Starfish Scope Rotation Attachment Insert Manual

1.0

Packaging and Labeling

All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary.

2.0

Information

In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. In CE Accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.

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3.0

Warnings/Cautions:

3.1

Prior to use, read this manual carefully and become familiar with the operation of the device and the accessories before use during surgical procedures.

3.2

Prior to use, read the entire Arthrex SynergyHD3™ System [950-0027-XX] or SynergyUHD4™ System [9500047-XX] video instruction manuals before use during surgical procedures.

3.3

Risk of injury due to faulty Starfish™. 3.3.1 Carry out visual inspection and function check prior to each use. 3.3.2 Only use Starfish which are in perfect condition.

3.4

Starfish are delivered non-sterile as reusable products. Ensure that the processing, material, and personnel are suitable for achieving the results necessary. 3.4.1 Caution: Federal law restricts this device to sale by or on the order of a physician. 3.4.2 This device is intended to be used by a trained medical professional.

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3.4.3 Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 3.4.4 Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.

3.4.5 Surgeons are advised to review the productspecific surgical technique prior to performing any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration.

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4.0

About This Document

This document describes the correct handling, functioning, and reprocessing of the Arthrex Starfish Scope Rotation Attachments. This document may not be used to carry out examinations or surgeries, nor may it be used for training purposes. The current version of this document can be found on the internet at www.arthrex.com. You can also request this document from Arthrex. Users of the Starfish attachments are encouraged to contact their representatives if, in their professional judgment, they require more comprehensive information on its use and care.

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5.0

Intended Use

Arthrex Synergy Starfish Scope Rotation Attachments are used to rotate eye-coupler endoscopes during use. The Arthrex Synergy C-Mount Starfish Scope Rotation Attachment is used to rotate C-Mount arthroscopes during use. Both attachments will be referred to as the Starfish unless there is the need to differentiate between the two.

6.0

Safety Information

The Starfish may only be used by trained medical professionals in medical facilities. 6.1

After receipt of device(s), inspect the Starfish for completeness and damage.

6.2

Read, observe and store these instructions and any other applicable instructions.

6.3

Use Starfish only as intended.

6.4

For storage, transport and processing, ensure that the Starfish is not subjected to mechanical strain.

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7.0

Inspection Handling & Maintenance

7.1

Inspect the Starfish for damage prior to use and at all stages of handling thereafter.

7.2

If damage is detected, do not use the Starfish prior to consulting the manufacturer for guidance.

7.3

Do not subject the Starfish to impact forces. Set the Starfish down carefully.

7.4

Do not bend the Starfish or use as a prying tool.

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8.0

AR-3370-0006, Starfish Attachment Overview

Figure 8-1: AR-3370-0006 Starfish Attachment

8.1

Starfish Features: 1.

Scope Snap-Fit: Accepts and locks into place a compatible scope.

2.

Light Post Snap-Fit: Accepts and locks into place a compatible light post.

3.

Thumb Tabs: Intended to be pushed by hand to rotate the scope.

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8.2

Markings on the Starfish • • • • •

8.3

Article Number Lot Number CE Mark Arthrex Logo Unique Device Identifier (UDI)

Compatible Products The Starfish is intended to be used with the following instruments: • • • • •

AR-3210-XXXX (Arthrex Synergy Camera Heads) AR-3350 4030 (4mm, 30° eyecup Arthroscope) AR-3350 4070 (4mm, 70° eyecup Arthroscope) AR-3350 5030 (Sheathless, 30° eyecup Arthroscope) AR-3350 5070 (Sheathless, 70° eyecup Arthroscope)

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9.0

AR-3370-0008, C-Mount Starfish Attachment Overview:

Figure 9-1: AR-3370-0008 C-Mount Starfish Attachment

9.1 C-Mount Starfish Features 1.

Scope Snap-Fit - Accepts and locks into place a compatible scope.

2.

Light Post Alignment Hole - Accepts and locks into place a compatible light post.

3.

Thumb Tabs – Intended to be pushed by hand, to rotate the scope.

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9.2

Markings on the C-Mount Starfish • • • • •

9.3

Article Number Lot Number CE Mark Arthrex Logo Unique Device Identifier (UDI)

Compatible Products The C-Mount Starfish is intended to be used with the following instruments: • • • • • •

AR-3210-XXXX (Arthrex SynergyHD3 and UHD4 C-Mount Camera Heads) AR-3355-3030 (C-Mount Arthroscope, 30°, 3x138mm, HD) AR-3355-3070 (C-Mount Arthroscope, 70°, 3x140mm, HD) AR-3355-4000 (C-Mount Endoscope, 0°, 4x152.5mm) AR-3355-4030 (C-Mount Arthroscope, 30°, 4x152.5mm) AR-3355-4030H (C-Mount Hip Arthroscope 30°, 3.5x 202mm)

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• • • • • •

•

AR-3355-4030R (C-Mount Arthroscope, Reverse Light Post, 30°,4x152.5mm) AR-3355-4070 (C-Mount Arthroscope, 70°, 4x156.5mm) AR-3355-4070H (C-Mount Hip Arthroscope 70°, 3.5x 204mm) AR-3355-5230 (4K C-Mount Arthroscope, 30°, 4.8x 152.5mm) AR-3355-5270 (4K C-Mount Arthroscope, 70°, 4.8x 156mm) AR-3355-5430 (4K C-Mount Sheathless Arthroscope, 30°, 5x160mm) AR-3355-5470 (4K C-Mount Sheathless Arthroscope, 70°, 5x162mm)

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10.0

Preparation for Use

10.1

Visual Inspection & Function Check WARNING: Risk of injury due to faulty Starfish. 10.1.1 Carry out visual inspection and function check prior to initial use and each subsequent use. 10.1.2 Only use Starfish which are in perfect condition. 10.1.3 Clean/Disinfect and sterilize the Starfish prior to initial use, as well as each subsequent use of the Starfish. 10.1.4 Ensure that there are no residual cleaning agents or disinfectants on the Starfish. 10.1.5 Inspect the entire Starfish for contaminants and damage of any type, such as dents, scratches, cracks, bending and/or sharp edges. WARNING: Do not bend the endoscope optics while installing or removing the Starfish. Handle the endoscope by the light post barrel and eyepiece only.

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11.0

Installation

11.1

AR-3370-0006, Starfish 1.

Press the Starfish Scope Snap-Fit onto a compatible endoscope such that the Thumb Tabs reach back towards the camera head.

Figure 11-1: Installing Scope Snap-Fit

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2.

Rotate the Starfish around the scope until the Light Post Snap-Fit engages the light post.

Figure 11-2: Installing Light Post Snap-Fit

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11.2

AR-3370-0008, C-Mount Starfish

Align the light post hole on the C-Mount Starfish to the light post on the scope. Press the Starfish Scope Snap-Fit onto a compatible C-Mount arthroscope such that the thumb tabs reach back towards the camera head.

Align light post hole with light post and snap together

Figure 11-3: Installing Scope Snap-Fit

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12.0

Operation

12.1

(AR-3370-0006 Starfish only) When using the Starfish attachment in conjunction with a camera head, allow the camera head’s scope mount to spring closed around the scope automatically. Do not manually adjust the tightness of the scope mount.

12.2

During use, press the Thumb Tabs to rotate the scope.

12.3

Prepare the Starfish for reprocessing immediately after use to prevent surface damage.

13.0

Reprocessing Limitations

Repeated processing has minimal effect on the Starfish. End of life is normally determined by wear and damage due to intended use.

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14.0

Cleaning and Disinfection

Devices must be adequately cleaned and sterilized prior to use or re-use. All devices are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile devices. Effective cleaning is an indispensable requirement for effective sterilization of the devices. CAUTION: If the Starfish is cracked or damaged, properly dispose of the device. 14.1

Point-of-Use Preparation, Containment, and Transportation 14.1.1 It is recommended that devices are reprocessed within a maximum of 2 hours of use. At point of use, soiled devices must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-to-reach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down

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protein matter and prevent blood and proteinbased materials from drying on devices. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety. 14.2

Detergent Selection Consider the following points during selection of the cleaning detergent: 1. 2.

Suitability of the cleaning agent for ultrasonic cleaning (no foam development). Compatibility of the cleaning agent with the devices. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent.

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Enzol® and neodisher® MediClean forte were utilized during the validation of these instructions. Caution: Low acid or alkaline solutions are not recommended, as they corrode metal parts and compromise plastics. 14.3

Follow the instructions of the detergent manufacturer regarding use concentration and temperature for either manual or automated cleaning. Please use only freshly prepared solutions as well as only purified (critical, e.g. RO or DI) water for final rinse.

14.4

Preliminary Cleaning •

•

•

Remove excess soil from devices, especially in areas such as joints and crevices, by cleaning the surfaces with a sponge or brush under cold running water or with a non-shedding disposable wipe for a minimum of 1 minute. Rinse the devices at least 1 minute under running utility water (temperature < 35°C/95°F). Special attention should be given to lumens, joint, crevices, and other hard-to-reach areas. Immerse the devices in cleaning solution inside an ultrasonic bath. While immersed in solution,

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