MITEK Endoscopes Sheaths, Trocars, Obturators and Bridge System

275309 Rev. B

en

Endoscopes and Sheaths Trocars and Obturators Bridge System Some products may not be licensed in all jurisdictions.

DESCRIPTION Endoscope Medical endoscopes are used to visualize body cavities. Two detachable Light Post Adapters are provided. The eyepiece of the endoscope is compatible with C-mount camera couplers. The C-mount endoscopes are directly compatible with the camera via the c-mount.

1 - Distal end 2 - Shaft 3 - Body 4 - Coupler 5 - C-Mount 6 - Proximal end 7 - Light post Figure 2. C-Mount Endoscope

Sheaths, Trocars, Obturators and Bridge System

1 - Distal end 2 - Shaft 3 - Body 4 - Eyepiece 5 - Proximal end 6 - Light post

Arthroscopic sheaths, trocars and obturators (endoscopic accessories), and bridge system when used with other endoscopic accessories, provide access to the joint space for visualization during arthroscopic surgery.

Figure 1. Endoscope

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INTENDED USER AND PATIENT TARGET GROUP Intended for use in a surgical setting by personnel trained in endoscopic procedures. It is at the discretion and judgment of the surgeon to determine which patients will be treated with the device.

CONTRAINDICATIONS None known.

WARNINGS Non-Sterile

Figure 3. Sheaths, Trocars and Obturators Note: Figure is representative

INDICATIONS AND INTENDED USE Endoscopes The DePuy Synthes Mitek Sports Medicine Arthroscope and accessories are tubular endoscopic devices with accessory devices that attach to the Arthroscope, and are intended to examine and/or perform surgery on the interior of a joint. Arthroscopic minimally invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporomandibular joint, ankle, elbow and feet (plantar fascia release). The Mitek Sports Medicine Sinuscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. Refer to the product label supplied with the device for an indication of whether the device contains hazardous substances. One or more components of this device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0 Current scientific evidence supports that medical devices manufactured from cobalt alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.

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• NON-STERILE: The endoscope and endoscopic accessories are provided NON-STERILE, and must be cleaned and sterilized prior to first use, before each subsequent use, and after returning from repairs. Use instructions in these Instructions for Use for cleaning and sterilization. • Do not use the endoscope and endoscopic accessories if you are unable to clean and sterilize according to the procedures contained in these instructions. • To reduce possible risk of infection, discard the endoscope and endoscopic accessories after surgery in patients with Creutzfeldt Jakob Disease (CJD), or suspected possible variants of CJD. Dispose according to hospital procedures.

Prior to Use • Before assembly and sterilization, make sure that sheath O-rings are in place (Refer to Figure 5) and are not damaged. The system can leak or malfunction if an O-ring is missing or damaged. • To prevent electric coupling between the patient and the device, Mitek Sports Medicine recommends the use of Mitek Sports Medicine devices and accessories. • Do not use a damaged or defective endoscope. Inspect the endoscope prior to each examination or procedure and before sterilization based on the instructions in this document.

During Use • Use care when handling and do not rest the endoscope directly on a patient or flammable material. The connection between the endoscope and the light source can become very hot. • When operated at maximum brightness, endoscope surface temperature may exceed 41°C. Always adjust the light source to the minimum light output necessary to illuminate the endoscopic image.

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• Do not use the endoscope with Xenon light sources greater than 300W, or serious burns may occur. • Arthroscopes may become hot and cause burns from high energy radiated light. • Do not look directly into the light source; the intense light may cause eye injury. • Contact with a rotating shaver or cutting instrument may cause surface of endoscope to become rough or jagged: endoscope fragments could enter the surgical site. Contact with Radiofrequency Ablation, RFA, could damage the endoscope. • Do not attempt to modify the endoscope. Modifying the device in a manner other than specified by in this document may result in injury.

PRECAUTIONS • Read and keep the user manuals for the endoscope and endoscopic accessories. • Do not hold the endoscope by its shaft; this may cause damage. • Do not bend the endoscope or subject the endoscope to impact. • Do not accelerate cooling; this may damage the endoscope. • Cleaning and sterilization is guaranteed only if instruments are cleaned and sterilized according to properly validated methods. This IFU provides validated cleaning and sterilization procedures. • Do not use damaged, defective, endoscopes or endoscopic accessories. • Do not clean endoscope in an ultrasonic bath.

3. Examine the light guide post for damage. 4. Test the image quality by looking through the proximal end. The image should be clear and distinct. If the image is not clear, check the distal window, eyepiece lens, and light guide post surface for cloudiness, dirt, or scratches. Check the shaft for bending, scratches, dents, corrosion, pitting, or other surface irregularities. If the image is unclear, do not use the endoscope. Send for repair or remove from service. 5. Check light transmission by applying room lighting to the end of the light post. Inspect the distal end of the endoscope. Uneven illumination indicates broken light fibers. Individual broken fibers do not necessarily result in a noticeable reduction in image quality; however, do not use the endoscope if approximately 25% of the transmitting surface is transmitting unevenly. Send for repair or remove from service. CAUTION: Handle the endoscope with care. Hard impacts, contact with abrasive surfaces, particularly to the distal end, may cause damage.

Endoscope Accessories Inspection before Use 1. Remove and discard protection caps from distal tip if present. 2. Before sterilization, make sure that sheath O-rings are in place and are not damaged. The system can leak or malfunction if an O-ring is missing or damaged. 3. Inspect for damaged, defective, or bent endoscopic accessories.

ASSEMBLY Endoscope Preparation

ADVERSE EFFECTS The following list of adverse effects may be associated with the use of this device: • Infection.

EXPECTED CLINICAL BENEFIT Intended to facilitate endoscopic procedures.

INSTRUCTIONS FOR USE Endoscope Inspection before Use 1. Remove and discard the protection caps from the distal tip, eyepiece and light guide post upon receipt. 2. Examine the lumen through the proximal end for condensation to make sure that the endoscope is free of internal moisture.

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1 2

   1 - Light Post 2, 3 - Light Post Adapters

3 Figure 4. Endoscope Parts

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1. If necessary, mount the light post adapter. 2. Ensure that the light post is clean. 3. Mount light cord (see manufacturer’s specifications). 4. Connect the camera (see manufacturer’s specifications).

Sheath Preparation Prior to assembly for sterilization, grease sliding surfaces of stopcocks with water-soluble medical lubricant (Refer to Figure 5). Lubricate moving parts with a water-soluble lubricant in accordance with the lubricant manufacturer’s instructions. IMPORTANT: Use Mitek Sports Medicine O-rings to ensure the proper functioning of the sheath system. 1. Make sure all of the O-rings are in place on the Body.

1 - Knurled Nut 2 - Bridge 3 - O-ring 4 - Stopcock assembly

2. Reassemble the Stopcock(s) to the Bridge. 3. Assemble the Bridge to the Body. 4. Install the Knurled Nut to hold the Bridge in place on the Sheath.

DISASSEMBLY Endoscope Disassembly 1. Disassemble from sheath. 2. Disconnect the camera. 3. Remove light post adapter if applicable.

Sheath Disassembly NOTE: Refer to Figure 5 for sheath disassembly steps. 1. Unthread the Knurled Nut and gently pull the Bridge away from the Body. In the case of the bridge system, disconnect the bridge from the cannula by disengaging the Mitek Lock. 2. Remove O-rings. 3. Remove the Stopcocks from the Bridge by unscrewing and lifting them out of the Body. 4. Clean the device according to the Cleaning and Disinfection Instructions in this document.

1 - Knurled Nut 2 - Bridge 3 - O-ring 4 - Stopcock assembly Figure 5. Disassembly NOTE: Figures are representative.

CLEANING, THERMAL DISINFECTION AND STERILIZATION These cleaning and sterilization instructions have been validated for preparing reusable Mitek Sports Medicine instruments for reuse. It is the responsibility of the end user to ensure that the cleaning and sterilization is actually performed using appropriate equipment, materials, and personnel to achieve the desired result. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences.

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General Considerations for Processing • Observe Point of Use and transport procedures as described below. • Highly alkaline conditions (pH>10) can damage components / device. • Complete each procedure: Preparation for Cleaning, Manual Cleaning or Automated Cleaning and Sterilization when reprocessing the instruments. • Personnel trained in the appropriate reprocessing techniques and safety should complete all reprocessing. Wear appropriate protective equipment (gloves, eye protection, etc.) when reprocessing any medical device.

Point of Use Care • The drying of gross soil (blood, tissue and/or debris) on devices following surgical use should be avoided. It is preferred that gross soil is removed from devices following use and in preparation for transportation to a processing area. Gross soil can be removed using sponges, cloths, or soft brushes. Water and/or cleaning detergents (labelled for use on medical devices) may be used. • Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodineor chlorhexidine-containing products.) Flush all lumens, blind holes, small clearances, and moving and intricate parts with water (or detergent solution) to prevent the drying of soil and/or debris. • If gross soil cannot be removed at the point of use, the devices should be transported to prevent drying (e.g., covered with a towel dampened with purified water) and cleaned as soon as possible at a designated processing area.

Transport to Processing Area • Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with local policies. Complete the cleaning procedures for the instruments within 30 minutes following their use.

Preparation for Cleaning • It is recommended that devices should be reprocessed as soon as is reasonably practical following surgical use. • Instruments must be cleaned separately from instrument trays and cases. • Care should be taken in the handling and cleaning of sharp devices. These are recommended to be cleaned separately to reduce risks of injury.

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• Disassemble the instruments. 1. Disconnect the light cable from the light guide post. 2. Disconnect the camera-coupling device from the eyepiece. 3. Remove any light cable adapters from the endoscope. 4. Disassemble the endoscope from any devices or accessories used during the procedure. 5. Disassemble the sheath including the stopcocks according to Figure 5: Disassembly 6. Perform either the Manual Cleaning Procedure or the Automated Cleaning procedure below.

MANUAL CLEANING Perform the following steps at the point of central reprocessing: 1. Rinse the instruments under cold running tap water for a minimum of three (3) minutes. Brush all surfaces and actuate moving parts during the rinse. 2. Prepare a neutral (pH 7-9) detergent (cleaning) solution (which may or may not include enzymes) in accordance to the detergent manufacturer’s instructions. Use a fresh mixture of cleaning solution for each set of instruments when cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 3. Immerse the instruments completely in the detergent solution for a minimum of 15 minutes. 4. Soak for five (5) minutes and then use soft bristle brushes to remove any debris / soil from the instruments while they are submerged. Brush for a minimum of 3 minutes. Ensure that the brushes can access the hard to reach areas such as cannulations, cracks, crevices and threads. Remove all visible debris. 5. Fill a syringe with the detergent and use to flush cannulations, crevices and threads while submerged. 6. Repeat the Brushing step (Step 3) and the Flushing step (Step 4) an additional 2 times. 7. Check for remaining debris and remove as needed. 8. For the Sheath, Trocar and Obturator only: Completely submerge the devices in an ultrasonic soaking bath in a neutral pH detergent solution for 10 minutes. (Refer to cleaning agent solution manufacturer’s instructions for immersion time and temperature).

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CAUTION: Endoscope CANNOT be placed in an ultrasonic bath. NOTE: Ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of ultrasonic cleaning. 9. Rinse the instruments under cold running tap water for at least three (3) minutes while brushing with a soft bristle brush during the rinse. 10. For the final rinsing processes, soak the devices for a minimum of three (3) minutes in purified (e.g., deionized, reverse osmosis, distilled, or Critical Water), per AAMI TIR 34:2014. Dry with a lint-free soft cloth.

AUTOMATED CLEANING Equipment Required: Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and-2, or to an equivalent standard. Automated washing can be included as part of a validated washing, disinfection, and/or drying cycle in accordance to manufacturer’s instructions. 1. Manually clean the instruments by immersion prior to automated cleaning (reference manual cleaning section). 2. Place the endoscope and its light cable adapters into a separate mesh basket. Ensure that the endoscope and light cable adapters do not touch each other when placed into the basket. Place a mesh screen over the basket to contain the endoscope and light cable adapters in the basket during processing. 3. Clean in a validated washer disinfector using the “INSTRUMENTS” cycle and a pH neutral cleaning agent intended for use in automated cleaning as shown in Table 1. Table 1: Automatic Cleaning Parameters: Recirculation Time set points 2 minutes

Water Temperature Cold tap water

Detergent Type N/A

1 minute

Hot tap water

Enzymatic detergent

Wash 1

2 minutes

65°C (Set Point)

Rinse 1 Dry Phase

15 seconds 15 minutes

Hot tap water 66°C (Set Point)

Phase Pre Wash Enzyme Wash

Neutral pH instrument cleaner N/A N/A

INSPECTION AFTER CLEANING After either Manual Cleaning or Automated Cleaning, visually inspect the instruments to verify the absence of visible soil, stains and debris. If soil is present after cleaning, repeat cleaning procedure.

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Thermal Disinfection Thermal disinfection is recommended to render devices safe for handling prior to steam sterilization. Thermal disinfection should be conducted in a washer-disinfector compliant to ISO 15883-1 and-2, or to an equivalent standard. Thermal disinfection in the washer-disinfector shall be validated to provide an A0 of at least 600 (e.g., 90°C (194°F) for 1 min). Higher levels of A0 can be achieved by increasing the exposure time and temperature (e.g., A0 of 3000 at >90°C (194°F) for 5 min, in accordance with local requirements). Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens can drain freely. Lumened devices should be placed in a vertical position. If this is not possible due to space limitations within the washer-disinfector, use an irrigating rack /load carrier with connections designed to ensure an adequate flow of process fluids to the lumen or cannulation of the device if provided. The following automated cycles are examples of validated cycles: Recirculation Time (mins)

Water Temp

Thermal Disinfection

1

> 90°C (194°F)

Thermal Disinfection

5

> 90°C (194°F)

Phase

Water Type Critical water (RO, deionized or distilled water) Critical water (RO, deionized or distilled water)

STERRAD® Sterilization: Endoscope and adapters only CAUTION: The sheaths are not validated for sterilization using STERRAD. 1. Ensure the endoscope and light cable adapters are disassembled before sterilization. 2. The endoscope and light cable adapters can be sterilized in the STERRAD® 100S, STERRAD® 100NX and STERRAD® NX sterilization systems. 3. Clean and thoroughly dry the endoscope and light cable adapters per the Cleaning Section. 4. Place the endoscope and light cable adapters into the appropriate location within the Mitek Sport Medicine sterilization tray that is compatible with the STERRAD 100S, NX and 100NX sterilization systems. Package trays/ instruments with a barrier wrap material in accordance with local procedures, using standardized wrapping techniques such as those described in ANSI/AAMI 79. In the United States, use an FDA-cleared sterilization wrap. Include a

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STERRAD® indicator strip in the wrapped package. Run the STERRAD® machine per the manufacturer’s instructions.

Autoclave (Steam) Sterilization CAUTION: Do not use an “Immediate use /flash” cycle to sterilize the instruments. 1. Before assembly of the sheath for sterilization, make sure that all O-rings are in place and are not damaged. Remove and replace any O-rings that show any sign of damage or wear. Use a water-soluble lubricant in accordance with the lubricant manufacturer’s instructions to lubricate parts as necessary. Remove any excess lubricant. Sterilize the sheath with the stopcocks in the open position. 2. Sterilize the endoscope and light cable adapters disassembled. 3. If the instruments come with a protective transport sleeve, do not sterilize the accessories with the protective transport sleeve. 4. Place the endoscope, sheath, trocar, and obturator into the appropriate locations within the Mitek Sports Medicine sterilization tray. 5. Package trays/instruments with a barrier wrap material in accordance with local procedures, using standardized wrapping techniques such as those described in ANSI/ AAMI ST79. In the United States, use an FDA-cleared sterilization wrap. 6. The total combined sterilization tray system should not exceed 22 lbs (weight limit). Do not stack tray systems for sterilization. 7. Steam (moist heat) sterilization shall be performed in a locally approved, pre-vacuum (forced air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285 or AAMI/ANSI ST8. The steam sterilizer should be installed and maintained in compliance to manufacturer’s instructions and local requirements. Ensure that the steam sterilizer cycle is chosen that is designed to remove air from porous or lumened device loads in accordance to manufacturer’s instructions and does not exceed the criteria for sterilizer load. 8. When the autoclave cycle is complete, remove container from the autoclave and allow the instruments to cool to room temperature before removing the top of the container.

Table 2: Steam (moist heat) sterilization • Use validated, properly maintained and calibrated steam sterilizer. • Effective steam sterilization can be achieved using the following cycles: Minimum Cycle Type Exposure Time Pre-vacuum 4 minutes Pre-vacuum 3 minutes (outside the U.S.)

Sterilization Temperature 132 °C

Drying Time 30 minutes

134-137 °C

30 minutes

Extended steam exposure cycle can be used to meet local requirements such as 134°C (274°F) for 18 minutes. Immediate-Use steam sterilization is only intended for individual instruments and should only be performed when approved by local policies. Mitek Sports Medicine does not support immediate-use steam sterilization of instrument sets, cases or implants using this method. The following steam sterilization cycle is an example of a validated cycle for individual instruments only: • Unwrapped instrument • A minimum 3 (three) pulse prevacuum cycle • 132 °C (270 °F) for 4 minutes

STORAGE Store the endoscope and endoscopic accessories in a dry, clean and safe place at room temperature. For storage, transport and processing, ensure that the endoscope is not subjected to mechanical strain, particularly to prevent damage to the sensitive lens system.

REPORTING OF SERIOUS INCIDENTS Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: a) the death of a patient, user or other person, b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, c) a serious public health threat.

*All third-party trademarks used herein are trademarks of their respective owners.

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WARRANTY The device is guaranteed to be free from defects in material and workmanship for the warranty period. In the United States, contact your Mitek Sports Medicine representative or Mitek Sports Medicine Customer Service at +1 (800) 382-4682 for specific questions regarding your product warranty. Outside the United States, contact your Mitek Sports Medicine representative.

SERVICE AND REPAIR • Mitek Sports Medicine offers Service and Replacement Programs for its products to minimize downtime in your

operating room. Contact your Mitek Sports Medicine representative or Mitek Sports Medicine Customer Service at +1 (800) 382-4682 for specific Service and Replacement Programs available for your product. Outside the United States, contact your local affiliate. Before returning any product to Mitek Sports Medicine, please contact Customer Service to obtain a return goods authorization and product return packaging. • Please clean, disinfect, and sterilize the endoscope and/or endoscopic accessories as described in this document and mark it as “Sterilized” prior to return.

PRODUCT CODES, ACCESSORIES AND SPARE PARTS This IFU is applicable to the following endoscopes, sheaths, trocars and obturators:

Description Part Number 4K C-mount endoscope 4 x 167 x 0°, MITEK 242267 4K C-mount endoscope 4 x 167 x 30°, MITEK 242268 4K C-mount endoscope 4 x 167 x 70°, MITEK 242269 4K Eyepiece endoscope 4 x 167 x 0°, MITEK 242136 4K Eyepiece endoscope 4 x 167 x 30°, MITEK 242137 4K Eyepiece endoscope 4 x 167 x 70°, MITEK 242138 HD C-mount endoscope 3.5 x 205 x 30°, MITEK 242271 HD C-mount endoscope 3.5 x 205 x 70°, MITEK 242272 HD C-mount endoscope 1.9 x 60 x 0°, MITEK 242273 HD C-mount endoscope 1.9 x 60 x 30°, MITEK 242274 HD C-mount endoscope 2.7 x 75 x 0°, MITEK 242275 HD C-mount endoscope 2.7 x 75 x 30°, MITEK 242276 HD C-mount endoscope 2.7 x 75 x 70°, MITEK 242277 HD Eyepiece endoscope 3.5 x 205 x 30°, MITEK 242041 HD Eyepiece endoscope 3.5 x 205 x 70°, MITEK 242042 HD Eyepiece endoscope 1.9 x 60 x 0°, MITEK 242094 HD Eyepiece endoscope 1.9 x 60 x 30°, MITEK 242095 HD Eyepiece endoscope 2.7 x 75 x 0°, MITEK 242105 HD Eyepiece endoscope 2.7 x 75 x 30°, MITEK 242107 HD Eyepiece endoscope 2.7 x 75 x 70°, MITEK 242109 Sheath universal, 4K accessory, single 4.0 x 167, MITEK 242031 Sheath universal, 4K accessory, dual 4.0 x 167, MITEK 242032 Sheath universal, single 3.5 x 205, MITEK 242061 Sheath universal, dual 3.5 x 205, MITEK 242062 Sheath universal, single 1.9 x 60, MITEK 242071 Sheath universal, dual 1.9 x 60, MITEK 242072 Sheath universal, single 2.7 x 75, MITEK 242083 Sheath universal, dual 2.7 x 75, MITEK 242084

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Minimum Instrument Channel Width (mm)

N/A

4.12 4.12 3.62 3.62 2.05 2.05 3.15 3.15

Maximum Insertion Portion Width (mm) 4.05 4.05 4.05 4.05 4.05 4.05 3.55 3.55 1.95 1.95 2.75 2.75 2.75 3.55 3.55 1.95 1.95 2.75 2.75 2.75

DOV (°) 0±5 30 ± 5 70 ± 5 0±5 30 ± 5 70 ± 5 30 ± 5 70 ± 5 0±5 30 ± 5 0±5 30 ± 5 70 ± 5 30 ± 5 70 ± 5 0±5 30 ± 5 0±5 30 ± 5 70 ± 5

FOV (°) 105+10/-5 105+10/-5 105+10/-5 105+10/-5 105+10/-5 105+10/-5 100+10/-5 100+10/-5 65+10/-5 65+10/-5 80 +10/-5 80 +10/-5 80 +10/-5 100+10/-5 100+10/-5 65+10/-5 65+10/-5 80 +10/-5 80 +10/-5 80 +10/-5

N/A

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Working Length (mm) 165.9 ± 0.5 165.9 ± 0.5 169.6 ± 0.5 165.9 ± 0.5 165.9 ± 0.5 169.6 ± 0.5 205.6 ± 0.5 207.6 ± 0.5 53.0 ± 0.5 53.0 ± 0.5 70.6 ± 0.5 70.6 ± 0.5 73.1 ± 0.5 205.6 ± 0.5 207.6 ± 0.5 53.0 ± 0.5 53.0 ± 0.5 70.6 ± 0.5 70.6 ± 0.5 73.1 ± 0.5 150.9 ± 0.2 150.9 ± 0.2 190.6 ± 0.2 190.6 ± 0.2 38.1 ± 0.2 38.1 ± 0.2 55.7 ± 0.2 55.7 ± 0.2

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Description Trocar, button 3.5 x 205, MITEK Obturator, button 3.5 x 205, MITEK Trocar, button, 4K accessory 4 x 167, MITEK Obturator, button, 4K accessory 4 x 167, MITEK Trocar, button 1.9 x 60, MITEK Obturator, button 1.9 x 60, MITEK Obturator, button 2.7 x 75, MITEK Trocar, button 2.7 x 75, MITEK

Part Number 242064 242063 242139 242143 242074 242073 242085 242086

242796 C-Mount O-ring 242793 HIP ACCESS CANNULA- O-ring Kit 242794 HIP ACCESS CANNULA-Knurled Nut 242795 HIP ACCESS OBTURATOR – Button 242693 MITEK Button 242694 Instrument Adapter Wolf Light Post 242695 Instrument Adapter Storz Light Post 242696 Sheath Dual Stop Cock Bridge 242698 Sheath Knurl Nut 242699 Sheath O-ring Kit 242691 Sheath Single Stop Cock Kit 242692 Sheath Single Stop Cock Bridge 242697 Sheath Dual Stop Cock Kit If damage is observed to the C-Mount O-Ring, it can be replaced with the part code in the above list. 242358 Adaptor ACMI Light Source Universal Tip 242359 Adaptor Olympus Light Source Universal Tip 242360 Adaptor Storz Light Source Universal Tip 242361 Adaptor Wolf Light Source Universal Tip 242362 Adaptor Storz/Olympus Instrument Universal Tip 242363 Adaptor Wolf Instrument Universal Tip 242364 Adaptor ACMI Instrument Universal Tip Light adaptors can be ordered to allow the Mitek Sports Medicine endoscopes to mate with ACMI, Olympus, Storz, and Wolf connections. Light source adaptors connect with the light source, while the instrument adaptors connect to the endoscopes. Refer to Figure 4 for assembly instructions.

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Minimum Instrument Channel Width (mm)

Maximum Insertion Portion Width (mm)

DOV (°)

FOV (°)

N/A

Working Length (mm) 211.3 ± 0.5 210.4 ± 0.5 172.3 ± 0.5 171.7 ± 0.5 56.9± 0.5 56.4 ± 0.5 74.7 ± 0.5 75.85 ± 0.5

242266 C-MOUNT WRENCH The C-Mount Wrench can be used with the C-Mount Endoscope to tighten or loosen the endoscope connection to the camera. Position the wrench head onto the endoscope torque ring grooves and turn in the direction of the arrows.

Figure 6. C-Mount Wrench Caution Contains hazardous substances Medical Device N  onsterile

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Medos International SARL Chemin-Blanc 38 2400 Le Locle, Switzerland Revised 2021/07 © DePuy Synthes 2021. All rights reserved. 2021-8-6 22:38:24

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