1688 4K Camera System Instructions for Use

Contents Warnings and Cautions... EN-3 Cautions...EN-3 Warnings: General...EN-3 Warnings: Laser...EN-5 Operating a Light Source...EN-6 Product Description and Intended Use... EN-7 Indications...EN-8 Contraindications...EN-9 The Camera Console...EN-9 The Camera Head... EN-11 Additional Features of the Pendulum Camera Head... EN-12 The C-Mount Coupler... EN-14 Device Compatibility... EN-15 Setup... EN-17 Setting Up the Console... EN-18 Wiring Diagram... EN-20 Setting Up the Camera Head... EN-21 Setting Up the Coupler... EN-22 SPY Mode Requirements... EN-25 Clinical Applications Requirements... EN-25 Operation... EN-26 Powering the Console On/Off... EN-26 Performing the White Balance Test... EN-26 Controlling Remote Video Accessories... EN-27 Using the Touchscreen Interface... EN-28 Using the Camera Head Buttons... EN-33 Using the Display Monitor Menu... EN-36 Programming Camera Head Buttons... EN-39 Checking the Software Version... EN-41 Advanced Features... EN-41 Troubleshooting... EN-42 Processing... EN-47 Processing Camera Heads... EN-47 Cleaning and Disinfecting the Console... EN-48

Maintenance... EN-49 Inspecting the Console... EN-49 Inspecting the Camera Head... EN-49 Using Sterile Drapes... EN-50 Storage... EN-50 Replacing the Fuses... EN-50 Periodic Maintenance Schedule... EN-51 Service Life... EN-51 Adverse Event Reporting... EN-51 Disposal... EN-51 Technical Specifications... EN-54 Electromagnetic Compatibility... EN-55 Symbol Definitions... EN-59

Note: Supplemental information may be available in your region; refer to endoifu.stryker.com or contact your Stryker representative.

Warnings and Cautions In this manual, the terms and definitions below apply. • Warning: Possible injury to the patient or user. • Caution: Possible damage to the equipment. • Note: More information to clarify the instructions.

Cautions To avoid potential damage to this device, please note the following cautions. 1. 2. 3. 4.

5.

Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, refer to the warranty. Do not sterilize the camera console. The device is not designed to withstand sterilization procedures. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines. 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. Repairs and equipment modifications shall be performed only by Strykerauthorized personnel. Stryker Endoscopy assumes no product liability or warranty responsibility for devices repaired by or purchased from thirdparty service organizations.

Warnings: General To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following general warnings. 1. 2. 3.

4.

Federal (USA) law restricts this device to sale by or on the order of a physician. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device. Although the product was fully tested at the factory before shipment, the user should always test it for proper function prior to a surgical procedure. Always test that the endoscope produces a live, clear, correctly-oriented image prior to using it in a procedure and immediately after any viewing mode or setting is changed in the camera system. EN-3

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 camera head and coupler are shipped non-sterile. The devices shall be cleaned and sterilized prior to the first use and after every subsequent use. To prevent device damage and infection risk to the patient or user, follow all instructions in the Video Devices Processing Guide (P46385). 7. To minimize electromagnetic interference that may impact functionality of the 1688 Video Camera, position any active electrosurgical generator and its cables at least 12 inches (30 cm) away from the camera console. When the electrosurgical generator is placed on a boom with the camera console, it is advised to position the generator on the lowest shelf. 8. Do not position the console so that it is difficult to disconnect the power cord from the supply mains. 9. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground. 10. Portable multiple socket-outlets shall not be placed on the floor. Additional portable multiple socket-outlets or extension cords shall not be used with the equipment. 11. Use of third-party HDMI cables with the camera console is not recommended due to potential problems with secure connections or electromagnetic compatibility. Use the provided HDMI high speed cable (or other Stryker-approved HDMI cable) with the camera console. 12. Certain clinical applications may require a specific equipment setup. Refer to the Setup section prior to the clinical procedure. 13. Do not use camera system in the presence of flammable anesthetic gases. 14. To prevent tampering, physically secure the device when not in use. 15. Disconnect the console from the electrical outlet when inspecting fuses. 16. Do not remove covers on the console, as doing so may cause damage to electronics and/or electric shock. 17. Do not disassemble any part of the camera head; doing so may break the seals, causing leakage and/or electric shock. 18. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. 19. Do not repair or adjust the device through a third-party service organization. Devices repaired by or purchased from third-party service organizations could expose patients to significant risk. These devices are no longer validated by Stryker for cleanliness, disinfection, and sterilization, or for safety and efficacy.

EN-4

Warnings: Laser IMPORTANT SAFETY NOTICE - LASER RADIATION: SPY mode and the Defog feature control a Class 1M laser emitted from the L11 LED Light Source with Advanced Imaging Modality (0220230300), also referred to as the “L11 LED Light Source.” Use of controls or performance of procedures other than those specified herein can result in hazardous laser radiation exposure and can cause severe eye injury to the patient or user. To avoid exposure to laser radiation, follow all warnings and guidelines presented below and throughout this user manual. 1. 2. 3. 4. 5.

6.

7.

Before using SPY mode or Defog, read and be familiar with all instructions and warnings found in this user manual and the light source user manual. Protect the camera system against unqualified use. Wear eye protection as appropriate. Refer to any applicable regional regulations or standards for personal protective equipment. Do not manipulate tissue while Contrast mode (a SPY mode) is on. When SPY mode or Defog is activated, do not view the laser output with telescopic optical instruments (for example, microscopes or magnifiers). Do not direct the laser output into an area where such instruments are likely to be used. Do not turn on SPY mode when the endoscope is outside of the patient’s body. If the endoscope is outside of the patient’s body when SPY mode is off but the laser is still activated by Defog, do not point the endoscope toward any person. When SPY mode or Defog is activated, never look into the following apertures or direct the light emitted from the apertures toward another person: • the light cable connection on the light source (if the cable is not attached) • the end of the light cable (if the SafeLight™ adapter is attached) • the endoscope tip

8.

When SPY mode or Defog is activated, never leave a SafeLight adapter attached to the light cable without an endoscope attached. Laser radiation can continue to emit from the adapter.

EN-5

Operating a Light Source Please note the following warnings to avoid user or patient injury or product damage when using a system with a light source. Note that the light source adjustments described apply only to operating the light source manually (i.e., with Auto Light off ). IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES: When using 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 display 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 deactivate the light output from the light source before removing the scope from the light cable or leaving the device unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after deactivating the light output, 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.

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Product Description and Intended Use The 1688 4K Camera System with Advanced Imaging Modality (or “1688 Video Camera”) is an endoscopic camera system that is used to produce live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. 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 system consists of a camera console and a camera head with an integral cable that connects to the console. A coupler is also available for attaching a scope to the camera head. The available models for each part are listed below. Console 1688010000

1688 4K Camera Control Unit with Advanced Imaging Modality

Camera Heads 1688210080

1688 4K Microscope Camera Head, C-Mount1, 2

1688210105

1688 4K Camera Head, C-Mount, with Advanced Imaging Modality

1688310130

1688 4K Pendulum Camera Head with Integrated Coupler3

1688410105

AIM (Advanced Imaging Modality) 4K Autoclave Camera Head, C-Mount4

1688610122

1688 4K Camera Head, Integrated Coupler, with Advanced Imaging Modality

1688710105

1688 4K Inline Camera Head, C-Mount, with Advanced Imaging Modality

Coupler 1688-020-122

4K Coupler, C-Mount, with Advanced Imaging Modality5

1688410110

AIM (Advanced Imaging Modality) 4K Autoclave Coupler, C-Mount4

1

Complete instructions are available in Stryker user manual P45082. Note that 1688210080 does not have the same intended use or indications as stated in this user manual. 2

Not intended for use with SPY/ENV modes or Defog.

3

Not compatible with SPY/ENV modes or Defog.

4

Complete instructions are available in Stryker user manual P49350.

5

Complete instructions are available in Stryker user manual P43901.

Note: For complete system requirements to use the camera’s SPY mode, see the user manual for the L11 LED Light Source with Advanced Imaging Modality (0220230300), also referred to as the “L11 LED Light Source.” EN-7

The camera console is also packaged with the following connection cables: • Remote cables, 2.5 mm to 3.5 mm (Qty: 2) • HDMI high speed cable (Qty: 1) • Hospital-grade power cord (Qty: 1) Contact your Stryker representative for availability of other cables that may be required for alternate configurations.

Indications The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope 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 detection • laparoscopically assisted hysterectomy • laparoscopic and thorascopic anterior spinal fusion • anterior cruciate ligament reconstruction • knee 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. Note: Supplemental information may be available in your region; refer to endoifu.stryker.com or contact your Stryker representative. EN-8

Contraindications There are no known contraindications.

The Camera Console The camera console-or Camera Control Unit (CCU)-is the control center for the 1688 Video Camera, and it processes the video and photographic images produced during the surgical procedure. Front Panel The console front panel features a touchscreen where different menus can be accessed. The touchscreen can be used to adjust camera settings (such as Brightness, Zoom Level, and White Balance), select surgical specialties that optimize camera performance for specific surgical procedures, and turn on SPY mode. The touchscreen also allows activation of remote outputs, which are commonly used with a Stryker digital capture console to record images and video. See the Operation section for more information about using the front panel.

1

2

3

1. Power Switch

Powers the camera on and off

2. Touchscreen

Allows navigation through different menus for controlling the camera and adjusting the video settings

3. Camera-Connector Port

Connects to the 1688 Camera Head

EN-9

Rear Panel The console rear panel provides ports for connecting the 1688 Video Camera to other equipment such as a display monitor, a light source, and a device control console and/or digital capture console.

9

1

2

3

4

5

6

7

8

1. HUB Port

Connects to a Stryker device control console to enable voice operation and/or graphic tablet control

2. Remote Out 1

Connects to a video accessory remote input

3. Remote Out 2

Connects to a video accessory remote input

4. HDMI Out 1

HDMI 2.0 output (supports 4K UHD video resolution)

5. HDMI Out 2

HDMI 2.0 output (supports 4K UHD video resolution)

6. Light Source Port

Connects to Stryker light source

7. AC Power Inlet

Connects to AC mains with separable power cord

8. Fuse Panel

Contains two 1.6A 250V fuses (slow blow, high breaking capacity 1500A, size 5 mm x 20 mm)

9. Equipotential Ground Plug

Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

EN-10

The Camera Head The camera head 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). See the Product Description section for the different camera head models that are available. The 1688 4K Camera Head, C-Mount, with Advanced Imaging Modality (1688210105) is shown below with a list of features that are common to each camera head.

1

2

3

4

1. Soaking Cap

Protects the cable connector during cleaning, disinfection, and sterilization

2. Cable Connector

Connects the camera head to the camera console

3. Camera Cable

The camera cable length is 10 feet (3.05 m)

4. Camera Head

Produces photographic and video images, provides camera controls, and connects with (1688210105 and 1688710105) or integrates (1688310130 and 1688610122) a focusing coupler.

EN-11

Additional Features of the Pendulum Camera Head The 1688 4K Pendulum Camera Head with Integrated Coupler (1688310130) utilizes each of the features described in the previous section, The Camera Head, and it has additional features that are described below. The Pendulum Camera is designed with a 90° angle between the camera head and the scope to allow for easier access during urological procedures. The camera also incorporates image focusing and rotation features described in the following sections. 2 1 3

1. Endobody Clamp Secures the endoscope to the camera head 2. Endobody Brake

Prevents rotation of the endoscope

3. Focusing Knob

Adjusts the focus of the camera head

Adjusting the Focus (1688310130 only) To adjust the focus of the Pendulum Camera Head, slide the focusing knob 1 from side to side as needed (i.e., in the direction of the Camera button or the Menu button).

1

EN-12

Rotating the Image (1688310130 only) To allow rotation of the endoscope inside the endobody clamp, release the endobody brake 1 by rotating it counterclockwise (when facing the camera head buttons). The endoscope can then be rotated as needed 2 .

2

1

To prevent the endoscope from rotating inside the endobody clamp, lock the endobody brake by rotating it clockwise (when facing the camera head buttons). If the endoscope is not secured in a fixed position, slightly rotate the endobody clamp in either direction until the lock engages with an audible click. Automatic Image Flip (1688310130 only) By default, the Pendulum Camera Head will automatically flip the video image back to the initial orientation when the camera is rotated 180°. 1.

Hold the camera head with the endoscope axis parallel to the ground 1 .

2.

Rotate the camera head from the “cable down” position 2 to the “cable up” position 3 . Once the camera head cable is fully rotated, the video image will rotate back to the initial orientation. 1

2

3

The video image will also flip when the camera head is rotated from the “cable up” position to the “cable down” position. EN-13

If you want to change the Pendulum Auto Flip setting, follow these steps: 1. 2. 3. 4.

Hold down the Settings button on the camera console Home screen for about 5 seconds. Select Options. Press the right arrow to advance to the second menu page, and change the Pendulum Auto Flip setting. Click X in the top-right corner to return to the Home screen.

The C-Mount Coupler The coupler threads onto the face of the camera head, enabling a scope to be attached to the camera. It provides a focusing ring to adjust image sharpness. The 4K Coupler enables use of SPY mode and Defog when the camera is connected to the the proper system. See the Product Description section for the different coupler models that are available. The 4K Coupler, C-Mount is shown below with a list of features that are common to each coupler. 2

3 4

1

1. Scope End

Receives the endoscope

2. Endobody Clamp

Secures the scope to the coupler

3. Focusing Ring

Adjusts the coupler focus

4. Rear Adapter

Threads onto the camera head

EN-14

Device Compatibility For optimal use, the 1688 Video Camera is designed to work with the L11 LED Light Source (0220230300) and the Connected OR Hub (0240200100) with software version 1.2.1 or higher. All features and instructions described in this user manual apply to this system unless otherwise noted. The 1688 Video Camera is also compatible with other light sources and digital capture devices that are listed below. The features and instructions that are different than the rest of this user manual are noted below. Please contact a Stryker representative for assistance with alternate system configurations. Alternate Light Sources 0220220300

L10 LED Light Source with AIM Technology • Connect to the camera console using the USB A-to-A cable provided with light source, P30883 (required to use ENV mode) • Auto Light and Defog features are not available • Overlay mode and Contrast mode (SPY modes) are not available (although ENV mode is still available) • No camera control over ENV laser level (although the camera can control the Backlight level) • No camera control over IRIS mode and settings • Some display monitor menu options are not available (options that appear in grey)

0220220000

Precision LED Light Source • Connect to the camera console using the USB A-to-A cable provided with light source, P30883 • Auto Light and Defog features are not available • SPY and IRIS modes are not available • Some display monitor menu options are not available (options that appear in grey)

0220210000

L9000 LED Light Source • Connect to the camera console with a USB A-to-B cable • No camera control of light levels (only activate/ deactivate) • Auto Light and Defog features are not available • SPY and IRIS modes are not available • Some display monitor menu options are not available (options that appear in grey) EN-15

Alternate Digital Capture Device 0240060100

SDC3 HD Information Management System • Send the video signal from the camera console to the SDC3 by connecting an HDMI-to-DVI adapter cable (P32235) from one of the camera console’s HDMI outputs to one of the SDC3’s DVI inputs • Send the video signal from the SDC3 to a compatible display monitor by connecting a DVI cable from one of the SDC3’s DVI outputs to an available DVI input on the display monitor • The SDC3 does not have device control over the 1688 Video Camera or other devices that could be controlled by the camera head. (Although the user can still capture images and record video when SDC3 is connected to the camera console with remote cables.) • The SDC3 is not designed to add device control options in the camera’s display monitor menu.

EN-16

Setup Stryker Endoscopy considers instructional training, or inservice, an integral part of the 1688 Video Camera. Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative after your equipment has arrived. Setting up the 1688 Video Camera involves three steps: 1. Setting up the console 2. Setting up the camera head 3. Setting up the coupler • Always connect the console to an appropriate power source, using a hospital-grade power cord. Loss of AC power will cause the camera to shut down and the surgical image to be lost. • Only connect items to the 1688 Video Camera that have been specified for use with the camera system. Connecting incompatible equipment may cause unexpected results. • When the camera system is used with other equipment, leakage currents may be additive. Ensure that all systems are installed according to the requirements of IEC 60601-1. • 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. • Equipment which employs RF communications may affect the normal function of the 1688 Video Camera. When choosing a location for the camera system, consult the Electromagnetic Compatibility section to ensure proper function. • Always set up the console in a location that allows adequate ventilation (airflow) to the console. Insufficient ventilation may cause the console to overheat and shut down. EN-17

Setting Up the Console Refer to the following instructions and wiring diagram for a typical 1688 Video Camera configuration. 1. 2.

3.

Using the provided power cord, connect the camera console’s AC power inlet to a hospital-grade outlet. Using the provided HDMI cable, connect the HDMI 1 output from the camera console to the HDMI 4K/HD IN 1 input on the Connected OR Hub (0240200100). • As a precaution against video loss related to the Connected OR Hub or primary display monitor, the camera console’s second HDMI output can be connected directly to an HDMI input on an auxiliary display monitor. Connect the HDMI 4K/HD OUT 1 output from the Connected OR Hub to the HDMI 4K input on the 32” 4K Surgical Display (0240-031-050). For 4K camera resolution, the 1688 Video Camera shall be used with a 32” 4K Surgical Display that has firmware version 1.3.12 or higher. If not available, the camera resolution shall be operated in 1080p resolution. This setup is required to avoid degraded camera performance. To determine the 32” 4K Surgical Display’s firmware version: a. Power on the Connected OR Hub and the 32” 4K Surgical Display. They must be connected, as described in step 3. b. Press the Specialty button on the display front panel. c. The firmware version is listed in the upper-right corner of the menu that appears. If the version is 1.3.12 or higher, proceed to step 4. If the display firmware version is less than 1.3.12, follow these additional steps to operate the camera in 1080p resolution: d. Power on the camera console. e. On the camera console Home screen, hold down the Settings button for about 5 seconds until the Advanced Settings screen appears. f. Press the Options button to go to the Options screen. g. Press the HDMI1 and HDMI2 output buttons to toggle from 4K to 1080p resolution. h. Click X in the top-right corner to return to the Home screen.

EN-18

4.

Using the provided remote cables, connect Remote outputs 1 and 2 from the camera console to Remote inputs 1 and 2 on the Connected OR Hub. • Devices connected to the remote outputs can be operated using the console touchscreen or the Camera button on the camera head. See the Operation section for details.

5.

Connect a USB A-to-B cable from the HUB output on the camera console to an available Devices input on the Connected OR Hub. It is recommended to use the USB cable provided with the Connected OR Hub (0105-187-988), as use of third-party cables may prevent the devices from properly communicating. • Once connected to the 1688 Video Camera, the Connected OR Hub can control SPY mode and other camera functions. The user can also customize 1688 Camera Head button configurations through the Connected OR Hub. See the Connected OR Hub user manual for more details.

6.

Connect a USB 3.0 A-to-B cable from the Light Source output on the camera console to the CCU input on the L11 LED Light Source (0220230300). It is recommended to use the USB cable provided with the Stryker light source (P40171), as use of third-party cables may prevent the devices from properly communicating. • To use SPY mode and Defog, the 1688 Video Camera requires a connection to the L11 LED Light Source.

Please contact a Stryker representative for alternate system configurations.

EN-19