Contraindications

The LAHayeSIK™ Surgical System has no known contraindications.
Please note that all Warnings and Precautions and the User Manual should be read and understood before any use of this equipment.

WARNINGS:
• Federal (USA) Law restricts this device to sale by or on the order of a physician.
• LAHayeSIK™ Handpiece should not be placed on a patient that is uncooperative, excessively nervous, agitated or moves excessively.
• The use of LAHayeSIK™ Plume Evacuation is not intended to replace the need for the use of a plume-filtering mask while in the operating room. It is recommended that an FDA approved ULPA filtering mask be worn by all persons, including the patient, while in the Laser Operating room.
• The use of LAHayeSIK™ may affect your outcomes and require adjustment to the nomograms. It is advised that the Surgeon begin use with LAHayeSIK™ conservatively to prevent over corrections.
• Depending on surgeons methods and techniques, laser used, room humidity, amount and type of refractive error to be corrected, the surgeon will need to develop his personal plume evacuation vacuum settings as well as personalized nomograms for correction of the refractive error.
• The LAHayeSIK™ Handpiece is provided non-sterile and must be sterilized prior to use. Refer to Section 4.0 of User Manual for detailed instructions.
• The LAHayeSIK™ Handpiece is reusable and must be cleaned and sterilized between each use. Refer to Section 4.0 of User Manual for detailed instructions.
• LAHayeSIK™ is to be used only in properly constructed nasal or superior hinged flaps.
• The platform should not to be used if a flap is suspected or observed to be fragile, torn, has epithelial defects or has a thin or small hinged. The platform use is indicated for use in only properly formed flaps and complication free keratotomy.
• Excessive use of the plume evacuation function may create spatial variability and/or temporal variability in the hydration status of the corneal tissues that may in turn seriously affect patient outcomes.
• Excessive use of the air delivery function may create spatial variability and/or temporal variability in the hydration status of the corneal tissues that may in turn seriously affect patient outcomes.
• Excessive use of the air delivery function to assist with flap fixation may result in excessive drying and cause adverse events such as flap wrinkling (not limited to) resulting in complications seriously affecting outcomes.
• Ensure that the flap moves freely on the platform prior to repositioning on the corneal bed. Caution should be taken not to move or flip platform rapidly.
• Do not operate this device in the presence of explosive gases.
• It is important that the fluid canister be visually checked periodically during the surgery to prevent "over filling" which will affect performance and possibly result in damage to the plume/fluid evacuation electrical system.
• LAHayeSIK™ Plume Filter/Tubing Assembly should be changed according to the life of the filter. The Plume Filter/Tubing Assembly should not be used for more than the forty-five minute filter life. Failure to change the Plume Filter/Tubing Assembly may result in decreased efficiency and contamination of the electric motor, vacuum pump, and other electrical and non-electrical components within the unit.
• Use only with the power cord provided and always plug into a grounded outlet.
• This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:
o Reorient or relocate the receiving device
o Increase the separation between the equipment
o Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connect
o Consult the manufacturer or field service technician for help
• Care must be exercised in the installation of hoses, adapters and suction canisters. Failure to follow the procedures outlined in this manual may result in overheating of the motor and may void the unit warranty.
• The 1200cc fluid canister incorporates a shut off valve that prevents fluid from entering the Plume Filter. Failure of this valve will affect performance and possibly result in damage to the plume/fluid evacuation and electrical systems.
It is recommended that the fluid collection canister be replaced before or when the fluid level reaches the 900cc mark. It is also recommended that the Y-Tubing be replaced along with the fluid collection canister.
• Use caution to prevent thermal burns when removing LAHayeSIK™ Handpiece from autoclave.
• Do not block either the tubing or the filter. If either becomes occluded or significantly restricted, the motor/blower may overheat and cause the unit to fail.
• There are no user serviceable components in the LAHayeSIK™ Surgical System. Contact Vision Pro LLC at 888-400-8844 or 337-267-1153 if service is required.
PRECAUTIONS:
• LAHayeSIK™ Surgical System is not to be used by anyone other than a licensed ophthalmic surgeon that has undergone LAHayeSIK™ Training.
• It is recommended as is with any new technique that the surgeon uses each of the LAHayeSIK™ functions conservatively.
• If the pre-operative visual inspection and performance testing of LAHayeSIK™ is found to be defective, damaged, or fails the performance testing LAHayeSIK™ will not be used and will be immediately removed from the surgical field.
• The LAHayeSIK™ Smoke/Evacuation Accessories are to be disposed after completion of the surgery day. The Plume Filters are completely disposable. Dispose of these components according to your local codes or regulations or hospital policy.
• The use of LAHayeSIK™ platform movement (as opposed to the surgeon directly grasping the flap with forceps and lifting off of platform) to reposition the flap to the corneal bed is optional and is based on a surgeon’s technique and judgment.

Contact: If you have any questions regarding LAHayeSIK™ Surgical System, please do not hesitate to contact Vision Pro, LLC at tel. 888-400-8844 or 337-267-1153, or email at info@LAHayeSIK.com.


 
 
Patients
Physicians
 
 
 
  Contraindications, warnings & precautions
PHYSICIANS: [Overview] [News| [About Us] [Home]
Copyright ©2007. Vision Pro, LLC. All rights reserved.
Site by: E Grafxx
Email Us