LaserSecure
Durette III External Laser Shields Instructions for Use
20 Pages
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e Durette® III External Laser Shields ... 1 f Protecteurs laser externes Durette® III ... 3 d Durette® III Laserschutzschilde ... 6 s Protectores láser externos Durette® III ... 9 i Occhialini protettivi Durette® III ... 12 h
Durette® III Uitwendige Laser Oogafdekkingen ... 14
p Protetores Externos Contra Laser Durette® III ... 17
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CAUTION, consult accompanying documents.
Get our instructions for use at oculoplastik.com.
This Product is sold Non Sterile. This Product (elastic) Contains Dry Natural Rubber (latex).
This stainless steel (surface treated) eye wear covers all wavelengths. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT. After every case application and before cleaning and sterilization, always verify visually and manually the condition of all surfaces of the metal cups, of the nasal and temporal attachments and of the elastic headband. Before each use, make sure that the plastic attachments are properly inserted onto the ball on the metal eye shields (fig. 1). Verify that they swivel loosely without force. Never use forceps, pliers or any type of tools to attach or remove the attachments (fig. 2).
USE ONLY ORIGINAL REPLACEMENT ATTACHMENTS. DURETTE® III EXTERNAL LASER SHIELDS INSTRUCTIONS FOR USE READ ALL INSTRUCTIONS BEFORE USING THIS PRODUCT.
The nasal and temporal plastic attachments require a slight force during assembly to insert and remove from the ball on the eye shields and should be well fastened to the eye shields before each use. IU17 (08)
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To prevent entrance of light the metal cups must be held securely in place over the eyes (by the doctor or O.R. personnel) while moving the plastic attachments during a procedure.
The surgeon should control the proper placement and positioning of the Durette® III at all times. After the placement and positioning of the eye shields over the lids and before any procedure the patient can verify and confirm to the surgeon that there is no entrance of ambient light. The patient must keep the eyes closed at all times during the procedure.
WARNING Do not use with ANY SYSTEMS that are integrated with RF (radio-frequency). Due to the electrical current from the RF, metal will conduct and retain heat causing burns to the surface of the skin.
We have designed the Durette® externals as small as possible to still provide maximum protection of the patient for periorbital and temporal procedures without pressing the globe.
Do not use any device that is scratched or damaged. Any scratch on the non-reflective surface of the device renders it reflective and dangerous and may cause burns to the surface of the skin of the O.R. personnel.
WARNING: when working any closer, internal laser shields should be used.
Do not use any device that has been dropped accidentally without thorough examination of its condition.
Lasers and other light sources should always be aimed away from the ocular globe and away from the plastic temporal and nasal pieces.
The plastic temporal and nasal pieces must be inspected after every procedure for cracks, change of color or any damage to the plastic from the light beam sources. Dispose of them immediately and replace them with new ones if any visible changes are apparent.
THE ELASTIC HEADBAND SHOULD NEVER BE TIED FOR ADJUSTMENT. The elastic headband must always be adjusted by sliding the side fasteners in order to ensure a comfortable and secure fit (fig. 5). The adjusting of the side fasteners renders the eyewear tighter or looser according to the need of each patient in order to ensure there is no entrance of light. If the elastic headband is too tight, the nasal area may open allowing entrance of light and may also render the eyeshields uncomfortable. If the elastic headband is too loose the eye shields may not block all light from the edges. Before every procedure the eye shields must be properly positioned on the patient and the elastic headband must be well adjusted. The patient should open his/her eyes to verify for any entrance of light. The patient must close his/her eyes before the procedure begins.
Avoid direct light beam impact onto the plastic temporal and nasal pieces. Direct light beam impact will damage the plastic causing breakage and dislodging of the shields during a procedure exposing the eyes to potential dangerous lasers, lights, or energies. Accidental exposure of the eyes during a procedure may result in serious personal injury, burns, or blindness. Do not use any black or dark colored markers on the plastic attachments. The dark colors will attract the light beam and will destroy the plastic causing the shields to dislodge, which may result in serious personal injury, burns, or blindness.
Our LaserSecure® shields and instruments are made of high quality stainless steel with a non-reflective finish. Even though these devices are low maintenance, they must be handled with extreme care in order to maintain their quality and safety performances. To ensure protection of the patient and the O.R. personnel a yearly refurbishing is suggested,
Verify that the Durette® III eyewear is completely covering the eyelids by adjusting the elastic headband attached on the plastic temporals or on the hooks on the eyecups themselves (fig. 3 and 4). Always transport the Durette® eyewear in a hard box such as the case provided. -2-
although the condition of the shield or instrument will give a better indication.
Before sterilizing the external shields, separate the plastic attachments from the metal shields.
DECONTAMINATION
To sterilize the plastic temporal and nasal pieces follow the instructions of the sterilizing solution manufacturer.
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Immerse the instruments in a decontaminating solution and follow the manufacturer’s instruction. • Avoid the use of chlorine that may corrode the stainless steel instruments.
STEAM AUTOCLAVE Steam sterilize following a validated cycle according to your institution’s standards OR the following recommended parameters.
CLEANING PROCEDURE FOR THE DEVICES
Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the following recommended parameters.
Devices must be cleaned before sterilization. Use procedures that have been previously established and validated for your institution or use the following recommendations. • • • • •
Mild soap solution and soft bristled toothbrush Ultrasonic procedure for at least 5 minutes Using a washing machine Dry instruments quickly and completely Rinse extensively with distilled or demineralized water after cleaning.
Temperature
Exposure Time
Dry Time
UK Prevacuum
134°C (273°F)
3 minutes
30 minutes
Prevacuum
132°C (270°F)
4 minutes
30 minutes
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If you cannot remove stains from your shields or instruments we may be able to restore the surface qualities by refurbishing the instruments for a minimal cost. • Please note that in severe cases of pitting or corrosion, refurbishing may not be possible. • We will evaluate your shields or instruments at no cost and inform you of our suggestions and/or cost evaluation. • Please do not return any shields or instruments without a return authorization number. (Shipping and handling is the responsibility of the sender).
The plastic nasal and temporal attachments and elastic headbands can be cleaned with soap and water. Do not use isopropyl alcohol for plastic. STERILIZATION RECOMMENDATIONS The stainless steel metal eye shields and the elastic headband can both be autoclaved.
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Cycle Type
THE PLASTIC TEMPORAL AND NASAL PIECES CANNOT BE AUTOCLAVED.
Call or fax for an RA number and for further details. f
Do not sterilize stainless steel devices in bleach, as bleach will corrode them.
PROTECTEURS LASER EXTERNES DURETTE® III INSTRUCTIONS D’UTILISATION
ONLY The plastic temporal and nasal pieces can be sterilized by soaking in a sterilizing solution.
LIRE ATTENTIVEMENT LE MODE D’EMPLOI AVANT D’UTILISER CE PRODUIT. -3-