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Summary of Contents for ArtiCure Isolator Transpolar pen
- Page 1 ™ ™ Isolator Transpolar Instructions for Use (Page 2) For use with the following ™ ™ Isolator Transpolar pen models: MAX1 - A000163 MAX5 -A000625...
- Page 2 ™ ™ Isolator Transpolar Instructions for Use DESCRIPTION ™ ™ ® The Isolator Transpolar pen System is comprised of the AtriCure Ablation and Sensing ™ ™ ™ Unit (ASU), Isolator Transpolar pen (Pen) or Isolator Long Pen TT (Pen), Footswitch, ASU Source Switch.
- Page 3 ™ ISOLATOR LONG PEN TT ILLUSTRATION AND NOMENCLATURE Distal Tip Handle Electrodes Cable Malleable Shaft Connector Rigid Shaft Alignment Arrow...
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Page 4: Indication For Use
INDICATION FOR USE • ™ ™ The Isolator Transpolar 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 to the ASU Source Switch in Ablation mode. •... - Page 5 patient injury, operator injury, or equipment damage. • Do not allow the connectors of the Pen WARNINGS to get wet. Wet connectors may affect • Do not touch the electrodes of the Pen the device performance. while activating the ASU. Touching the •...
- Page 6 PRECAUTIONS • The Pen is only compatible with the • AtriCure ® ASU and ASB. Use of the Read all instructions carefully for the Pen with another manufacturer’s ™ ™ AtriCure ® ASU, Isolator Transpolar generator may damage the device and Pen, ASU Source Switch, and any result in patient injury.
- Page 7 INSTRUCTIONS FOR USE Stamping ablation technique: Cardiac Ablation Mode 4.1. Apply constant firm pressure to the tissue without movement. Using sterile technique, remove the Maintain full contact of the Pen from its packaging. With the electrode surface with the tissue. Connector Alignment Arrow symbol in the 12 o’clock position, push the A stamping lesion is...
- Page 8 gold of the electrode is visible INSTRUCTIONS FOR USE and coagulum is removed. Pacing and Mapping Mode 8.3. If the Pen is idle between Inspect the package and product to ablations, place the Pen distal ensure the expiration date has not tip onto saline-soaked gauze to passed and no damage occurred to prevent any coagulum not...
- Page 9 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.
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Page 10: How Supplied
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 ®... - Page 12 Explanation of symbols on package labeling Refer to the outer package label to see CE Mark with Notified Body - class which symbols apply to this product II and III medical devices comply with EC Directive 93/42/EEC Non-Pyrogenic Sterilized by Ethylene Oxide Single Use Only Expiration Date Lot Number...
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