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General| Brand | ArthroCare |
|---|---|
| Model | COBLATOR II |
| Category | Medical Equipment |
| Language | English |
Provides an overview of the electrosurgical system and its components.
Specifies the medical procedures for which the system is intended.
Lists conditions or situations where the system should not be used.
Illustrates how the system components are connected.
Details critical safety instructions, hazards, and essential usage considerations.
Describes potential negative outcomes of electrosurgery and patient injury.
Details the various controls and status indicators on the Controller.
Explains the audio and visual alarms indicating system status or faults.
Instructions for verifying received items and handling packaging.
Steps for connecting components and performing initial system verification.
Specifies the necessary qualifications and training for users.
Outlines the fundamental procedures for operating the system.
Details the output voltage levels for Coblate and Coagulation modes.
Steps for preparing the system for surgical use, including connections and checks.
Guidance on choosing the appropriate Wand type for the procedure.
Procedures for safely powering down and disconnecting the system.
Environmental conditions for storing and transporting the system components.
Guidelines for the proper disposal of electronic waste and used items.
Instructions for cleaning non-sterile components.
Procedures for cleaning and disinfecting the foot control unit.
Information regarding the single-use nature and handling of the Wand.
Steps for safely replacing fuses in the Controller unit.
A guide to identify and resolve common system issues.
Detailed technical data for the Controller, Foot Control, and Flow Control Valve Unit.
Details RF emissions and compliance with standards like CISPR 11.
Covers ESD, transient, surge, voltage dips, and power frequency field immunity.
Specifies immunity levels for conducted and radiated RF fields.
