AtriCure CGG100 LAA Exclusion System Instructions

AtriCure CGG100 LAA Exclusion System

Product Information

Specifications

• Accessory to the AtriClip LAA Exclusion System
• Material: Aluminum and cured polyurethane ink
• Sterile and non-pyrogenic
• Not made with natural rubber latex
• It does not contain phthalates
• Storage Relative Humidity: 15% to 85%
• Transit Relative Humidity: 30% to 85%

Description
The AtriClip Selection Guide (Guide) is an accessory that works in conjunction with the AtriClip LAA Exclusion System. The AtriClip LAA Exclusion System includes the AtriClip LAA Exclusion Device (Clip), the AtriClip Applier, and the Guide. The Guide is a sterile accessory composed of aluminium and cured polyurethane ink. It is not made with natural rubber latex and does not contain phthalates.

Usage Instructions

Preparation

1. Ensure sterile conditions before using the Guide.
2. Remove the Guide from its packaging using a sterile technique.
3. Inspect the sterile package for any damage or breach of the sterile barrier. If the package is damaged or the barrier is breached, discard the device and do not use to avoid the risk of patient infection.

Handling and Placement

4. Handle the Guide with care to avoid dropping or inducing damage to the device. If the device is dropped, do not use it and replace it with a new device.
5. Align the Guide adjacent to the LAA (Left Atrial Appendage) as shown in Figure 2.
6. Evaluate the LAA at the base of the appendage using the Guide.

Clip Selection

7. Using the Guide, select the appropriate Clip size for the LAA.
8. Do not apply excessive force when using the Guide to avoid tissue damage.
9. Avoid bending the Guide in the area of the indication marks as this may lead to incorrectly determining the corresponding AtriClip size.
10. Ensure proper sizing of the Clip to avoid tissue trauma, dehiscence, tissue tearing, displacement, and/or lack of desired hemostasis.

FAQ (Frequently Asked Questions)

• Q: Can I re-sterilize and reuse the Guide?
  No, the Guide is provided sterile and is intended for single use only. Re- sterilization may cause injury to the patient.

• Q: What should I do if the sterile package is damaged?
  If the sterile package is damaged and/or the sterile barrier is breached, discard the device and do not use it to avoid the risk of patient infection.

• Q: Does the Guide contain any allergenic materials?
  The Guide contains small amounts of Nickel (CAS# 7440-02-0). Do not use the device if the patient has a sensitivity to Nickel as this may result in an adverse patient reaction.

INDICATION FOR USE
The AtriClip Selection Guide (Guide) is intended to be used as an accessory to the AtriClip LAA Exclusion System.

CONTRAINDICATIONS
None known

DESCRIPTION

The Guide is an accessory that works in conjunction with the AtriClip LAA Exclusion System. The AtriClip LAA Exclusion System comprises the AtriClip LAA Exclusion Device (Clip), the AtriClip Applier, and the Guide. The Guide is a single patient-use surgical instrument designed to assist in the selection of the appropriate Clip. The Guide is malleable and may be placed directly adjacent to the Left Atrial Appendage (LAA) for sizing. The markings on the Guide facilitate the evaluation of the structure and selection of the appropriate Clip size. The markings on the Guide are 4 mm +/- 0.5 mm (0.16 in +/- 0.02 in) shorter than the Clip nominal dimensions to approximate the appendage compression when the Clip is applied. Tissue thickness, appendage geometry, and other factors can affect sizing decisions. Therefore, it is the physician’s judgment to select the appropriate size. The Guide (CGG100) is a sterile accessory composed of aluminium and cured polyurethane ink. It is not made with natural rubber latex and does not contain phthalates.

ENVIRONMENTAL SPECIFICATIONS

140°F
Relative Humidity: 15% to 85%| Relative Humidity: 30% to 85%
Atmospheric Pressure: N/A| Atmospheric Pressure: N/A

PACKAGE CONTENTS

1. One (1) Guide

The Guide is supplied STERILE and NON-PYROGENIC in an unopened, undamaged package. For single use only. Do not re-sterilize. Do not reuse.

ATRICLIP SELECTION GUIDE

NOMENCLATURE (SEE FIGURE 1)

1. Handle
2. Base
3. Indication Mark

WARNING!

• Do not apply excessive force when using the Guide. Using excessive force may cause tissue damage.
• Read all instructions in the Guide before use and use the device only as intended. Use of the Guide should be limited to properly trained and qualified medical personnel. Improper use of this device may lead to device malfunction, failure to provide intended therapy, and/or serious injury.
• Do not bend the Guide in the area of the indication marks. This may lead to incorrectly determining the corresponding AtriClip size. Failure to correctly size the Clip may result in tissue trauma, dehiscence, tissue tearing, displacement, and lack of desired hemostasis.
• DO NOT RESTERILIZE. The Guide is provided STERILE and is intended for SINGLE use only. Re-sterilization may cause injury to the patient.
• Use caution when using the Guide to determine the corresponding AtriClip size. Failure to correctly size the Clip may result in tissue trauma, dehiscence, tissue tearing, displacement, and lack of desired hemostasis.

WARNING!
This device contains small amounts of Nickel (CAS# 7440-02-0). Do not use the device if the patient has sensitivity to Nickel as this may result in an adverse patient reaction.

INSTRUCTIONS FOR USE

Using a sterile technique, remove the Guide from its packaging.

WARNING!
If the sterile package is damaged and/or the sterile barrier is breached, discard the device and DO NOT USE to avoid the risk of patient infection.

CAUTION:
Do not drop the device as this may induce damage to the device. If the device is dropped, do not use it. Replace with a new device.

Align the Guide adjacent to the LAA (See Figure 2).

NOTE: Evaluation should occur at the base of the appendage.

Evaluate the LAA and select the appropriate Clip size.

CAUTION:
The Guide is to be used only to assist with selecting the appropriate Clip.

DISPOSAL INFORMATION

After use, this device should be treated as medical waste and disposed of following hospital protocol.

SERIOUS INCIDENT
Any serious incident that has occurred with this device should be reported to AtriCure.

RETURN OF USED PRODUCT

• If, for any reason, this product must be returned to AtriCure, Inc., a return goods authorization (RGA) number is required from AtriCure, Inc., before shipping.
• If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before packing. It should be shipped in either the original carton or an equivalent carton, to prevent damage during shipment; and it should be properly labelled with an RGA number and an indication of the biohazardous nature of the contents of the shipment.
• Instructions for cleaning and materials, including appropriate shipping containers, proper labelling, and an RGA number may be obtained from AtriCure, Inc.

DISCLAIMER STATEMENTS

Users assume responsibility for approving the acceptable condition of this product before it is used, and for ensuring that the product is only used in the manner described in these instructions for use, including, but not limited to, ensuring that the product is not re-used.

Under no circumstances will AtriCure, Inc. be responsible for any incidental, special or consequential loss, damage, or expense, which is the result of the deliberate misuse or re-use of this product, including any loss, damage, or expense which is related to personal injury or damage to property.

EXPLANATION OF SYMBOLS ON PACKAGE LABELING

| Single sterile barrier system with protective packaging outside| | Single sterile barrier system with protective packaging inside
---|---|---|---
| Manufacturer| | Caution
| Does not contain phthalates| | Contains hazardous substances
| Do not use if the package is damaged| | Non-pyrogenic
| Sterilized using irradiation| | Consult Instructions For Use
| Do not re-use| | Do not re-sterilize
| Not Made with Natural Rubber Latex| | Catalogue Number
| Model Number| | Unique Device Identifier
| Lot Number| | Use-by date
| Caution: Federal Law (US) restricts this device to sale by or on the order of a physician| | The product complies with the requirements of directive 93/42/EEC
| Country of Manufacture| | Medical Device
| Authorized representative in the European Community| | Keep dry

Transit Temperature limit

|

Transit Humidity limit

AtriCure Inc.

• 7555 Innovation Way Mason, Ohio 45040 USA
  Customer Service:

• +1 866 349 2342 (toll free)

• +1 513 755 4100 (phone)

European Representative:

• AtriCure Europe B.V. De entree 260 1101 EE Amsterdam NL
• +31 20 7005560
• [email protected].

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