Cyclops Multi-Angle Endoscope and Accessories Instructions for Use Rev E

Instructions for Use

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Acclarent Cyclops® Multi-Angle Endoscope and Accessories

CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

PACKAGING STERILITY: NON-STERILE: The ACCLARENT CYCLOPS® endoscope is provided NON-STERILE. The ACCLARENT CYCLOPS® endoscope must be cleaned and sterilized or disinfected prior to its first use, before each subsequent use and after returning from repairs. See instructions below for cleaning, sterilization and disinfection methods.

DESCRIPTION The ACCLARENT CYCLOPS® endoscope is a rigid endoscope. It incorporates two image adjustment control dials. Specifications Working Length

175 mm

Shaft Diameter

4.3 mm

Shaft Direction Control Dial

Allows shaft to be rotated between 0° and 160° in either direction from the 12 o’clock rotation position.

Angle Control Dial

Angle of view can be adjusted between 10° and 90°.

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and chosen to minimize the risk of splashing and spills of chemicals. Follow all detergent and liquid chemical disinfectant manufacturer warnings, cautions, and instructions closely. Do not use a damaged or defective ACCLARENT CYCLOPS® endoscope. Inspect the ACCLARENT CYCLOPS® endoscope prior to each examination or procedure and before sterilization or high level disinfection based on the instructions below. Surface temperature of the endoscope tip may exceed 41°C as a result of high energy light radiated through the endoscope if the device is operated at maximum brightness. Tissue injury that is not visually obvious can occur before visible burns. To avoid tissue injury or burns to the patient or user, do not use light cables with a diameter greater than 5.0mm. Acclarent strongly recommends the use of a 3.5mm fiber optic light cable as it will generate lower surface temperatures compared to a 5.0mm light cable. Always adjust the light source to the minimum light output necessary to illuminate the endoscopic image. DO NOT leave the tip of the scope in direct contact with patient tissue, flammable, or combustible materials, as burns or permanent damage may result. This should be avoided. When adjusting the direction of view with the endoscope remaining within the nasal cavity, maintain endoscopic visualization to assure that the endoscope tip is not resting directly on nasal tissue. Do not use the ACCLARENT CYCLOPS® with Xenon light sources greater than 300W.

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Figure 1. ACCLARENT CYCLOPS® Multi-Angle Endoscope

Legend: 1) Distal Window 2) Shaft 3) Shaft Direction Control Dial 4) Scope Body 5) Angle of View Scale 6) Angle Indicator (small bump on surface of Angle Control Dial)

7) Angle Control Dial 8) Eyepiece 9) Light Guide Post ACMI Light Cable Configuration (fixed) 10) Wolf Light Cable Adapter (detachable) 11) Olympus / Storz Light Cable Adapter (detachable)

INDICATIONS FOR USE The ACCLARENT CYCLOPS® Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

CONTRAINDICATIONS Do not use ACCLARENT CYCLOPS® on patients who already have active implanted devices that would be affected by a magnetic field (e.g. pacemaker, implantable cardioverterdefibrillator, cochlear implant and/or deep brain stimulator) because ACCLARENT CYCLOPS® contains small rare-earth permanent magnets. Additionally, do not use ACCLARENT CYCLOPS® on patients with inferior vena cava filters that have been implanted within the previous two weeks.

WARNINGS NON-STERILE: The ACCLARENT CYCLOPS® endoscope is provided NON-STERILE. The ACCLARENT CYCLOPS® endoscope must be cleaned and sterilized or high level disinfected prior to its first use, before each subsequent use and after returning from repairs. See instructions below for cleaning, sterilization and high level disinfection. Do not use the ACCLARENT CYCLOPS® endoscope if you are unable to clean and sterilize or high level disinfect according to the validated procedures contained in these instructions. Never attempt to perform manual cleaning or high level disinfection of the ACCLARENT CYCLOPS® without all necessary personal protective equipment. Some reprocessing chemicals produce strong odors which can result in adverse health effects to reprocessing staff and other persons. Ensure that all reprocessing is performed in an appropriately designed and wellventilated area, such as under an exhaust hood. Containers selected for reprocessing should be closable English

Turn off the light source and allow the endoscope to cool for at least two minutes prior to disconnecting the fiber optic cable or allowing staff to handle the endoscope. The connection between the ACCLARENT CYCLOPS® endoscope and the light source can become very hot. Use care when handling and do not rest the scope directly on a patient or flammable material. Turn off the light source whenever the endoscope is withdrawn from the nose, to allow cooling. These Instructions for Use are meant to facilitate use of the ACCLARENT CYCLOPS® and are not instructions on how to perform endoscopic procedures.

PRECAUTIONS Do not bend the ACCLARENT CYCLOPS®. Do not hold the ACCLARENT CYCLOPS® by its shaft, as this can cause damage. Acclarent recommends the use of a sterilization tray to protect ACCLARENT CYCLOPS® from damage during sterilization. When using the ACCLARENT CYCLOPS® sterilization tray, only press or lift the ACCLARENT CYCLOPS® endoscope where it is supported by the tray inserts. Do not press or lift ACCLARENT CYCLOPS® where it is unsupported by the tray inserts as this can cause damage to the endoscope. The minimum angle of view allowed by the ACCLARENT CYCLOPS® is 10°. Use caution when advancing the scope. To maintain optical quality, do not clean the ACCLARENT CYCLOPS® or light cable adapters in an ultrasonic bath. Do not accelerate the cooling of the ACCLARENT CYCLOPS®, as this can cause damage. Do not flash sterilize the ACCLARENT CYCLOPS®. Cleaning and sterilization or high level disinfection can only be ensured if the ACCLARENT CYCLOPS® is cleaned and sterilized or disinfected according to properly validated methods. The minimum cleaning and sterilization or high level disinfection procedures are provided in this IFU. The Automated Cleaning procedure has not been validated as effective in accomplishing disinfection. It is the responsibility of the user to qualify any deviations from the recommended procedures. Manual Cleaning PLUS Automated Cleaning must be performed each time the ACCLARENT CYCLOPS® and light cable adapters are reprocessed by sterilization. If the ACCLARENT CYCLOPS® was used in a patient with Creutzfeld-Jakob Page 2/8

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Instructions for Use

Acclarent Cyclops® Multi-Angle Endoscope and Accessories

disease (CJD), suspected CJD or possible variants of CJD, Acclarent recommends safely disposing of the ACCLARENT CYCLOPS®. For disposal instructions, see Section D. When the angle control dial is set to greater than 70°, the illumination provided by the ACCLARENT CYCLOPS® becomes less intense.

INSTRUCTIONS FOR USE A. Inspection and Testing 1. Remove and discard the protection caps from the eyepiece and light guide post immediately upon receipt. If the endoscope has a protective tube covering the shaft and distal tip, remove and discard the protective tube immediately upon receipt. If endoscope has a protective cap covering the distal tip, remove and discard the protective cap from the distal tip immediately upon receipt. 2. Inspect the endoscope immediately upon receipt, and before and after every procedure. 3. Inspect the distal window and eyepiece for scratches, nicks, chips, sharp and/or irregular edges and surfaces. Examine the distal window for anomalies such as, fingerprints or residual debris by observing reflected light on the surfaces of the distal window and eyepiece. Confirm that the endoscope shaft and distal end are not bent. 4. To test image quality, look through the eyepiece. The image should be clear and distinct. If the distal window, eyepiece lens and light guide post surface are cloudy, dirty or scratched, or if the shaft is bent, scratched, dented, corroded, pitted or exhibits other surface irregularities, the image may not be clear. If the image is not clear, the ACCLARENT CYCLOPS® should not be used, and should be sent in for repair or taken out of service. 5. Check light transmission by pointing the distal window of the ACCLARENT CYCLOPS® at a light source and inspecting the light transmitting surface of the light guide post connector (see Figure 2). If the glass light fibers are broken, the light transmitting surface of the light guide post will illuminate unevenly. Individual broken fibers do not necessarily result in a noticeable reduction in image quality. However, if approximately 25% of the transmitting surface of the light guide post is illuminating unevenly, the endoscope should not be used, and should be sent in for repair or taken out of service.

Xenon (up to 300W) light sources. c. Make sure that the distal window, eyepiece lens or light guide post surface do not contact abrasive surfaces. Anti-fog solution (e.g. Covidien’s FRED™ or DeRoyal DeFogger™) may be used with ACCLARENT CYCLOPS® to help prevent fogging of the distal window and eyepiece lens. d. Handle the ACCLARENT CYCLOPS® endoscope with care. Hard impacts, particularly to the distal end, may result in damage or cracks. 10° Angle of View

Angle Control Dial 90° Angle of View

Rotate the Angle Control dial to “+” for the 90° Angle of View

Rotate the Angle Control dial to “-” for the 10° Angle of View

Figure 3. ACCLARENT CYCLOPS® Angle of View

e. To change the ACCLARENT CYCLOPS® endoscope’s angle of view, rotate the Angle Control dial. The angle indicator on the Angle Control dial aligns with the set of reference markings on the body of the endoscope. The ACCLARENT CYCLOPS® endoscope displays angles between 10° and 90° as shown in Figure 3. Rotate the Angle Control dial in the direction of the “-“ to reduce the direction of view. Rotate the Angle Control dial in the direction of the “+” to increase the direction of view. f. To rotate the ACCLARENT CYCLOPS® endoscope’s shaft, rotate the Shaft Direction Control dial. The scope allows shaft rotation of 160° in both clockwise and counterclockwise directions from the 12 o’clock rotational position. A triangleshaped marker that displays the 12 o’clock rotational position is visible in the endoscopic view. A round silver indicator on the Shaft Direction Control dial illustrates the location of the 12 o’clock rotational position.

Shine light source here Endosopic view

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Indicator at 12 o’clock position

Figure 4. ACCLARENT CYCLOPS® Shaft Direction Indicator Inspect light transmitting surface of the light guide post here

C. Point of Use Cleaning

Figure 2. Method for Checking Light Transmission

The following steps are to be performed at the point of use:

6. Test the image adjustment control dials. Rotate the angle control and shaft direction control dials while looking through the eyepiece. Ensure that the image changes appropriately. ACCLARENT CYCLOPS® requires no lubrication to maintain proper function. If the image does not change appropriately, the endoscope should not be used, and should be sent in for repair or taken out of service. B. Point of Use 1. Assembly: a. Connect appropriate light cable adapters as required. i. To connect the Wolf light cable adapter, slide the adapter over the light guide post and tighten in place using the screw threads. ii. To connect the Olympus / Storz light cable adapter, slide the adapter over the light guide post and tighten in place using the screw threads. b. If a camera is utilized, connect the camera coupler to the eyepiece. i. The standard B-cup eyepiece can be used with cameras or universal C-mount camera couplers. c. Connect the light guide cable to the light guide post/adapter. Only light cables with a diameter of 5.0 mm and smaller should be used to prevent overheating of the distal tip. 2. Usage: a. Observe the respective manufacturer’s instructions when using the ACCLARENT CYCLOPS® endoscope with other implements, instruments or optical cables. b. Acclarent recommends use with

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1. During surgery, keep the device moist by periodically wiping with a wet gauze or a lap sponge and sterile water. 2. After surgery has concluded, use a wet gauze or a lap sponge and sterile water to wipe off any visible debris. Keep the device moist by adding a moist towel to the transport container until it can be cleaned according to the reprocessing instructions described below. Cleaning should be completed on the ACCLARENT CYCLOPS® and the light cable adapters within 30 minutes following their use. CAUTION: Prior to immersing the Cyclops in cleaning or reprocessing liquids carefully assess the distal window and eyepiece for damage such as scratches, nicks, chips, sharp and/or irregular edges and surfaces. Confirm that the endoscope shaft and distal end are not bent. Immersing a damaged device in liquids may lead to fluid invasion and device damage. Note on Device Reprocessing: The ACCLARENT CYCLOPS® Multi-Angle Endoscope may be sterilized or high level disinfected by following all applicable instructions provided in this document. When methods of both sterilization and high level disinfection are conveniently available to the user, Acclarent recommends that users consider the use of sterilization versus high level disinfection. In order to ensure that the device may be robustly cleaned and disinfected or sterilized, all steps in the respective group of instructions must be followed. Users must not interchange steps from different reprocessing methods. For all reprocessing methods described below, Sections D, E, F, K, L, and M apply.

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®

Instructions for Use

Acclarent Cyclops® Multi-Angle Endoscope and Accessories

High Level Disinfection

Sterrad Sterilization

Steam Sterilization

Table 1: Summary of Reprocessing Methods Step 1

Step 2

Step 3

Manual Cleaning

Automated Cleaning

Steam Sterilization

See

section F

See

section G

See section H

Manual Cleaning

Automated Cleaning

Sterrad

Sterilization

See section F

See section G

See section I

Manual Cleaning

High Level Disinfection

Not Applicable

See section F

See section J

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D. General Considerations for Endoscope reprocessing (ALL reprocessing methods) 1. All reprocessing should be completed by personnel trained in the appropriate reprocessing techniques and safety. All reprocessing personnel should wear personal protective equipment appropriate for the reprocessing method chosen. The reprocessing should only be performed in an area designed for the purpose. 2. Cleaning should be completed on the ACCLARENT CYCLOPS® and the light cable adapters within 30 minutes following their use. Keep device continuously moist with a moist towel prior to cleaning. 3. If the ACCLARENT CYCLOPS® endoscope was used in a patient with Creutzfeld-Jakob disease (CJD), suspected CJD or possible variants of CJD, Acclarent recommends safely disposing of the ACCLARENT CYCLOPS® endoscope. The safest and most unambiguous method for ensuring that there is no risk of residual infectivity on contaminated instruments and other materials is to discard and destroy them by incineration. For more information regarding exposure to Creutzfeld-Jakob disease (CJD) or possible variants of CJD, and for information about disposing contaminated devices, please see the following references: a. Brown, S. A., Merritt, K., Woods, T. O., & Busick, D. N. (2005). Effects on instruments of the World Health Organization – Recommended protocols for decontamination after possible exposure to transmissible spongiform encephalopathy contaminated tissue. Appl Biomater, 72B, 186-190. DOI 10.1002/ jbm.b.30125. b. World Health Organization Infection Control Guideline for Transmissible Spongiform Encephalopathies. Geneva, Switzerland, March, 1999 available from: http://www.who.int/csr/resources/ publications/bse/WHO_CDS_CSR_ APH_2000_3/en/ CAUTION: Do not place the ACCLARENT CYCLOPS® directly on or next to an active implantable device that may be affected by magnetic fields as the device contains small rare earth permanent magnets. E. Preparation for Cleaning (ALL reprocessing methods) 1. Disassembly a. Disconnect the light cable from the light guide post. b. If a camera was utilized, disconnect the camera coupler from the eyepiece. c. Remove any light cable adapters used. d. Keep ACCLARENT CYCLOPS® and light cable adapters continuously moist until Manual Cleaning can commence at the point of central reprocessing. The device may be kept moist by placing a damp towel over the device while it is in the transport container. F. Cleaning: Manual (ALL reprocessing methods) The following steps are to be performed at the point of central reprocessing: 1. Manual Cleaning: a. Prepare a neutral pH enzymatic detergent (e.g. Enzol®) per the manufacturer’s instructions (e.g. for Enzol®, mix 1 oz/gal with lukewarm tap water). Prepare a fresh mixture of cleaning solution for each use. Rinse the Cyclops Endoscopes and Light Cable Adapters under cold running tap water for a minimum of 3 minutes.

b. While rinsing, rotate both of the Image Adjustment Control dials on the endoscope 5 times. One cycle of rotation for the controls will consist of a full rotation clockwise and counterclockwise. c. Brush all surfaces of the Endoscope and Light Cable Adapters with a new/ unused or decontaminated soft bristle brush for the remainder of the rinse time. d. Fully immerse the Cyclops Endoscope and Light Cable Adapters in the prepared detergent and allow to soak for 45 +/- 2 minutes. If cleaning multiple devices, use a separate container for each. e. After the first 15 min of soaking, begin rotation, syringe, and brushing to remove soil. While continuing to soak in Enzol, rotate both of the Image Adjustment Control dials on the Endoscope 5 times while immersed in the enzymatic detergent. One cycle of rotation for the controls will consist of a full rotation clockwise and counterclockwise. f. While continuing to soak, brush all surfaces of the endoscope and adapters with a new/unused or decontaminated soft bristle brush for a minimum of 3 minutes. Ensure that hard to reach areas such as cracks, crevices and threads on the Light Guide Post and Light Cable Adapters are fully cleaned.

Figure 5. Areas such as Cracks, Crevices, and Threads on Cyclops

g. While the sample remains submerged in the detergent solution, use a 60 mL syringe filled with Enzol solution to flush crevices around the Image Adjustment Control dials and the threads of the Light Cable Adapters. While continuing to soak, brush all surfaces of the endoscope and adapters a second time with a new/ unused or decontaminated soft bristle brush for a minimum of 3 minutes. Ensure that hard to reach areas such as cracks, crevices and threads on the Light Guide Post and Light Cable Adapters are fully cleaned. Repeat the flushing of the crevices 2 additional times for a total of 3 times for each sample. CAUTION: The light cable adapters must be reprocessed each time the ACCLARENT CYCLOPS® is reprocessed. CAUTION: The Neither Manual Cleaning or Automated Cleaning reprocessing parameters alone have been validated as effective in accomplishing complete disinfection of the ACCLARENT CYCLOPS®. Automated and/or Manual cleaning must be followed by sterilization or high level disinfection prior to clinical use. Visual Inspection Procedure 1. Soak for a minimum of 3 minutes with ambient temperature sterile water. 2. Dry with a lint free soft cloth. 3. Visually inspect the Endoscopes and Light Cable Adapters (without magnification at a distance of 20cm and with ambient lighting) and verify that the samples do not have visible soil. A lint free cloth may be used to wipe the endoscope to assist in checking for the presence of retained soil. If soil is found, repeat the cleaning steps described above until all soil is removed from the device. G. Cleaning: Automated (required prior to sterilization only) The following steps are to be performed at the point of central reprocessing after completion of Manual Cleaning (described above). Automated Cleaning: a. Place the ACCLARENT CYCLOPS® together with its light cable adapters into a separate mesh basket. Ensure that the ACCLARENT CYCLOPS® and light cable adapters do not touch each other when placed into the basket. b. Place a mesh screen over the basket to prevent the ACCLARENT CYCLOPS® and light cable adapters from coming out of the basket during processing. c. Place the mesh basket with ACCLARENT CYCLOPS® and

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Instructions for Use

Acclarent Cyclops® Multi-Angle Endoscope and Accessories

light cable adapters into a general instrument washer-disinfector (e.g. Amsco Steris 444, Steris GenFore Washer / Disinfectors) to clean the ACCLARENT CYCLOPS® and light cable adapters. d. Select a neutral pH enzymatic detergent (e.g. Enzol) and a neutral pH instrument cleaner (e.g. RenuKlenz™, ). Prepare per the instructions of the detergent manufacturer (for example, Enzol 1oz/gal and RenuKlenz ¼oz/ gallon). Prepare a fresh mixture of cleaning solution for each use. e. Run the washing machine cycle per the instructions provided by the manufacturer. The minimum cleaning cycle is described below in Table 2: Table 2: Automatic Cleaning Parameters Phase

Recirculation Time

Water Temperature

Pre Wash

Detergent Type

3 minutes

Cold tap water

N/A

Enzyme Wash

5 minutes

Hot tap water

Neutral pH enzymatic detergent

Wash 1

5 minutes

65°C (Set Point)

Neutral pH instrument cleaner

Rinse 1

2 minutes

Hot tap water

N/A

Dry Phase

7 minutes

66-115°C

N/A

f. Remove the ACCLARENT CYCLOPS® and light cable adapters from the washing machine following the cleaning cycle and after allowing sufficient time for the devices to cool so they can be safely handled. g. Inspect the devices to ensure that all visible soil, stains and debris have been removed. CAUTION: Manual Cleaning PLUS Automated Cleaning must be performed each time the ACCLARENT CYCLOPS® and light cable adapters are reprocessed using sterilization. CAUTION: The Automated Cleaning reprocessing parameters have not been validated as effective in accomplishing disinfection of the ACCLARENT CYCLOPS®. H. Sterilization: Steam 1. Do not “Flash” sterilize the ACCLARENT CYCLOPS® or light cable adapters. 2. Ensure the ACCLARENT CYCLOPS® and light cable adapters are disassembled before sterilization. 3. Place the ACCLARENT CYCLOPS and light cable adapters in a sterilization tray and lid suitable for steam sterilization (e.g. ACCLARENT CYCLOPS® Sterilization Tray). Double wrap the closed sterilization tray containing the ACCLARENT CYCLOPS® and light cable adapters with 1-ply polypropylene wrap (e.g. Kimguard KC600).

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4. Complete sterilization per AAMI ST79:2006, A1:2008,A2:2009. The validated parameters are listed in Table 3. Table 3: Parameters for Steam Sterilization Sterilization Method Pulses (minimum) Temperature Exposure time Drying Time

Pre-Vacuum 3 132°C / 270° F 4 minutes 20 minutes

5. After sterilization, allow the ACCLARENT CYCLOPS®, and light cable adapters to cool down to room temperature. Do not accelerate cooling, as this may damage the ACCLARENT CYCLOPS® endoscope. I. Sterilization: Sterrad 1. Ensure the ACCLARENT CYCLOPS® and light cable adapters are disassembled before sterilization. 2. The ACCLARENT CYCLOPS® and light cable adapters are compatible with the STERRAD 100S, 100NX and NX sterilization systems. 3. Place ACCLARENT CYCLOPS® and light cable adapters in a STERRAD® compatible tray (e.g. ACCLARENT CYCLOPS® Sterilization Tray or APTIMAX™ instrument tray, Advanced Sterilization Products, Johnson & Jonson Co., Part Number 13827), and double wrap with 1-ply polypropylene wrap (e.g. Kimguard KC600). Include a STERRAD® indicator strip in the wrapped English

package. 4. Load the tray with ACCLARENT CYCLOPS® and light cable adapters into the STERRAD® sterilizer. 5. Run the STERRAD® machine per the manufacturer’s instructions. Acclarent recommends the following cycles: a. STERRAD® NX: Standard cycle b. STERRAD® 100S: Standard cycle c. STERRAD® 100NX: Standard cycle J. High Level Disinfection (HLD) 1. The ACCLARENT CYCLOPS® and light cable adapters may be chemically disinfected using high level disinfectant solutions containing one of the following active ingredients: glutaraldehyde (e.g. Cidex® Solution) or orthoPhthalaldehyde (e.g. Cidex® OPA). 2. Prepare the disinfectant solution per the manufacturer’s instructions and for the required solution temperature. 3. Fully immerse the ACCLARENT CYCLOPS® and light cable adapters in the disinfectant solution for the following minimum times depending on the active ingredient of the solution: 2.4% Gluteraldehyde (e.g. Cidex®)

45 minutes minimum

0.55% orthoPhthalaldehyde (e.g. Cidex® OPA)

30 minutes minimum

4. After a minimum of 5 minutes of soaking, keeping the device submerged, rotate both of the image adjustment control dials (shaft direction and angle control dials) on the ACCLARENT CYCLOPS® a minimum of 5 times. Note: One cycle of rotation for the controls will consist of a full rotation clockwise and counter-clockwise. 5. While continuing to fully submerge and soak device in the disinfectant solution: a. Brush all surfaces of the ACCLARENT CYCLOPS® and light cable adapters with a new or decontaminated soft bristle brush for a minimum of 3 minutes. b. Use a syringe filled with the disinfection solution to flush crevices around the image adjustment control dials and the threads of the light cable adapters. c. Repeat the brushing and flushing steps once more (at minimum). d. Ensure that hard to reach areas such as cracks, crevices and threads on the light guide post and light cable adapters are fully cleaned. 6. Remove any air bubbles that are present on the ACCLARENT CYCLOPS® or light cable adapters with a sterile cloth or syringe and allow the device to soak for the remaining time. 7. Rinse the ACCLARENT CYCLOPS® and light cable adapters in a warmed (31-51°C) sterile water bath in a clean container. Gently agitate the rinse vessel for a minimum of 5 minutes. While rinsing the device in sterile water: a. Rotate both of the image adjustment control dials on the ACCLARENT CYCLOPS® a minimum of 5 times. Note: One cycle of rotation for the controls will consist of a full rotation clockwise and counter-clockwise. b. For the remainder of the rinse time, brush all surfaces of the ACCLARENT CYCLOPS® and light cable adapters with a new or decontaminated soft bristle brush. c. Rinse the ACCLARENT CYCLOPS® and light cable adapters 3 more times by fully submerging the device in sterile water for a minimum of 1 minute each time, using new sterile water for each rinse. d. Wipe the entire surface of the ACCLARENT CYCLOPS® and light cable adapters using sterile gauze and 70% isopropyl alcohol (IPA) and allow to dry for approximately 10 minutes. K. Post-cleaning Inspection and Testing (ALL reprocessing methods) After cleaning is complete, inspect the ACCLARENT CYCLOPS® per the Page 5/8

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Instructions for Use

Acclarent Cyclops® Multi-Angle Endoscope and Accessories

instructions in Section A. L. Storage 1. Store the ACCLARENT CYCLOPS® endoscope in a dry, clean and safe place at room temperature, in its polypropylene wrap. 2. Acclarent does not recommend storing the ACCLARENT CYCLOPS® and light cable adapters in their shipping box. M. Disposal 1. For disposal, observe standard protocols for disposal of surgical devices (see Section D for references).

Technical service, maintenance or repairs: • Contact Acclarent Customer Service: • Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 U.S.A. • Toll Free: 1-877-SPLASTY (1-877-775-2789) • Before returning any product to Acclarent, please contact Acclarent Customer Service to obtain a return goods authorization and product return packaging. • Please clean and sterilize or high level disinfect the endoscope and mark it as “Sterilized” or “High Level Disinfected” prior to return.

GRAPHIC SYMBOLS CONTAINED IN DEVICE LABELING Non-Sterile Consult Instructions For Use

Working Length RX ONLY

On Order of Physician Only

Scope Outer Diameter

Product Code

Serial Number

Light Cable Adapter

Keep Away from Sunlight

Caution

Manufacturer

Manufacturing Date

ACCLARENT CYCLOPS™ Multi-Angle Endoscope

Manufactured for: Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 USA Toll Free: 1-877-SPLASTY (1-877-775-2789)

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© Acclarent, Inc. 2016