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CooperVision Onefit Instructions For Use Manual

Rgp contact lenses

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Manufacturer and registered owner: CooperVision Israel Ltd, Bar-Lev, 2015600, IL
Telephone number: 04-9955600
General Inquiries & Technical Support:
CooperVision CL Kft.
Gorcsev Iván street 7. Building C. 2360 Gyál Hungary
All information in this manual is believed to be correct. CooperVision shall not be liable for
errors contained herein with the performance or use of this manual.
1. Introduction
This operator's manual provides the information necessary to safely wear of RGP Contact
Lenses for annual replacement schedule.
DOC026 Revision: 7
Revised Date: August 7 ,2022
RGP Contact Lenses
Instruction For Use
contact@coopervision.co.il
Page 1 of 13

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Summarization of Contents

RGP Contact Lens Device Description
Product Names and Indications
Details RGP contact lens types, their indications, and trade names.
Intended Use and Indications for RGP Lenses
Daily Wear and Orthokeratology Applications
Explains uses for daily wear and orthokeratology for myopia correction.
Packaging and Storage Requirements
Lens Packaging and Storage Guidelines
Describes how lenses are supplied and storage requirements.
Warnings and Precautions for RGP Lenses
Health Conditions Prohibiting Lens Wear
Lists health conditions and symptoms that contraindicate lens wear.
Safety Warnings During Lens Use
Highlights risks of water exposure, injury from improper use, and overnight wear.
RGP Lens Care Regimen and Safety Protocols
General Lens Care and Solution Usage
Instructions on hand hygiene, using recommended solutions, and avoiding contamination.
Safe Handling and Wearing Practices
Lens Inspection and Handling Techniques
Details on inspecting lenses, hand hygiene, and avoiding damage during handling.
Environmental and Occupational Safety for Wearers
Advises on avoiding fumes, informing employers, and follow-up visits.
Usage Restrictions and Adverse Event Identification
Restrictions on RGP Lens Use
Emphasizes personal use and initial lens cleaning/soaking procedures.
Identification of Adverse Events
Identifies potential adverse events that may occur during lens wear.
RGP Lens Fitting and Operating Procedures
Professional Lens Fitting Process
Explains that lenses are fitted by an Eye Care Practitioner (ECP).
Step-by-Step Lens Insertion and Removal
Step-by-step instructions for inserting and removing RGP contact lenses.
RGP Lens Wearing Schedule Recommendations
Daily Wear Schedule Guidelines
Provides a table of maximum suggested wearing times for daily wear RGP lenses.
Orthokeratology Wearing Schedule
Recommends a guideline sequence for Ortho-K lens wearers.
Comprehensive RGP Lens Care Directions
General Lens Cleaning and Hygiene
Covers hand hygiene, using fresh solutions, and following system instructions.
Lubricating Solutions and Lens Case Management
Using Lubricating and Rewetting Solutions
Guidance on using solutions to improve lens comfort during wear.
Lens Case Cleaning and Maintenance Best Practices
Instructions for cleaning and maintaining lens cases to prevent bacterial growth.
Sticking Lens Care and Product Disposal
Procedure for a Sticking Contact Lens
Procedure to follow if a lens adheres to the eye.
Safe Disposal of RGP Contact Lenses
Information on the annual disposal of RGP contact lenses.
Emergency Procedures and Adverse Reaction Reporting
Emergency Response for Eye Exposure
Actions to take in case of contact with hazardous substances or environments.
Reporting Serious Adverse Reactions
Instructions for reporting serious adverse experiences to CooperVision and authorities.