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AngioDynamics VenaCure 1470 Pro - User Manual

AngioDynamics VenaCure 1470 Pro
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DGM001357 (User Manual VenaCure 1470 Pro WW) REVISION HISTORY
Revision no.
Description
Prepared by:
Approved by:
Date
00
First release
M. Lusso
E. Rubino
07/05/2018
01
Revision based on FDA feedbacks
E. Rubino
P. Bimbi
16/08/2018
02
Device pictures update
E. Rubino
P. Bimbi
21/09/2018

Table of Contents

Questions and Answers

Summary

1 GENERAL INFORMATION

1.1 Introduction

Device overview, laser type, power, and classification.

1.2 Purpose of the manual

Explains the manual's intended use, audience, and scope of information.

1.3 Manufacturer

Identifies the manufacturer and the device's medical classification.

1.4 Symbols and Abbreviations used in this manual

Lists and explains symbols and abbreviations used throughout the manual.

2 SAFETY INSTRUCTIONS

2.1 General Safety Information

Essential safety rules and guidelines for safe device operation and environment.

2.2 Training of the staff

Specifies the required training and expertise for personnel operating the device.

2.3 Working area

Defines requirements for the laser device working area, including safety measures.

2.4 Eye and skin exposure

Details potential risks of laser beam exposure to eyes and skin, and protective measures.

2.5 MPE and NOHD

Explains Maximum Permissible Exposure (MPE) and Nominal Ocular Hazard Distance (NOHD).

2.6 Potential fire hazard

Discusses fire risks associated with laser use and necessary precautions.

2.7 Emission of plume

Addresses concerns regarding laser plume (vapor/smoke) and recommended capture methods.

2.8 Interference with other devices

Information on potential electromagnetic interference from other devices.

2.9 Emission of toxic gas or vapor

Notes on the potential emission of toxic gases or vapors from laser use.

2.10 Instructions for the device disposal

Guidelines for the proper and legal disposal of the laser device at its end of life.

2.11 Labels

Illustrates and explains all safety, rating, and informational labels on the device.

3 WORKING AREA REQUIREMENTS and INSTALLATION

3.1 Responsibility of the customer

Outlines customer responsibilities for site preparation before device installation.

3.2 Requirements for the electrical connection

Details electrical connection requirements for safe and compliant device operation.

3.3 Temperature and Humidity

Specifies the recommended environmental conditions for device operation.

3.4 Space requirements

Defines minimum room size and clearance needed for device installation and ventilation.

3.5 Installation procedure

Step-by-step guide for unpacking, checking, and installing the laser device.

4 DEVICE DESCRIPTION

4.1 Introduction

General overview of the VenaCure 1470 Pro laser system, its features, and components.

4.2 Electrical controls

Explains the function of the main switch, key switch, and emergency stop button.

4.3 Optical fiber check

Describes how to check the optical fiber's integrity using the aiming beam.

5 OPERATING INSTRUCTIONS

5.1 Startup procedure

Steps to power on the device, initiate system checks, and reach the welcome screen.

5.2 Main Screen

Details the functions and interactive elements of the device's main operating screen.

5.2.1 Fiber INFO area

Displays information about the connected optical fiber, including status and expiration.

5.2.2 Modulation modes

Explains the different laser emission modes: Continuous, Single Pulse, and Continuous Pulsed.

5.3 Main menu

Navigation and functions available within the device's main menu system.

5.4 Program Menu

Options for managing user-defined programs: Save, Save as new, Change name, Erase.

5.5 Settings menu

Allows modification of device settings such as sound levels and beep tones.

5.6 Laser Emission procedure

Steps to prepare the system and safely initiate laser emission after parameter setup.

5.7 Alarms

Describes potential alarms, their messages, and troubleshooting guidance.

5.8 Shut down procedure and protection against authorized use

Instructions for safely turning off the device and preventing unauthorized operation.

6 CLINICAL APPLICATION

6.1 Training requirements

Discusses the necessary training and knowledge for effective laser therapy use.

6.2 Indications for use

Specifies the approved medical uses and applications for the VenaCure 1470 Pro laser.

6.3 Contraindications

Lists medical conditions or patient factors that contraindicate the use of this device.

6.4 Side effects and complications

Details potential adverse reactions, complications, and risks associated with laser therapy.

6.5 Suggested parameters

Notes that specific treatment parameters are left to operator judgment and preference.

7 CALIBRATION and MAINTENANCE

7.1 Calibration and Maintenance

Recommends annual calibration and preventative maintenance by authorized service personnel.

7.2 Service Indicator

Explains the service indicator, wrench symbol, and when system service is required.

7.3 Type and nominal value of the fuses

Details the specifications and types of fuses used in the device's main power connector.

7.4 Device cleaning

Provides instructions for safely cleaning the device's external surfaces and display.

7.5 Optical fiber maintenance

Guidelines for proper handling, inspection, and maintenance of the optical fiber.

7.6 Check the Power cable

Highlights the importance of periodically inspecting the power cable for wear or damage.

7.7 Safety labeling check

Procedure for verifying the integrity and readability of the device's safety labels.

8 TROUBLESHOOTING

9 CUSTOMER SERVICE

9.1 Contact Information

Provides contact details for AngioDynamics customer service for support and inquiries.

9.2 Manufacturer Warranty and Responsibility

Outlines warranty terms, limitations, and the manufacturer's responsibilities.

9.3 Repairs and modifications of the device

Information on authorized personnel for repairs and restrictions on device modifications.

10 TECHNICAL SPECIFICATIONS

10.1 General Specifications

Lists general technical details including model, classification, dimensions, and operating conditions.

10.2 Laser characteristics

Details specific laser parameters such as wavelength, power, pulse modes, and beam properties.

11 ACCESSORIES and DETACHABLE PARTS

11.1 Accessories

Lists included accessories such as user manual, warning signs, test fiber, and goggles.

11.2 Detachable parts

Lists detachable components like power cable, footswitch, and interlock connectors.

Appendix A: EMC Tables

AngioDynamics VenaCure 1470 Pro Specifications

General IconGeneral
BrandAngioDynamics
ModelVenaCure 1470 Pro
CategoryMeasuring Instruments
LanguageEnglish

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