Viking Systems Couples User Manual Rev B

Table of Contents Product Overview... 4 Product Description ... 4 How Supplied ... 4 Indications for Use... 4 Contraindications ... 4 Setup ... 4 Directions for Use ... 4

Maintenance and Cleaning ... 5 Sterilization and High Level Disinfection ... 5

Warranty and Service Troubleshooting ... 6 Warranty... 6 Repairs and Returns... 6

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Product Overview Product Description The Optical Coupler is used to connect Camera heads to scopes.

How Supplied The Optical Coupler is supplied non-sterile and is intended to be reused.

Indications for Use For use with the Camera head to connect camera with scopes, in all types of video assisted procedures to aid in visualization of images.

Contraindications None known

Setup Prior to use on a patient, the coupler must be sterilized.

Directions for Use 1. The sterilized camera and coupler are placed onto the sterile optical field. The scrub nurse will connect the coupler to the camera by gently screwing the coupler to the camera head until snug. 2. The scrub nurse will hand the circulating nurse the distal end of the camera cord for attachment to the camera unit. 3. The surgeon or scrub nurse will attach the scope to the optical coupler by sliding the gripper, inserting the scope eyepiece and releasing the gripper. 4. Refer to camera system User manuals for further information on instructions for use and assembly of other components. 5. After the procedure, the coupler, camera head, and scope should be disassembled for cleaning.

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Maintenance and Cleaning Follow the instructions in the appropriate user manuals for camera heads, scopes and light cables. 1. Inspect coupler for cracks or defects. 2. Rinse coupler with distilled or de-mineralized water and wipe dry. Coupler can be wiped with 70% isopropyl alcohol.

Sterilization and High-Level Disinfection Prior to sterilization, devices must be thoroughly cleaned and dried.

N OT E Use a biological indicator to confirm effective sterilization after each procedure.

STERRAD® Sterilization The coupler was validated for use in the STERRAD 100S, NX and 100NX Systems. Follow the STERRAD Systems User’s Guide for general processing instructions including proper cleaning, drying and packaging prior to reprocessing and medical device in a STERRAD system. The user of this medical product is responsible for the performance of the appropriate validation of the sterilization procedure.

High-Level Disinfection Material compatibility was verified using a 2.4% Gluteraldehyde solution, with an immersion time of 45 minutes. Users must validate their own conditions to assure disinfection. Follow the disinfectant’s manufacturer instructions. Use proper safety attire such as gloves, protective eyewear, and a facemask, according to your institutional guidelines. Make sure your working area is well ventilated. To perform a high-level disinfection: 1. Perform a thorough cleaning. 2. Immerse the entire optical coupler in the disinfectant solution. Refer to your institutional and the disinfectant’s manufacturer guidelines regarding the concentration of the solution and recommended soaking time. 3. Rinse with distilled or de-mineralized water, then wipe and dry external surfaces thoroughly.

N OT E Disinfection is generally recognized as a less preferable method of sterilization. Follow the recommended guidelines of the manufacturer and individual hospital protocol for soak disinfection.

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Warranty and Service Troubleshooting PROBLEM

CAUSE

INTERVENTION

Image is fuzzy or unclear

Out of focus

Adjust the coupler focusing ring until picture becomes well defined.

Fogging of picture

Moisture on the scope, eyepiece, or coupler window

Check for fogging on eyepiece of endoscope (antifogging solutions are available as well as devices that warm the distal portions of the endoscopes).

Warranty 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.

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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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