Viking Systems 3DHD Video Cart User Manual Rev A

©2010 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 Components ...4 How Supplied ...4 Indications for Use ...4 Contraindications ...4 Table of Symbols...4 Combinations ...5 Maintenance and Cleaning ...5

Warranty and Service... 6 Repairs and Returns ...6 Disposal of the Product, Packaging, and Accessories...6

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Product Overview Product Description The 3DHD Video Cart is for use with the 3DHD System. Please refer to the individual User Manual provide with each component for complete instructions on the proper setup, use of each product and warnings & precautions.

Components ƒ ƒ

(1) 3DHD Video Cart (1) Power cable

How Supplied The 3DHD Video Cart is supplied non-sterile and is intended to be reused.

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

Contraindications None are known.

Table of Symbols Following are the various symbols shown on the product. Symbol

Meaning

MAXIMUM LOAD

Maximum weight allowed

Manufacturer

Catalogue Number

Serial Number

Date of Manufacture

Separate collection required. Do not dispose equipment in municipal waste

Authorized Representative

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Symbol

Meaning

Combinations

IMPORTANT All the equipment connected to this unit shall be certified according to Standard IEC60601-1-1, IEC 60601-218, IEC60950, IEC60065 or other IEC/ISO Standards applicable to the equipment. Persons combining products to form a system are responsible for not impairing the system’s compliance with the performance and safety requirements, and that the technical data and intended use are adequately fulfilled. Do not connect item(s) which are not specified as part of the system. The equipment or system should not be adjacent to or stacked with other equipment and that adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Do not touch connecting devices for electrical connections between the different components (such as signal input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the same time. Portable and mobile RF Communications equipments can affect medical electrical equipment. The use of accessories, transducers, and/or cables other than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.

Maintenance and Cleaning Follow the instructions in the appropriate user manuals for camera heads, endoscopes and light cables. The 3DHD Video Cart 1. Inspect 3DHD Video Cart for any defects in the cables and castors. 2. 3DHD Video Cart can be wiped with 70% isopropyl alcohol.

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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.

Disposal of the Product, Packaging, and Accessories For disposal, observe the relevant regulations and laws in your country. For further information contact your local Viking distributor.

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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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