1588 Pendulum Camera Head with Integrated Coupler User Guide

Contents Warnings and Cautions... 1 Warnings...1 Cautions...2 Operating the Camera with a Light Source...2 Product Description and Intended Use... 3 Indications...4 Device Features...5 Setup... 6 Installing the Soaking Cap...9 Operation... 9 Using the Camera Head Buttons... 10 Performing the White-Balance Test... 11 Adjusting the Focus... 11 Rotating the Image... 12 Processing... 13 User Maintenance... 14 Inspection... 14 Using Sterile Drapes... 14 Storage... 14 Expected Service Life... 14 Adverse Event Reporting... 15 Disposal and Recycling Information... 15 Recycling Diagram... 16 Technical Specifications... 17 Symbol Definitions... 18

Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meaning and should be carefully reviewed: Warning

Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.

Caution

Indicates risks to the equipment. Failure to follow cautions may result in product damage.

Note: Clarifies the instructions or presents additional useful information. An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual.

Warnings To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following general warnings. 1.

Must be a qualified physician to use this equipment.

2.

Read this user manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device.

3.

Before using this device, read Stryker user manual P29923 (English) or P29924 (multilingual) for warnings and other information about using the camera system.

4.

Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment.

5.

The camera head surface may exceed 41 °C (106 °F) in operating conditions with high ambient temperatures and it should be handled with caution.

6.

The device is shipped non-sterile. Clean and sterilize the devices before the first use and after each use. To prevent device damage and infection risk to the patient or user, follow all cleaning and sterilization instructions in the Video Devices Processing Guide (P46385).

7.

Certain clinical applications may require a specific setup. Refer to the Setup section prior to the clinical procedure.

8.

Never use the camera system in the presence of flammable or explosive gases.

9.

Do not disassemble any part of the camera head; doing so may break the seals, causing leakage and/or electric shock.

10. Attempt no internal repairs or adjustments not specifically detailed in this user manual.

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Cautions To avoid potential damage to this device, please note the following cautions. 1. 2.

3.

Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, refer to the standard warranty. Always treat the camera system with care. The camera system contains sensitive parts that are precisely aligned and may suffer damage if dropped or mistreated. Ensure that readjustments, modifications, and/or repairs are carried out by persons authorized by Stryker Endoscopy.

Operating the Camera with a Light Source Please note the following warnings to avoid user or patient injury or product damage when using the camera with a light source. IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES: 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 (exceeding 41 °C/106 °F) 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. If the brightness level of the light source can be adjusted, set it 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. The warranty is void if any of the above warnings or cautions are disregarded. 2

Product Description and Intended Use The Stryker 1588 Pendulum Camera Head with Integrated Coupler (“Pendulum Camera”) is an endoscopic camera used to produce still and video images in the surgical field during surgical endoscopic procedures. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes which are attached to the camera head. The Pendulum Camera is designed with a 90° angle between the camera head and the scope to allow for easier access during urology procedures. The Pendulum Camera also allows rotating the camera head 360° to properly orient the video image. The Pendulum Camera is used in conjuction with the 1588 AIM Camera Control Unit (1588-010-000). For more information about the camera console, see Stryker user manual P29923 (English) or P29924 (multilingual). Note: The Pendulum Camera is not compatible with Endoscopic NearInfrared Visualization (ENV) mode on the 1588 AIM Camera Control Unit.

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Indications The 1588 Pendulum Camera Head with Integrated Coupler 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 listed below. • 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 • examination of the evacuated cardiac chamber during performance of valve replacement The users of the 1588 Pendulum Camera Head with Integrated Coupler are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

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Device Features The Pendulum Camera connects to the camera console and produces video and photographic images, which it relays to the camera console. Several controls are accessible through a button keypad located on the top of the camera head (see the Operation section). 2 3

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1

4 5

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1. Image rotation joint

Allows rotating the camera head 360° to reorient the video image as needed

2. Endobody clamp

Secures the scope to the camera head

3. Endobody brake

Prevents rotation of the scope

4. Focusing knob

Adjusts the focus of the camera head

5. Camera head buttons

Provide camera controls

6. Camera cable

The camera cable length is 10 feet (3.05 m)

7. Soaking cap

Protects the cable connector during cleaning, disinfection, and sterilization

8. Cable connector

Connects the camera head to the camera console 5

Setup When used in a cardiothoracic application, make sure your system provides Type CF (Cardiac Floating) protection by connecting the camera system to a Stryker light source, Stryker light cable, and Stryker eyepiece endoscope with PEEK insulation (such as the Stryker Precision Ideal Eyes® HD Laparoscope, Ideal Eyes® HD Laparoscope, or AIM HD Laparoscope). Contact your Stryker representative for questions about configurations that provide Type CF protection. 1. 2.

3.

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Set up the 1588 AIM console according to the instructions provided in Stryker user manual P29923 (English) or P29924 (multilingual). Connect the Pendulum Camera to the console. • Unscrew the soaking cap from the cable connector if necessary. • Align the arrow on the cable connector with the arrow on the camera-connector port on the front console panel. • Push in the connector until it locks in place. • (To unplug the Pendulum Camera from the console, grasp the knobbed portion of the connector and pull straight out.)

Attach an endoscope to the Pendulum Camera. • Remove the red dust cap if it is present. • Lock the endobody brake by pushing it to the left.

• Twist the endobody clamp and hold it open.

• Insert the endoscope into the endobody clamp.

• Release the endobody clamp. It will return to the original position and secure the endoscope. (Twisting the endobody clamp in the reverse direction can make it difficult to remove the endoscope.)

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4.

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

Installing the Soaking Cap Before processing the camera head, the soaking cap must be installed to avoid damaging the cable connector.

Caution: Failure to properly tighten the soaking cap will corrode the connector pins and void the warranty. • To install the soaking cap, screw the cap onto the threads of the cable connector until it forms a tight seal. • To remove the soaking cap, unscrew the cap and pull it away from the cable connector.

Operation Before using the Pendulum Camera in a surgical procedure, ensure all system components have been set up according to the instructions in the Setup section. Test all system components to ensure proper function. Ensure that a video image appears on all video monitors before beginning any procedure. The operation instructions below describe the functions of the Pendulum Camera that are specific to the camera head. For instructions and troubleshooting about using the 1588 AIM Camera Control Unit, see user manual P29923 (English) or P29924 (multilingual).

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Using the Camera Head Buttons The camera head features a two-button keypad for controlling the Pendulum Camera. These buttons are labeled P and W.

P (Picture) Button The P button controls up to two functions of a remote video accessory. Commonly this enables the user to capture images or start and stop video recording. See user manual P29923 (English) or P29924 (multilingual) for connection requirements. • Press the P button for less than two seconds to select Remote 1. One beep will sound. When the camera is connected to a Stryker digital capture console, this will capture a photo. • Press the P button for more than two seconds to select Remote 2. Two beeps will sound. When the camera is connected to a Stryker digital capture console, this will start or stop video recording. W (White-Balance) Button The W button activates the white-balance function or the zoom-cycle function. • Press the W button for less than two seconds to activate the zoom-cycle function. Each press will raise the zoom level in eight steps. When the zoom level has reached its maximum, pressing the button again will cycle the level back to the lowest setting. • Press the W button for more than two seconds to activate the white-balance function. White balancing will correct slight color differences that exist between different light sources or endoscopes. See “Performing the White-Balance Test” below.

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Performing the White-Balance Test Before each surgical procedure, perform the white-balance test to adjust the camera’s perception of white so it can display other colors correctly. 1. 2. 3. 4. 5.

Ensure that a scope and light source are attached to the camera system, and that the console, light source and monitor are powered on. Point the scope tip at several stacked white gauze pads, a white laparoscopic sponge, or any clean white surface. Look at the monitor and make sure there is no visible glare off of the white surface of the image. Press and hold the camera head W button (or “WB” on the touchscreen) until the monitor displays the message “WHITE BALANCE IN PROGRESS.” Continue pointing the scope at the white surface until the video monitor displays the message “WHITE BALANCE COMPLETE.” The image may change color. If you cannot achieve an acceptable white balance, refer to the Troubleshooting section.

Adjusting the Focus Slide the focusing knob 1 to the left or right to adjust the focus.

1

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Rotating the Image Rotate the camera head at the image rotation joint 1 to reorient the image as needed. The camera head will rotate 360° independently of the scope. To allow rotation of the scope inside the endobody clamp, release the endobody brake 2 by pushing it to the right. To prevent the scope from rotating inside the endobody clamp, lock the endobody brake by pushing it to the left.

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2

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Processing For proper cleaning and sterilization, follow the processing instructions in P46385. Tray Compatability

The following sterilization trays are validated as compatible with the device: Tray PN

Tray Description

Tray IFU PN

0233-032-105

Endoscope and Camera Sterilization Tray

1000400907

0233-032-301

Advanced Imaging Modality (AIM) Sterilization Tray

P31027

0233-032-302

Endoscope and Camera Sterilization Tray

P31027

0233-410-002

Camera Sterilization Tray

P31027

Consult the tray user guide for instructions when sterilizing in a tray.

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User Maintenance Inspection Inspect all components of the camera head for cleanliness before each use. If fluid or tissue buildup is present, repeat the cleaning and sterilization procedures in the Video Devices Processing Guide (P46385). Inspect the camera head before each use. If a problem (such as but not limited to the list below) is observed or suspected, contact your Stryker representative or return the device to Stryker for service. • The image output performance of the camera is unacceptable. • The camera head shall be able to provide an image that is clear and focusable with adequate response to lighting of various scenes. • The console is unresponsive to pressing camera head buttons. • Visible cuts or breaks in the camera head cable or keypad area. • Unacceptable deterioration such as corrosion, pitting, cracked seals, or abnormal noises. The camera has an integrated coupler - inspect the coupler prior to use for the following conditions. • Significant physical damage such as: cloudiness, particles in the system, scratches, cracks, or sharp edges • The endoclamp cannot be actuated fully and does not return to its original position when released. • The endoclamp is unable to securely hold the endoscope. • The focusing ring is unable to rotate or provide focus.

Using Sterile Drapes Using sterile drapes will ensure maximum longevity of the device. For best results, follow the instructions provided by the drape manufacturer.

Storage Store the device in a dry, clean, and dust-free environment at room temperatures.

Expected Service Life The device’s service life is largely determined by wear, processing methods, and any damage resulting from use. To extend the time between device servicing, always follow the care and handling instructions in this user manual. Before each use, test the device functionality and inspect it for any sign of damage per the Inspection section. If the device does not properly 14

function or appears to be damaged, return it to Stryker for evaluation and possible repair or replacement. Repairs through Stryker as the equipment manufacturer bring the device back to manufacturer specifications. Clean and (when applicable) sterilize all potentially contaminated devices per the Video Devices Processing Guide (P46385) before returning them to Stryker.

Adverse Event Reporting Any serious incident that has occurred in relation to this device should be reported to Stryker, and in the European Union, to the competent authority of the Member State in which the affected person resides.

Disposal and Recycling Information 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. Device(s) may present a biohazard and should be handled in accordance with accepted medical practice and local and national requirements. It is recommended that devices are decontaminated per the Video Devices Processing Guide (P46385). Dispose of the camera system according to local laws and hospital practices. Refer to the diagram below to identify components that must be recycled.

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Recycling Diagram

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Item Material

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Qty. Comments

1

Camera Head Enclosure (PC Boards)

1

The camera head enclosure that contains PC Boards is sealed and cannot be dismantled without special equipment and training.

2

Cable

1

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Technical Specifications Imaging System

1/3″ Progressive Scan CMOS High Definition

Operating Conditions

Temperature: 10–30 °C Relative Humidity: 25–75%

Transport and Storage Conditions

Temperature: -18–60 °C

Device Weight

1.0 lb (0.5 kg) (approximate weight)

Dimensions

Camera Head Cable: 10 ft (3.05 m) sealed cable

Classification

Type BF Applied Part1

Relative Humidity: 15–90%

Ingress Protection, IPX7-Protected against the effects of temporary immersion in water The camera system has a Type BF (Body Floating) rating when tested independently. Clinically, the camera system is capable of Type CF (Cardiac Floating) protection when connected to a Stryker light source, Stryker light cable, and Stryker eyepiece endoscope with PEEK insulation (such as the Stryker Precision Ideal Eyes® HD Laparoscope, Ideal Eyes® HD Laparoscope, or AIM HD Laparoscope). Contact your Stryker representative for questions about configurations that provide Type CF protection. 1

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Symbol Definitions This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below. Federal law (USA) restricts this device to use by, or on order of, a physician Caution / Consult instructions for use Consult instructions for use

Product is manufactured in the USA

Date of manufacture

Legal manufacturer

Device is shipped non-sterile and must be sterilized before use Product catalog number Serial number

The device meets European Union medical device requirements

Stryker European representative Medical device in the European Union

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