Model #528339PS Installation, Operation and Service Manual R00

TABLE OF CONTENTS 1.

INTENDED USE

2.

WARNINGS / CAUTIONS

3.

ASSEMBLING THE HEADLAMP SYSTEM

4.

MAINTENANCE

5.

CLEANING

6.

REPLACEMENT PARTS

7.

WARRANTY AND REPAIR

8.

CHART OF MEDICAL DEVICE SYMBOLS USED

INTENDED USE This fiber optic headlamp system is designed to deliver illumination from a high intensity light source for surgical site illumination. This Operator Manual will help you to install the device and optimally integrate it with other components of your system. It will also instruct you how to adjust the fit and provide cleaning and sterilization instructions. It will give you maintenance and service guidelines as well as recommendations for best performance results.

WARNINGS / CAUTIONS CAUTION Rx only. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. WARNING The user of this product should be thoroughly familiar with the use and care of this product. WARNING The user should carefully study this manual before making any attempt to use this product clinically. WARNING Use of this illuminator with accessories or attachments requires that the end-user follow all accessory or attachment instructions which could affect illuminator setup, usage and/or settings.

CAUTION: HOT SURFACE The module may become warm during use; if uncomfortably warm, open the iris and adjust illuminator output. WARNING Light sources using high intensity lamps will produce heat as well as light. The high output of such systems can cause burns. Use care to avoid pointing the light directly at anyone’s eyes during operation as the brilliant light can cause severe eye discomfort. WARNING The metal end fittings of the fiber optic cable get hot during operation. Allow to cool outside the light source for at least five minutes before touching. WARNING FIRE or INJURY HAZARD: Energy released by illuminators used with fiber optic light guides is retained in the cable and transmitted through a connected instrument or the cable end tip. The output of a connected headlight module or instrument, or a bare end tip left in close proximity or contact with tissue or flammable materials presents a risk of injury or fire. Qualified personnel must determine a safe working distance and intensity setting for each application. The output should never be left on unattended. The headlamp should never be brought closer than 12” to the patient without decreasing the light source output.

ASSEMBLING THE HEADLIGHT SYSTEM Before continuing remove the protective caps on the headlamp module. To attach the fiber optic cable, insert the instrument end into the headlamp module until it snaps in place. A bifurcated cable fits through the velcro strips on top band and into the cable clips on both sides on rear of the headband. To remove the cable from the headlight module, grasp the body of the module in one hand and the silicone junction of the cable in the other and pull up. Do not pull the cable by its legs. Remember, the fiber optic cable is made of glass fibers. When adjusting the cable on the headband, do not bend the cable at an angle of more than 60 degrees. Next, place the headband on your head with the Rear Cranial Support sitting comfortably on the back of your head; you can make size adjustments by turning the knob on the rear of the headband until it feels comfortable. Then adjust the top velcro straps for more comfort. Once the headlamp module and cable are connected, the unit is ready for use. The headlight is provided with one joystick which is to be used to align and position the module. The system comes with two gown clips to relieve the weight of the cable from the headband. One gown clip is attached below the shoulder at the bifurcated junction;

the other is used to connect the cable to the surgeon’s gown. This eliminates the risk of tripping or dropping the illuminator end.

MAINTENANCE Storing the headlamp system in a safe place will prolong the life of the unit. Fiber optic cables are an optical instrument. The following guidelines will help in sustaining the headlamp systems useful life: •

•

•

Forming the cable in sharp angles and kinks should be avoided whenever possible. The internal fibers are made of glass, which will break under these conditions. Keep the optical faces of the cable from touching hard surfaces, which may cause scratches on the surface. Scratches on the surface will diminish the light output. When cuts or punctures are visible in the silicone tubing the cable is no longer safe to use, it should be taken out of service immediately.

CLEANING WARNING: Do not autoclave the Joystick, Headband, Lensed Cables or Sweatband. Follow all applicable bloodborne pathogen procedures as required by OSHA and/or your hospital, when cleaning, disinfecting and sterilizing. The headlamp module and joystick can be wiped down with alcohol. The lens should be cleaned only with lens tissue, available in any camera store, follow the directions on the package. The headband inserts may be cleaned using a standard wash cycle in warm water and detergent. The headband can be cleaned with an alcohol wipe down or washed with a lukewarm solution of water and mild detergent. Rinse thoroughly. WARNING: Do not steam autoclave lensed fiberoptic cables. Steam will enter the cable and moisture will condense between the lens and the cable when it cools. When heated again in use the water will evaporate, leaving water spots that can degrade the cables performance and can cause a damaging hot spot. The headlamp cable can be wiped cleaned with 70% Isopropyl alcohol or mild soap.

REPLACEMENT PARTS / ACCESSORIES Description Order Number Headlight Cable 9’, 3.5mm, Bifurcated Lensed (Wolf) ...….. #W359LWPS Headband Front Insert, Breath-O-Prene (Pkg of 5)…………. #528351P Headband Top Insert, Breath-O-Prene (Pkg of 5)…..………. #528352P Headband Back Insert, Breath-O-Prene (Pkg pf 5)…………. #528353P Joysticks (Pkg of 5)…………………………………………...… #528354P Gown Clips (Pkg of 10). ……………………………………….. #528355P Contact Teleflex® Medical for all replacement parts or fiberoptic accessories at (866) 246-6990.

LIMITED WARRANTY Teleflex® Medical warrants the Headlamp Systems when new, to be free of defects in material and workmanship and to perform in accordance with manufacturer’s specifications when subject to normal use and service for a period of three years from date of purchase from Teleflex® Medical or an authorized agent. Teleflex® Medical will either repair or replace any components found to be defective or at variance from manufacturer’s specification within this time at no cost to the customer. It shall be the purchaser’s responsibility to return the product to the authorized distributor, agent, or service representative. This warranty does not cover the product of breakage or failure due to tampering, misuse, neglect, accidents, improper installation, modification, shipping, or to improper maintenance, service and cleaning procedures. This warranty is also void if the product is not used in accordance with manufacturer’s recommendations or if required service by other than Teleflex® Medical or an authorized agent. Purchase date determines warranty requirements. No other express or implied warranty is given. Fiberoptic Cables. One Year Warranty – Fiberoptic Cables are warranted against damage at the strain relief and endfittings proving to be defective. There is no warranty for fiber breakage or broken clad rods or cable endfittings due to abuse or poor handling. DISPOSAL: When life of this product has ended, dispose of it reliably and properly in a dedicated container and not with general waste. Teleflex® Medical cannot advise users as to general or specific disposal regulations for federal, state/provincial, and/or local municipalities. It is the responsibility of the waste generator to ensure proper classification and disposal of waste products. NOTATIONS:

The information contained in this manual is subject to change without notice. Teleflex® Medical makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Teleflex® Medical shall not be liable for errors contained herein or for incidental consequential damages in connection with the furnishing, performance, or use of this material. REPAIRS All repairs and troubleshooting should be directed to Teleflex® Medical (866) 246-6990

CHART OF MEDICAL DEVICE SYMBOLS USED Manufacturer Do not use if package is damaged

Caution, consult accompanying documents Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner) Consult Instructions for Use

Caution: Hot Surface Nonsterile Product