Viking Systems 8090-0x 2D and 3D Scopes User Manual Rev K

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 Indications ... 4 Contraindications ... 4 Notes on Safety... 4 Regulations and Standards ... 5 Labeling and Connections ... 5 Reprocessing... 6 Cleaning ... 6 Sterilization... 7 Sterrad... 7 Autoclaving... 7 Gravity Steam Sterilization... 7 Prevacuum Sterilization ... 7 Ethylene Oxide Sterilization ... 8 Steris ... 8 Cidex... 8 Warranty and Service... 8 Repairs and Returns ... 9 Parts List ... 9

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Product Overview Product Description The Viking Systems 3D Endoscopes deliver a 3-Dimensional image when used with the Viking Systems 3D camera heads. The Viking Systems 3D Endoscopes should be used only with the Viking Systems camera heads and will not fit conventional camera couplers. Light is provided by a standard 300 watt Xenon light source through a multi-fiber light guide. Viking Systems 2D Laparoscopes are used in conjunction with the Viking Systems 2D camera and endocoupler. The Viking Systems 2D Laparoscopes are compatible with other manufacturers’ 2D medical cameras and endocouplers.

Indications For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT, and as an aid in visualization of cardiac structures.

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

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

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Read this manual carefully before you begin work. Follow instructions specifically, giving special attention to warnings, contraindications, controls, features, and user specifications. You must be thoroughly familiar with the assembly, use, and care of this device and in all applicable surgical procedures. This manual must be available to the surgical team during every procedure. If you are using other manufacturer’s equipment in conjunction with this device, follow the instructions in the operating manuals for using that equipment as well. Before every procedure, carefully inspect the device to ensure it has been properly maintained, is cleaned and sterilized, and is fully functional. Do not use this device if an inspection reveals any damage. Improper use can lead to severe patient injuries and/or damage to the scope. 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). To avoid burns to the patient tissue, do not leave the tip of the Scope or the light guide connection junction in direct contact with the patient. To prevent potential safety threats to the patient caused by a defective scope, always have at least one additional scope (sterile) ready to be used for the current procedure. If High Frequency (HF) electro surgical instruments are used, keep the working element always within the field of view to prevent accidental burns. Always ensure a sufficient distance from the tip of the scope with conductive accessories before activating the HF output. Only medical electrical equipment, which complies with IEC 60601-1, is allowed to be used with this scope. Scopes are fragile opto-mechanical devices, which need to be handled with caution. To avoid damages caused from Laser burns it is necessary to keep the Laser delivery fiber away from all parts of the scope. To avoid potential eye damages to operator do not look into scope eyepiece when using with Laser equipment. Remove the scope and camera before defibrillating the patient.

Regulations and Standards  

These devices comply with IEC 60601-2-18 (Particular Requirements for Safety of Endoscopic Equipment) The quality assurance system of Viking Systems is certified in accordance with ISO 13485.

Labeling and Connections

Figure 1: 2D Scope Coupling Interface Models: 8090-01, 8090-02, 8090-03

Figure 2: 3D Single Channel Scope Coupling Interface Models: 8191-01, 8191-02

Figure 3: 3D Dual Channel Scope Coupling Interface Models 8191-05, 8191-06, 8191-11, 8191-12 Number

Description

1

Serial and Catalog number for the scope

2

Direction of view

3

Light guide connection – Connect light guide here.

4

Scope Eyepiece – Fits into the mount of the Camera head.

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Camera Head Scope Coupling Interface. 5

Reprocessing Prior to Sterilization, device must be thoroughly cleaned and dried. The scopes are designed to undergo routine cleaning and sterilization. For maximum performance and life, clean and sterilize this device according to your institutional guidelines and within the parameters specified in this section. Refer to the appropriate operator manual for cleaning and sterilization of other products used in conjunction with this device.

Cleaning Always clean the Viking Systems scopes immediately after use. Thoroughly remove bioburden prior to disinfecting or sterilizing the scope. The scopes should be cleaned with a neutral pH solution recommended for reprocessing of medical endoscopes, prepared according to manufacturer's instructions. To clean the scope: 1. Inspect the scope for cracks or other defects. 2. Remove the light guide post adaptors. 3. Soak and clean the scope and adaptors according to your institutional guidelines. Use a sponge or soft brush to remove debris while holding the device underwater. 4. Rinse with distilled or demineralized water. 5. Dry with a soft cloth. . The scope has optical surfaces that must be thoroughly cleaned and checked routinely to ensure both maximum transmission and a high-quality image. These are the distal tip, the proximal window(s), and the fiber optic light post. To clean the optical surfaces: 1. Scrub each optical surface with a 4" x 4" (10cm x 10 cm) gauze pad soaked in an enzymatic solution to break down organic material. Rinse thoroughly with distilled water. 2. Repeat step 1 with a 4" x 4" (10cm x 10 cm) gauze pad soaked in isopropyl alcohol. Rinse thoroughly with distilled water. 3. Repeat step 1 with a 4" x 4" (10cm x 10 cm) gauze pad soaked in acetone. Rinse thoroughly with distilled water. 4. Reflect light off all optical surfaces to detect foreign material remaining or scratches that may degrade image quality. Removing Deposits The aluminum oxide polishing paste is provided as an accessory and included in the packaging for every Viking Systems scope. Note: Cleaning with polishing paste should not be part of your routine cleaning procedures and should only be performed when the image - as viewed through the scope - is cloudy and deposit is detected in viewing an optical surface in reflected light. To remove deposit: 1. Dab some polishing paste on a clean cotton-tipped swab. 2. Press the swab to the optical surface and scrub in circles. 3. Rinse the optical surface with tap water and brush with a soft bristle brush while under running water to remove the polishing paste. 4. Clean optical surfaces as instructed in section "To clean optical surfaces" above. 5. Look at optical surfaces in reflected light and also look through the scope to ensure no image degradation due to remaining deposit. Repeat deposit removal steps if necessary.

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Sterilization n

CAUTION Do not use steam sterilization on endoscopes 8190-05 and 8190-06. High temperature will damage these scopes.

NOTE Sterilization refers to the destruction of all microorganisms and inactivation of all viruses. The scope must be sterile before you use it on a patient. 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. AUTOCLAVING (For Models 8191-01, 8191-02, 8191-11, 8191-12, 8090-01, 8090-02, 8090-03 ONLY) The scope must be carefully cleaned before autoclaving, as foreign matter will impede sterilization and harden into a crust, which is difficult to remove. Scopes that are not cleaned properly before autoclaving will experience reduced optical performance and a shortened service life. Place the clean scope in a suitable sterilization tray. A suitable tray will hold the scope firmly but gently. When using a metal tray, the scope should not be allowed to be in intimate contact with the tray. This will result in direct heat transfer from the tray to the instrument, which can cause damage to the instrument. GRAVITY STEAM STERILIZATION Follow standard hospital procedure for gravity steam sterilization (double wrapped muslin) at 270F (132C) for ten minutes. PREVACUUM STERILIZATION Follow standard hospital procedure for prevacuum steam sterilization (double wrapped in muslin) at 270F (132C) for three minutes. If this procedure is not observed, the scope may be destroyed and the warranty made void. After completing the sterilization, the scope should be cooled slowly in the autoclave to room temperature.

WARNING Do not immerse or rinse instruments in cold water or any other liquid to accelerate cooling.

NOTE These parameters have been validated to ensure sterility. Sterilizer functioning should be monitored at regular intervals with biological indicators to ensure products have been subjected to sterilization conditions.

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ETHYLENE OXIDE STERILIZATION ETO Parameters: Gas Sterilization (100% EO) Follow standard hospital procedure maintaining the following parameters: Temperature: 131 deg. F +/-5 deg. F (55 deg. C +/- 3 deg. C) Relative Humidity: 35-70% EO Concentration: 735 mg/L Exposure Time: 60 minutes Aeration: 11 hours minimum @ 131 deg. F +/-5 deg. F (55 deg. C +/- 3 deg. C) STERIS For USA customers: For Endoscopes that cannot be autoclaved (8191-05, 8191-06 ONLY). These devices have been validated for use in Steris System 1E. Follow manufacturer’s user guide for processing instructions. For customers outside of the USA: These devices are materially compatible with Steris System 1 processing for Liquid Chemical Sterilization. User is responsible for validating methods to ensure sterility and following the manufacturer’s recommendations for use of the processor.

Cidex 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 scope 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.

NOTE 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.

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 product is being sold only for the purposes described herein and such warranty runs only to the customer. In no event shall Viking Systems be liable for any breach of warranty in any amount exceeding the purchase price of the product. The Viking scope is covered by the warranty by the original purchaser for a period of one (1) year beginning from the date of shipment. Its warranty covers 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 representative immediately. 8

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.

NOTE 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.

Parts List Component

Model #

Field of View

Working Length

Laparoscope 5.5mm 0°

8090-01

75°

300mm

Laparoscope 5.5mm 30°

8090-02

75°

300mm

Laparoscope 5.5mm 45°

8090-03

75°

300mm

Stereo Endoscope 10mm 0° 3DHD Single Channel

8191-01

70°

345mm

Stereo Endoscope 10mm 30° 3DHD Dual Channel

8191-02

70°

345mm

Stereo Endoscope 10mm 0° 3DHD Dual Channel

8191-05

75°

415mm

Stereo Endoscope 10mm 30° 3DHD Dual Channel Stereo Endoscope Autoclavable 10mm 0° 3DHD Dual Channel Stereo Endoscope Autoclavable 10mm 30°

8191-06

75°

415mm

8191-11

75°

415mm

8191-12

75°

415mm

3DHD Single Channel

Specifications are subject to change without notice. 9

Manufactured By: 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]

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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

J02944-125 Rev. B

J02944-053 Rev. K