AtriCure MCR1 Coolrail Linear Pen Instruction Manual

AtriCure MCR1 Coolrail Linear Pen

Product Information

• Product Name: Coolrail Linear Pen
• Model: MCR1
• Manufacturer: AtriCure Incorporated
• Manufacturer Address: 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
• Email: ear@atricure.com

Product Usage Instructions

1. Examine the packaging of the device to ensure the sterility of the product has not been breached.
2. Remove the sterilized instrument from its package using standard sterile technique.
3. Place the Pump Box on a flat surface before priming the system.
4. Fill a syringe with 30cc of sterile water to prime the pump system. Do not use saline.
5. Insert the syringe tip into the Injection port of the Pump Box and prime the pump system with sterile water.
6. Continue filling the pump system until sterile water flows from the vent.
7. Remove the syringe from the injection port.
8. With the Connector Alignment Arrow symbol in the 12 o’clock position, push the Connector into the Pen receptacle on the Coolrail Linear Pen.
9. Ensure that both electrodes of the Coolrail Linear Pen are in full contact with the targeted tissue before and during RF activation. Partial contact may cause tissue perforations.
10. Avoid placing anything in front of or behind the target tissue to prevent heating and tissue damage to non-target tissue.
11. Ensure that non-target tissue is adequately separated from the RF field by carefully placing and orienting the electrodes.
12. Do not perform ablations directly on the atrial appendage to prevent clotting.

DESCRIPTION

The AtriCure® Coolrail® linear pen System is comprised of the AtriCure Ablation and Sensing Unit (ASU), Coolrail® linear pen, Footswitch, and AtriCure Switch Matrix (ASB). The Coolrail® linear pen is a sterile, single- use electrosurgical instrument designed for use with the ASU and ASB. The device is designed with internally cooled electrodes to produce continuous, full thickness lesions. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail® linear pen. The Operator controls the application of energy by pressing the Footswitch.

COOLRAIL LINEAR PEN NOMENCLATURE

1. End Effector
2. Electrodes
3. Malleable portion of shaft
4. Rigid portion of shaft
5. Handle
6. Cable
7. Pump Box
8. Injection Port
9. Vent
10. Connector

INDICATION FOR USE
The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency (RF) energy.
CONTRAINDICATIONS
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
POTENTIAL COMPLICATIONS
Potential Adverse events with surgical RF ablation of cardiac and soft tissues, apart from those that may occur as a result of surgical/mechanical manipulation of the target tissues, include, but are not limited to:

• Ablation or burns to non-targeted tissues – Refer to Atrio-Esophageal Fistula Signs and Symptoms below
• Damage to adjacent nerve and/or blood vessels
• Tissue perforation
• Postoperative embolic complications
• Extension of extracorporeal bypass
• Perioperative heart rhythm disturbance (atrial and/or ventricular)
• Pericardial effusion or tamponade
• Valve leaflet damage
• Conduction disturbances (SA/AV node)
• Acute ischemic myocardial event

ATRIO-ESOPHAGEAL FISTULA (AEF) SIGNS AND SYMPTOMS FOLLOWING ABLATION SURGERY

• Fever
• Dysphagia (Painful or Difficulty Swallowing)
• Persistent Chest Pain (Different from Incisional Pain)
• Seizure(s)
• Change in Mental Status (Confusion)
• Sudden Weakness on One Side of the Body
• Vomiting Blood
• Blood in Stool
• Fainting
• Dyspnea (Shortness of Breath)
• Difficulty Speaking
• Numbness, Tingling Sensation, Dizziness, Double Vision

WARNINGS

• Read all instructions carefully for the AtriCure ASU, Coolrail linear pen, and AtriCure Switch Matrix, prior to using the device. Failure to properly follow instructions may result in improper functioning of the device and may lead to electrical or thermal injury.
• To avoid damage to the device or sterility breach, do not drop the Coolrail linear pen.
• If the Coolrail linear pen is dropped, do not use. Replace with a new Coolrail linear pen.
• Ensure the full lengths of both electrodes are in contact with the targeted tissue prior to and throughout RF activation.
• Partial contact of electrodes may produce perforations in the tissue.
• As with other unidirectional devices, do not place anything in front of or behind the target tissue (tissue being ablated). A ny tissue within the RF energy field may experience heating and/or tissue damage.
• Ensure that non-target tissue is adequately separated from the RF field. Ensure non-target tissue is protected from the
• RF field by carefully placing and orienting the electrodes. Refer to potential complications list.
• Do not perform ablations directly on the atrial appendage. Clotting may occur.
• Do not touch the electrodes of the Coolrail linear pen while activating the ASU. Touching the Coolrail® linear pen electrodes during ASU activation could result in a burn to the operator.
• Total duration of ablation(s) per lesion not to exceed recommended ablation time. Do not overlap ablations by more than 50%. Ablations exceeding recommended time and/or overlap by more than 50% may produce perforations in tissue.
• The Coolrail® linear pen device is inteded for single-use only.
• Do not resterilize. Resterilization may cause loss of function or injury to patient.
• To prevent ineffective cardioversion, always remove the Coolrail linear pen from the patient during defibrillation.
• No representation or warranty is made that failure or cessation of function of the device will not result in an adverse event or that medical complication (including tissue perforation) will not follow the procedure, or that the use of the device will in all cases restore adequate cardiac function.
• To avoid the risk of patient infection, 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 Coolrail linear pen.

PRECAUTIONS

• To ensure a continuous ablation, assure the full length of both electrodes is in full contact with the targeted tissue during RF activation.
• The Coolrail linear pen is only compatible with the AtriCure Generator (ASU) and AtriCure Switch Matrix (ASB). Use of the Coolrail linear pen with another manufacturer’s generator may damage the device.
• Before activating the ASU, inspect the electrodes for foreign matter. Foreign matter on the tip may adversely affect the ablation. Use saline-soaked gauze for cleaning debris off of the electrodes.
• The Coolrail linear pen has an eight hour useful life that is tracked by the ASU. The device will no longer function after it has reached its time limit expiration and the ASU will display a message indicating that the Coolrail linear pen must be replaced.
• Excessive bending of the malleable shaft will cause the shaft to harden and may increase the potential for breakage. Only bend the shaft in the malleable zone.
• Do not touch the electrodes of the Coolrail linear pen to metal staples or clips, or to sutures while activating the ASU.
• Do not immerse the Coolrail linear pen Pump Box in liquids as this may damage the device.
• Only use sterile water when filling the Pump Box, as other fluids may affect the performance of the device.
• Do not allow the connectors of the Coolrail linear pen to get wet, as this may affect the device performance.
• Use caution during device insertion, removal, articulating, and if bending the malleable portion of the shaft with surgical tools.
• Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of the electrosurgical devices could cause devices such as pacemaker to enter an asynchronous mode or can block the pacemaker conduction entirely. Consult the pacemaker manufacturer or hospital Cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers.

INSTRUCTIONS FOR USE

1. Examine the packaging of the device to ensure the sterility of the product has not been breached. Remove the sterilized instrument from its package per standard sterile technique.

2. Place the Pump Box on a flat surface prior to priming the system.

3. Fill a syringe with 30cc of sterile water in order to prime the pump system. (See Figure 2)
   NOTE: Do not use saline, as device performance may be affected.

4. Placing the tip of the syringe into the Injection port of the Pump Box, prime the pump system with sterile water. (See Figure 2A)

5. Fill the pump system until sterile water flows from the vent. This may require slightly more than 30cc of sterile water. (See Figure 2B)

6. Remove the syringe from the injection port.

7. With the Connector Alignment Arrow symbol in the 12 o’clock position, push the Connector into the “Pen” receptacle on the front of the ASB. (See Figure 3) Verify proper ASB connections by consulting the ASB package insert. Verify that the connections between the Coolrail® linear pen and the ASB are secure. If the connections are loose, do not use the Coolrail® linear pen.

8. Hang the Pump Box upright on the handle of the ASU or ASB using the hook on the top of the Pump Box. If necessary, the handle of the ASU or ASB can be rotated to a horizontal position. (See Figure 4)

9. Rotate the ASB knob to indicate “Pen” for ablation.

10. If desired, bend the malleable portion of the shaft of the Coolrail linear pen into the desired configuration and position the distal tip into 1 of 3 set locations (-25°, 0°, 25°).

11. Identify and expose the sites to be ablated using standard surgical techniques. Place the electrodes against the targeted tissue under direct visualization of the surgeon. Assure the full lengths of both electrodes are in contact with the targeted tissue.

12. Press and hold the Footswitch to activate the ASU and deliver RF energy to the tissue. Do not move the device during ablation.

13. When the RF is activated, the ASU will emit an audible tone indicating that current is flowing between the selected electrodes and through the tissue. The audible tone will change pitch every 10 seconds to indicate ablation time.
    NOTE: The internal pump will continue to run after the RF activation has stopped.
    The following standard techniques should be utilized to mitigate the potential for collateral injury to the esophagus.
    NOTE: During bench testing, the exposed (non-ablating) face of the end- effector reached up to 73°C during lesion creation.

    • Determine the location of the esophagus utilizing thoracoscopic visualization and the TEE probe.
    • Prior to energy delivery, the Transesophageal echocardiography (TEE) probe should be retracted from the area of ablation as a measure to protect the esophagus and other surrounding tissue structures.
    • Ablation: Ablations should be visualized and atrial tissue should be elevated up and away from the posterior pericardium with the ablation device(s) in order to avoid collateral injury to surrounding tissue.
    • Post Ablation: Prior to repositioning the device and prior to resting the atrium onto the posterior pericardium, the device should remain in place for 30 seconds while simultaneously quenching the device, the ablated tissue, and the surrounding tissues with saline. This will allow these areas to adequately cool.
    • In addition, it is recommended that a Proton Pump Inhibitor (PPI) be prescribed to the patient for a minimum of seven (7) days prior to the procedure and continued for a minimum of 30 days post-procedure.

14. The depth of the lesion will be determined by the duration of activation. The following table lists anticipated lesion depths at various ablation times:
    Data was obtained from ablations performed on excised bovine myocardium and represent 95% confidence intervals. Results may vary on live tissues.

15. Inspect the surgical area to ensure adequate ablation.

16. Between ablations, wipe the distal tip clean with a saline-soaked gauze pad.
    NOTE: For optimal performance, keep the Coolrail® linear pen electrodes clear of coagulum. The coagulum is much easier to remove within the first several seconds after ablation. In a brief period of time, the coagulum may dry making removal more difficult.

17. Inspect electrodes before each ablation to ensure the surface of the electrode is clean and coagulum is removed.

18. Repeat ablation if necessary.
    NOTE: If an E03 error is indicated on the ASU and the LED light is illuminated on the pump box, a hi-temp error has occurred indicating that the end effector has overheated. Ensure that the fluid cable is not kinked or occluded and that there is a sufficient amount of water in the pump box. If the hi-temp error continues, the Coolrail® device will need to be replaced. For any other errors seen on the ASU during use, reference the ASU user manual.

19. If a continuous lesion is required, always overlap the ablations by 5-10 mm using the black marker as the ablation location indicator. The location indicated by the distal end of the previous ablation should overlap to the proximal end of the next ablation. (See Figure 5)

20. Upon completion of the surgical procedure, disconnect the Coolrail® linear pen from the generator and discard the Coolrail® linear pen after use. Follow local governing ordinances and recycling plans regarding disposal or recycling of device component.

HOW SUPPLIED

• The AtriCure Coolrail® linear pen 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.

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 bio-hazardous nature of the contents of 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 whichis related to personal injury or damage to property.

SYMBOLS GLOSSARY

• Non-Pyrogenic
• Sterilized with Ethylene Oxide
• Single Use Only
• Lot Number
• Authorized Representative in the European Community
• Do Not Resterilize
• Waste Electrical Electronic Equipment
• Product complies with the requirements of directive 93/42/EEC
• Caution: Federal Law (US) restricts this device to sale by or on the order of a physician
• Follow instructions for use
• Manufacturer
• Not made with Natural Rubber Latex
• Expiration Date\de Ablaufdatum
• Do Not Use if the Package is Damaged
• Caution

CONTACT

Manufacturer

• AtriCure Incorporated
• 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
• ear@atricure.com

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