Viking Systems Light Guides User Manual Rev C

2012 by Viking Systems, Inc – All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or other use of this publication is prohibited without express written consent of Viking Systems, Inc. Viking Systems, Inc. reserves the right to make changes shown herein without notice or obligation. Contact Viking Systems, Inc. or your representative for the latest information.

Important general instructions for use. Ensure that this product is only used as intended and described in the instruction manual by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user or third parties.

CAUTION- USA only: Federal law restricts this unit to be used or sold, except under the supervision of a medical doctor.

Safety instructions and levels of danger

WARNING Failure to observe can result in death or severe injury.

IMPORTANT Failure to observe can result in damage to the product or surroundings.

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CAUTION Failure to observe can result in slight injury or damage to the product.

NOTE Tips for optimum use and other useful information.

Table of Contents Product Overview ... 4 How Supplied...4 Indications for Use...4 Contraindications ...4 Notes on Safety... 5 Light guide Care ...5 Maintenance ... 6 Cleaning ...6 Disinfecting ...6 Sterilization ...6 Warranty and Service... 7 Repairs and Returns ...7

Product Overview How Supplied The Light Guide is supplied non-sterile and is intended to be reused.

Indications for Use This fiber optic light guide is designed to deliver illumination from a high intensity light source to a surgical instrument for surgical site illumination, either standard or minimally invasive. It is compatible for use with light sources made with the following: Xenon with lamp power rating of up to 300 Watts, Halogen with lamp power rating of up to 250 Watts, or Metal Halide with lamp power rating of up to 100 Watts. Any light source used with this light guide should have a minimum of 90% IR filtering to prevent light guide damage during use.

Contraindications Operators who are not trained and qualified to perform endoscopic or laparoscopic surgery should not use this device.

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Notes on Safety This manual contains procedures for inspecting, preparing, operating, maintaining, and storing this device. This manual does not describe how to perform actual procedures or teach proper surgical techniques. Following are some important safety notes for operating this device:        

The user of this product should be thoroughly familiar and trained in the use and care of this product. The user should carefully study this manual before making any attempt to use the product clinically. Instructions should be followed specifically, with special attention given to warnings and cleaning instructions. This manual should also be available to the surgical team during a procedure. Follow the instructions in the operating manuals of other manufacturers’ equipment when they are used in conjunction with this product. Before every procedure, carefully inspect the light guide to ensure it has been properly maintained, cleaned and sterilized and that it is fully functional. Light sources use high intensity lamps, which produce heat as well as brilliant light. The high brightness produced by the light source and the light output of the light guide can cause burns. Care should be taken to follow the maintenance and cleaning instructions. Excessive bending of the light guide should be avoided. Due to the high energy from the illumination fiber, the light guide connection area of the scope and the distal end of the scope (within a distance of 10mm from the tip) may reach temperature above 106°F (41°C). Use care not to point the light guide directly at the eye while in operation. The brilliant light output can cause severe eye discomfort. WARNING FIRE HAZARD: Do not drape or cover the light source or the light guide while it is operating. Do not place the light guide on a drape while it is operating. WARNING Safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock, fire hazard, or equipment damage. WARNING The temperature of the connection area between the light guide and the light source may reach elevated levels during use. To avoid potential burns do not touch the metal portion of the proximal light guide connector until the light source is shut down and cooled off.

Light Guide Care Fiber optic light guides are fine, high quality optical instruments. You can prolong the useful life by following a few guidelines.  Avoid stretching your light guide, forming configurations involving sharp angles or kinks, or contact with sharp or pointed objects. The internal light fibers are made of glass, a material that breaks under stress. Fiber breakage will result in diminished light output.  Do not use your fiber optic light guide with any alterations to its original design or fabrication. Bundle size (aperture) of the fiber optic light guide should be matched to the aperture of the instrument to obtain maximum light output.  NOTE: A larger aperture fiber optic light guide will not increase light output of a smaller aperture instrument.  Keep the optical faces from contacting the floor or other hard surfaces. The resulting scratches will diminish light output. Store the light guides in sterilization trays for additional protection.  Any inadvertent cut or puncture to the silicone tube will render the light guide unsafe. It should be taken out of service immediately.

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Maintenance Follow all applicable bloodborne pathogen procedures as indicated by OSHA and/or your hospital requirements when cleaning, disinfecting, and sterilizing instruments and accessories.

Cleaning Lukewarm water with mild detergent is recommended to remove all blood and debris. (Do not use synthetic detergents or oil-based soap, as these chemicals may be absorbed into the light guide and could subsequently leak out and cause tissue reactions.) Rinse thoroughly with distilled water, taking care to rinse the face of glass fiber at both ends of the light guide.

Disinfecting CIDEX PLUS® 28 day Solution Clean and dry the light guide taking care not to scratch any of the optical surfaces. Follow manufacturer’s instructions to prepare the CIDEX PLUS® Sterilant to the recommended effective concentration. Use the CIDEX PLUS® solution test strip to verify effectiveness of the sterilant.

Sterilization: Follow manufacturer’s instructions for sterilizer to achieve a sterility assurance level of 10-6. Use of a biological indicator is recommended to confirm effective sterilization. STERRAD® This device was validated for use in the STERRAD 100S, STERRAD NX ™, and STERRAD 100NX™ systems. Follow the STERRAD System User’s Guide for general reprocessing instructions, including proper cleaning, drying, and packaging prior to reprocessing any medical device in a STERRAD system. For Light Guide models 8054-3, 8054-5, 8054-7 the following parameters were validated: Devices were validated in self sealed sterilization pouches:  Steam autoclave (pre-vacuum) 270F (132C) for 4 minute cycle with a 20 minute dry time.  Ethylene Oxide (EtO) 100% concentration for 60 minutes exposure time 131F (55C) >50% Humidity with 8 hour minimum aeration. For Light Guide model 8054-8: Devices were double wrapped in FDA approved CSR wrap: Steam Autoclave Prevacuum: 1320C 4 minutes 2 minute dry time Gravity:

1320C 10 minutes 2 minute dry time

1210C 45 minutes 2 minute dry time

IMPORTANT Following sterilization of your fiberoptic light guide, allow it to cool very slowly to room temperature. DO NOT immerse or rinse in a cold liquid, as this will cause fiber breakage and extensive light transmitting losses.

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Warranty and Service The warranty as set forth herein is exclusive and in lieu of all other warranties, express or implied, remedies, obligations, and liabilities, merchantability and fitness for use and of consequential damages. The products are being sold only for the purposes described herein and such warranty runs only to the customer. In no event shall Viking be liable for any breach of warranty in any amount exceeding the purchase price of the product. The Viking Systems, Inc. product is covered by the warranty by the original purchaser for a period of two years beginning from the date of shipment, excluding fiber breakage. It is warranted against defects in materials and defects that occur under normal utilization. The warranty is void if the system has been misused, abused, improperly installed or operated. Should the medical equipment described become inoperable within the period of usage specified for the applicable equipment due to a defect in material or workmanship, Viking will, at its sole option, either repair or replace the applicable equipment at no charge. Viking reserves the right to make design changes on its product without liability to incorporate said change in Viking products previously designed or sold. Work performed on Viking products by anyone other than Viking or an authorized representative will void any and all warranties. Carefully inspect the product upon receipt. If you discover a defect, notify Viking or your local distributor immediately.

Repairs and Returns Contact Viking Customer Service or your local distributor at the address shown on the back page of this User Manual before returning a product for credit, exchange, warranty repair, or non-warranty service repair. 1. Provide the following information:  The product model and serial number  The reason the product requires repair  The hospital purchase order number 2. You will receive a Return Goods Authorization (RGA) tracking number for the returning product, which must be displayed on the return outer packaging.

IMPORTANT Viking Systems, Inc. or its authorized representative reserves the right to refuse and/or return merchandise, for which an RGA number has not been obtained or properly displayed on the outer packaging 3. All shipping and insurance charges must be prepaid. Sender is responsible for any loss or damage during shipment. 4. Clean and sterilize (if applicable) all returned goods. 5. Pack the product in the original or comparable shipping carton. Clearly write the RGA number on the outside of the shipping carton along with the shipping address. A restocking charge may be issued for all customer returns unless there was a shipping error. No credit will be issued for the return if the product is damaged or opened. For repairs, upon receipt of the product, Viking, or its authorized representative, will determine if the product is covered under warranty. In the event the product is not covered under warranty or violates the warranty, the sender will be notified with an estimated cost for repair. The product will not be repaired until it has been authorized with a written purchase order. Viking Systems, Inc., or its authorized representative, is responsible for shipment of the repaired device back to the sender.

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Manufactured For: Vision System Group, a Division of Viking Systems, Inc. 134 Flanders Road Westborough, MA 01581 Tel: 1 800-200-9824 or 1 508-366-3668, ext. 8119 Fax: 1 508-366-1543 E-mail: [email protected]

Authorized Representative: Medical Device & QA Services 76 Stockport Road Timperley, Cheshire WA15 7SN United Kingdom Tel: 44 161 980 4310 Fax: 44 161 903 9787

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