LaserSecure
Durette IV External Laser Shields Instructions for Use
24 Pages
Preview
Page 1
I
!
!ENLC
E N L
f Protecteurs laser externes Durette® IV ... 4 d Durette® IV Äußere Laserschutzschilde ... 7 s Protectores láser externos Durette® IV ... 10 i Occhialini protettivi Durette® IV ... 14 h Durette® IV Uitwendige Laser Oogkapjes ... 17 p Protetores externos contra laser Durette® IV ... 20
e DURETTE® IV EXTERNAL LASER SHIELDS INSTRUCTIONS FOR USE READ ALL INSTRUCTIONS BEFORE USING THIS PRODUCT.
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 metal attachments are properly inserted onto the ball on the metal eye shields. Verify that they swivel loosely without force. Never use forceps, pliers or any type of tools to attach or remove the attachments. DO NOT BEND OR MANIPULATE THE METAL ATTACHMENTS. USE ONLY ORIGINAL REPLACEMENT ATTACHMENTS. IU04 (10)
e Durette® IV External Laser Shields ... 1
CAUTION, consult accompanying documents.
The nasal and temporal metal 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.
Widening or deformation of any one of the mobile metal pieces, especially the nasal piece will allow entrance of dangerous light sources medially or temporally. Entrance of dangerous light sources may result in serious personal injury, burns, or blindness.
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 metal attachments during a procedure.
Avoid direct light beam impact onto the metal eye shields. Direct light beam impact will heat the metal and might reflect on the surroundings, including personnel.
WARNING
Accidental exposure of the eyes during a procedure may result in serious personal injury, burns, or blindness.
Do not use with ANY SYSTEMS that are integrated with RF (radiofrequency). Due to the electrical current from the RF, metal will conduct and retain heat causing burns to the surface of the skin.
EXPANSION or deformation of any one of the mobile attachments especially the nasal attachment will allow entrance of dangerous light sources medially or temporally. Entrance of dangerous light sources may result in serious personal injury, burns, or blindness.
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.
Verify that the Durette® IV eyewear is completely covering the eyelids by adjusting the elastic headband attached on the metal temporals or on the hooks on the eyecups themselves.
Do not use any device that has been dropped accidentally without thorough examination of its condition.
Always transport the Durette® eyewear in a hard box such as the case provided.
The metal mobile pieces and especially the nasal piece must be inspected after every procedure for any scratches or deformation from their original shape. The nasal piece will widen with repeated usage creating a wider distance between the eye cups. Do not force the nasal piece during installation and removal of the goggles. To avoid premature deformation, it is recommended to always release tension of the cord lock on the elastic to help maintain the original form of the metal pieces. When deformation of any one of the metal pieces is evident, the piece or pieces must be disposed of immediately and replaced with a new one or new ones to ensure secure and proper protection of the globe.
The surgeon should control the proper placement and positioning of the Durette® eyewear 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. 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. -2-
WARNING: when working any closer, internal laser shields should be used.
DECONTAMINATION •
Lasers and other light sources should always be aimed away from the ocular globe and away from the metal device.
•
THE ELASTIC HEADBAND SHOULD NEVER BE TIED FOR ADJUSTMENT.
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. CLEANING PROCEDURE FOR THE DEVICES
Devices must be cleaned before sterilization. Use procedures that have been previously established and validated for your institution or use the following recommendations.
The elastic headband must always be adjusted by sliding the cordlock in order to ensure a comfortable and secure fit (fig. 1). The adjusting of the cordlock 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.
• • • • •
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. STERILIZATION RECOMMENDATIONS
•
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, although the condition of the shield or instrument will give a better indication.
• •
• •
-3-
Stainless steel instruments can be sterilized repeatedly by steam autoclave. Do not sterilize stainless steel devices in bleach, as bleach will corrode them. The stainless steel metal eye shields, the mobile pieces and the elastic headband can all be autoclaved. You may sterilize the external shields, without separating the mobile metal attachments from the metal shields. Treat the instruments made from different metals separately. Do not mix instruments in good condition with instruments that are corroded or damaged.
STEAM AUTOCLAVE
!
Steam sterilize following a validated cycle according to your institution’s standards OR the following recommended parameters.
E N L
Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the following recommended parameters. Cycle Type
Temperature
Exposure Time
Dry Time
UK Prevacuum
134°C (273°F)
3 minutes
30 minutes
Prevacuum
132°C (270°F)
4 minutes
30 minutes
•
• • •
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).
ATTENTION, consulter les documents joints. Obtenez nos instructions d'utilisation en visitant oculoplastik.com. Ce produit est vendu non stérilisé.
Ce produit (élastique) contient du caoutchouc naturel sec (latex).
Ces lunettes en inox (dont la surface a été traitée) filtrent toutes les longueurs d’onde. UTILISER UNIQUEMENT AVEC LES SYSTÈMES DE LASER PUR OU LUMIÈRE PULSÉE INTENSE PURE. NE PAS UTILISER AVEC LES SYSTÈMES INTÉGRÉS AVEC UN COURANT ÉLECTRIQUE. Après chaque application et avant le nettoyage et la stérilisation, toujours vérifier visuellement et manuellement l’état de toutes les surfaces des coques en métal, des pièces nasales et temporales et de l’élastique.
Call or fax for an RA number and for further details.
Avant chaque utilisation, vérifier que les attaches en métal sont correctement insérées sur la rotule des coques en métal. Vérifier que les attaches pivotent librement sans forcer. Ne jamais utiliser de pincettes, de pinces ou d’outils divers pour fixer ou retirer les attaches.
f PROTECTEURS LASER EXTERNES DURETTE® IV INSTRUCTIONS D’UTILISATION LIRE ATTENTIVEMENT LE MODE D’EMPLOI AVANT D’UTILISER CE PRODUIT.
NE PAS PLIER OU MANIPULER LES ATTACHES EN MÉTAL. N’UTILISER QUE DES ATTACHES DE RECHANGE ORIGINALES. -4-