • Page 12: Lower Leg Garment

    Note: If you received a belt, follow the instructions packaged with it. Lower Leg Garment Ready the Garment by ensuring that the mesh side is facing outward, and the narrow end is facing downward toward your foot. Align the top of the Garment just below your knee. Starting at the ankle, attach the buckle to the hook on the opposite side of the Garment.

  • Page 13: Y-Connector

    Y-Connector If you have a bilateral prescription and received a Y-Connector, you are able to treat both legs at once. Ensure that the Y-Connector is securely connected to the controller and each Garment as shown. Figure 9. Lower Leg Garment with Y-Connector connected at three locations.
  • Page 14 The cable ties enable adjustment of the Y-Connector cable length. To shorten cable length, pull the loops on both sides to extend them. Figure 11. Pull cable ties to adjust Y-Connector length.

  • Page 15: Upper Extremity Care

    Upper Extremity Care Preparing the Liner Place the gauntlet on your hand. Then slide your arm through the liner and pull it up toward your shoulder to make sure it’s completely unwrapped and smooth, as shown below. Figure 12. Gauntlet and arm liner are worn on the hand and arm. Arm Garment Use the adjustable straps to form the Garment into a loose cone shape.
  • Page 16 When the Garment is properly donned, the breathable mesh should be positioned along the outer bend of your elbow, while the straps are on the inner side. The white stitched oval on the outer mesh should closely align with your elbow. Do not forcibly bend your elbow.

  • Page 17: Treatment

    Treatment The cable that goes to the Garment is removable. Ensure that this cable is attached before starting treatment. Figure 15. The cable connected to the Garment. Connect the Garment to the Controller and press play/pause twice to begin treatment. Note that the first press is to “wake” it and the second press begins treatment. Figure 16.

  • Page 18: Selecting Treatment Intensity

    A single lit bar indicates low intensity, two bars indicate medium intensity (default), and three bars indicate high intensity. Intensity cannot be changed while Dayspring is delivering active compression. If adjusting during use, the system must be paused before changing intensity. INTENSITY BUTTON Figure 17.

  • Page 19: Starting Treatment

    Starting Treatment If the Controller is off, press play/pause to wake it. Then, press play/pause again to start treatment. An illuminated light ring will appear, indicating that the treatment has started. The light ring counts down to reflect how much time is remaining for the current treatment session. PLAY/PAUSE BUTTON Figure 18. Start, pause, and end treatment using the Play/Pause button.

  • Page 20: Pausing & Resuming Treatment

    Pausing & Resuming Treatment When a treatment session is active, press play/pause to pause the treatment at any time. Press play/pause again to resume treatment. Note: Dayspring will remain paused for ten (10) minutes before it turns off.

  • Page 21: Completing Treatment

    Completing Treatment Each session will automatically end after sixty (60) minutes. At the end of treatment, the Controller will vibrate to indicate the session is complete. To manually end treatment at any time press and hold play/pause for three (3) seconds. Note: Perform the treatment as prescribed by your healthcare provider.

  • Page 22: Dayspring App

    (2) seconds on the Controller until a blue light appears, indicating that it is in pairing mode. Once the blue light appears, open the Dayspring app and follow the prompts on the screen. Updating Firmware The Dayspring app enables you to ensure Dayspring is always up to date. To update firmware, launch the Dayspring app...

  • Page 23: Cleaning & Care

    Do not wring, iron, dry clean, or bleach. Clean them at least once a week or as needed. Handle Dayspring with care. When not in use, store components in the provided carrying case. Store in a clean, cool,and dry location. Avoid exposure to extreme...

  • Page 24: Troubleshooting

    Issues with Bluetooth Reset the connection by going to the Bluetooth connection settings on your phone and removing Dayspring from your connected devices. Place your device in pairing mode and try again. Status indicator light...

  • Page 25: Potential Complications & Adverse Events

    Standard Warranty Koya Medical warrants to the original purchaser of the Dayspring device that your device is free from defects in materials and workmanship for one (1) year from the date of original purchase. This warranty extends to only the original purchaser and is not transferable.

  • Page 26: Extended Warranty

    EXCLUSIONS This warranty does not apply if the Dayspring device has been: • • Changed or modified by any person or entity other than Koya Medical. • • Serviced or repaired by any person or entity other than Koya Medical. • • Damaged by an act of God, external causes, misuse,...

  • Page 27: Bluetooth Trademark

    Bluetooth Trademark The Bluetooth word, mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Koya Medical is under license. Other trademarks and trade names are those of respective owners.

  • Page 28: Technical Information

    All rights reserved. Atmospheric Pressure: 70 to 106 kPa EMC Safety Information Electromagnetic Compatibility The Dayspring system has been tested for immunity to electrostatic discharge, radio frequency interference, proximity RF fields from wireless equipment, and power frequency magnetic fields as specified in the table below. Emissions of energy are not likely to cause interference with nearby electrical equipment.
  • Page 29 Guidance and Manufacturer’s Declaration – Emissions Medical Equipment and Medical Systems The Dayspring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Dayspring System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
  • Page 30 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Dayspring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Dayspring System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level...

  • Page 31: Label Symbols

    Label Symbols Caution Do not use if damaged. Temperature limits to which the medical device can be safely exposed Humidity limits to which the medical device can be safely exposed Type B Applied Part Controller and Garment are protected against solid foreign objects greater than 12.5 mm.
  • Page 32 Koya Medical 1-833-999-KOYA (5692) 2461 Peralta Street support@koyamedical.com Oakland, CA 94607 www.koyamedical.com ©2024 Koya Medical. All rights reserved. C-0294-01 REV B...

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