Instruction for Use
40 Pages
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English
560H 3-CCD High Definition Camera Head
Indications for Use The 560H Camera Head is intended for use in endoscopic surgical procedures to provide illumination and visualization of articular cavities, body cavities, hollow organs, and canals when used in conjunction with an appropriately indicated endoscope.
Preface
Additionally, the 560H Camera Head can be used, in conjunction with an appropriately indicated thoracoscope, in endoscopic surgical procedures in the thoracic cavity.
The Smith & Nephew 560H 3-CCD High Definition Camera Head is part of a family of products specifically designed for chemical sterilization by ethylene oxide (EtO), the STERIS SYSTEM 1®, STERRAD® 100S or STERRAD NX Systems, optimizing efficiency in the surgical suite.
Contraindications
Prior to using the equipment, read these instructions thoroughly, paying particular attention to the warnings and cautions. These instructions will familiarize the user with the 560H Camera Head and the steps necessary for proper setup and maintenance.
Introduction The 560H Camera Head provides Full HD 1080i digital video output from the camera head to preserve the best possible signal integrity, image quality and lowest noise performance. The digital video is transmitted to the 560P Camera Control Unit in low-voltage differential serial (LVDS) digital format, without further degradation along the 12-foot cable. When used in conjunction with the 560P Camera Control Unit and a Full HD 1080i video display, this camera head has the capability of producing Full HD 1080i HDTV quality images that are compliant with the SMPTE-274M:2005 HDTV standard without up-conversion. The 560H Camera Head provides Full HD 1080i digital video output to preserve the best possible signal integrity and image quality.
Device Description The 560H Camera Head is a high-resolution, 3-chip camera head which is compatible with the Smith & Nephew 560P Camera Control Unit (REF 72200559). Smith & Nephew surgical equipment is designed for use only by medical professionals who are completely familiar with the appropriate surgical techniques and video procedures.
None known.
Warnings • The camera head is shipped non-sterile. It must be sterilized before the first use. It must be cleaned and sterilized before every subsequent use. • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • Read the Operations/Service Manual for the applicable camera control unit and the Instructions for Use for other components used in the procedure. • To prevent patient burns, Do not place the camera head on the patient when it is not in use. The camera head contains heat-generating components that raise its surface temperature higher than that of the surrounding environment. Prolonged contact with the patient may cause burns. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. • To prevent electric shock, do not disassemble the camera head. There are no userserviceable parts. Dismantling the equipment will void your warranty.
The 560H Camera Head is a state-of-the-art high definition video camera head designed for use in all endoscopic surgical applications. For optimal image quality, this product must be used with light sources that incorporate infrared filtering.
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use
10600280 Rev. C
English
Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, ensure the device is functioning properly and is not damaged. Do not use a damaged device. • This product may be sterilized with chemical sterilants (ethylene oxide [EtO], STERIS SYSTEM 1®, STERRAD ® 100S, or STERRAD NX). The product may be sterilized with any of the above-specified chemical sterilization methods. Failure to comply with this caution may result in damage to the product and will void your warranty. • To avoid fogging during surgery, the videoarthroscope or coupler and the camera head must be entirely free of moisture before connecting them to the camera head. • Handle all endoscopic instruments with care. If the camera head is dropped or damaged in any way, it must be returned immediately for service. • Electrical safety testing should be performed by a biomedical engineer or other qualified service person. • Do not point the camera head toward direct sunlight, extremely bright lights or laser beams for prolonged periods as damage may occur.
• Carry and store the cable in loose coils to prevent kinks and stress on the internal wires. Do not carry the camera head by the cable. • Avoid pinching or damaging the camera head cable (i.e., rolling heavy equipment over it, securing with clamps, pinching in doors, etc.). • This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment.
Instructions for Use The camera head buttons perform a different set of functions depending upon whether the On Screen Display (OSD) Menu or Live Video is displayed on screen (Tables 1 and 2). When the OSD menu is displayed, use the camera head buttons to navigate through the menus. When Live Video is displayed, each of the camera head buttons is assigned to default or customized functions for short or long presses. The default functions can be changed using the CUSTOMIZE PROCEDURE SETTINGS menu. Middle
• Do not plug the camera cable connector into the camera control unit if wet. Moisture on the card edge connector of the camera head cable will damage the circuitry and void your warranty. Ensure that the card edge connector is completely dry before plugging the camera head into the camera control unit. • Do not sterilize equipment that is damaged as further damage may result. Use standard hospital decontamination procedures to clean the camera head prior to returning to Smith & Nephew.
Right
Left
• Do not put scopes or camera heads into ultrasonic cleaners or automatic washer/ decontaminators. These may damage the sealing integrity of the equipment. • Do not autoclave camera head. • Ensure that there are no deposits on the optical surfaces prior to sterilization. • Extreme caution must be taken to dry out mating portions of both the scope and camera head; otherwise trapped moisture may condense on glass surfaces, blurring the image.
10600280 Rev. C
Figure 1. 560H Camera Head
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use
English
Table 1, “Live Video Functions,” and Table 2, “OSD Menu Functions,” below, summarize the button functions for the camera head for both the Live Video and OSD Menu modes. Refer to Operations/Service Manual for the applicable camera control unit for more information regarding default and customized settings.
Table 1: Live Video Functions Camera Head Control
Short Press (<1.5 seconds)
Long Press (>1.5 seconds)
Left Button
Single Image Capture (ACC1)
Last Image Review
Middle Button
Brightness (Up/Down)
Main Menu
Right Button
Video Loop Capture (ACC2)
White Balance
Table 2: OSD Menu Functions Camera Head Control
Default Button Function
Left Button
Move the cursor UP to highlight a menu choice.
Middle Button
SELECT the highlighted menu choice.
Right Button
Move the cursor DOWN to highlight a menu choice.
Connect the Camera Head
Cleaning and Sterilization
Connect the camera cable connector to the control unit by plugging the card edge connector into the appropriate receptacle on the front of the camera control unit and pushing in firmly (Figure 2).
The 560H Camera Head requires sterilization because it is used in the sterile field. No protection is needed for the camera head connector during sterilization. The camera head connector must be dry prior to plugging into the camera control unit. CAUTION: Do not autoclave camera head.
DO NOT PLUG IN WET
CAMERA IN
CAUTION: Do not plug the camera cable connector into the camera control unit if wet. Moisture on the card edge connector of the camera head cable will damage the circuitry and void your warranty. Ensure that the card edge connector is completely dry before plugging the camera head into the camera control unit. CAUTION: Do not sterilize equipment that is damaged as further damage may result. Use standard hospital decontamination procedures to clean the camera head prior to returning to Smith & Nephew. Four steps are involved in cleaning and sterilization: 1. Decontamination 2. Equipment Inspection 3. Equipment Preparation
Figure 2. Connect camera head to control unit
Smith & Nephew 560H 3-CCD High Definition Camera Head
4. Sterilization
Instructions for Use
10600280 Rev. C
English
Approved Cleaners/Precleaners Enzymatic cleaner with neutral pH (pH 7.2 enzymatic cleaner).
Water Distilled water is recommended for cleaning and rinsing the camera head assembly.
Decontamination Immediately after a procedure, manually decontaminate the endoscope, camera head, coupler and light guide to make them safe for further handling. The following steps constitute a general guideline for routine decontamination of the video camera and other equipment, but specific hospital procedures must supersede where appropriate.
7. Thoroughly rinse off any residue using distilled water. Do not use saline as salt can increase pitting or corrosion of surfaces. 8. Use a soft, lint-free cloth to thoroughly dry each piece. 9. Do not let the exposed lenses and glass surfaces air dry. Use a cotton applicator, dipped in 70% isopropyl alcohol to remove stubborn spots, streaks and residual debris. Dry thoroughly with an additional applicator. 10. Wipe the camera head cable connector with isopropyl alcohol and air dry or dry thoroughly with a sterile, lint-free cloth. Ensure that the connector is completely dry. Note: Do not lubricate scopes, camera heads, cables, or light guides.
WARNING: To prevent electric shock, do not disassemble the camera head. There are no user-serviceable parts. Dismantling the equipment will void your warranty.
CAUTION: Do not put scopes or camera heads into ultrasonic cleaners or automatic washer/ decontaminators. These may damage the sealing integrity of the equipment.
1. Turn the camera control unit off. Disconnect the light guide from the endoscope and light source. Unplug the camera cable and unplug any remote controls that were used in the sterile field.
11. Visually inspect the device to ensure all visible tissue and debris have been removed.
2. Contain contaminated instruments for transportation to the decontamination area and prepare for manual decontamination.
Inspect the camera head to ensure the following:
3. Do not use germicides or any other agents containing benzene or phenol derivatives. This will damage the cable and will void the warranty. 4. Rinse the camera head assembly in lukewarm distilled water. 5. To prevent coagulation and help remove protein materials and other resistant debris, soak in a solution of distilled lukewarm water and a mild, high-sudsing, enzymatic cleaner. 6. To remove debris from the card edge connector and cable, clean manually using a soft-bristled brush. Rinse and dry thoroughly.
Equipment Inspection Camera cable jacket: There are no burn holes, cracks, tears, swelling, etc. Camera head cable connector: There is no corrosion, damaged card edge, etc. Glass window: There are no scratches and no deposits. If any of the listed conditions are present, contact Smith & Nephew using the procedure outlined under the “Warranty” section in this Instructions for Use. Using damaged equipment could compound the problem, harm interfacing equipment, or void the warranty.
When using brushes, scrub under water to prevent contamination. Pay particular attention to the button area. Visually inspect the device to ensure that all visible tissue and debris have been removed. To prevent the scratching of lenses and electrical components, limit the number of items in the sink at any one time. Never use scouring pads or abrasive powders. To avoid scratching lenses, wipe them in one direction; do not scrub. Note: It is the responsibility of the health care facility to ensure adequate cleaning of the brushes between each use.
10600280 Rev. C
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use
English
Equipment Preparation
The Smith & Nephew 560H Camera Head may be sterilized by the following methods:
After every use, ensure that the camera head has been thoroughly cleaned, sterilized and inspected according to the directions in this document.
STERIS SYSTEM 1 Sterilize the device using the STERIS SYSTEM 1 Sterile Processing System. Follow all recommended directions and warnings included with the STERIS SYSTEM 1.
Sterilization READ ALL WARNINGS AND CAUTIONS BEFORE STERILIZING. CAUTION: This product may be sterilized with chemical sterilants (ethylene oxide [EtO], STERIS SYSTEM 1®, STERRAD ® 100S, or STERRAD NX). The product may be sterilized with any of the abovespecified chemical sterilization methods. Failure to comply with this caution may result in damage to the product and will void your warranty.
STERRAD 100S or STERRAD NX
CAUTION: Ensure that there are no deposits on the optical surfaces prior to sterilization.
Ethylene Oxide (100% EtO)
Sterilize the device using the STERRAD 100S or STERRAD NX Sterilization Systems. Follow all recommended directions and warnings included with the STERRAD 100S or STERRAD NX Sterilization Systems.
CAUTION: Extreme caution must be taken to dry out mating portions of both the scope and camera head; otherwise trapped moisture may condense on glass surfaces, blurring the image. Notes: ∫ Disinfection is not a substitute for sterilization. ∫ Always inspect for damage and debris prior to sterilization. Please select the appropriate sterilization method for your equipment. For sterilization of light guides, couplers and endoscopes refer to the “Sterilization” section of the respective product’s Instructions for Use.
Sterilization Methods CAUTION: To avoid fogging during surgery, the videoarthroscope or coupler and the camera head must be entirely free of moisture before connecting them to the camera head.
Smith & Nephew 560H 3-CCD High Definition Camera Head
Follow standard hospital procedure maintaining the following parameters: Temperature: 131° ± 5° F (55° C ± 3° C) Relative Humidity: 35–70% Gas Concentration: ~736 mg/l Exposure Time: 120 minutes Aeration: 12 hours minimum 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.
Storage To prevent damage, store camera heads in such a way as to ensure that they remain immobile.
Instructions for Use
10600280 Rev. C
English
Service
Maintenance
There are no user-serviceable components in the 560H Camera Head. Repairs and adjustments are to be performed only by Smith & Nephew authorized service centers.
Recommended Annual Performance Checks
If service becomes necessary, call your authorized Smith & Nephew Customer Service Representative prior to returning the device, and request a Return Authorization (RA) number. Your representative can also explain the available Service Replacement and Repair Programs. Service items should be carefully cleaned, decontaminated and repackaged and returned postpaid to Smith & Nephew. Your Smith & Nephew Customer Service Representative can provide additional instructions.
Smith & Nephew recommends that Dielectric Strength Testing be performed annually to assure continued compliance with applicable safety requirements. These tests should be conducted in accordance with specifications UL 60601-1/IEC 60601-1. CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified service person.
Note: Product that has been returned that is found to have been serviced by an unauthorized third party repair facility and/or sterilized with a sterilization method other than the one approved for it by Smith & Nephew will incur additional costs, regardless of warranty status.
10600280 Rev. C
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use
English
Camera Head Specifications* Equipment Classification
Protection against electrical shock Class I, applied part Type CF
Video Imager
Three 1/3" interline transfer micro-lens high sensitivity CCD image sensors
Imaging Resolution
Vertical: 1080i native TV lines Horizontal: 1920 TV lines
Signal-To-Noise Ratio
>64 dB
Video Data Acquisition
Three 14-bit RGB channels, digitized inside camera head
Video Data Transmission
High-speed, low-voltage differential serial (LVDS), uncompressed 42-bit RGB digital transmission via 12-foot camera cable
Video Output Format
Full HD 1080i, 100% compatible with SMPTE-274M:2005 HDTV standard when used with the 560P Camera Control Unit
Video Field Rate
60 Hz or 50 Hz universal camera head, software switchable
Operating Temperature
41°–108° F (5°–42° C)
Operating Humidity
38–75% non-condensing
Transport and Storage Temperature
-4°–140° F (-20°–60° C)
Transport and Storage Humidity
20–90% non-condensing
Transport and Storage Atmospheric Pressure
5500 meters
Camera Head Dimensions
(Width x depth x height) 1.8" x 2.6" x 2.25"
Camera Head Weight
161 grams
Camera Head Cable
12 ft +/- 3 in., (3.65 m +/- 7.6 cm)
Lens Mount
1" – 32 UN C-mount thread
Compatible Control Units
Smith & Nephew 560P High Definition Camera System
*Specifications subject to change without notice.
Ordering Information REF 72200561
Smith & Nephew 560H 3-CCD Camera Head
REF 10600259
Smith & Nephew 560H 3-CCD Camera Head Instructions for Use (Swedish, Dutch, Portuguese, Danish, Norwegian, Korean)
REF 10600280
Smith & Nephew 560H 3-CCD Camera Head Instructions for Use (English, German, Spanish, French, Italian)
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use
10600280 Rev. C
English
Warranty
Repair Service Program
Smith & Nephew products are guaranteed to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.
For devices no longer under warranty, repairs can be made by Smith & Nephew or by an authorized agent. Non-warranty repairs will be made at the list price of replacement parts, plus labor. If requested, we will provide an estimate of repair cost and time required for the repair before any work is done. Repair items should be carefully repackaged, marked with the Return Authorization (RA) number, and returned postpaid to the appropriate Smith & Nephew Service Center. Smith & Nephew Customer Service or your local authorized representative can provide shipping information.
This limited warranty is restricted to repair or replacement by Smith & Nephew, at its option, of any product found to be defective during the warranty period. Damage inflicted to a product by the user that causes it to be unsuitable for refurbishment may result in additional charges, regardless of warranty status. All warranties apply to the original buyer only. In no event shall Smith & Nephew, be liable for any anticipated profits, consequential damages or loss of time incurred by the buyer with the purchase or use of any product. NO OTHER WARRANTY, EXPRESSED OR IMPLIED, IS GIVEN.
For Further Information If further information on this product is needed, please contact Smith & Nephew Customer Service at +1-800-343-5717 in the U.S., or your authorized Smith & Nephew representative.
Service Replacement Units Warranty Smith & Nephew service replacement units are warranted to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.
Service Replacement Program Smith & Nephew offers a 24-hour Service Replacement Program for its products to minimize downtime in your operating room. Our goal is to ship you a service replacement unit within 24 hours** of your call (during normal business hours). For a Return Authorization (RA) number or for additional information on this program, call Customer Service at +1-800-343-5717 in the U.S., or contact your authorized representative. **24-hour shipment is not offered in all countries.
All trademarks acknowledged.
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10600280 Rev. C
Smith & Nephew 560H 3-CCD High Definition Camera Head
Instructions for Use