Stryker 1688-020-122 User manual

4K Coupler, C-Mount, with
Advanced Imaging Modality
REF
1688-020-122

English.................................................... EN-1
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EN-1
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 dierent-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., 0220-220-300, 0220-230-300), the coupler can
visualize the near-infrared light produced by the light source.1Refer to
the light source user manual for complete system requirements.
1To 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).
3
1
2
4
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, general
arthroscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and
plastic surgery wherever a laparoscope/endoscope/arthroscope/
sinuscope and the Stryker 1688 Video Camera are indicated for use.
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, indications,
intended use, and other information 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.

EN-2
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 rst use and after every subsequent use. Follow the
cleaning, disinfection, and sterilization instructions provided in this
user manual.
8. Do not use the coupler and the camera system in the presence of
ammable or explosive gases or in an oxygen-rich environment.
9. No modication 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.
2. Depress the endobody clamp 1and insert an endoscope into the
endobody 2.

EN-3
Before each use, check the outer surface of the
endoscope to ensure there are no rough surfaces, sharp
edges, or protrusions.
1
2
4
3
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 4to 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.
Reprocessing
These reprocessing instructions are provided in accordance with
ISO17664, ISO15883 AAMITIR12, and AAMITIR30. The instructions
have been validated by Stryker as being capable of preparing the
device for re-use. To achieve the desired result, the processor shall
ensure that the following instructions are performed as written
in their entirety and as appropriate in the processor’s facility. This
normally requires routine monitoring and validation of the facility’s
reprocessing procedures. Stryker recommends users observe these
standards when reprocessing medical devices.
Overview
Reprocessing the device involves manual or automated cleaning
with either an enzymatic or a non-enzymatic detergent, optional
disinfection, and sterilization.
• Step 1 (required): Cleaning with Enzymatic or Non-Enzymatic
Detergent
• Step 2 (optional): Disinfection
• Step 3 (required): Sterilization
Warnings
• This device must be cleaned and sterilized prior to the rst use and
after every subsequent use.
• Use only the sterilization cycles outlined in this document. Using
unspecied sterilization cycles can damage the device or result in
incomplete sterilization.
• Separate the camera head, coupler, and endoscope prior to
cleaning, disinfection, and sterilization. Failure to follow this
instruction will render the devices non-sterile. (Refer to the camera
head and endoscope product manuals for reprocessing instructions
of those devices.)

EN-4
• The sterilization parameters presented in this document apply only
when the device is sterilized outside of a sterilization tray. When
using a sterilization tray, consult the instructions provided with
the tray for proper sterilization parameters. Stryker recommends
sterilizing the device inside of a sterilization tray.
• To avoid health risks from aerosol contamination, brush the device
only when it is submerged in liquid.
• Wear appropriate protective equipment: gloves, eye protection, etc.
• Devices repaired by or purchased from third-party service
organizations could expose patients to signicant risk. These devices
are no longer validated by Stryker for cleanliness, disinfection, and
sterilization, or for safety and ecacy.
• The user shall defer to the facility’s procedures regarding
occupational exposure to bloodborne pathogens.
Cautions
• Do not use brushes or pads with metal or abrasive tips during
manual cleaning, as permanent scoring or damage could result.
• The device cannot withstand automated disinfection.
• The 4K Coupler is not autoclavable. Steam sterilizing couplers that
are not marked autoclave will result in product damage.
• To minimize galvanic corrosion, avoid soaking dissimilar metals in
close proximity.
Limitations on Reprocessing
• Do not cross-sterilize the device. Using multiple sterilization
methods can signicantly reduce the performance of the device.
• Repeated automated cleaning can degrade the product’s cosmetic
appearance.
• Damage incurred by improper processing will not be covered by the
warranty.
Materials and Equipment
All materials and equipment required to reprocess the coupler shall be
supplied by the user unless otherwise noted.
Item Description
All phases
Gloves, eye protection, etc. Wear protective equipment as
required by the medical facility
and procedure
Cleaning
Water basin Large enough to accommodate
the device
Lukewarm water To prepare cleaning solutions
Detergent1Used in cleaning solution to
remove surgical debris
Soft-bristle brush2To clean exterior or hard-to-
reach areas of the device
Reverse osmosis/
deionized water3
To rinse the device

EN-5
Clean lint-free cloth or ltered
pressurized air (≤ 40 psi)
To assist with drying
Automated washer For using the automated
cleaning procedure
Disinfection
Water basin Large enough to accomodate
the device
Disinfecting solution4≥ 2.4% glutaraldehyde
Lukewarm water To prepare disinfecting solution
Reverse osmosis/
deionized water3
To rinse the device
Clean lint-free cloth or ltered
pressurized air (≤ 40 psi)
To assist with drying
Sterilization
Sterilization system • STERRAD® 100S, NX®, 100NX®,
NX ALLClear®, or 100NX
ALLClear
• STERIS/AMSCO® V-PRO® 1,
V-PRO 1 Plus, V-PRO maX,
V-PRO maX 2, or V-PRO 60
Sterilization wrap5, 6 To maintain sterile barrier
Sterilization tray6, 7 Optional. Must be compatible
with sterilization method.
1The following detergents were validated for cleaning ecacy according to the
manufacturer’s instructions. Choose one of the detergents listed below or a substantially
equivalent detergent:
Detergent Type Minimum
Concentration
Minimum Soak
Time
ENZOL® Enzymatic
Detergent
Enzymatic 1 oz/gal. 1 minute
Prolystica® 2X
Neutral Detergent
Non-enzymatic 1/8 oz/gal. (1 ml/L) 5 minutes
Neodisher®
MediClean Forte
Enzymatic 5/8 oz/gal. (5 ml/L) 5 minutes
2Cleaning was validated with an M16 soft-bristle brush.
3Rinsing the device during cleaning and disinfection was validated using reverse osmosis/
deionized (RO/DI) water at ≤30°C.
4Disinfection was validated using CIDEX® Activated at 25 °C with a soaking time of
45minutes.
5Sterilization was validated using Kimberly-Clark® KC600 KIMGUARD sterilization wrap.
6For United States users: when sterilizing the device, use only sterilization wraps and
sterilization trays that have been cleared by the FDA to use with the selected sterilization
cycle.
7Stryker sterilization trays 0233-032-301, 0233-032-302, and 0233-410-002 are validated as
compatible with the 4K Coupler.

EN-6
Instructions for Reprocessing
Point of Use
• Disassemble the coupler from the endoscope and camera head. To
disconnect the endoscope, depress the endobody clamp on the
coupler and remove the endoscope from the coupler. To disconnect
the coupler, grip the rear adapter of the coupler and unscrew it
counterclockwise from the camera head.
• Wipe excess soil from the device.
Containment and Transportation
• Reprocess the device as soon as possible following use.
• Transport the device in a tray to avoid damage. Follow the facility’s
internal procedures for the transportation of contaminated surgical
instruments and devices.
Cleaning
1Follow the Preparation for Cleaning instructions below.
2Then clean the device using either the Manual Cleaning or
Automated Cleaning instructions below.
Note: for necessary materials and equipment, see the Materials and
Equipment table.
Preparation for Cleaning
1. Fill a wash basin with lukewarm water.
2. Measure and dispense the desired amount of detergent into the
water.
Note: see the Materials and Equipment table for validated
detergents with their minimum concentration.
3. Gently mix the detergent into the water by hand.
4. Submerge the device into the prepared wash basin.
5. With the device immersed in the solution, thoroughly brush the
exterior with a soft-bristle brush, focusing on any mated or rough
surfaces.
6. Actuate and brush any movable parts in all extreme positions.
7. Rinse the device with water until all detergent residue is removed.
8. Once all detergent residue is removed, continue to rinse for
30seconds.
9. Drain excess water from the device and dry it using a clean cloth or
pressurized air.
10. Visually inspect the device for cleanliness, paying close attention to
hard-to-reach areas. If visible soil remains, repeat steps 1– 10.