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Acteon Piezotome Cube - User Manual

Acteon Piezotome Cube
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User Manual
Piezotome Cube
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Summary

1 Documentation

1.1 Associated documentation

Lists related documents required for use with the Piezotome Cube.

1.2 Electronic documentation

Information on how to access and obtain user instructions electronically.

2 Required information

2.1 Intended use

Specifies the target users and the general purpose of the Piezotome Cube.

2.2 Indication for use

Details the specific dental surgical procedures for which the device is indicated.

2.3 Operating principle

Explains the mechanism by which the device generates ultrasonic vibrations.

2.4 Using accessories not supplied by the manufacturer

Warning against using non-approved accessories to prevent damage.

2.5 Connecting and disconnecting accessories during use

Instructions for safe connection and disconnection of tips during operation.

2.6 Repairing or modifying the medical device

Advises contacting the supplier for repairs to maintain safety and warranty.

2.7 Warranty

Notes on warranty voidance related to specific screws.

2.8 Latest document update

Indicates the last revision date of the user manual.

2.9 Date of first CE marking

States the initial date of CE marking for the device.

3 Unpacking the medical device

4 Connect the medical device

4.1 Connecting the medical device to the electrical network

Guidelines for safely connecting the device to the mains power supply.

4.2 Connecting the medical device to the electrical network

Step-by-step procedure for connecting the power cord and mains socket.

5 Installing the medical device

5.1 Install cords

Guidance on managing handpiece and control pedal cords to prevent hazards.

5.2 Installing the control pedal

Recommendations for positioning the control pedal for accessibility and ease of use.

5.3 Connecting the handpiece

Procedure for connecting the handpiece assembly to the main control unit.

5.4 Installing an irrigation line

Detailed steps for setting up the irrigation system, including bag and line placement.

5.5 Attaching a tip

Instructions on how to attach and tighten tips correctly using the provided wrench.

6 Dispensing a treatment

6.1 Accessory usage conditions

Requirements for cleaning, disinfection, and sterilization of accessories before use.

6.2 Preparation for use

Comprehensive steps for preparing the medical device and accessories for operation.

6.3 Switching off the medical device

Procedure for powering down the device and cleaning the irrigation system.

7 Medical device description

7.1 Front view of the medical device

Identification of key components on the front panel of the device.

7.2 View of the right-hand side of the medical device

Identification of components located on the right-hand side of the device.

7.3 Rear view of the medical device

Identification of components found on the rear panel of the device.

7.4 Overview of the interface

Explanation of the device's interface, including modes and tactile zones.

7.5 Control unit

Description of the control unit and its incorporated Newtron® technology.

7.6 Handpiece

Information regarding the handpiece and its support, including placement advice.

7.7 Screen of the medical device

Details about the device's touch-sensitive screen and its interaction methods.

7.8 Setting the power

Guidance on adjusting the ultrasound power according to tip and treatment needs.

7.9 Setting the irrigation flow

Instructions for adjusting the water flow rate for the irrigation system.

7.9.1 Activating the purge function;starting irrigation

Steps for activating the purge function and initiating irrigation.

7.10 Air inlets

Importance of keeping air inlets unobstructed for proper ventilation.

7.11 Control pedal

Description of the control pedal's operational modes and functionality.

7.12 Mains Connector

Explanation of the mains connector's role in connecting to the electrical network.

7.13 Switch

Instructions on how to use the main power switch to turn the device on or off.

7.14 Fuse recess

Information about the fuse holder and a reference to fuse replacement.

7.15 Irrigation lines

Guidelines for the use, cleaning, and disposal of irrigation lines and bags.

8 Disinfection and sterilising

8.1 Clean and disinfect the medical device

Daily procedures for cleaning and disinfecting the device's control unit and pedal.

8.2 Cleaning, disinfecting and sterilising accessories

Refers to associated documentation for detailed accessory cleaning protocols.

9 Monitoring and routine maintenance

9.1 Cleaning the irrigation system

Detailed steps for cleaning the internal irrigation system of the device.

9.2 Corrective Maintenance

Actions for corrective maintenance that can be performed by the user.

9.2.1 Replacing the fuses

Step-by-step instructions for replacing the fuses in the mains connector.

10 Identifying incorrect operation

10.1 Not working

Troubleshooting steps for when the device is not functional or the screen is off.

10.2 No spray

Solutions for issues related to the absence of water spray from the tip.

10.3 The power is not as expected

Troubleshooting guide for when the tip vibration frequency is not as anticipated.

10.4 Ultrasounds not working

Steps to diagnose and fix problems where the tip does not vibrate.

10.5 Water leakage

Troubleshooting procedures for water leaks in the irrigation line or handpiece.

10.6 Disturbance of settings defined by the practitioner

Solutions for unexpected changes in device modes or irrigation flow.

11 Technical specifications of the medical device

11.1 Identification

Manufacturer and product name details for the medical device.

11.2 Generator

Technical specifications pertaining to the device's generator component.

11.3 Length of cords

Specification of the lengths for the handpiece and control pedal cords.

11.4 Irrigation

Technical details concerning the device's irrigation system capabilities.

11.5 Footswitch

Technical specifications and dimensions of the footswitch.

11.6 Environmental characteristics

Operating and storage conditions, including temperature, humidity, and pressure.

11.7 Environmental restrictions

Lists usage premises and environmental conditions to avoid for safe operation.

11.8 Main performance characteristics

Summary of the primary performance function of the device.

12 Regulations and standards

12.1 Applicable standards and regulations

Details the device's compliance with European directives and ISO quality standards.

12.2 Medical class of the device

Classification of the medical device according to regulatory directives.

12.3 Symbols

Explains the meaning of various symbols used throughout the manual.

12.4 Quick Start and Quick Clean symbols

Explains symbols associated with quick start and cleaning procedures.

12.5 Manufacturer identification

Provides contact details and identification information for the manufacturer, SATELEC.

12.6 Branch addresses

Lists contact addresses for ACTEON group branches worldwide.

12.7 Disposal and recycling

Instructions for the proper disposal and recycling of the device at its end of service life.

Acteon Piezotome Cube Specifications

General IconGeneral
TypePiezoelectric surgical device
Power Supply100-240 VAC, 50/60 Hz
DisplayLCD
Oscillation Amplitude60-200 µm
ModesContinuous
TechnologyPiezoelectric ultrasonic

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