Quantel Medical Aviso - User Manual

XE AVI MT AN APRIL 2009
QUANTEL MEDICAL SAS
Head Office : 21, rue Newton, Z.I. du BREZET
63039 - Clermont-Ferrand cedex 2 - FRANCE
Tel: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
E-mail: contact@quantel-medical.fr
Web site: www.quantel-medical.fr
SERVICE MANUAL
OPHTHALMIC ECHOGRAPH
BIOMETRY AND IOL CALCULATION

Summary

Warnings and Safety Information

Warranty Terms and Conditions

Details warranty terms, CPU board replacement policy, and voiding conditions for unauthorized repairs.

Technical Specifications

Classification and Standards

Specifies the system's classification regarding electric security and protective class according to EN 60 601-1.

Electrical Requirements

Details the power supply voltage, frequency, and maximum power consumption for the device.

Compliance Information

Outlines the device's compliance with European directives and electromagnetic compatibility standards.

Device Dimensions

Provides the global size and user interface touch screen dimensions in metric and imperial units.

Environmental Conditions

Specifies the required operating and storage temperature and humidity ranges for the device.

Minimum Computer Requirements

Lists the minimum hardware specifications for a computer to be used with the Aviso device.

Overall Block Diagram

Disassembling Procedures

Cover Removal Steps

Provides step-by-step instructions and diagrams for removing the device cover for access.

Device Subsystem Components

Introduces the device subsystem and its components, focusing on the touch screen and CPU board.

Touch Screen and CPU Board Disassembly

Details the procedure for disassembling the touch screen block and CPU board, with a warning about fragility.

Interface Board Removal

Explains how to remove the interface board, including disconnecting B-probe connectors and unscrewing.

Power Supply Board Removal

Describes the process of disconnecting connectors and removing the power supply board from the device.

Special Unmounting and Mounting

Covers specialized procedures for unmounting and mounting components, focusing on the touch screen.

Touch Screen Block Disassembly

Provides detailed steps for disassembling the touch screen block, including screw removal and cable disconnection.

Touch Screen Block Assembly

Details the procedure for assembling the touch screen block, including placing new joints and securing the screen.

Maintenance Procedures

Touch Screen Calibration

Explains how to calibrate the touch screen sensitivity after transport, repair, or software changes.

Fuse Replacement Guide

Provides instructions for replacing fuses, including fuse specifications and a caution to disconnect power.

Probe Calibration Process

Guides on calibrating Biometry and ProBeam probes for correct marker positioning, especially after software updates.

Software Operations

Database Management

Details procedures for saving and managing the device database across different software versions (1.x, 2.x, 3.x).

Saving 1.x Software Database

Instructions for saving the database file (BusBdataAxl.mdb) for the 1.x software version.

Saving 2.x Software Database

Instructions for saving the database file and specific folders for the 2.x software version.

Saving 3.x Software Database

Instructions for saving database files and folders for the 3.x software version, noting OS differences.

Upgrading 1.x Software Database

Explains how to upgrade the 1.x database to 2.x or 3.x using UpdateAvisoDatabase, including UAC considerations.

Module Software Release

Describes probe differentiation in software 3.0.0, icon changes, and obtaining new CD-ROM parameters.

Computer Upgrade Software Installation

Guides on installing the UsbProg software on a computer (Windows XP), including folder selection and user preferences.

Module Software Release Procedure

Details how to release the module software using the USB Prog shortcut, selecting a script file, and running the process.

Validation and Revision Information

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Aviso is an ophthalmic echograph designed for biometry and IOL (Intraocular Lens) calculation. It is a medical device used in ophthalmology for diagnostic purposes, specifically for measuring the eye's axial length and other parameters necessary for calculating the power of an IOL before cataract surgery.

Function Description

The core function of the Aviso is to perform ophthalmic echography, which involves using ultrasound waves to create images and measurements of the eye's internal structures. This is crucial for biometry, the measurement of biological parameters, particularly the axial length of the eye, anterior chamber depth, lens thickness, and vitreous length. These measurements are then used in conjunction with various IOL calculation formulas to determine the appropriate IOL power for each patient, ensuring optimal post-operative vision.

The device supports both A-scan and B-scan modes. A-scan (amplitude scan) is primarily used for precise axial length measurements, providing a one-dimensional display of echoes from different ocular structures. B-scan (brightness scan) provides a two-dimensional, cross-sectional image of the eye, which is useful for visualizing ocular pathologies, especially when the ocular media are opaque (e.g., dense cataract, vitreous hemorrhage), preventing direct visualization.

The Aviso system integrates a main unit, which houses the core electronics, and various probes for different types of examinations. The main unit includes a touch screen for user interaction and display. The system is designed to connect to an external computer (laptop or personal computer) via a USB link, allowing for more extensive data management, software operation, and display on a larger screen. The external computer runs the Aviso software, which provides the interface for performing exams, managing patient data, and performing IOL calculations.

The device features different types of probes:

• Biometry probes (A-probes): These are used for axial length measurements and IOL calculations. The manual mentions TP-01 and TP-02-las probes, with the latter potentially incorporating a laser diode for alignment.
• B-probes: These are used for 2D imaging. The manual lists 10 MHz B-probes (short and long focus), 20 MHz B-probes (short and long focus), and linear probes (25 MHz and 50 MHz). The higher frequency probes offer better resolution for superficial structures.
• ProBeam probes: These are specifically mentioned in the context of the 3.0.0 software version, suggesting a specialized probe type, possibly for enhanced biometry or other specific measurements.

The system's block diagram illustrates the signal flow:

• Power Supply: Converts AC input (100-240 V) to 12 Vdc for the Aviso module.
• Probe Selection & Emitter/Receiver Control: Manages which probe is active and controls the ultrasound emission and reception.
• A-scan Pulser & Receiver: Handles the A-scan ultrasound generation and echo detection.
• B-10 Driver & Receiver: Specifically for 10 MHz B-probes.
• B-HF Driver & Receiver: For high-frequency B-probes (20 MHz and 50 MHz linear probes).
• Digital/Analog Converter: Processes the analog signals from the receivers into digital data.
• Memory: Stores data within the Aviso module.
• USB Interface & Link: Connects the Aviso module to the external computer.
• User Interface Touch Screen: Allows direct interaction with the Aviso module.
• Digital Potentiometer: Likely for gain or other parameter adjustments.
• Footswitch: Provides hands-free control during examinations.

The software on the external computer plays a critical role in data management, including patient and physician files, probe calibration data, and keycode information. It also manages cineloop savings (short video clips of ultrasound scans) and stores all exam data, organized by physician and patient names.

Usage Features

The Aviso is designed for continuous operation, indicating its suitability for busy clinical environments. The user interface on the device itself is a touch screen, allowing for intuitive control. The ability to connect to an external computer enhances usability by providing a larger display and more comprehensive software features for data analysis and management.

The system's design emphasizes ease of use for IOL calculation, a critical step in cataract surgery planning. The software guides the user through the process of selecting probes, performing measurements, and applying IOL formulas. The differentiation between biometry and ProBeam probes, along with visual cues like colored icons in the software, helps prevent measurement errors by ensuring the correct probe is selected for the intended examination.

The inclusion of a footswitch allows the user to trigger measurements or capture images without needing to touch the device, which can improve workflow and maintain sterility during exams.

Maintenance Features

The manual provides detailed instructions for several maintenance procedures, highlighting the importance of proper handling and authorized intervention.

• Disassembly: Step-by-step instructions are provided for removing the cover, accessing internal components like the CPU board, interface board, and power supply board. This is crucial for troubleshooting, component replacement, or internal cleaning. The process involves unscrewing specific screws and carefully unplugging cables.
• Touch Screen Block Disassembly and Assembly: Given the fragility of the touch screen, a dedicated, detailed procedure is outlined for its removal and reinstallation. This includes using specific tools (e.g., 1.25 Allen key), carefully handling flat cables, and ensuring proper placement of flat strip joints and the tactile glass. A critical warning is given against overtightening screws during assembly, as this can damage the tactile glass or cause disfunction.
• Touch Screen Calibration: This is a key maintenance feature, necessary after transport, screen replacement, or software upgrades. The calibration procedure ensures the touch screen accurately registers user input. It involves a sequence of pressing 'START', 'P', and the four corners of the screen, with a recommendation to use a thin plastic stick for better results. The calibration can be saved, aborted, or restarted.
• Fuse Replacement: Instructions are provided for replacing the main fuses, located at the rear of the Aviso. This involves pulling out the fuse block and replacing the glass fuses (1 AT - 250V, 5 x 20 mm).
• A-probe Calibration: This procedure is essential for ensuring accurate biometry measurements. It involves using a test block to verify the probe's accuracy and adjusting the "Position of marker #1 in Contact" and "Zero (Probe)" parameters in the software to achieve a precise 10.00mm measurement on the test block. The manual emphasizes that this adjustment is reserved for technicians.
• Software Management:
  • Database Saving: Instructions are provided for saving the database for different software versions (1.x, 2.x, 3.x). This involves backing up specific files (BusBdataAxl.mdb) and folders (Cineloop, Data, Probes) that contain patient data, exam results, and probe parameters. The location of these files varies depending on the Windows operating system and UAC (User Account Control) settings.
  • Database Upgrade: The "UpdateAvisoDatabase" software is used to upgrade the database from 1.xx to 2.xx or 3.xx versions. For Windows Vista 32-bit systems, it's noted that UAC must be un-activated for the upgrade to proceed.
  • Module Software Release (Upgrade): The manual details how to install and run the "USB Prog" software on an external computer to upgrade the Aviso module's internal software. This process involves selecting a script file (FlashBCont102.scr) and clicking "Prog Device" to initiate the update. The progress is visualized, and the module restarts upon completion. This upgrade is important for displaying correct probe icons and preventing measurement errors due to incorrect probe selection.
  • Probe Parameter Updates: For new Aviso orders or unit upgrades, it's mentioned that new CD-ROM parameters for probes are necessary to display correct icon colors in the software. This requires contacting Quantel Medical and performing a probe calibration after installing the new parameters.

The overall maintenance philosophy emphasizes careful handling, adherence to specific procedures, and the importance of authorized personnel for certain adjustments, particularly those affecting measurement accuracy.

Quantel Medical Aviso Specifications

General

Category	Medical Equipment
Manufacturer	Quantel Medical
Model	Aviso
Type	Ultrasound Biomicroscope
Frequency	50 MHz
Image Acquisition	Real-time
Applications	Ophthalmology
Dimensions	Compact design
Weight	Lightweight for portability
Power Supply	AC power
Connectivity	USB