4K Coupler and C-Mount REF 1688-020-122 Instructions for Use June 2020

English 4K Coupler, C-Mount, with Advanced Imaging Modality Product Description and Intended Use The Stryker 4K Coupler, C-Mount, with Advanced Imaging Modality (or “4K Coupler”) is used to attach endoscopes to Stryker surgical camera heads that do not have an integrated coupler. The coupler facilitates the easy exchange of different-sized endoscopes during a surgical procedure and allows users to focus the image captured through the endoscope. When used in a system with a Stryker light source with Advanced Imaging Modality (e.g., 0220220300, 0220230300), the coupler can visualize the near-infrared light produced by the light source.1 Refer to the light source user manual for complete system requirements. 1

To verify if the 4K Coupler can visualize near-infrared light produced by other Stryker light sources, refer to the light source user manual.

Note: the 4K Coupler is not intended for use with the InfraVision™ Illuminator (0220-180-521). 1

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1. Endobody clamp 2. Endobody (endoscope end) 3. Rear adapter (camera end) 4. Focusing ring

Indications The 4K Coupler is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope and the Stryker 1688 Video Camera are indicated for use.

Contradindications There are no known contraindications.

Warnings and Cautions 1. Read these instructions thoroughly before using the device. 2. Before using this device, read the 1688 Video Camera user manual (P38139 English, P38888 multilingual) for warnings, troubleshooting, indications, intended use, and other information EN-1

about using the camera system. 3. Federal law (USA) restricts this device to use by, or on order of, a physician. 4. Inspect the coupler for any damage that might have occurred during shipment or prior use. 5. The coupler contains optomechanical parts that are precisely aligned. Dropping the coupler can cause mechanical damage and/or misalignment. 6. Test the coupler for functionality before using it in a surgical procedure. 7. This coupler is shipped non-sterile. Clean and sterilize the coupler prior to the first use and after every subsequent use. Follow all instructions in the Video Devices Processing Guide (P46385). 8. Do not use the coupler and the camera system in the presence of flammable anesthetic gases. 9. No modification of this device is authorized by Stryker.

Operating the Endobody Clamp To perform setup, disassembly, and cleaning of the coupler, the endobody clamp (or “endoclamp”) must be depressed and/or released.

• To depress the endoclamp, push down as illustrated by the down arrow. • To release the endobody clamp, release pressure on the clamp and allow the spring to push the clamp into its original position, as illustrated by the up arrow.

Setting Up the Coupler When attaching or removing the coupler, grip only the rear adapter, as twisting other parts of the coupler with force can result in mechanical damage. Do not overtighten the coupler, as this can damage the front window of the camera. 1. Gripping the rear adapter, screw the coupler clockwise onto the camera head until it forms a tight seal.

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2. Depress the endobody clamp 1 and insert an endoscope into the endobody 2 . Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions. 1

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3. Release the endobody clamp to secure the endoscope. 4. Attach a light cable from the light source to the light post on the endoscope 3 . 5. With the camera console turned on, rotate the coupler’s focusing ring 4 to establish a sharp focus on the display monitor. Note: to remove the coupler, grip the rear adapter and unscrew the coupler counterclockwise from the camera head.

Processing The AIM 4K Coupler is used in the sterile field and shall be cleaned and sterilized prior to the first use and after every subsequent use. Follow the instructions in the Video Devices Processing Guide (P46385).

Sterilization Tray Compatibility The following Stryker sterilization trays are validated as compatible with the device. Tray Part #

Tray Description

Tray User Manual #

0233032105

Endoscope and Camera Sterilization Tray

1000400907

0233032107

Endoscopic Tray

1000400926

0233032301

Advanced Imaging Modality (AIM) Sterilization Tray

P31027

0233032302

Endoscope and Camera Sterilization Tray

P31027

0233410002

Camera Sterilization Tray

P31027

Verify device compatibility and loading configuration in the applicable sterilization tray instructions for use.

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Maintenance Inspection Inspect the coupler for cleanliness before each use. If fluid or tissue buildup is present, repeat the cleaning and sterilization procedures described in the Video Devices Processing Guide (P46385). Inspect the coupler 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. • Significant physical damage such as: cloudiness, particles in the system, scratches, cracks, or sharp edges. • The endoclamp cannot be actuated fully or 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. • The image quality performance of the coupler is unacceptable.

Transport and Storage Conditions Observe the following environmental conditions for transport and storage: • Temperature: -18–60 °C • Relative Humidity: 15–90%

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

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 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 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 The device may present a biohazard and should be handled and disposed of in accordance with accepted medical practice and local and national requirements. Prior to disposal, ensure the device is decontaminated per the Video Devices Processing Guide (P46385). EN-4

Symbols 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 Date of manufacture Legal manufacturer Device is shipped non-sterile and must be sterilized before use Product catalog number Serial number Quantity The device meets European Union medical device requirements Medical device in the European Union Stryker European representative Product is manufactured in Singapore

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Produced For: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: the Stryker logo. All other trademarks are trademarks of their respective owners or holders. P40880D 2020/06