1288 HD Urology Camera Head User Guide Aug 2010

Contents Warnings and Cautions. ...3 Symbol Definitions...5 Product Description and Intended Use. ...6 Indications/Contraindications...6 Product Features...6

Setup...8 Operation...10 Using the Urology Camera Head Buttons...10 Adjusting the Focus...13

Cleaning, Reprocessing, and Maintenance...14 Reprocessing the Urology Camera Head...14 Using Sterile Drapes...20

Technical Specifications...21

Warnings and Cautions Please read this manual and follow its instructions carefully. IMPORTANT SAFETY NOTICE: Before operating this device, please read this operating manual thoroughly and carefully. When using this device with a light source, fire and/or severe injury may result to the patient, user, or inanimate objects if the instructions in this manual are not followed. All light sources can generate significant amounts of heat at the scope tip, the scope light post, the light cable tip, and/ or near the light cable adapter. Higher levels of brightness from the light source result in higher levels of heat. Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source. Adjust the brightness level of the light source to the minimum brightness necessary to adequately illuminate the surgical site. In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity. Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user. In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire. Always place the light source in standby mode whenever the scope is removed from the light cable or the device is unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in standby mode, and therefore may still result in fire or burns to the patient, user, or inanimate objects.

Warnings and Cautions

To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings: 1. Be a qualified physician, having complete knowledge of the use of this device. 2. Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, refer to the standard warranty. 3. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device. 4. Read the entire instruction section of the manual before assembling or connecting the camera. 5. Pay close attention to the care, cleaning, disinfection, and sterilization instructions in this manual. Any deviation may cause damage. 6. Test this device prior to a surgical procedure. This device was fully tested at the factory before shipment. Never use this device in the presence of flammable or explosive gases. 3

7. Avoid disassembling any part of the camera head, as doing so may break the seals, causing leakage and/or electric shock. This device has been factory sealed to prevent moisture from entering electronic components. If the camera head or cable seal is intentionally broken, the warranty will be void. 8. Before each use, check the outer surface of the camera and endoscope to ensure that there are no rough surfaces, sharp edges, or protrusions. 9. Using the camera head with broken connector tabs may damage the CCU. If any tab is missing or damaged, please refer to the Stryker Standard Warranty. 10. Ensure that readjustments, modifications, and/or repairs are carried out by persons authorized by Stryker Endoscopy. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Doing so may result in unintended performance or product damage. 11. Always treat the urology camera with care. The camera system contains sensitive parts that are precisely aligned and may suffer damage if dropped or mistreated. 12. Repeated sterilization via Ethylene Oxide may result in degradation in image quality. The warranty is void if any of these warnings are disregarded.

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Symbol Definitions In addition to the cautionary symbols already listed, other symbols found on the 1288 HD Urology Camera Head and in this manual have specific meanings that clarify the proper use and storage of the 1288 HD Urology Camera Head. The following list defines the symbols associated with this product: Warns of presence of important operating and maintenance instructions in the manual Date of manufacture

Legal manufacturer

SN

Serial number

Catalogue number

Operating humidity ratings

Operating pressure ratings Operating temperature ratings

Denotes compliance to CAN/CSA C22.2 No 601.1- M90 UL60601-1. Type BF applied part This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. 5

Product Description and Intended Use The 1288 HD Urology Camera Head is a high-definition camera used to capture still and video images of endoscopic urology procedures. It is designed with a 90° angle between the camera head and the scope to allow for easier access during urology procedures. The urology camera head is used in conjunction with the 1288 HD Camera Console (REF 1288010000; REF 1288010001).

Indications/Contraindications

The 1288 HD Urology Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. There are no known contraindications.

Product Features

The urology camera head connects to the camera console and captures video and photographic images, which it relays to the camera console. It features several controls that are accessible through a button keypad located on the top of the urology camera head (see the “Operation Instructions” section of this manual).

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1

2

3

4 5

8 6

7

1. Endoscope

-

2. Endobody clamp

Secures the scope to the camera head

3. Endobody brake

Prevents rotation of scope

4. Focusing knob

Adjusts the focus of the camera head

5. 1288 HD Urology Captures photographic and video images and provides camera head camera controls 6. Urology camera cable

-

7. Cable connector

Connects the camera head to the camera console

8. Soaking cap

Protects the cable connector during cleaning and sterilization 7

Setup 1. Set up the 1288 HD Camera Console according to the instructions provided in its user manual. 2. Connect the urology camera head to the console. • Unscrew the soaking cap from the cable connector if necessary. • Align the blue arrow on the cable connector with the blue arrow on the urology camera-connector port on the front console panel. • Push in the connector until it locks in place. • (To unplug the urology camera from the control unit, grasp the knobbed portion of the connector and pull straight out.)

3. Attach an endoscope to the urology camera head. • Remove the red dust cap if it is present. • Lock the endobody brake by pushing it to the right.

•

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Twist the endobody clamp and hold it open.

•

Insert the endoscope into the endobody clamp.

•

Twist the endobody brake in the reverse direction to secure the endoscope.

4. Attach a light cable from the light source to the light post on the endoscope.

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Operation Warning: Before using the 1288 HD Urology Camera in a surgical procedure, test all components to ensure proper function. Ensure that a video image appears on all video monitors before beginning any procedure. The 1288 HD Urology Camera can be controlled using buttons on the camera head or the touchscreen interface on the console.

Using the Urology Camera Head Buttons

The urology camera head features an oval, two-button keypad for controlling the 1288 urology camera. These buttons are labeled P and W.

P (Picture) Button The P button controls up to two remote video accessories. • Press the P button for less than two seconds to select Remote 1. One beep will sound. • Press the P button for more than two seconds to select Remote 2. Two beeps will sound.

W (White Balance) Button The W button activates the white-balance function or the light/zoom function. The white balance function is used to correct slight color differences that exist between different light sources or endoscopes. • Press the W button for more than two seconds to activate the white balance function. • Press the W button for less than two seconds to increase the zoom one of eight levels. (The zoom will cycle to the lowest level after completing the cycle.) Perform the white balance procedure before every surgical procedure.

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Note: Ensure that a scope and light source are attached to the camera, and that the camera, light source and monitor are powered on before adjusting the white balance. 1. Point the scope at several stacked 4 × 4 white gauze pads, a white laparoscopic sponge, or any clean white surface. 2. Look at the monitor and make sure that no glare is visible off of the white surface. 3. Press and hold the W button until “WHITE BALANCE IN PROGRESS” begins flashing on the video monitor. 4. Continue pointing the scope at the white surface until the video monitor indicates that white balance is “WHITE BALANCE COMPLETE.” The video picture may change color. If you cannot achieve an acceptable white balance, refer to the 1288 HD Camera Console user guide.

Using the Touchscreen Interface

The touchscreen interface on the console provides controls for operating the camera and selecting system settings. From the touchscreen, you can: • choose camera settings for urology procedures • capture photos • capture video • activate white balance

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Scroll through preset camera settings designed for surgical specialties. Choose from: • • • • •

Arthroscopy Cystoscopy ENT Flexi-Scope Hysteroscopy

• • • •

Laparoscopy Laser Microscope Standard

Capture photo. Press and hold button for two seconds before it activates. Capture video. Press and hold button for two seconds before it begins recording. Press again to stop. Activate white balance. Press and hold button for two seconds before it activates. •

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Press once to proceed to the Menu screen.

Adjusting the Focus

Slide the focusing knob to the left or right to adjust the focus.

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Cleaning, Reprocessing, and Maintenance Reprocessing the Urology Camera Head

These reprocessing instructions are provided in accordance with ISO 17664, AAMI TIR12, AAMI ST79, and AAMI ST81. While they have been validated by Stryker as being capable of preparing the device for re-use, it remains the responsibility of the processor to ensure that the reprocessing as actually performed, using equipment, materials, and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process. Stryker recommends users observe these standards when reprocessing medical devices.

Warnings • • • •

This device must be cleaned and sterilized prior to the first use and after every subsequent use. Use only the sterilization cycles outlined in this document. Using unspecified sterilization cycles may damage the device or result in incomplete sterilization. Separate the urology camera head and scope prior to cleaning, disinfection, or sterilization. Wear appropriate protective equipment: gloves, eye protection, etc.

Cautions • • • • • •

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Always install the soaking cap prior to processing the urology camera. Failure to properly tighten the soaking cap will corrode the connector pins and void the warranty. Inspect the camera cable for cuts and breaks before soaking in any fluid. Return any damaged camera to Stryker for service. Do not use brushes or pads with metal or abrasive tips during manual cleaning, as permanent scoring or damage could result. To minimize galvanic corrosion, avoid soaking dissimilar metals in close proximity. Never soak the camera in the same tray with sharp instruments. Repeated sterilization via Ethylene Oxide may result in degradation in image quality.

Limitations on Reprocessing • • • •

Do not cross-sterilize the device. Using multiple sterilization methods may significantly reduce the performance of the device. Do not leave the device in solutions longer than necessary. This may accelerate normal product aging. Proper processing has a minimal effect on this device. End of life is normally determined by wear and damage due to use. Damage incurred by improper processing will not be covered by the warranty.

Instructions Point of Use • •

Wipe excess soil from the device using disposable paper towels. If an automated reprocessing method will be used, rinse any channels in the device with 50mL of sterile distilled water immediately after use.

Containment and Transportation • • 1

Reprocess the device as soon as reasonably practical following use1. Transport the device in a tray to avoid damage. A 30 minute wait time was used during cleaning validation.

Preparation for Cleaning 1. Disassemble the coupler from the scope and camera head. 2. Prepare an enzymatic detergent according to the manufacturer’s recommendations (one ounce per gallon of tap water at 35 - 40°C)2. 3. Wipe the entire device with the detergent, using a clean cloth. 4. Immerse the device in the detergent. Using a syringe, inject any inside regions of the device with 50mL of the detergent to ensure all parts of the device are reached. 5. Soak the device in the detergent for a minimum of 15 minutes.

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Cleaning: Manual 1. Brush • Prepare a fresh solution of enzymatic detergent according to the manufacturer’s recommendations (one ounce per gallon of tap water at 35 - 40°C)2. • Thoroughly brush the exterior of the device with a soft-bristled brush, focusing on any mated or rough surfaces. • Using a syringe, inject any lumen or mated surface a minimum of 5 times with 50mL of the detergent. • Brush any lumens a minimum of 5 times from each end, using an appropriate bottle brush. • Brush any movable parts in all extreme positions. 2. Rinse • Rinse the device with reverse osmosis/de-ionized (RO/DI) water at ambient temperature until all detergent residue is removed. Flush any lumens or mated surfaces a minimum of 5 times. Once all detergent residue is removed, continue to rinse for a minimum of 30 seconds. • Drain excess water from the device and dry it using a clean cloth or pressurized air. • Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 and 2. 3. Soak • Prepare a non-enzymatic detergent according to the manufacturer’s recommendations (0.25 ounces per gallon of tap water at 35 - 40°C)3. • Fully immerse the device and use a syringe to inject any lumens and mated surfaces with 50mL of the detergent. • Soak the device for a minimum of 15 minutes. 4. Brush • Thoroughly brush the exterior of the device using a soft-bristled brush. • Using a syringe, inject 50mL of the detergent into any cannulae, lumens, or mated surfaces a minimum of 5 times. • Brush any lumens a minimum of 5 times from each end, using an appropriate bottle brush. • Actuate the device, brushing around any movable parts in all extreme positions. 5. Rinse • Thoroughly rinse the device with RO/DI water until all detergent residue is removed. Flush any lumens or crevices a minimum of 5 times. Once all detergent residue is removed, continue to rinse for a minimum of 30 seconds. • Drain the excess water from the device and dry it using a clean cloth or pressurized air. 16

Cleaning: Automated 1. Brush • Using a syringe, inject 50mL of the enzymatic detergent (from the “Preparation for Cleaning” section) into any lumen and mated surface a minimum of one time. • Brush from both ends of any lumens a minimum of 1 time, using an appropriate bottle brush. 2. Rinse • Rinse the device with RO/DI water at ambient temperature until there is no visible detergent residue. Continue to rinse for a minimum of 30 seconds after all detergent residue has been removed. • Place the device in the washer on an incline to facilitate drainage. 3. Automated wash • Program the washer using the following parameters: Phase

Recirculation Time

Water Temperature

Detergent Type and Concentration (if applicable)

Pre Wash

2 minutes

Cold tap water

N/A

Enzyme Wash

2 minutes

Hot tap water

Enzymatic Detergent2

Wash 1

2 minutes

Set point (66°C)

Non-enzymatic Detergent3

Rinse 1

2 minutes

Hot tap water

N/A

Dry Phase

7 minutes

115°C

N/A

• • • 2 3

Upon completion of the draining phase after Rinse 1, stop the cycle and open the washer door. Remove the device from the washer during the thermal phase and place the device back into the washer for the dry phase. If necessary, use pressurized air to aid in drying. Visually inspect each device for cleanliness. ENZOL® Enzymatic Detergent is validated for cleaning efficacy. Renu-Klenz® is validated for cleaning efficacy.

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Low Level Disinfection (optional) 1. Disinfect the device in a disinfecting solution that has one of the following active Ingredients: • ≥ 2.4% glutaraldehyde4 with a minimum soaking time of 45 minutes at 25 °C or • ≥ 3.4% glutaraldehyde5 with a minimum soaking time of 20 minutes at 25 °C or • ≥ 0.55% ortho-phthalaldehyde6 with a minimum soaking time of 12 minutes at 25 °C. 2. Prepare the disinfecting solution according to the manufacturer’s instructions. 3. Per manufacturer’s recommendations, immerse the device, filling all lumens, in the disinfecting solution for the required time at the appropriate temperature. 4. Thoroughly rinse and flush all parts and lumens with running, demineralized water to remove the disinfectant. 5. Dry all parts with a lint-free towel immediately after rinsing. CIDEX Activated® is validated for disinfection efficacy. CIDEX Plus® is validated for disinfection efficacy. 6 CIDEX® OPA is validated for disinfection efficacy. 4 5

Drying • • •

For automated drying, use the drying cycle provided with the washer/ disinfector. For manual drying, use a lint-free cloth. Dry any lumens with compressed air.

Maintenance, Inspection, and Testing • • •

Inspect the device on a continual basis. If a problem is observed or suspected, the device should be returned for repair. Inspect all components for cleanliness. If fluid or tissue buildup is present, repeat the above cleaning and disinfection procedures. Inspect the camera cable for cuts and breaks. Return any damaged urology camera to Stryker for service.

Packaging N/A

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Sterilization After performing the cleaning instructions specified above, perform one of the following sterilization cycles.

Ethylene Oxide (EtO) •

Double wrap camera head and cable prior to sterilization.

Preconditioning parameters Temperature

55°C (131°F)

Chamber Humidity

70% RH

Vacuum Set Points

1.3 psia

Time

30 minutes

Exposure Concentration (100% EtO)

725 mg/L

Temperature

55 ± 2°C (131 ± 5°F)

Time

1 hour

Chamber Humidity

70 ± 5% RH

Aeration parameters Aeration Time

12 hours

Temperature

35 – 54°C (95 – 129°F)

Steris® System 1 1. Clean and prepare the urology camera head and cable as recommended in the Cleaning section. 2. Sterilize the urology camera head and cable using Steris® System 1 with Steris® Sterilant 20. 3. Allow the urology camera head, cable, and scope to completely dry before reassembly. Any moisture may cause the camera window to fog during use. Sterrad® 1. Clean and prepare the urology camera head and cable as recommended in the Cleaning section. 2. Sterilize the urology camera head and cable using the Sterrad™ NX or 100S Sterilization System.

Storage Never store the device in a non-ventilated, humid environment such as a carrying case. This may present an infection control risk.

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Using Sterile Drapes

Using sterile drapes will ensure maximum longevity of your 1288 HD Camera Head. For best results, follow the instructions provided by the drape manufacturer.

Disposal This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment. The 1288 HD must be disposed of according to local laws and hospital practices.

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