Stryker 1188 Series Bedienungsanleitung

1188 C-Mount

Couplers

1188-020-122

1188-410-110

User Guide

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Contents

1188 C-Mount Couplers.................................. 1

Coupleur à monture en C 1188..................... 11

1188 Koppler mit C-Fassung ........................ 23

Innesti con attacco a C 1188.......................... 35

Acopladores do tipo “C-Mount” 1188.......... 47

Acopladores C-Mount 1188 .......................... 59

1188 C-mount-koppelstukken ...................... 71

1188 C-Mount Koblingsanordninger ........... 81

1188 C-kiinnitysliitinosat ............................. 93

1188 C-monteringskoplinger...................... 103

1188 Koppling med C-fattning................... 113

Łączniki 1188 C-Mount................................. 125

Συζεύκτες στερέωσης C 1188..................... 137

1188 C-Mount 转接器................................. 149

1188 C- マウントカプラー ........................ 159

1188 C-봉입 결합기

(C-Mount Couplers).................................... 169

English

1188 C-Mount Couplers

Warnings and Cautions

1. Read these instructions thoroughly before using the coupler.

2. Inspect the coupler for any damage that may have occurred during

shipment or prior use.

3. The coupler contains optomechanical parts that are precisely aligned.

Dropping the coupler may cause mechanical damage and/or

misalignment.

4. Test the coupler for functionality before using it in a surgical

procedure.

5. This coupler is shipped non-sterile. Clean and sterilize the coupler

prior to the first use and after every subsequent use. Follow the

cleaning, disinfection, and sterilization instructions provided in these

instructions.

6. Federal law (USA) restricts this device to use by, or on order of a

physician.

7. The camera head surface may exceed 41°C (106°F) in operating

conditions with high ambient temperatures and should be handled

with caution.

8. No modification of this equipment is allowed.

Product Description and

Intended Use

Stryker Endoscopy C-mount couplers are used to attach endoscopes to

Stryker surgical camera heads. They facilitate the easy exchange of

different sized scopes during a surgical procedure and allow users to

focus the image captured through the scope.

Figure 1 labels the parts of the coupler discussed in this manual.

Figure 1: C-Mount Coupler

1. Rear adapter (camera end)

2. Focusing ring

3. Endobody clamp

4. Endobody (scope end)

Stryker C-mount Couplers are available in autoclavable and non-

autoclavable models:

Indications/Contraindications

C-mount couplers are indicated for use in surgical procedures where a

Stryker endoscopic camera and a compatible endoscope are used. There

are no known contraindications.

Setting Up the Coupler

1. Gripping the rear adapter, screw the coupler into the camera head until

it forms a tight seal (see Figure 2).

Caution When attaching or removing the coupler, grip only the rear

adapter, as twisting other parts of the coupler may result in

mechanical damage.

Figure 2: Connecting the coupler and camera head.

2. Rotate the endobody clockwise (a) until the endobody clamp is aligned

with the camera (b) as in Figure 3.

Autoclavable

1188-410-110

(marked AUTOCLAVE)

Non-autoclavable

1188-020-122

Caution Rotating the endobody counterclockwise may cause the

coupler to unscrew from the camera head.

Figure 3: Aligning the endobody clamp with the camera.

3. Depress the endobody clamp with your thumb and insert a scope into

the endobody.

4. Release the endobody clamp to secure the scope.

5. With the camera console turned on, rotate the focusing ring to

establish a sharp focus.

6. To remove the coupler, grip the rear adapter and unscrew the coupler

from the camera head.

Reprocessing

These reprocessing instructions are provided in accordance with

ISO 17664. While they have been validated by the manufacturer of the

medical device 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.

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 camera head, coupler, and scope prior to cleaning,

disinfection, or sterilization. If the coupler and camera head are

cleaned, disinfected, or sterilized as a single unit, disconnecting

the coupler during use will compromise the sterility of the two

products. (Refer to the camera head and scope product manuals

for reprocessing instructions.)

• Wear appropriate protective equipment: gloves, eye protection, etc.

(a) (b)

Cautions

• 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.

• Only couplers marked AUTOCLAVE can withstand steam

sterilization. Autoclaving couplers that do not bear this

marking will result in product damage.

•CouplersmarkedAUTOCLAVE are not suitable for sterilization

with Sterrad or Steris System 1E. Steam sterilization is the

preferred method.

• Allow the device to air cool following steam sterilization. Rapid

cooling or “quenching” in a liquid will damage the device and

void the warranty.

Limitations on Reprocessing

• Do not cross-sterilize the device. Using multiple sterilization

methods may significantly reduce the performance of the

device.

• 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

• Reprocess the device as soon as reasonably practical following use.

• Transport the device in a tray to avoid damage.

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).

3. Wipe the entire device with the detergent, using a clean cloth.

4. Immerse the device in the detergent. Inject any inside regions of

the device with 50mL of the detergent solution to remove loose

debris.

5. Soak the device in the detergent for at least 15 minutes.

Cleaning: Manual

1. Brush

• Thoroughly brush the exterior of the device with a soft-

bristled brush, focusing on any mated or rough

surfaces.

• Inject any lumen or mated surface a minimum of five

times with at least 50mL of the detergent.

• Brush any lumens a minimum of five times from each

end, using an appropriate bottle brush.

• Brush any movable parts in their extreme open and

closed positions.

2. Rinse

• Rinse the device with treated water at ambient

temperature to remove all detergent residue. Flush any

lumens or mated surfaces a minimum of 5 times. Once

all detergent residues have been 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 of 0.25 ounces/gallon

tap water at 35 – 40°C.

• Fully immerse the device and inject any lumens and

mated surfaces with at least 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.

• Inject the prepared 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 treated water until all

detergent residue is removed. Flush any lumens or

crevices 5 times. After the detergent residue is removed,

continue rinsing for a minimum of 30 seconds.

• Drain the excess water from the device and dry it with a

clean cloth or pressurized air.

Cleaning: Automated

1. Brush

• Brush both ends of any lumens a minimum of five

times, using an appropriate bottle brush.

2. Rinse

• Rinse the device with treated 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:

Disinfection (optional)

1. Disinfect the device by submerging it in a disinfection agent.

Follow the disinfection agent manufacturer’s recommended

concentrations, temperatures, and exposure times.

2. Thoroughly rinse and flush all parts and lumens with running,

demineralized water to remove the disinfectant.

3. Dry all parts with a lint-free towel immediately after rinsing.

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.

* If necessary, use pressurized air to aid in drying. Visually inspect each

device for cleanliness.

Phase Recirculation

Time

Water

Temperature

Detergent Type

and Concentration

(If applicable)

Pre Wash 2 minutes Cold N/A

Enzyme

Wash

2 minutes Hot Enzymatic

Detergent

Wash 1 2 minutes Set Point

(66°C)

Regular Detergent

Rinse 1 2 minutes Hot N/A

Dry

Phase

7 minutes 115°C N/A

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