Quantel Medical OPTIMIS FUSION - User Manual

User manual
IV - Maintenance
XL_FUSION_ME_AN_160314
1
1 PREVENTIVE MAINTENANCE
Contact your QUANTEL MEDICAL or your local distributor at least every six months to carry out a preventive
maintenance visit to confirm the correct function of your system.
At each six-monthly visit QUANTEL MEDICAL or your local distributor will clean the optics, check the safety
filter coatings, and check general performance, alignment and calibration of the system.
At least once a year QUANTEL MEDICAL or your local distributor will fully re-calibrate the system and check
ground resistance and earth leakage current (in accordance with IEC 60601-1).
2 CARE AND MAINTENANCE OF THE OPTIMIS FUSION LASER SYSTEM
2.1 CLEANING AND DISINFECTION FOR PATIENT AREAS
The use of the
OPTIMIS FUSION
involves only brief skin contact with the patient, but attention should be
given to the possibility of cross-contamination between patients via the patient contact areas of the system.
These are the chin rest, headrest and steadying handles.
2.1.1 RESPONSIBILITIES FOR CLEANING AND DISINFECTION
The health care facility where the instrument is to be used is responsible for:
1) Determining the level of cleaning and disinfection of patient contact areas required between patients.
2) Appropriate education and training for staff required to carry out cleaning and disinfection.
3) Ensuring that routine cleaning and disinfection methods used in the facility are compatible with the
instrument.
4) Routine cleaning of the entire system.
2.1.2 CLEANING AND DISIFECTION OF PATIENT AREAS
Although cleaning and disinfection procedures and standards within different health care facilities may vary
considerably, the following points are provided as general guidelines:
1) Thorough cleaning of all patient contact areas is recommended for each procedure.
2) Disposable chinrest papers can also be attached to the chinrest area and changed between patients.
3) Manual cleaning can be carried out by wiping all contact areas using a suitable liquid cleaning agent
which is non-corrosive, non-toxic and Iow in residue.
2.1.3 CLEANING THE GONIOSCOPY CONTACT LENSES
The contact lenses for use with the
OPTIMIS FUSION
have a special
low
-
reflectivity coating bonded to
the lens, and they must therefore be handled carefully.
As soon as a lens is removed from the patient’s eye, thoroughly rinse it in cold or warm water to remove
salts, mucous and gonioprism solution. Wash in warm water with a few drops of clear dishwashing liquid,
then rinse with cool water and blot dry. Dry completely before storing in the case.
To effectively disinfect the lens, soak in a solution of sodium hypochlorite 1,2° chl. for a recommended
exposure time of 30 minutes. Rinse thoroughly with cool water and blot dry. Dry completely before storing
in the case.
To sterilize, use ethylene oxide gas with aeration not to exceed 125°F (52°C), following the sterilizer
manufacturer’s recommendation. Remove the lens from the case before sterilizing.
CAUTION:
Do not boil or autoclave a lens. Do not use alcohol, hydrogen peroxide or acetone on a lens, as this will
damage it and render it unusable.

Summary

Care and Maintenance of the Optimis Fusion Laser System

Cleaning and Disinfection for Patient Areas

Focuses on preventing cross-contamination via patient contact areas like chin rest and headrest.

Responsibilities for Cleaning and Disinfection

Outlines the health care facility's duties for cleaning, staff training, and method compatibility.

Cleaning and Disinfection of Patient Areas

Provides general guidelines for cleaning patient contact areas, including disposable papers and manual wiping.

Cleaning the Gonioscopy Contact Lenses

Details careful cleaning, disinfection with sodium hypochlorite, and sterilization methods for contact lenses.

Maintenance of the Optimis Fusion Laser System

Highlights minimal user maintenance required, outlining four routine tasks for trouble-free operation.

External Cleaning of the Optimis Fusion System

Instructions for safely cleaning external surfaces using damp cloths and mild detergents, avoiding abrasives.

Cleaning the Optics

Procedure for cleaning laser head objective lens and oculars using lint-free tissues, solvent, and gentle wiping.

Checking YAG Aiming Beam Accuracy

Procedure to check aiming/treatment beam coincidence using photographic paper, ensuring accuracy for treatment.

Checking SLT Aiming Beam Accuracy

Procedure to verify SLT aiming/treatment beam coincidence using photographic paper for accurate targeting.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features
4. Preventive Maintenance (Professional Service)
5. User-Level Care and Maintenance

The OPTIMIS FUSION is a laser system designed for ophthalmic treatments, specifically incorporating both YAG and SLT (Selective Laser Trabeculoplasty) functionalities. This dual-purpose system allows for a range of anterior segment procedures, offering versatility in a single platform. The design emphasizes user-friendliness and reliability, aiming to provide consistent performance with minimal downtime.

Function Description

The OPTIMIS FUSION system integrates two distinct laser technologies:

• YAG Laser: This component is typically used for posterior capsulotomy after cataract surgery and for peripheral iridotomy in cases of narrow-angle glaucoma. It delivers precise laser pulses to create openings in ocular tissues. The system ensures accurate aiming and treatment beam coincidence (1064nm) for effective and safe procedures.
• SLT Laser: This component is designed for the treatment of open-angle glaucoma. It selectively targets pigmented cells in the trabecular meshwork, improving aqueous humor outflow and reducing intraocular pressure, without causing thermal damage to surrounding tissues. Similar to the YAG laser, the SLT aiming and treatment beam coincidence (532nm) is critical for its efficacy.

The system's core function is to deliver controlled laser energy to specific ocular structures, enabling therapeutic interventions for various eye conditions. Its integrated design allows practitioners to switch between YAG and SLT modes, streamlining workflows and potentially reducing the need for multiple devices.

Usage Features

The OPTIMIS FUSION is designed with several features to enhance usability and patient safety:

• Integrated Slit Lamp: The laser system is typically integrated with a slit lamp, which provides magnification and illumination for precise visualization of the eye during treatment. The slit lamp automatically turns on when the main switch of the OPTIMIS FUSION unit is activated.
• Aiming Beams: Both YAG and SLT functions utilize aiming beams to guide the user to the target tissue. These beams converge to form a single spot, indicating the focal point of the treatment laser. Users can adjust the slit lamp position and eyepieces to achieve optimal focus and alignment.
• Control Module: The system includes a control module with a STANDBY/READY button, allowing the user to select the operational status and fire the laser.
• Magnification Changer: The slit lamp typically features a magnification changer (e.g., x16) to allow for detailed viewing of the target area.
• Adjustable Parameters: Users can adjust various treatment parameters, such as burst mode (for YAG), focus offset (for YAG), and energy levels (for both YAG and SLT), to suit specific clinical needs.
• Patient Contact Areas: The system includes patient contact areas such as a chin rest, headrest, and steadying handles, designed for patient comfort and stability during procedures. These areas are designed for easy cleaning and disinfection.
• Safety Features: The system incorporates warnings regarding the use of appropriate safety glasses for all persons present when the laser is in use and emphasizes ensuring no reflective surfaces are behind the target. It also provides clear instructions on what to do if aiming and treatment beams do not coincide, stressing that the system should not be used on patients in such cases.

Maintenance Features

Regular maintenance is crucial for the OPTIMIS FUSION to ensure its continued performance, accuracy, and longevity. The manual outlines both preventive maintenance and user-level care tasks:

Preventive Maintenance (Professional Service):

• Bi-annual Visits: QUANTEL MEDICAL or local distributors are recommended to perform preventive maintenance visits every six months. These visits include cleaning the optics, checking safety filter coatings, and verifying general performance, alignment, and calibration.
• Annual Re-calibration: At least once a year, a full system re-calibration is performed, along with checks for ground resistance and earth leakage current, in accordance with IEC 60601-1 standards.

User-Level Care and Maintenance:

• External Cleaning: External surfaces of the system should be kept clean using a damp cloth and mild detergents. Abrasive cleaners, solvents, or alcohol should be avoided. The system should be covered with a dust cover when not in use.
• Cleaning and Disinfection of Patient Areas:
  • Thorough cleaning of all patient contact areas (chin rest, headrest, steadying handles) is recommended for each procedure.
  • Disposable chinrest papers can be used and changed between patients.
  • Manual cleaning can be performed using a suitable liquid cleaning agent that is non-corrosive, non-toxic, and low in residue.
  • The healthcare facility is responsible for determining the level of cleaning and disinfection, staff training, and ensuring compatibility of cleaning methods with the instrument.
• Cleaning the Optics:
  • The laser head objective lens and oculars must be kept free of dust, fingerprints, and other contamination.
  • Required equipment: Lint-free optical tissues, cotton swabs, and pure or AR grade ethanol or methanol.
  • Method: Dust removal with a lens brush, followed by gentle wiping with a solvent-moistened tissue or Q-tip in linear strokes. Light pressure is crucial to avoid misaligning mirrors. Tissues/Q-tips should be used once and discarded.
  • Cautions: Never use dry swabs or tissues, as this can damage the surface. If scratching is visible, the system should not be used, and QUANTEL MEDICAL should be contacted.
• Cleaning Gonioscopy Contact Lenses:
  • These lenses have a special low-reflectivity coating and require careful handling.
  • After use, rinse thoroughly in cold or warm water to remove salts, mucous, and gonioprism solution.
  • Wash in warm water with clear dishwashing liquid, then rinse with cool water and blot dry.
  • For disinfection, soak in a 1.2° chl sodium hypochlorite solution for 30 minutes, then rinse and blot dry.
  • For sterilization, use ethylene oxide gas with aeration not exceeding 125°F (52°C), following the sterilizer manufacturer's recommendations. Lenses should be removed from their case before sterilizing.
  • Cautions: Do not boil or autoclave lenses. Avoid using alcohol, hydrogen peroxide, or acetone, as these will damage the lens.
• Checking YAG Aiming Beam Accuracy:
  • This procedure should be performed at least every three months or as needed.
  • It involves attaching photographic paper to an alignment target/focusing bar, firing the YAG laser at low energy, and inspecting the burn mark through binoculars to ensure it coincides with the aiming beam spot.
  • If the aiming beam is not centered or does not coincide with the burn mark, the system should not be used on patients, and QUANTEL MEDICAL must be contacted.
• Checking SLT Aiming Beam Accuracy:
  • Similar to the YAG check, this procedure should be performed at least every three months or as needed.
  • It involves attaching photographic paper to an alignment target/focusing bar, firing the SLT laser at low energy, and inspecting the burn mark through binoculars to ensure it coincides with the aiming beam spot.
  • If the aiming beam is not centered or does not coincide with the burn mark, the system should not be used on patients, and QUANTEL MEDICAL must be contacted.

The comprehensive maintenance guidelines ensure that the OPTIMIS FUSION remains a reliable and accurate tool for ophthalmic procedures, emphasizing both routine user care and professional service.

Quantel Medical OPTIMIS FUSION Specifications

General

Wavelength	532 nm (green)
Power Supply	100-240 VAC, 50/60 Hz
Cooling System	Air-cooled
Spot Size	50-500 μm (Photocoagulation)
Slit Lamp Compatibility	Yes
Operating Modes	Single, Repeat
Display	Touchscreen
Footswitch	Included
Biometry Measurement Range	14 - 40 mm
IOL Calculation Formulas	SRK/T, Holladay 1, Hoffer Q, Haigis
A-Scan Frequency	10 MHz
UBM Frequency	50 MHz
Laser Type	Diode-Pumped Solid-State (DPSS)
Energy Range	50-1200 mW