AtriCure OSL2 Bipolar RF Ablation Clamps Instruction Manual

AtriCure OSL2 Bipolar RF Ablation Clamps Instruction Manual

(ATRICURE ISOLATOR INLINE SYRINGE GRIP CLAMPS)

1. Distal Jaw
2. Proximal Jaw
3. Attachment Tip*
4. Electrode
5. Jaw Heel
6. Handle
7. Closure Lever
8. Release Mechanism
9. Connector
10. Connector Alignment Arrow

*Only on devices packaged with GLIDE PATH™ Tape Instrument Guide

GLIDEPATH TAPE INSTRUMENT GUIDE ILLUSTRATION AND NOMENCLATURE

1. Lateral Tab
2. Distal Pocket
3. Instrument Attachment Tip
4. Clear Ribbon
5. Distal Pocket
6. Red Elastic Leader
7. Accessory Ribbon

DESCRIPTION

The ATRICURE ISOLATOR Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU2-115/ASU3-230), an ATRICURE ISOLATOR device, and a footswitch. The ISOLATOR is a single patient use electrosurgical instrument designed for use only with the ASU. The ISOLATOR is used for cardiac tissue ablation. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the ISOLATOR. The Operator controls the application of this RF energy by pressing the Footswitch.

All ISOLATOR devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures.

There are three families of ISOLATOR clamps available for use with the system.

The ATRICURE ISOLATOR (See Figure 1) Clamps feature an in-line handle with syringe-type actuation  and button release mechanisms. Some ISOLATOR Devices have an integral attachment tip and related Glidepath™ Tape Instrument Guide (Guide) as device options (See Figure 1 and Figure 2). The Guide is packaged with ISOLATOR devices that have the Attachment Tip.

The ISOLATOR Synergy™ (See Figure 1) Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanisms. The ISOLATOR Synergy™ requires the use of the AtriCure Switch Matrix (ASB3, US and EU, respectively)

There are two families of GLIDEPATH™ Tape Instrument Guides for use with ATRICURE ISOLATOR Devices. The GLIDEPATH™ Tape Instrument Guide is a single patient, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures

The GLIDEPATH™ Tape Instrument Snap Guide (See Figure 2) is designed to fit devices that have the integral attachment tip.

The GLIDEPATH™ Tape Instrument Press Guide (See Figure 2) is designed to fit instruments without integral attachment tips.

NOTE: Please refer to the ATRICURE ASU and ASB3 Instructions for Use for information specific to the ASU and ASB3.

INDICATION FOR USE

The ATRICURE Bipolar (Transpolar) System is indicated for ablation of cardiac tissue during surgery including pulmonary vein isolation and atrial connecting lesions for the treatment of atrial fibrillation.

CONTRAINDICATIONS

The Bipolar (Transpolar) System is not indicated for contraceptive coagulation of the fallopian tubes.

POTENTIAL COMPLICATIONS

DEVICE

Possible complications related to the creation of the linear lesions in cardiac tissue using a clamp-type device may be included but not limited to:

• Tissue Cutting
• Perioperative heart rhythm disturbance (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conduction disturbances (SA/AV node)
• Acute ischemic myocardial event
• Injury to unintended surrounding tissue structures, including tears and punctures
• Bleeding requiring intervention to repair
• Extension of cardiopulmonary bypass

PROCEDURE

Serious adverse events that may be associated with surgical ablation procedures on the heart (stand aloneor concomitant to other cardiac surgery), include:

• Death,
• Excessive bleeding related to the procedure (defined as bleeding which requires >3 units of blood products and/or surgical intervention),
• Cardiac tamponade (if either open or catheter drainage is required),
• Pulmonary vein stenosis,
• Restrictive (constrictive) pericarditis,
• Endocarditis,
• Myocardial infarction (MI) per ACC guidelines,
• Stroke (resulting in permanent neurological deficit),
• Transient Ischemic Attack (TIA),
• Thromboembolism,
• Diaphragmatic paralysis,
• Esophageal-LA fistula or esophageal rupture,
• Atrial perforation or rupture,
• Ventricular perforation or rupture,
• Atelectasis,
• Pneumonia,
• Congestive Heart Failure,
• Cardiac Valve Injury,
• Persistent Pneumothorax (requiring intervention),
• Excessive Pain and Discomfort,
• Deep Sternal Wound Infection,
• Ventricular Arrhythmia (V. Tachycardia or V. Fibrillation),
• New Sinus Node Dysfunction, and
• Drug Reaction.

WARNINGS

• Do not touch the electrodes of the ISOLATOR while activating the ASU. Touching the ISOLATOR electrodes during ASU activation could result in an electrical shock or burn to the operator.
• Do not touch the electrodes of the ISOLATOR to metal staples or clips, or to sutures while activating the ASU. This may damage the ISOLATOR or tissue, or result in an incomplete ablation.
• Do not use abrasive cleaners or electrosurgical tip cleaners to clean debris from the Jaws. Use of abrasive cleaners or electrosurgical tip cleaners can damage the electrodes and result in device failure. Use saline soaked gauze to clean debris off the electrodes.
• Do not immerse any part of the ISOLATOR in liquids as this may damage the device.
• Always wear the appropriate surgical gloves when using the ATRICURE ISOLATOR Surgical Ablation System to avoid shock/ burn hazards.
• Inspect the product packaging prior to opening to ensure that the sterility barrier is not breached. If the sterility barrier is breached, do not use the ISOLATOR to avoid the risk of patient infection.
• Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker entirely. Consult the pacemaker manufacturer or hospital Cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers.

PRECAUTIONS

• Read all instructions carefully for the ATRICURE ISOLATOR Surgical Ablation System, prior to using the device. Failure to properly follow instructions may lead to electrical or thermal injury and may result in improper functioning of the device.
• Use of the ISOLATOR should be limited to properly trained and qualified medical personnel.
• Use ISOLATOR only for soft tissue ablation. Variations in specific procedures may occur due to individual physician techniques and patient anatomy.
• Do not drop or toss the ISOLATOR as this may damage the device. If the ISOLATOR is dropped, do not use. Replace with a new ISOLATOR.
• Do not use the ISOLATOR in the presence of flammable materials.
• Do not re-sterilize or reuse the ISOLATOR. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
• Keep the Jaws of the ISOLATOR clean of debris during surgery to avoid loss of power.
• Do not use of the ISOLATOR with another manufacturer’s generator to avoid damage to the device, which may result in patient injury. The ISOLATOR is only compatible with the ATRICURE ASU and ASB3.
• Do not ablate tissue greater than 10 mm thick with the ISOLATOR. Tissues greater than 10 mm thick may not be fully ablated.
• Do not use the ISOLATOR for coagulation or ablation of veins or arteries.
• Inspect the area between the Jaws of the ISOLATOR for foreign matter before activating the ASU or ASB3. Foreign matter captured between the Jaws will adversely affect the ablation.
• Do not insert excessive tissue into the Jaw heel as it may result in poor ablation at the Jaw Heel.
• Do not ablate in pool of blood or other fluids as this may extend the ablation time. Users should suction excess fluids away from the jaws prior to ablation.
• Do not attempt to use an ISOLATOR that has reached its time limit expiration. The ISOLATOR has an 8 hour useful life that is tracked by the ASU. The ISOLATOR will no longer function after 8 hours of use and the ASU will display a message indicating that the ISOLATOR must be replaced.
• Do not use the ISOLATOR if signs of damaged wire insulation are noted upon inspection of the area around the Jaw heel as it may adversely affect ablation performance.
• When the ASU (RF generator) and Handpiece are used on a patient simultaneously with physiological monitoring equipment, ensure that the monitoring electrodes are placed as far as possible from the surgical electrodes. Be sure to position the Handpiece cables so that they do not come in contact with the patient or the other leads.
• Needle monitoring electrodes are not recommended for use when operating the ASU (RF generator) and Handpiece.
• Monitoring systems that incorporate high frequency current-limiting devices are recommended for use with the ASU (RF generator) and Handpiece.
• When the ASU (RF generator) is activated in conjunction with the Handpiece, the conducted and radiated electrical fields may interfere with other electrical medical equipment. Refer to the ASU IFU for more information regarding potential electromagnetic or other interference, and advice regarding avoidance of such interference.

INSTRUCTIONS FOR USE

SET UP

1. Examine the packaging of the devices to ensure the sterility of the product has not been breached. Remove the sterilized instruments from their package per standard sterile technique.

2. With the Connector Alignment Arrow symbol in the 12 o’clock position, push the Connector into the appropriate ISOLATOR receptacle on the front of the ASU or ASB3. Each ISOLATOR has a unique receptacle on the ASB3. To ensure device performance, verify proper connections to the ASB3 by consulting the ASB3 package insert. Verify that the connections between the ISOLATOR and the ASU or ASB3 are secure. If the connections are loose, do not use the ISOLATOR. Inspect the Cable and do not use the ISOLATOR if the cable is frayed or the insulation is damaged.
   Insert with Connector Alignment Arrow at the 12 o’clock position

3. If the ISOLATOR is to be used with a supplied GLIDEPATH™ Instrument Guide (Integrated Guide – Figure 2), go to step 4. If the ISOLATOR is not to be used with the instrument guide, go to step 20.
   POSITIONING OF GLIDEPATH™ TAPE GUIDE (SEE FIGURE 3)
   
   

4. The Guide may be used with commercially available general dissection or surgical clamping tools (auxiliary tools) to create and maintain a dissection plane that facilitates placement of the ISOLATOR clamp around structures per standard surgical technique.

5. Examine the Guide package to ensure the sterility of the product has not been breached. Remove the Guide from its packaging per standard sterile technique.

6. Secure the proximal end of the Guide to the sterile drape near the surgical site.

7. Insert the distal end of the auxiliary tool completely into the distal pocket of the clear ribbon portion of the Guide.

8. Maintain attachment of the distal portion of the Guide to the auxiliary tool during positioning of the Guide.
   Note: Lubrication may be applied to the Guide at the user’s discretion.

9. Once the desired placement of the Guide is achieved, use a grasping device to grasp one of the Lateral Tabs (Figure 2) on the Guide and remove the Guide from the auxiliary tool. Externally secure the distal end of the Guide near the surgical site.
   Note: If an articulating dissection tool is used, un-articulating the device may facilitate removal of the Guide.

10. If desired, the Guide can be used for soft tissue retraction or to introduce additional Instruments through the previously created positioning plane.

11. If the Guide incorporates a snap feature, refer to steps 13-14 for instrument exchange.

12. If the Guide incorporates a press feature, refer to steps 15-19 for instrument exchange.
    INSTRUMENT EXCHANGE (SNAP GUIDE) (SEE FIGURE 4)

13. Prior to attaching the Guide to the ISOLATOR, unclamp the proximal end of the leader from the sterile drape.

14. While holding the Guide as shown, in the illustration below, insert the Instrument Attachment Pin (Figure 2) into the ISOLATOR attachment tip (Figure 1). Once Guide is attached, do not attempt to remove by forcibly pulling on Guide.
    INSTRUMENT EXCHANGE (PRESS GUIDE) (SEE FIGURE 4)

15. If using an AtriCure Instrument Press Guide, attach the guide to the distal tip of the ISOLATOR per standard surgical technique.

16. Use the guide to facilitate the placement of the ISOLATOR in the previously created positioning plane.

17. Carefully remove the guide from the distal jaw after ISOLATOR placement.

NOTE: The Press Guide is to be removed prior to ablation. (Refer to Step 28)

NOTE: The accessory ribbon allows the surgeon to create a dissection plane in one direction (inferior or superior) and maneuver the tape and leader through the dissection plane so that an instrument (clamp) can be used from the opposite direction.

| Caution\de Vorsicht\nlLetop| Rx ONLY| Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician\de Vorsicht| | Do not use if package is damaged\
---|---|---|---|---|---
| Non-pyrogenic| | Lot Number| | Manufacturer\de Hersteller\
| Sterilized by Ethylene Oxide\deSterilisiert mit| | Not made with natural rubber latex| | Product Complies with the requirements of directive 93/42/EEC\
| n Do not re-use\de Nicht wiederverwenden\nl Niet opnieuw gebruiken\fr Ne pas| | Follow instructions for use| | Authorized Representative in the European Community\
| Expiration Date| | Do not Re-Sterilize\de Nicht|

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