AtriCure CGG100 Gillinov Cosgrove Selection Instruction Manual

AtriCure CGG100 Gillinov Cosgrove Selection

Product Information

The AtriClip Gillinov-CosgroveTM Selection Guide is an accessory for the AtriClip LAA Exclusion System. It is designed to assist in selecting the appropriate clip size for the left atrial appendage (LAA) during surgical procedures. The guide comes in four clip
sizes to accommodate different LAA sizes ranging from 29-50mm. The product is supplied as a sterile instrument and is for single patient use only. The sterility is guaranteed unless the package is opened or damaged. The product should not be re-sterilized and should not be used after the expiration date indicated.

Product Usage Instructions

1. Using sterile technique, remove the Guide from its packaging.
2. Align the Guide adjacent with the LAA. (See Figure 2) Note that evaluation should occur at the base of the appendage.
3. Evaluate the LAA and select the appropriate Clip size using the table provided in the instructions.
4. Discard the Guide after use. Follow the local governing ordinances and recycling plans regarding disposal or recycling of device components.

It is important to read all instructions for the AtriClip Gillinov-Cosgrove Selection Guide prior to using the device. Do not use the Guide if the sterility barrier is breached. To avoid the risk of patient infection, inspect the product packaging prior to opening to ensure that the sterility barrier is not breached. Do not apply excessive force when using the Guide, as this may cause tissue damage.

If for any reason the product must be returned to AtriCure, Inc., a return goods authorization (RGA) number is required from AtriCure, Inc., prior to 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 labeled with an RGA number and an indication of the biohazardous nature of the contents of shipment.

DESCRIPTION

The AtriClip Gillinov-Cosgrove Selection Guide (Guide) is an accessory that works in conjunction with the AtriClip LAA Exclusion System. The AtriClip LAA Exclusion System is comprised of 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. There are markings on the guide which facilitate the evaluation of the structure and selection of the appropriate Clip size. The markings on the guide are 4 mm +/- 0.5 mm 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 does not contain natural rubber latex components.

ATRICLIP GILLINOV-COSGROVE SELECTION GUIDE NOMENCLATURE (SEE FIGURE 1)

1. Handle
2. Base
3. Indication Marks

BEFORE USING PRODUCT READ THE FOLLOWING INFORMATION THOROUGHLY

IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques.

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

CONTRAINDICATIONS
None known

WARNINGS
Do not use the Guide if the sterility barrier is breached. To avoid the risk of patient infection, inspect the product packaging prior to opening to ensure that the sterility barrier is not breached.
Do not apply excessive force when using the Guide. Using excessive force may cause tissue damage.

PRECAUTIONS

1. Carefully read all instructions for the AtriClip Gillinov-Cosgrove Selection Guide prior to using the device. Failure to properly follow instructions may lead to injury and/or may result in improper use of the device.
2. The AtriClip Gillinov-Cosgrove Selection Guide is to be used only to assist with selecting the appropriate Clip.
3. Use of the Guide should be limited to properly trained and qualified medical personnel.
4. To avoid damage to the device, do not drop or toss the Guide. If the Guide is dropped, do not use. Replace with a new Guide.
5. To avoid damage to the Guide, use caution when handling and interfacing with other devices.
6. Do not bend the guide in the area of the indication marks.
7. Do not re-sterilize or reuse the Guide. Single Patient use only.

INSTRUCTIONS FOR USE

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

2. Align the Guide adjacent with the LAA. (See Figure 2) NOTE: Evaluation should occur at the base of the appendage.

3. Evaluate the LAA and select the appropriate Clip size.
   Clip Size| LAA Size Range
   ---|---
   35 mm| 29 – 35 mm
   40 mm| 34 – 40 mm
   45 mm| 39 – 45 mm
   50 mm| 44 – 50 mm

4. Discard the Guide after use. Follow the local governing ordinances and recycling plans regarding disposal or recycling of device components.

HOW SUPPLIED
The AtriClip Gillinov-Cosgrove Selection Guide is supplied as a STERILE instrument and is for single-patient use only.
Sterility is guaranteed unless the package is opened or damaged. Do not re- sterilize.
Do not use the Gillinov-Cosgrove Selection Guide after the expiration date indicated.

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., prior to 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 labeled 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 labeling, and an RGA number may be obtained from AtriCure, Inc.

CAUTION: It is the responsibility of the health care institution to adequately prepare and identify the product for shipment.

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
Refer to the outer package label to see which symbols apply to this product.

Manufacturer
AtriCure Incorporated 7555 Innovation Way Mason, Ohio 45040 USA

Customer Service:
1-866-349-2342 (toll free)
+1 513-755-4100 (phone)

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