Olympus IR Series Instructions For Use Manual
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Olympus IR Series Instructions For Use Manual

Olympus IR Series Instructions For Use Manual

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INSTRUCTIONS FOR USE
TELESCOPE
IR
WAIR100A
WAIR130A

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Summary of Contents for Olympus IR Series

  • Page 1 INSTRUCTIONS FOR USE TELESCOPE WAIR100A WAIR130A...

  • Page 3: Table Of Contents

    Contents 1 General information ..............5 1.1 User instructions ..............5 1.2 Signal words ............... 5 1.3 Conventions throughout this document ....... 5 1.4 Trademarks ................. 6 1.5 Manufacturer ............... 6 1.6 Serious incident reporting ........... 7 2 Safety information ..............8 2.1 Intended use ...............
  • Page 4 7 General information for reprocessing ......... 27 7.1 Overview of the reprocessing cycle ........27 7.2 Validated reprocessing methods ........30 8 Cleaning and disinfection ............ 32 8.1 Safety notes for cleaning and disinfection ......32 8.2 Manual cleaning ..............33 8.3 Automated cleaning and thermal disinfection ....

  • Page 5: General Information

    1.1 User instructions ● Before use, thoroughly read the instructions for use. ● If the instructions for use are missing, immediately contact an Olympus representative. ● Keep the instructions for use in a safe, accessible location. 1.2 Signal words The following signal words are used throughout this document.

  • Page 6: Trademarks

    – Cidex OPA ® – One-Step ® are trademarks of their respective owner. 1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany Refer to the contact information for customers included in the scope of delivery for country-specific information.

  • Page 7: Serious Incident Reporting

    General information 1.6 Serious incident reporting If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

  • Page 8: Safety Information

    Safety information 2 Safety information This section provides general safety information for using the telescope. The safety information includes: – Intended use – Contraindications – Necessary user qualifications – Environment of use – General safety notes 2.1 Intended use Telescope intended for visualization using a compatible imaging system for white light imaging and fluorescence imaging.

  • Page 9: User Qualification

    Safety information 2.3 User qualification Medical use This product is only intended to be used by a qualified physician. These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of the product may only be performed by qualified hygiene personnel.
  • Page 10 Safety information ● Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. WARNING Risk of injury to the patient and the user The use of a damaged product or of a product with improper functioning can cause an electric shock, mechanical injury, infection and thermal injury.
  • Page 11 ● Do not attempt to repair or modify the product. ● Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. ● Contact an Olympus representative or an authorized service center for repair information. CAUTION...
  • Page 12 Safety information NOTICE Risk of damage to the product The endoscope is a precise optical device. Careless handling can damage the endoscope. ● Always handle the endoscope with care. ● Do not hold the endoscope by the distal end only. ●...

  • Page 13: Product Description

    – Explanation of symbols – Warranty information 3.1 Scope of delivery Before use, check that all items listed below are available. Contact an Olympus representative or an authorized service center if any items are missing or damaged. WAIR100A, WAIR130A: – Telescope –...

  • Page 14: Operating Elements

    Product description An IR telescope is designed for fluorescence imaging in the near infrared range using indocyanine green (ICG) as dye. A filter exclusively designed for ICG is built into the telescope. Light of suitable wavelength passes through the filter and enhances visualization on compatible imaging systems.
  • Page 15 Product description 3.3.2 Insertion tube Distal end 1) Objective cover glass For viewing the endoscopic image. 2) Light emission surface For illumination of the endoscopic image. 3.3.3 Main body 1) Insertion tube For insertion into the patient. 2) Light-guide connector For connecting the light-guide cable.

  • Page 16: Symbols

    Product description Eyepiece cup 1) Eyepiece cover glass For viewing the endoscopic image. Direction of view The direction of view is indicated in degree on the main body of the telescope. 3.4 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product.

  • Page 17: Warranty

    3.5 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse...

  • Page 18: Before Use

    Before use 4 Before use This section describes all necessary steps to prepare the telescope for use. Full preparation includes the following: – Inspection – Connection of a light-guide cable – Connection of a camera head 4.1 Safety information for preparation WARNING Risk of injury to the patient and the medical personnel Improper and incomplete reprocessing can cause infection of the...

  • Page 19: Inspecting The Telescope

    Before use 4.2 Inspecting the telescope Some reprocessing methods can lead to increased wear of the products. Inspect the products thoroughly before use for traces of wear as described in this section. 4.2.1 Checking for mechanical defects 1. Check that the product has: –...

  • Page 20: Connecting The Telescope

    Before use 4.2.3 Checking the light transmission 1. Hold the distal end of the telescope against a lamp. 2. Look into the light-guide connector of the telescope. Black dots indicate damaged light-guide fibers. 3. Only use the telescope if less than 25 to 30% of light-guide fibers are damaged.
  • Page 21 Before use 2. Connect the light-guide cable to the light-guide connector of the telescope. 3. Screw the light-guide cable onto the thread of the light-guide connector until it stops. Make sure that the light-guide cable is fully connected to the telescope.

  • Page 22: Use

    5 Use This chapter describes safety information for use and provides information on how to use regular visible light imaging and fluorescence imaging. 5.1 Safety information for use WARNING Risk of injury to the patient There is a risk of electric shock if the following conditions apply simultaneously: –...
  • Page 23 – burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials). ● Do not place the endoscopic equipment on the patient’s skin, on flammable materials, or on heat-sensitive materials. ● Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area.

  • Page 24: Using Visible Light Imaging

    CAUTION Risk of injury to the user There is a risk of damaging the eye when looking into the distal end of the endoscope and the light source is switched on. ● Do not look into the distal end of the endoscope when the light source is switched on.

  • Page 25: After Use

    After use 6 After use CAUTION Hot light-guide connector can cause burns The light-guide connector on the telescope becomes hot during use. There is a risk of burns when touching the light-guide connector directly after use. ● Let the telescope cool down after use. 6.1 Disconnecting the telescope 1.

  • Page 26: Preparation For Reprocessing At The Point Of Use

    ● Reprocess this product immediately after use. Do not leave used instruments overnight before reprocessing. ● Olympus recommends to return the product from the point of use to the reprocessing area in dry condition to avoid protein fixation caused by detergents or disinfectants.

  • Page 27: General Information For Reprocessing

    General information for reprocessing 7 General information for reprocessing This chapter provides basic safety information for reprocessing. It also provides a general overview of the reprocessing cycle and the compatible reprocessing methods for the product. The products are delivered in unsterile condition. Reprocess the products before first and each subsequent use.
  • Page 28 General information for reprocessing The following sections of these instructions for use include detailed information on every validated reprocessing method.
  • Page 29 General information for reprocessing Preparation for reprocessing at the point of use Refer to section “6.2 Preparation for reprocessing at the point of use” on page 26. Select manual cleaning or automated cleaning method. Manual cleaning Automated cleaning Refer to section “8.2 Manual and thermal cleaning”...

  • Page 30: Validated Reprocessing Methods

    They also provide standardized and validated procedures. Olympus recommends steam sterilization Olympus recommends to use steam sterilization for the product. 7.2 Validated reprocessing methods In accordance with ISO 17664, the following table provides an overview over the reprocessing methods that are validated for the microbiological efficacy of the product.
  • Page 31 General information for reprocessing Phase Method Compatibility WAIR100A WAIR130A Cleaning and Preparation Selection according to the reprocessing method disinfection Cleaning Manual Ultrasonic – Alkaline detergent Acidic detergent Neutral detergent Automated Alkaline detergent Acidic detergent Neutral detergent Rinsing Disinfection Manual Automated Chemical Thermal Sterilization...

  • Page 32: Cleaning And Disinfection

    Cleaning and disinfection 8 Cleaning and disinfection This section describes all necessary steps for cleaning and disinfection of the product. This is a prerequisite for the subsequent sterilization steps. 8.1 Safety notes for cleaning and disinfection Compatible detergents and disinfectants Cleaning and disinfection avoid infections of patients and the medical personnel.

  • Page 33: Manual Cleaning

    – Brushes must not have metal bristles or any other types of bristles that can scratch and damage the product 8.2.2 Validated detergent Olympus has validated manual cleaning of the product with the following detergent: – Neodisher MediZym 0.5% manufactured by Chemische Fabrik Dr.
  • Page 34 Cleaning and disinfection 8.2.3 Manually cleaning the product A complete manual cleaning cycle consists of 3 steps: – Cleaning – Rinsing – Drying Specific instructions for these steps are given on the following pages. Cleaning 1. Create a detergent solution as instructed by the manufacturer of the detergent.

  • Page 35: Automated Cleaning And Thermal Disinfection

    Do not use instrument trays made from plastic material for automated cleaning. They are designed for sterilization only. 8.3.1 Validated detergents Olympus has validated automated cleaning of the product with the following detergent and neutralizer: Detergent – Neodisher MediClean forte manufactured by Chemische Fabrik Dr.
  • Page 36 Cleaning and disinfection – Selecting programs for the washer-disinfector – Removing the product from the washer-disinfector Specific instructions for these steps are given on the following pages. 8.3.3 Preparing for automated cleaning WARNING Unwashed areas in plastic instrument trays can cause infection Detergents cannot come in contact with all parts of the product in the plastic instrument tray.

  • Page 37: Inspection And Maintenance

    – Pre-cleaning – Cleaning – Neutralization – Final rinsing with deionized water Olympus has validated automatic cleaning with the following program: – Vario TD program – Pre-cleaning for 4 min. – Cleaning for 10 min. at 55 °C (131 °F) –...
  • Page 38 Cleaning and disinfection 2. Check that the telescope has: – no dents, cracks, kinks, or deformations – no deep scratches – no corrosion – no lens damages or cover glass damages – no missing or loose parts 3. Check all markings on the telescope for clear visibility. 4.

  • Page 39: Sterilization

    The product must be completely dry before sterilization. Steam sterilization in Olympus plastic instrument trays Olympus plastic instrument trays are only compatible with steam sterilization. They cannot be used for any other sterilization method. Sterilization wraps and pouches Use only sterilization wrap and pouches that are certified for the selected sterilization method.

  • Page 40: Selecting Compatible Sterilization Methods

    – Removing the product from the autoclave Specific instructions for these steps are given on the following pages. 9.3.1 Validated sterilization accessories Olympus has validated steam sterilization of the product with the following sterilization accessories: – Broemeda sterilization wrap manufactured by Broemeda...
  • Page 41 – Temperature: 132 °C (269.6 °F) – Holding time: 3 min. Drying time For steam sterilization, Olympus recommends a drying time of at least 15 to 30 minutes. ● Choose a suitable drying time, depending on the autoclave. ● Refer to the autoclave’s instructions for use.

  • Page 42: Hydrogen Peroxide Plasma Sterilization (Sterrad)

    Allergic reaction due to Olympus plastic instrument trays Olympus plastic instrument trays are not compatible with hydrogen peroxide plasma sterilization. Using hydrogen peroxide plasma sterilization in an Olympus plastic instrument tray can cause allergic reactions of the patient. ● Only use plastic instrument trays that are certified for hydrogen peroxide plasma sterilization by their manufacturer.

  • Page 43: Vaporized Hydrogen Peroxide Sterilization (Steris)

    Consult local guidelines and hospital protocols. 5. Select a compatible sterilization system and cycle. 9.4.3 Validated sterilization systems Olympus has validated hydrogen peroxide plasma sterilization of the product in the following sterilization systems and cycles: – Sterrad 100S: short cycle and long cycle –...
  • Page 44 Sterilization 9.5.1 Validated sterilization accessories Olympus has validated vaporized hydrogen peroxide sterilization of the product with the following sterilization accessories: – 10x21 Steris sterilization tray (model number: VP0004) – H600 One Step sterilization wrap ® 9.5.2 Preparing the product for sterilization 1.

  • Page 45: Repair, Shipment And Disposal

    10 Repair, shipment and disposal This section provides instructions how to contact Olympus for any repairs and how the ship the product to Olympus for repair or warranty claims. Information on how to dispose of the product are located at the end of this section.

  • Page 46: Shipment

    10.2 Shipment WARNING Risk of infection for the servicing personnel Sending used products to Olympus represents a risk of infection for the personnel. Olympus is entitled to refuse soiled or contaminated products for reasons of safety. ● Reprocess the product before sending in.

  • Page 47: Compatible Equipment

    Compatible equipment 11 Compatible equipment Olympus recommends the use of equipment as listed in this chapter. If combinations are used that are not listed in this chapter, the user takes the full responsibility. Future equipment can also be compatible. For more information, contact an Olympus representative.

  • Page 48: Visible Light Imaging

    Compatible equipment 11.1 Visible light imaging OTV-S300 OTV-S200 WA03310A A0460 A0464 O0332 WAIR100A A5822 A5859 WAIR130A CH-S200-XZ-EB CH-S200-XZ-EA WA05990A A5940...

  • Page 49: Fluorescence Imaging

    Compatible equipment 11.2 Fluorescence imaging CLV-S200-IR WA03310A OTV-S200 OTV-S300 A0464 A0460 O0332 A5822 WAIR100A WAIR130A A5859 CH-S200-XZ-EB CH-S200-XZ-EA WA05990A A5940...

  • Page 50: Technical Data

    Technical data 12 Technical data This section provides all technical data of the telescopes. The technical data includes information on: – Diameter (maximum insertion portion width) – Working length – Direction of view – Field of view – Ambient conditions 12.1 General dimensions Working length WAIR100A ..............
  • Page 51 Technical data Storage conditions Temperature .........10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85% Transport conditions Temperature ........−40 to 70 °C (−40 to 158 °F) Relative humidity ............10 to 95%...
  • Page 56 W7513700_08 2021-02-08 © Copyright 2021 Olympus Winter & Ibe GmbH...

This manual is also suitable for:

Wair100aWair130a

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