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General| Model | MD4000-MC |
|---|---|
| Technology | Microwave energy |
| Manufacturer | Miramar Labs |
| Application | Treatment of excessive underarm sweating (hyperhidrosis) |
| Treatment Area | Underarms |
| Precision | Targeted delivery of microwave energy to sweat glands |
| FDA Approval | FDA-cleared |
| Treatment Duration | Approximately 1 hour per session |
| Number of Treatments | Typically 1-2 treatments |
| Recovery Time | Minimal downtime, usually a few days |
| Side Effects | Temporary swelling, tenderness, and numbness in the treated area |
Information about Miramar Labs, Inc., the manufacturer of the miraDry System.
Details for MedPass International Ltd., the authorized representative in Europe.
Explanation of symbols used on the miraDry device and its packaging.
Explanation of icons displayed on the miraDry System's Touchscreen Graphical User Interface.
Overview of the main components of the miraDry System, including console and handpiece.
Details on miraDry Console connections, ports, and control features for system operation.
Summary of a clinical study involving the miraDry System, detailing design, subjects, and results.
Details of a study using the miraDry System, focusing on efficacy and patient satisfaction.
Presents efficacy measures like hair count reduction, patient satisfaction, and odor self-assessment.
Safety guidelines for setting up and operating the miraDry System in specific environmental conditions.
Critical warnings and precautions for the safe operation and handling of miraDry System equipment.
Precautions related to patient selection, treatment, and anesthesia for the miraDry System.
Safety guidelines for cleaning the miraDry Console and its components.
Precautions to follow when performing maintenance on the miraDry System components.
Step-by-step guide on how to attach the miraDry Handpiece to the miraDry Console.
Instructions on how to power on the miraDry System using the standby button.
Guide on using the touchscreen interface to navigate through system operations and setup.
Procedure for adding deionized or distilled water when prompted by the system.
How to position the Handpiece in the holster to initiate the system's self-test.
Ensuring proper system positioning and vent obstruction check before patient treatment.
Instructions on how to access and use the Gear Menu icon on the Touchscreen GUI.
How to purge the bioTip and remove the bioTip from the Handpiece.
Adjusting microwave energy levels and touchscreen display brightness.
Controlling console volume and stopping a treatment session.
Steps required before initiating patient treatment, including handpiece attachment.
Instructions on how to start a treatment session using the system interface.
Procedure for attaching a new bioTip to the Handpiece for a single treatment session.
Understanding the meaning of different bioTip status indicators on the GUI.
Guidelines and precautions for administering local anesthesia before treatment.
Procedure for measuring and selecting the appropriate template size for patient treatment.
Using system defaults for template size and treatment number for patient axillae.
Options for customizing template size and treatment mode for each axilla.
How to apply templates as described for Guided Treatment Mode.
Choosing the appropriate microwave energy level for patient treatment.
Understanding the pop-up screen indicating treated side and template size.
Procedure for changing template size via the Change Template screen.
How to apply lubricant to the patient's axilla before positioning the Handpiece.
Correctly positioning the miraDry Handpiece on the patient's skin for treatment.
How to start the treatment cycle using the Handpiece handswitch or Console footswitch.
Understanding the normal treatment cycle sequence and status bar indicators.
Methods to stop microwave energy delivery during a specific placement.
How to end a treatment session without completing all placements.
Instructions for performing an instant system shutdown using the Emergency Stop Button.
Steps for removing the bioTip and cleaning the Handpiece after treatment.
Reviewing the treatment summary and applying an ice pack post-procedure.
Instructions for selecting touch-up mode, template, and administering anesthesia.
Resolving issues where the treatment cycle fails to start, including vacuum and contact checks.
Addressing problems related to loss of suction during the treatment cycle.
Procedures for dealing with power loss and system recovery.
Resolving issues related to missing or invalid bioTips and confirming axilla.
Steps to properly shut down the miraDry Console.
Information on required in-field training for operating the miraDry System.
Detailed instructions for cleaning and disinfecting miraDry Console components.
Recommendations for storing the miraDry System in a cool, dry place.
Information on maintenance, service, and how to change console fuses.
List of components supplied with the miraDry MD4000-MC Console.
List of additional components used with the miraDry System.
General steps to take when an error code or symbol appears on the GUI.
Solutions for common error codes related to power, communication, and handpiece issues.
Resolving issues with bioTip attachment and vacuum-related error conditions.
Addressing errors related to low water level, air in cooling system, and high room temperature.
Details on the physical dimensions, weight, and AC input specifications of the miraDry Console.
Specifications for operating temperature, humidity, altitude, and pressure.
Information on the safety standards and compliance certifications the miraDry System adheres to.
Information on ensuring electromagnetic compatibility with other medical devices.
Details on immunity test levels and environmental guidance for the miraDry System.
Information on RF immunity levels and recommended separation distances from RF transmitters.
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