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Details on how to contact ZELTIQ Customer Service for routine and urgent issues, including phone numbers and email.
Defines the intended uses of the CoolSculpting Elite System in cooling, heating, and massage modes.
Lists conditions where localized skin cooling is contraindicated for patient safety.
Provides critical warnings regarding system use, modification, and patient sensitivities or conditions.
Outlines precautions for system use and lists common adverse events that may occur during or after treatment.
Details rare adverse events that may occur with CoolSculpting Elite System treatments.
Details the various components of the CoolSculpting Elite System's control unit, including display, ports, and buttons.
Describes the CoolSculpting Elite System's applicators, their types, and associated user interface elements.
Explains the audible feedback provided by the system during operation and treatment.
Details the types of supplies required for system operation, including treatment cards, filters, and pretreatment wipes.
Describes the use of comfort straps, foam borders, and liners for applicator application and patient comfort.
Explains treatment profiles, cycles, and the role of treatment cards in defining temperature and duration.
Guides through the steps for setting up the CoolSculpting Elite System, including card insertion and patient information.
Details the process of selecting treatment areas on the body and choosing appropriate treatment profiles.
Instructions for preparing the applicator and patient, including gelpad application and skin site inspection.
Steps for initiating a CoolSculpting Elite System treatment, including single and dual applicator setups.
Specific guidance for starting a dual applicator treatment, including timing and options for starting each applicator.
Procedures for ending a treatment cycle, including vacuum off, massage, and cleaning.
Step-by-step instructions for cleaning the CoolSculpting Elite applicators after use.
Instructions on how to cancel a treatment that is currently in progress.
Guidance on how to respond when the system stops a treatment due to an error or condition.
How to access and navigate the system tools menu, including logs, service, settings, and about information.
Viewing system and card logs, and instructions for uploading log files for diagnostics.
Using service screens for diagnostics of vacuum, chiller, and modem functions.
Configuring modem settings and setting up system notifications for treatment status updates.
Adjusting the system's time zone and setting the current date and time.
Customizing system language, icon control, and viewing system version information.
Lists recoverable exceptions with ZELTIQ codes and recommended actions for troubleshooting.
Details error messages affecting specific applicators or the overall system, with corresponding actions.
Describes software launch messages and system notification texts transmitted during events.
Provides guidelines and approved products for cleaning the control unit and applicators safely.
Specific instructions for cleaning the touchscreen and bucket, and replacing the system filter.
Summarizes the efficacy of CoolSculpting treatments across various body areas based on clinical studies.
Details the assessments performed during clinical studies to evaluate treatment efficacy and safety.
Presents results from clinical studies including efficacy outcomes and reported adverse events.
Reports findings from clinical investigations on the efficacy of CoolSculpting for abdominal and thigh fat reduction.
Summarizes the safety and efficacy of CoolSculpting for submental fat reduction from a clinical study.
Presents findings on the safety and efficacy of CoolSculpting for upper arm fat reduction.
Compiles data from published clinical studies on CoolSculpting treatments across various anatomical areas.
Details findings from publications specifically on submental area treatments and their efficacy.
Tabulates different applicator placement methods used in clinical studies for submental and submandibular areas.
Explains system symbols related to warnings, cautions, and manufacturer identification.
Details symbols indicating instructions for use and general safety precautions.
Describes symbols related to storage conditions, handling, and electrical safety.
Explains symbols pertaining to environmental requirements and operational states.
Details symbols for operational controls and device identification, including regulatory compliance.
Outlines the performance characteristics required for the CoolSculpting Elite System's operation.
Provides physical dimensions, weight, and electrical specifications including safety standards and fuses.
Details the medical safety standards and electromagnetic compatibility requirements for the system.
Guidance and declarations regarding the system's electromagnetic emissions.
Guidance and declarations concerning the system's electromagnetic immunity.
Lists the specifications for the device's modem and Wi-Fi data modules.
Details the system's compliance with FCC rules for digital devices in the United States.
Instructions for the proper disposal of system components, including hazardous materials.
General| Brand | ZELTIQ |
|---|---|
| Model | CoolSculpting Elite |
| Category | Medical Equipment |
| Language | English |
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