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Sutter CURIS 36 0 00-01 User Manual

Sutter CURIS 36 0 00-01
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INSTRUCTIONS FOR USE
CURIS
®
4 MHz Radiofrequency Generator
REF 36 0 00 01
These instructions for use apply for all devices according to chapter 5.1.

Table of Contents

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Sutter CURIS 36 0 00-01 Specifications

General IconGeneral
BrandSutter
ModelCURIS 36 0 00-01
CategoryPortable Generator
LanguageEnglish

Summary

Explanation of Symbols and Abbreviations

Mode of Action and Intended Use

General Information about Electrosurgery

Explains electrosurgery and RF surgery principles, including monopolar and bipolar applications.

Intended Use of the CURIS®

Details the CURIS® device's applications in various surgical fields and its intended functions.

Transportation and Packaging

Receiving Inspection

Instructions for inspecting the device and accessories for transport damage upon receipt.

Returns

Guidelines for returning the device, including required documents and packaging.

Function and Meaning of Display and Control Elements

Commissioning

Validity of Instructions for Use

Specifies the validity of the manual based on device hardware and software versions.

Potential Equalization Connection

Explains the purpose and connection of potential equalization for electrical safety.

Mains Supply

Details the device's power requirements, voltage range, and connection procedure.

Turning the Device On and Off

Instructions on how to power the device on and off using the main switch.

Self-test

Describes the automatic self-test procedure performed upon device startup.

Connecting Accessories

Guides on connecting various accessories like neutral electrodes and handles.

Operation

Special Functions

Introduces special functions like AutoRF™ and p3™ for enhanced treatment control.

Program Memory

Describes how to store and recall device settings using the P1-P4 program memory slots.

Function Test

Outlines the procedure for performing functional tests before device use.

Safety Measures

General Information

Provides general warnings about high-frequency generators and safe usage practices.

Patient Positioning

Details critical aspects of patient positioning to prevent burns and ensure proper current flow.

Neutral Electrode and HF Current Application

Specifies correct application of the neutral electrode for safe and effective RF current delivery.

Pacemakers and Implants

Safety precautions for patients with pacemakers or metallic implants.

Setting Down RF Instruments

Warning against setting down electrosurgery instruments on the patient during pauses.

Risks due to Electromagnetic Interference

Discusses potential interference with other medical devices and equipment.

Accessories

Lists recommended accessories and precautions for using third-party accessories.

Operation with Bipolar Cutting Forms

Addresses hazards related to unintentional activation in bipolar cutting modes.

Risks due to High Electric Voltage

Warns about neuromuscular stimulation from high voltage RF currents.

Care Instructions

Cleaning and Disinfection

Detailed instructions for cleaning and disinfecting the device and accessories.

Sterilization of Accessories

Guidance on observing accessory-specific care and reconditioning information.

Accessories Not Sterilizable

Instructions for disinfecting non-sterilizable accessories.

Technical Information

Technical Data, Standards, Certification

Lists technical specifications, standards compliance, and certifications for the device.

Recurring Safety-Related Inspections

Specifies the schedule and requirements for periodic safety inspections.

Diagrams

Contains diagrams illustrating RF output characteristics for various operating modes.

Electromagnetic Compatibility Guidelines

Provides declarations and guidelines regarding electromagnetic compatibility (EMC).

Environmental Notices

Packaging

Information on packaging disposal and recycling options.

Environmentally Friendly Device Operation

Advice on energy conservation and minimizing environmental impact during operation.

Device Disposal

Guidelines for the proper disposal of the device at the end of its service life.

Error Diagnosis

Error Messages and Their Meaning

Explains common error messages, their causes, and user-resolvable rectification steps.

Foot Switch (Accessory)

Intended Use

Describes the purpose and function of the foot switch as a trigger mechanism.

Maintenance, Cleaning, Disinfection

Provides guidance on maintaining and cleaning the foot switch accessory.

Technical Data

Lists technical specifications and standards for the foot switch accessory.

Equipment Cart (Optional)