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W&H implantmed SI-923 User Manual

W&H implantmed SI-923
60 pages
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Instructions for Use
SI-915 / SI-923
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W&H implantmed SI-923 Specifications

General IconGeneral
ManufacturerW&H
ModelSI-923
ApplicationDental Implantology
Operating Frequency50/60 Hz
Max. Torque at the Instrument80 Ncm
Coolant FlowAdjustable
DisplayLCD
ControlFoot Control
Power Supply220-240V, 50/60Hz
Cooling SystemIntegrated
Weight2.8 kg

Summary

Symbols

Safety and Warning Symbols

Explains hazard warning and attention symbols used in the manual, including warnings and cautions.

General and Identification Symbols

Covers symbols for general information, manufacturer, CE marking, serial number, and device identification.

Introduction

Safety and User Qualifications

Emphasizes patient safety, user qualifications, and intended use of the medical device.

Manufacturer Responsibility and Usage Guidelines

Outlines manufacturer liability and strict adherence to usage instructions for warranty validation.

Unpacking

Scope of delivery

Standard Control Unit Components

Lists standard components of the control unit, including universal and irrigant support.

Optional Included Set Items

Details optional accessories like irrigation tubing, motor, and foot control.

Safety notes

General Safety Precautions

Covers initial storage, checks for damage, safe operation, and test runs before use.

Environmental Operation Restrictions

Prohibits operation in explosive or oxygen-rich environments.

Safety notes (continued)

Electrical Safety and Component Usage

Advises on using correct fuses, avoiding simultaneous contact with patient/contacts, and using approved handpieces.

Operational Notes and Failure Handling

Explains power failure behavior and that system failure is not critical.

Safety notes (continued)

Mains Connection and Power Switch Safety

Details safe use of the mains cable, power switch, and disconnection procedures.

Operational Precautions and Speed Settings

Warns about retaining screws and difficulty detecting low speeds.

Safety notes (continued)

Electromagnetic Field Risks

Warns about potential effects on active implantable medical devices (AIMD) and advises checking patient status.

Accessory Operation Guidelines

Stresses following safety notes for foot control, motors, and handpieces.

Safety notes (continued)

Coolant Supply and Irrigation Tubing

Details requirements for coolant, irrigation tubing, and proper disposal.

Pre-Use Hygiene and Maintenance

Instructs on cleaning and disinfecting the control unit and supports before initial use.

Description

Front Panel Overview

Identifies and describes the main components on the front panel of the control unit.

Description (continued)

Rear Panel Component Identification

Details the connectors, fuse holder, and power switch located on the rear panel.

Description (continued)

Foot Control Functionality and Buttons

Explains the function of each button (Green, Grey, Orange, Yellow) on the foot control.

Start-up

General Setup Procedure

Guides through connecting cables, inserting supports, and attaching the universal support.

Control unit

Control Unit Power Management

Details the procedure for switching the control unit on and off, including LED checks.

Control unit operation

Program Selection and Display Settings

Explains how to activate programs (P1-P5) and what is displayed for speed and torque.

Pump Function and Error Indicators

Covers controlling the pump and common error messages like motor overheating.

Control unit operation (continued)

Adjusting Motor Speed (P1-P3)

Details how to increase or decrease motor speed using the control unit buttons.

Control unit operation (continued)

Adjusting Motor Torque (P4-P5)

Explains how to set and adjust torque values for programs P4 and P5.

Control unit operation (continued)

Adjusting Coolant Volume (P1-P5)

Guides on how to adjust the coolant flow rate for different programs.

Operation

Foot Control Program and Pump Operation

Details how to change programs, turn the pump on/off using the foot control.

Motor Reverse Operation

Explains how to switch to reverse operation and associated signals.

Operation (continued)

Foot Control Setting Adjustment (P3)

Describes how to change the motor control mode from variable to ON/OFF for program P3.

Restoring factory settings

Factory Reset Procedure

Details the steps to reset the control unit to its original factory settings.

Thread cutter function (chip breaker mode)

Thread Cutter Functionality (P5)

Explains the thread cutter function (P5), its speed, torque, and operation.

Error messages

Troubleshooting Common Error Codes

Lists error codes, their meanings, and recommended solutions for the control unit.

Hygiene and maintenance

General Hygiene and Safety Guidelines

Covers adherence to laws, personal protective equipment, and air usage.

Cleaning Agents and Disinfectant Selection

Provides guidance on selecting and using appropriate cleaning agents and disinfectants.

Hygiene and maintenance (continued)

Processing Limitations and Lifespan

Discusses factors affecting product lifetime and recommends service for universal support.

Hygiene and maintenance (continued)

Initial Treatment at Point of Use

Details immediate cleaning and disinfection of the device after each treatment.

Hygiene and maintenance (continued)

Manual Cleaning Procedures

Provides instructions for manual cleaning of universal support, irrigant support, and control unit.

Hygiene and maintenance (continued)

Manual Disinfection Methods

Recommends wipe-down disinfection for all components and lists tested disinfectants.

Hygiene and maintenance (continued)

Automated Cleaning and Disinfection

Describes using washer-disinfectors for universal and irrigant supports, noting control unit is not approved.

Hygiene and maintenance (continued)

Drying Procedures

Specifies ensuring internal and external dryness after cleaning and disinfection.

Hygiene and maintenance (continued)

Inspection and Maintenance

Details inspection for damage, soiling, and surface changes after cleaning and sterilization.

Hygiene and maintenance (continued)

Sterilization Packaging Requirements

Outlines requirements for sterilization packages for the universal support.

Hygiene and maintenance (continued)

Sterilization Standards and Procedures

Recommends sterilization standards and lists recommended cycles and temperatures.

Hygiene and maintenance (continued)

Sterilization Test Results and Drying Times

Presents results of sterilization suitability tests and specifies drying times for different cycles.

Hygiene and maintenance (continued)

Storage Conditions for Sterile Goods

Instructs to store sterile goods dust-free and dry, noting shelf life dependency.

Servicing

Periodic Inspection Requirements

States the necessity and frequency of periodic inspections for safety and function.

Servicing (continued)

Repairs and Returns Procedures

Advises contacting service partners for malfunctions and proper processing before returning equipment.

Accessories, consumables, spare parts and other recommended medical devices by W&H

Recommended Accessories and Spare Parts

Lists various accessories such as cassette, case, supports, and fuses for the device.

Accessories, consumables, spare parts and other recommended medical devices by W&H (continued)

Additional Recommended Accessories

Lists additional accessories like motors, foot controls, irrigation tubing, and hose clips.

Technical data

Control Unit Specifications

Provides electrical, dimensional, and performance data for the SI-923 and SI-915 control units.

Ambient Operating and Storage Conditions

Details temperature and humidity requirements for storage and operation.

Technical data (continued)

Device Classification and Environmental Ratings

Specifies device classification (Class II), pollution level, overvoltage category, and altitude limits.

Data on electromagnetic compatibility according to IEC/EN 60601-1-2

EMC Operating Environment and Warnings

Discusses suitable operating environments and general EMC warning notes for the medical device.

Essential Performance Characteristics

States that the device has no critical functions or essential performance features.

Data on electromagnetic compatibility according to IEC/EN 60601-1-2 (continued)

RF Equipment Proximity and Usage Guidelines

Provides guidelines on the use of portable RF equipment and avoiding stacked or adjacent equipment.

HF Surgical Device Proximity Warning

Warns that the device is not intended for use near HF surgical equipment.

Results of the electromagnetic tests

Electromagnetic Emissions Test Results

Presents test results for conducted and radiated electromagnetic emissions according to standards.

Immunity to Electromagnetic Interference Test Results

Details test results for immunity to ESD, RF fields, bursts, surges, and magnetic fields.

Disposal

Safe Disposal Procedures

Advises ensuring parts are uncontaminated and following local disposal laws for device, waste, and packaging.

W&H course certificate

User Training Certificate

A certificate form to confirm user training on the medical device and understanding of its content.

Explanation of warranty terms

Warranty Period and Coverage

Explains the 12-month warranty for manufacturing defects and what is not covered.

Authorized W&H service partners

Finding Authorized Service Partners

Directs users to find their nearest authorized W&H service partner via the website or QR code.

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