AtriCure MAX3 Isolator Transpolar Pen Instruction Manual
- June 12, 2024
- AtriCure
Table of Contents
AtriCure MAX3 Isolator Transpolar Pen
Product Information
The IsolatorTM TranspolarTM pen (MAX3, MAX5) is a medical device manufactured by AtriCure Incorporated. The pen is designed for use in surgical procedures and is used for ablation of target tissue using RF energy. The pen consists of several components including a distal tip, electrodes, malleable shaft, handle, cable, connector, and alignment arrow (see Figure 1 and Figure 2). The pen is intended for single-use only and should not be resterilized.
Warnings:
- Read all instructions carefully before using the device.
- Do not touch the electrodes of the Pen while activating the ASU to avoid burns.
- Avoid placing anything in front of or behind the target tissue to prevent heating and tissue damage.
- Remove the Pen from the patient during defibrillation to prevent ineffective cardioversion.
- Inspect the product packaging for sterility before opening. Do not use if the sterility barrier is breached.
- Do not drop the Pen to avoid damage. Replace with a new Pen if dropped.
- Ensure both electrodes are in full contact with the targeted tissue to avoid perforations.
- Follow recommended ablation time and do not overlap ablations by more than 50% to prevent tissue perforations.
- Ensure isolation of connected equipment to EN60601-1 when using the ASB3 auxiliary device cable with supply mains operated equipment to avoid dangerous leakage currents into the heart.
Product Usage Instructions
- Using sterile technique, remove the Pen from its packaging.
- With the Connector Alignment Arrow symbol in the 12 o’clock position, push the Connector into the Pen receptacle on the handle.
- Ensure that the Connector is aligned properly with the arrow symbol.
- Follow the specific procedure for the desired ablation using the Pen as instructed by the medical professional.
- After use, dispose of the Pen properly according to medical waste disposal guidelines.
INSTRUCTIONS FOR USE
Isolator™ Transpolar™ pen
DESCRIPTION
The Isolator™ Transpolar™ pen System is comprised of the AtriCure® Ablation
and Sensing Unit (ASU), the Isolator™ Transpolar™ pen (Pen) or Isolator™ Long
Pen TT (Pen), Footswitch, and ASU Source Switch. The Pen is a single patient
use electrosurgical instrument designed for use only with the ASU2/ASU3. The
Pen is used to ablate cardiac tissues and as a surgical pacing and mapping
tool. When the Pen is connected to the ASU, the ASU provides the bipolar
radiofrequency (RF) energy flowing between both electrodes of the Pen. The
Operator controls the application of this RF energy by pressing the
Footswitch. When the Pen is connected to an auxiliary pace, sense, or
stimulation device; the Pen is designed to provide temporary pacing or
monitoring.
ISOLATOR™ TRANSPOLAR™ PEN NOMENCLATURE (SEE FIGURE 1)
- Distal Tip
- Electrodes
- Malleable Shaft
- Handle
- Cable
- Connector
- Alignment Arrow (See Figure 3)
ISOLATOR™ TT LONG PEN NOMENCLATURE (SEE FIGURE 2)
- Distal Tip
- Electrodes
- Malleable Shaft
- Handle
- Cable
- Connector
- Alignment Arrow (See Figure 3)
COMPATIBLE DEVICES
- OSCOR PACE 203H and ORLAB
INDICATION FOR USE
- The Isolator™ pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB3 in Ablation mode.
- The Isolator™ pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
CONTRAINDICATIONS
- The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
POTENTIAL COMPLICATIONS
- Possible complications related to the creation of spot or linear lesions in cardiac and soft tissues are:
- Tissue perforation
- Postoperative embolic complications
- Extension of extracorporeal bypass
- Perioperative heart rhythm disturbance (atrial and/or ventricular)
- Pericardial effusion or tamponade
- Damage to adjacent nerve and/or blood vessels
- Valve leaflet damage
- Conduction disturbances (SA/AV node)
- Acute ischemic myocardial event
WARNINGS
- Read all instructions carefully for the AtriCure ASU, Isolator Transpolar pen, ASU Source Switch, and any compatible auxiliary device being used prior to using the device. Failure to properly follow instructions may lead to electrical or thermal injury and may result in improper function of the device.
- Do not touch the electrodes of the Pen while activating the ASU. Touching the Pen electrodes during ASU activation could result in a burn to the operator.
- As with other unidirectional devices, do not place anything in front of or behind the target tissue (tissue being ablated). Any 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.
- To prevent ineffective cardioversion, always remove the Pen from the patient during defibrillation.
- 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 Pen.
- The Pen device is intended for single use only. Do not RESTERILIZE. Resterilization may cause loss of function or injury to patient.
- To avoid damage to the device or sterility breach do not drop the Pen. If the Pen is dropped, do not use. Replace with a new Pen.
- Ensure the full lengths of both electrodes are in contact with the targeted tissue, prior to, and throughout RF activation. Partial contact of the electrodes may produce perforations in the tissue.
- 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 may produce perforations in tissue.
- Do not connect the ASB3 auxiliary device cable to supply main (line voltage) operated equipment without verifying isolation of the connected equipment to EN60601-1. Supply mains operated equipment may introduce dangerous leakage currents into the.
PRECAUTIONS
- Do not allow the connectors of the Pen to get wet, as this may affect the device performance.
- Do not immerse the Pen in liquids as this may damage the device.
- Do not touch the electrodes of the Pen to metal staples or clips, or to sutures while activating the ASU.
- The distal tip of the Pen must be kept clean of debris during surgery to avoid loss of power. Before activating the ASU, inspect the area at the distal tip of the Pen for foreign matter. Foreign matter captured on the tip will adversely affect the ablation.
- The Pen is only compatible with the AtriCure ASU and ASB3. Use of the Pen with another manufacturer’s generator may damage the device.
- The Pen should only be used with compatible auxiliary cardiac pacing and sensing devices.
- The Pen has an eight hour useful life that is tracked by the ASU. If you attempt to plug in a device that has reached its time limit expiration, the Pen will no longer function and the ASU will display a message indicating that the Pen must be replaced.
- Excessive bending of the malleable stainless steel will cause the shaft to harden and may increase the potential for breakage. Only bend the shaft in the malleable zone.
- Use caution during device insertion and removal 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
- Using sterile technique, remove the Pen from its packaging.
- With the Connector Alignment Arrow symbol in the 12 o’clock position, push the Connector into the Pen receptacle on the front of the ASU (See Figure 3). Verify that the connections between the Pen and the ASU are secure. If the connections are loose, do not use the Pen. Inspect the Cable and do not use the Pen if the cable is frayed or the insulation is damaged.
- PACING AND MAPPING MODE
- Connect one end of the auxiliary device cable provided with the ASB3 into the compatible auxiliary device. Connect the other end of the auxiliary device cable into one set of PSS ports on the ASB3.
- Rotate the ASB3 knob to indicate the PSS port used.
- Turn on the temporary pacing or sensing equipment and ensure proper connections to validate electrical continuity. For detailed instructions refer to temporary pacemaker manual.
- Settings and procedures for the auxiliary device are determined according to the instructions for use provided with the auxiliary device. Set auxiliary device to atrial asynchronous mode (sensing disabled or increased to maximum value).
- Note: The Pen will pace when the auxiliary device is in the ON position.
- Identify and expose the sites for pacing and sensing using standard surgical techniques. Under direct visualization, place the electrodes against the targeted tissue. Assure both electrodes are in contact with targeted tissue.
- Ensure the pacing is only on when the end effector is in contact with the targeted tissue. The device will pace when the auxiliary device pacing is on.
- For sensing (mapping), place the distal tip onto the targeted tissue to display the electrogram (EGM).
- Upon completion of the surgical procedure, disconnect the Pen from the ASB3 and discard the Pen after use. Follow local governing ordinances and recycling plans regarding disposal or recycling of device component.
- ABLATION MODE
- Rotate the ASB3 knob to indicate the Pen port used.
- Painting ablation technique
- a) Maintaining visualization, move the distal tip gently across the targeted cardiac tissue.
- b) While maintaining continuous contact between the tissue and the electrodes, move the device continuously in an oscillating manner at a rate of approximately 1cm/sec.
- Painting Lesion Thickness
- 20 seconds
- 2 cm oscillation
- 2.0 – 4.0 mm
- Data was obtained from ablations performed on excised bovine myocardium and represent 95% confidence intervals. Results may vary based on live tissue properties.
- Stamping Ablation technique:
- a ) Apply constant firm pressure to the tissue without movement. Maintain full contact of the electrode surface with the tissue. A stamping lesion is approximately 8 mm x 6 mm.
- b) If creating longer lesions with the Stamp technique, overlap the contiguous ablations by 50% to ensure a continuous and complete lesion.
- Stamp Lesion Thickness
- 10 seconds: 15 seconds
- 3.3 – 3.8 mm: 3.8 – 4.4 mm
- Data was obtained from ablations performed on excised bovine myocardium and represent 95% confidence intervals. Results may vary based on live tissue properties.
- Press the Footswitch to activate the ASU.
- When the Footswitch is pressed, the ASU will emit an audible tone indicating that current is flowing between the electrodes located at the distal tip of the Pen and through the tissue.
- Inspect the surgical area to ensure adequate ablation.
- Between ablations, wipe the distal tip clean with a saline soaked gauze pad. Important: For optimal performance, keep the Pen electrodes clear of coagulum. To ensure the electrodes are clear of coagulum.
- a ) Use saline-soaked gauze to clean the electrodes after each ablation. 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 of coagulum more difficult.
- b ) Check both electrodes before each ablation to ensure that the gold of each electrode is visible and coagulum is removed.
- If the Pen is idle between ablations, place the Pen distal tip onto saline soaked gauze to prevent any coagulum not cleaned off the electrodes from drying. Repeat ablation if necessary.
- Upon completion of the surgical procedure, disconnect the Pen from the ASU/ASB3 and discard the Pen after use. Follow local governing ordinances and recycling plans regarding disposal or recycling of device component.
HOW SUPPLIED
The Isolator™ Transpolar™ 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 resterilize.
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 anddisinfected 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. 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 products 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.
SYMBOLS GLOSSARY
- Non-Pyrogenic
- Lot Number
- Caution
- Sterilized by Gamma
- Do Not Re-Use
- Follow instructions for use
- Expiration Date
- Not Use if the Package is Damaged
- Caution: Federal Law (US) restricts this device to sale by or on the order of a physician
- Not made with Natural Rubber Latex
- MR Conditiona
- Do Not Resterilize
- Manufacturer
- Authorized Representative in the European Community
- Product complies with the requirements of directive 93/42/EEC
- Manufacturer
- AtriCure Incorporated
- 7555 Innovation Way
- Mason, Ohio 45040 USA
- Customer Service:
- 1-866-349-2342 (toll free)
- +1513-755-4100 (phone)
- European Representative:
- AtriCure Europe B.V.
- De entree 260
- 1101 EE Amsterdam
- NL
- +31 20 7005560
- [email protected]
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AtriCure MAX3 Isolator Transpolar
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