Viking Systems 3DHD Glasses User Manual Rev B

©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 Product Description ...4 Component (Either)...4 How Supplied ...4 Indications for Use ...4 Contraindications...4 Handling & Cleaning ...4 Warranty and Service... 5 Repairs and Returns ... 5

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Product Overview Product Description The 3DHD Glasses are for use with the 3DHD LCD display. Please refer to the 3DHD LCD Display User Manual for complete instructions on the proper setup, use of this product and warnings & precautions. The Overwear glasses are worn over prescription eyewear.

Component (Either) ƒ ƒ

(1) 3DHD Glasses (1) 3DHD Overwear Glasses

How Supplied The 3DHD Glasses are supplied non-sterile and are intended to be reused.

Indications for Use For use in all types of video assisted procedures to aid in visualization of images.

Contraindications None known

Handling & Cleaning Handling • Do not touch the optical surfaces of the 3D glasses. • Do not leave the 3D glasses in ambient high-temperature, such as near heating equipment or inside a car. • Do not put extra pressure on the 3D glasses to avoid damage. • Make sure hard surfaces do not touch the optical surfaces of the 3D glasses while holding or transporting. • Avoid wearing the 3D glasses when they are aging, breaking or been damaged. Tiny scratches in the optical surface may interfere with viewing. Cleaning • Clean the 3D glasses with 50 to 70 v/v% concentration of isopropyl alcohol or a 76.9 to 81.4 v/v% concentration of ethanol using a swab method. Wipe the surfaces gently (using less than 1 N force). • Stubborn stains may be removed with a soft cloth such as a cleaning cloth lightly dampened with mild detergent solution using a swab method and then cleaned using the above chemical solution. Never use solvents such as benzene or thinner, or acid, alkaline or abrasive detergent, or chemical cleaning cloth for cleaning or disinfection, as they will damage the optical surfaces. • Do not use unnecessary force to rub the optical surfaces with a stained cloth. The optical surfaces may be scratched. • Do not keep the optical surfaces in contact with a rubber or vinyl resin product for a long period of time. The finish of the surface may deteriorate or the coating may come off.

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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. 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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