RIMSA OBSERVA L88-LED-M User Manual

Observation lamp

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USER MANUAL FOR OBSERVATION LAMP
ALFA-FIX
ALFA-FLEX
RIMSA P. LONGONI s.r.l. - Via Monterosa, 18/20/22 – 20831 SEREGNO (MB) ITALY
Introduction
Dear User, you are kindly invited to read this manual carefully before proceeding to use the Product in
order to safeguard yourself and other people from any injuries.
This appliance is a Class 1 medical device pursuant to REGULATION (EU) 2017/745 on medical devices
(Annex VIII) as amended and integrated.
The manufacturer declares that this Product complies with Annex I (General Safety and Performance
Requirements) of REGULATION (EU) 2017/745 as amended and integrated and certifies such
conformity by affixing the CE marking.
The Product is classified in risk group 1 according to IEC 62471 standard (Photobiological Safety of
Lamps).
This User manual is valid for the following models:
-
ALFA-FIX/ALFA-FLEX
L88-LED-M
-
(GIMANORD)
-
PRIMA-FIX/PRIMA-FLEX
The customer service is at your disposal in case of Product details, information concerning its use,
identification of spare parts being required and for any other queries you might have concerning the
appliance, for ordering spares and for matters relating to assistance and warranty.
RIMSA P. LONGONI SRL
Via Monterosa 18
I-20831 Seregno MB
Tel.: ++39 0362 325.709
Fax: ++39 0362 328.559
e-mail: info@rimsa.it
If the device causes the death or serious deterioration of the patient's or user's health conditions,
contact the manufacturer and the competent state authority where the event occurred.
The contents of this Manual may be amended by RIMSA, without prior notice or any further obligations,
in order to make changes and improvements. The reproduction and translation, including partial, of
any part of this manual is forbidden without the written permission of RIMSA.
RIMSA reserves the right to change, cancel or otherwise amend the data contained in this document
at any time and for any reason without prior notice inasmuch as RIMSA is constantly seeking new
solutions which lead to product evolution. RIMSA therefore reserves the right to make changes to the
supplied Product in terms of shape, fittings, technology and performances.
With regard to translations into languages other than Italian, reference shall always be made to the
Italian edition of this User manual.
USER MANUAL
OBSERVA SERIES
L88-LED-M
(GIMANORD)
Tel. +39 0362 325.709 Fax +39 0362 328.559
http://www.rimsa.it e-mail: info@rimsa.it
MO091-EN
15/05/24
Rev.6
Page 1 of 25
PRIMA-FIX
PRIMA-FLEX
EN

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Table of Contents
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Summarization of Contents

Introduction
Product Context
Provides context and general information about the product.
General Information
Operator Qualifications
Defines required qualifications for product operators.
Packaging, Transport, and Storage Guidelines
Details packaging, transport, and storage conditions.
Product Symbol Guide
Explains symbols found on the product and in the manual.
EU Declaration of Conformity
States conformity with EU regulations and standards.
Warranty Certificate Details
Outlines warranty terms and conditions for the product.
Personal Safety and Intended Use
Product Intended Use
Specifies the product's intended application and purpose.
Safety Precautions and Hazards
Lists crucial safety precautions and potential hazards.
Environmental Operating Conditions
Describes suitable environmental operating conditions.
Pre-Use Safety Checks
Outlines mandatory pre-use checks for safe operation.
Product Installation Guide
Table Mount Installation
Details the procedure for table-mounted installation.
Wall Mount Installation (S/12 MED)
Explains how to install the wall-mounted version.
Wall Mount Installation (Bar Rail)
Describes installation using a bar rail system.
Floor Stand Installation (RL)
Details the installation of the floor-standing version.
Handpiece Attachment (PRIMA Models)
Instructions for fitting the sterilizable handpiece.
Initial Power-Up Procedure
Guide for the initial power-up and basic checks.
Post-Installation Verification
Verifies correct installation and initial product functionality.
Product Description and Operation
ALFA-FIX and ALFA-FLEX Operation
Explains the operation of ALFA-FIX/ALFA-FLEX models.
L88-LED-M (GIMANORD) Operation
Details the operation of the L88-LED-M model.
PRIMA-FIX and PRIMA-FLEX Operation
Covers the operation of PRIMA-FIX/PRIMA-FLEX models.
Cleaning, Disinfection, and Sterilization
Product Cleaning Instructions
Provides instructions for cleaning the product.
Product Disinfection Instructions
Outlines the process for disinfecting the product.
Handpiece Sterilization Procedures
Details sterilization procedures for the handpiece.
Adjustments and Maintenance
Annual Operator Inspections
Specifies requirements for annual operator inspections.
Product Repair Information
Information on product repairs and restrictions.
Clutch Tension Adjustment
Instructions for adjusting clutch tension on arm joints.
Troubleshooting Common Issues
Lists common problems and their solutions.
Routine Maintenance Schedule
Outlines regular maintenance tasks.
Available Spare Parts
Lists available spare parts and their order codes.
Technical Specifications
ALFA-FIX/ALFA-FLEX Specifications
Detailed technical specifications for ALFA-FIX/ALFA-FLEX.
L88-LED-M (GIMANORD) Specifications
Detailed technical specifications for L88-LED-M.
PRIMA-FIX/PRIMA-FLEX Specifications
Detailed technical specifications for PRIMA-FIX/PRIMA-FLEX.
Wiring Diagrams
ALFA-FIX and L88-LED-M Wiring
Electrical wiring schematic for specific models.
PRIMA-FIX and PRIMA-FLEX Wiring
Electrical wiring schematic for PRIMA-FIX/PRIMA-FLEX.
EMC Declaration and Immunity
Emissions Compliance Standards
Details RF and harmonic emissions conformity.
Electrical Disturbance Immunity Tests
Lists immunity tests for ESD, RF, surge, etc.
Proximity Field Immunity Testing
Covers immunity to radio-frequency fields and magnetic fields.

Table of Contents