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Chattanooga Intelect Focus Shockwave User Manual

Chattanooga Intelect Focus Shockwave
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Operating Manual
Chattanooga Intelect F-SW
Published: October 2018
Original language: German
Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
TT.####
29097.0002
Part No. 26933.0012
Focus Shockwave
Operating Manual

Table of Contents

Questions and Answers:

Chattanooga Intelect Focus Shockwave Specifications

General IconGeneral
BrandChattanooga
ModelIntelect Focus Shockwave
CategoryMedical Equipment
LanguageEnglish

Summary

General Safety Information

Instructions for safe use

Provides safety instructions for operating the Chattanooga Intelect F-SW.

Intended use and operational safety

Details the device's intended purpose and requirements for safe operation.

Protection against electrical hazard

Guidelines for preventing electrical hazards during operation and maintenance.

Protection against high voltage

Information on high voltage components and associated dangers.

Protection against noise

Recommendations for minimizing noise exposure during treatment.

Protection against explosion

Warnings against using the device in potentially explosive environments.

Safety during treatment of the patient

Specific safety measures and precautions during patient treatment.

Warning against damage to equipment and the device

Information to prevent damage to the device from incorrect operation.

Set-up and operation

Checks and precautions for device setup and ongoing operation.

Storage and transport

Guidelines for proper storage and transport to prevent damage.

Disposal

Instructions for the correct disposal of the device and components.

Manufacturer's responsibility

Owner's responsibility

Defines the owner's responsibilities for device setup and operation.

Principles

Physical principles

Explains the basic principles of how the shock wave unit functions.

Indications

Lists the medical conditions and applications for which the device is designed.

Contraindications

Lists situations and conditions where the device should not be used.

Side effects

Describes potential side effects that may occur during or after treatment.

Preconditions for operation

Operating personnel

Specifies the qualifications and abilities required for device operators.

Training of the operator

Details the necessary training and instruction for operating the device.

System Description

Control and functional elements

Identifies and describes the various controls and connectors on the device.

F-SW handpiece and optional C-ACTOR handpiece

Describes the handpieces and their optical differences.

Use of stand-off devices

Explains how to use stand-off devices to adjust penetration depth.

Installation Instruction

Scope of supply

Lists all items included in the standard package of the Chattanooga Intelect F-SW.

Unpacking

Provides instructions on how to carefully unpack the instrument and accessories.

Correct positioning of the device

Guidelines for placing the device in its operational location.

Handpiece holder installation

Instructions for mounting the handpiece holder on the device.

Installing the F-SW holding arm (optionally)

Steps for attaching the optional holding arm for the F-SW handpiece.

Connecting power supply cables

Procedure for connecting the device to the mains power supply.

Handpiece connection

Instructions for connecting the F-SW handpiece to the device.

Connecting the optional foot switch

How to connect the optional foot switch to the instrument.

Potential equalisation (optional)

Instructions for connecting the potential equalisation.

USB connection

Details on connecting USB devices for data transfer and input/output.

Transport

Precautions and steps for safely transporting the device.

Compatibility

Lists compatible accessories for the Chattanooga Intelect F-SW.

Operation

User interface

Overview of the device's graphical user interface and controls.

Navigation bars

Explanation of navigation controls for moving through menus.

Parameter entry screen

Details on entering and saving treatment parameters.

Status bar

Information about the status bar icons and their functions.

Parameter display

Explains the display of treatment parameters like energy, shocks, and frequency.

Selection area

Describes the selection area for adjusting treatment parameters.

Overview of menu functions

Provides a flowchart of the device's menu structure and functions.

Parameter entry window

Details on determining treatment parameters and using sub-menus.

1st sub-menu

Explains functions available in the first level sub-menus.

Components

Lists the components of the device with their part numbers.

Warning history

Accessing and viewing past warning and error messages.

Language

Setting the display language for the instrument.

Time

Setting the date and time on the device.

Touch screen calibration

Procedure for recalibrating the touch screen for accurate input.

Draining the water circuit

Instructions for draining the water circuit for maintenance.

Filling the water circuit

Instructions for filling the water circuit.

Bleeding the water circuit

Procedure for bleeding air from the water circuit.

Resetting water renewal time

How to reset or adjust the water renewal reminder.

Software update

Procedure for updating the device's software.

Specification of shock wave number/total energy

Changing the display specification between shock count and total energy.

Autofreq. on/off

Controlling the automatic frequency adjustment feature.

Starting the instrument

Step-by-step guide to powering on and starting the device.

Filling the water circuit

First-time filling of the water circuit and steps involved.

Warm-up phase

Describes the daily warm-up phase and its duration.

Load test

Procedure for performing the daily load test after warm-up.

Setting the treatment parameters

Instructions for adjusting energy, shock count, and frequency for treatment.

F-SW Energy display task

Explains the energy level monitoring and display function.

Storing the treatment parameters

How to save current treatment settings for later use.

Loading treatment parameters

Steps to load previously saved treatment parameters.

Pre-programmed indications from the manufacturer

How to load pre-programmed treatment indications.

In-house applications

Instructions for saving and loading custom 'in-house' treatment applications.

Patient record

Managing patient records for tracking treatment history.

Loading a patient record

Steps to load existing patient records for treatment.

Visual analogue scale (VAS)

Using the VAS to assess and track patient pain intensity.

Setting the VAS value

How to record the patient's pain intensity using the VAS.

Data transfer

Exporting and backing up treatment data and settings.

Exporting treatment data

Process for exporting treatment data to a USB stick.

Backing up the settings

How to save device settings, patient and indication data as a backup.

Restoring the settings

Procedure for restoring device settings from a backup file.

Software updates

Instructions for updating the device's software.

Loading the software onto the USB stick

Instructions for preparing the USB stick for software updates.

Extracting the software using Windows

Steps to extract software files from a ZIP archive on Windows.

Extracting the software with WinZip

Instructions for extracting software using WinZip.

Updating the software on the instrument

Procedure for installing software updates onto the device.

Resetting the treatment shock counter

How to reset the shock counter to zero.

"Autofrequency" function

Controlling the automatic frequency adjustment feature.

Start-up

Step-by-step guide to powering on and starting the device.

Functional checks

Procedures to verify the device's functionality before use.

Standard settings

Recommended initial settings for F-SW and C-ACTOR treatments.

Treatment

Guidance on performing treatments with the device.

Safety information

Essential safety precautions and warnings before starting treatment.

Switching off the device

Instructions for safely powering down the device.

Cleaning, Maintenance and Overhaul

Cleaning the device

Instructions for regular cleaning of the device and its components.

Cleaning the handpiece

Procedures for cleaning and maintaining the handpiece.

Changing the stand-off device

Step-by-step guide to changing the stand-off device on the handpiece.

Reprocessing of the handpiece and the stand-off devices

Procedure for cleaning and disinfecting handpiece parts after use.

Cleaning

Detailed instructions for cleaning the handpiece and stand-off devices.

Disinfection

Procedure for disinfecting the handpiece and stand-off devices.

Cleaning the optional foot switch

How to clean the optional foot switch.

Water renewal

Procedures for renewing the water in the device's cooling circuit.

Draining the water circuit

Instructions for draining the water circuit when the instrument is not in use.

Filling the water circuit

Instructions for filling the device's water circuit.

Bleeding the water circuit

Procedure to bleed air from the water circuit.

Resetting the water renewal time

How to reset or adjust the water renewal reminder.

Fuse replacement

Instructions for safely replacing the mains fuse.

Maintenance and safety checks

Recommended periodic checks for device safety and performance.

Disposal

Guidelines for the environmentally sound disposal of the device.

Repair

Information on authorized repair procedures and personnel.

Service life

Expected service life of the device and its components.

Status messages and trouble-shooting

Status messages

Lists status messages and their meanings.

Trouble-shooting

Common faults, possible causes, and corrective actions.

Accessories

Technical Specifications

Chattanooga Intelect F-SW

General technical specifications for the Chattanooga Intelect F-SW device.

Shock wave source of the F-SW handpiece

Technical details about the F-SW handpiece's shock wave generation.

F-SW handpiece without stand-off device

Technical specifications for the F-SW handpiece without a stand-off device.

F-SW handpiece with stand-off device I (short)

Technical specifications for the F-SW handpiece with short stand-off.

F-SW handpiece with stand-off device II (long)

Technical specifications for the F-SW handpiece with long stand-off.

Shock wave source of C-ACTOR handpiece

Technical details about the C-ACTOR handpiece's shock wave generation.

C-ACTOR handpiece with stand-off device I (short)

Technical specifications for C-ACTOR handpiece with short stand-off.

C-ACTOR handpiece with stand-off device II (long)

Technical specifications for C-ACTOR handpiece with long stand-off.

Software version

Information on how to view the device's software and hardware versions.

Essential performance

Details on essential performance criteria as per IEC/EN 60601-1.

Type plate Chattanooga Intelect F-SW

Information found on the device's type plate.

Conformity with directives

Details on the device's conformity with relevant directives.

Conformity with standards

List of standards the device complies with.

EMC guidelines and manufacturer's declaration

Guidelines for electromagnetic compatibility and manufacturer's declaration.

Certificates

Declaration of Conformity and other relevant certifications.

Symbols and labels

Identifies symbols and labels attached to the front of the device.

Labels and symbols attached to the rear side

Identifies labels and symbols attached to the rear of the device.

Warranty and Service

Warranty for the control device

Details the warranty period and terms for the control device.

Warranty for the F-SW handpiece and the C-ACTOR Handpiece

Warranty terms for the handpieces and wear parts.

Service

Contact information for service inquiries and additional information.

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