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Miramar Miradry MD4000-MC User Manual

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MD4000-MC
User Manual
LB0261 Rev A 01/2018
© Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc.
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Summary of Contents for Miramar Miradry MD4000-MC

  • Page 1 MD4000-MC User Manual LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 1...

  • Page 2: Contact Information

    Bretforton United States Evesham Worcestershire WR11 7JJ Telephone: United Kingdom 1-855-miraDry (1-855-647-2379) Tel: +44 1 452 619 222 1-408-940-8700 medpass.ar@medpass.org Fax: 1-888-498-2878 1-408-940-8796 LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 2...

  • Page 3: Table Of Contents

    DESCRIPTION OF MD4000-MC CONSOLE COMPONENTS........37 11.2. DESCRIPTION OF MIRADRY SYSTEM COMPONENTS .......... 37 12. TROUBLESHOOTING GUIDE ..................... 38 13. SPECIFICATIONS ........................ 40 LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 3...

  • Page 4: Explanation Of Symbols

    Humidity limitation: Ship and store at an atmospheric pressure range store at a humidity range of 55kPa to 101kPa between15% to 90% RH LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 4...
  • Page 5 Adjust speaker volume up or down Remove the bioTip from the Stop the treatment session Handpiece Unlock fixed energy level in first few rows of template LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 5...

  • Page 6: System Description

    MD4000-BT miraDry bioTip • MD4000-HP miraDry Handpiece bioTip MD4000-MC Console Touchscreen MD4000-MC Console Handpiece Main Body and cable bundle Figure 1: Fully-assembled miraDry System. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 6...

  • Page 7: Miradry Console Connections And Control Features

    Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 7...

  • Page 8: Contraindications

    Pain in the arm or fingers that gradually goes away (can last for several months) • Pain in the underarm requiring prescription medications • Infection/abscess • Burns LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 8...

  • Page 9: Clinical Data

    In addition, the 81 treatment group subjects showed good long-term efficacy with 69.1% of these subjects having HDSS success at their final study visit. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 9...

  • Page 10: Single Group, Commercial Device Study

    26%). One subject experienced treatment-related neuropathy of the left tricep muscle after the first treatment session that was resolving at 6 months, after which she was lost to follow-up. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 10...
  • Page 11 (n=2 events). One patient experienced unilateral ulnar neuropathy that was improving but not completely resolved at study exit. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 11...

  • Page 12: Warnings And Precautions

    8.1. • DO NOT use the miraDry System until you have thoroughly read the Miramar Labs MD4000-MC Console User Manual, Handpiece Instructions for Use (IFU), and bioTip Instructions for Use (IFU). Observe all Warnings and Precautions. Failure to do so may result in complications.

  • Page 13: Equipment Use Warnings And Precautions

    DO NOT connect or disconnect the miraDry Handpiece when the miraDry Console is turned ON. Make sure to turn the miraDry Console OFF prior to connecting or disconnecting the miraDry Handpiece. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 13...

  • Page 14: Clinical Warnings And Precautions

    Make sure that for each recommended injection site the appropriate quantity is administered. DO NOT inject anesthesia into the dermis. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 14...

  • Page 15: Cleaning Warnings And Precautions

    DO NOT attempt to repair or alter any of the miraDry System components. OPERATING INSTRUCTIONS When you are ready to unpack and set up the miraDry System, contact a Miramar Labs Representative for assistance. It is important that a Miramar Labs Representative be present and set the System up for you.
  • Page 16 Figure 5. Only use new deionized or distilled water when filling the reservoir. The W01 prompt to add more water will appear occasionally. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 16...
  • Page 17 Place the Handpiece in the holster and lower it to the “down” position as shown in Figure 7. The Handpiece must be in the “down” position to complete the self-test. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 17...

  • Page 18: Operation - Gear Menu

    Figure 8: Gear Menu Drop Down To close the Gear Menu Drop Down, touch the X button ( at the top right of the Drop Down. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 18...
  • Page 19 ) to adjust the volume ) to confirm. up or down. Stop Remove bioTip by pressing Dispose of used treatment the handswitch. bioTip. session LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 19...

  • Page 20: Operation - Pre-Treatment Setup

    Figure 9. Refer to Section 9.1 for attachment instructions. Turn the System OFF before connecting the Handpiece. Figure 9: “Attach Handpiece” Screen LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 20...
  • Page 21 Figure 12: “Attach bioTip” Screen Once attached, the System will check the status of the bioTip and display the results on the “bioTip Status” Screen. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 21...
  • Page 22 If the Touchscreen GUI indicates that you have a valid bioTip, touch the right arrow button ( on the “bioTip Status” Screen to display the “Simple Template Selection” Screen. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 22...
  • Page 23 Template. Based on this assessment, determine what size Template to use and be ready to enter the Template dimensions on the “Simple Template Selection” Screen as shown in Figure “Simple Template Selection” Screen LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 23...
  • Page 24 Touch-up Treatment Mode – a Template that lets you control each placement and use the Touch-Up templates as guidance. The System will then simply count the number of placements completed (see Section 9.7). LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 24...

  • Page 25: Operation - Treatment

    9.4. Refer to the Instructions for Use for the miraDry Template System and miraDry Handpiece for additional instructions on the Treatment Template application. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 25...
  • Page 26 Handpiece/bioTip. You will need to select the microwave energy level for treatment as shown in Figure 17. Figure 17: “Microwave Energy Level Selection” Screen LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 26...
  • Page 27 (see Figure 20). There is an exception if the NO-TREAT (red X) was selected for the first axilla. In this case, changes to both axillae can be made. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 27...
  • Page 28 The next triangle in sequence will turn green to indicate the target site of the next treatment cycle. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 28...
  • Page 29 System will go back into ready mode. If termination occurred during the microwave energy delivery phase, the System will skip directly into the post-cool phase before going back into ready mode. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 29...
  • Page 30 After the treatment of one axilla is complete, proceed to the second axilla. After completion of the second axilla the Touchscreen GUI will automatically proceed to the cleaning and wrap-up procedures. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 30...

  • Page 31: Operation - Stopping A Treatment

    Both methods place the Handpiece in post-cool mode. Continue to keep the Handpiece in contact with the skin through the entire post-cool period. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 31...

  • Page 32: Operation - Post Treatment

    Remove the bioTip from the miraDry Handpiece by pressing the button on the Handpiece as shown in Figure 27. Figure 27: “Remove bioTip” Screen Dispose of bioTip according to local regulations. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 32...

  • Page 33: Operation - Touch-Up Mode

    Touch-up Template, and administering anesthesia. This includes any special safety instructions for administering anesthesia for touch-up placements. Then follow the instructions in sections 9.2 and 9.4 for selecting the appropriate microwave energy level. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 33...

  • Page 34: Operation - Procedure Troubleshooting

    Figure 31: Yellow outline indicates vacuum loss LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 34...
  • Page 35 If you do not wish to proceed with treatment after a power loss, you can display the Gear Menu Drop Down and press the Stop Session Icon (see Section 9.2) to cancel the rest of the current treatment session. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 35...

  • Page 36: System Shutdown Procedure

    AC supply before cleaning. STORAGE 10.3. The miraDry System should be stored in a cool, dry place out of direct sunlight. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 36...

  • Page 37: Maintenance And Service Information

    Miramar Labs representative for proper disposal of this product. HOW TO CHANGE THE CONSOLE FUSES 10.5. DO NOT attempt to change the Console fuses without the help of a Miramar Labs Representative. CAUTION: DO NOT replace miraDry Console fuses with fuses that have been repaired, or with short-circuited fuse holders.

  • Page 38: Troubleshooting Guide

    • If the Error cannot be cleared, restart the System (turn the System Off and then ON). • If the Error persists after the System restart, call a Miramar Labs Representative for assistance. Touchscreen GUI Pop-up Error What To Do Codes •...
  • Page 39 Red Hourglass (Screen 21) Use a new bioTip. Miscellaneous error conditions All other errors not listed in above table. Basic Error Recovery LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 39...

  • Page 40: Specifications

    IEC 60601-2-6:2012: Medical Electrical Equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment IEC 60601-1-2:2007: Medical Electrical Equipment - LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 40...
  • Page 41 It may be necessary to take mitigation measures, such as re-orienting or relocating the system or shielding the location. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 41...
  • Page 42 IEC 61000-4-8 typical commercial or hospital environment. NOTE: Ut is the a.c. mains voltage prior to application of the test level. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 42...
  • Page 43 System unit. (b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 43...
  • Page 44 United States, Argentina, Australia, Canada, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Switzerland. The Drop Design is a registered trademark in the United States and Japan. LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 44...

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