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Instructions for Use

Product Indications for Use:

  1. AXIUS™ VACUUM 2 Stabilizer Systems
  2. ACROBAT™ Mechanical Stabilizer System
  3. XPOSE™ Access Device 3
  4. VASOVIEW® 5 Endcoscpoic Vessel Harvesting System

AXIUS™ VACUUM 2 Stabilizer Systems
Indications for Use

Caution:
Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

Indications:
Each Guidant Axius™ Vacuum 2 Stabilizer System is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. The AccessRail Platform in combination with an Activator Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The Stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

Contraindications:
Do not position the stabilizer foot over a coronary artery, newly infarcted or aneurysmal heart tissue.

Warnings and Precautions:
1. Physicians should be properly trained to perform cardiac surgical procedures with Guidant instruments prior to use.

2. As with all surgical retractors, care should be taken to use only as much retraction as necessary to provide adequate access and visualization.

3)Perform the anastomosis only when the stabilizer foot is properly seated on the epicardium and adequate stabilization of the surgical site is achieved.

4. When removing the Axius™ Vacuum Stabilizer from the epicardium, care should be taken not to disrupt the anastomotic site.

5. Take care not to adjust or move the AccessRail Platform while pericardial sutures are engaged in the platform.

6. Suture holder features are designed for "0" size sutures.

7.The Guidant Activator Drive Mechanisms are supplied non-sterile and must be cleaned and sterilized prior to each use. Never use saline solution for cleaning surgical instruments.

8. Steam sterilization is recommended to sterilize the Activator Drive Mechanisms. Other methods of sterilization have not been demonstrated as effective and are not recommended.

Refer to the instructions for use for complete listing of indications, contraindications, warnings and precautions.

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ACROBAT(tm) Mechanical Stabilizer System
Indications for Use

Indications:
The Guidant ACROBAT(tm) Mechanical 2 Stabilizer System is intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The AccessRail Platform in combination with an Activator Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ACROBAT(tm) Mechanical 2 Stabilizer System isolates and provides local immobilization of the target vessel on the beating heart.

Contraindications:
Do not position the stabilizer foot over a coronary artery, newly infarcted or aneurysmal heart tissue.

Warnings and Precautions:
Physicians should be properly trained to perform cardiac surgical procedures with Guidant instruments prior to use.

As with all surgical retractors, care should be taken to use only as much retraction as necessary to provide adequate access and visualization.

Perform the anastomosis only when the stabilizer foot is properly seated on the epicardium and adequate stabilization of the surgical site is achieved.

When removing the ACROBAT(tm) Mechanical 2 Stabilizer from the epicardium, care should be taken not to disrupt the anastomotic site.

Take care not to adjust or move the AccessRail Platform while pericardial sutures are engaged in the platform.

Suture holder features are designed for "0" size sutures.
The Guidant Activator Drive Mechanism is supplied non-sterile and must be cleaned and sterilized prior to each use. Never use saline solution for cleaning surgical instruments.

Steam sterilization is recommended to sterilize the Activator Drive Mechanisms. Other methods of sterilization have not been demonstrated as effective and are not recommended. Care should be taken to ensure that mount and mount lever are clear of tissue when stabilizer is positioned on retractor.

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XPOSE™ Access Device 3
Indications for Use

Caution:
Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

Indications:
The Guidant Axius™ Xpose™ Device 3 is intended to expose coronary arteries during minimally invasive, off pump cardiac surgery through a sternotomy incision approach with a Guidant Stabilization System.

Contraindications:
Do not engage the Guidant Axius™ Xpose™ Device 3 over a coronary artery, newly infarcted or aneurysmal tissue. If hemodynamic instability is experienced, gently return the heart to its resting position.

Indications:
The Guidant Xpose™ Access Device is intended to expose coronary arteries during minimally invasive, off pump cardiac surgery through a sternotomy incision approach with a Guidant Stabilization System.

Contraindications:
Do not engage the Guidant Xpose™ Access Device over a coronary artery, newly infarcted or aneurysmal tissue. If hemodynamic instability is experienced, gently return the heart to its resting position.

Warnings and Precautions:
Physicians should be properly trained to perform cardiac surgical procedures with Guidant instruments prior to use. Many variables, including patient anatomy, pathology, and surgical techniques, may influence procedural outcomes. Patient and procedure selection is a responsibility of the medical professional. The device is intended solely for use with Guidant Stabilization Systems.

Refer to the instructions for use for complete listing of indications, contraindications, warnings and precautions.

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VASOVIEW® 5 Endcoscpoic Vessel Harvesting System
Indications for Use


VASOVIEW® 5 Harvesting Cannula Single-Use

Indications, Contraindications, Warnings, Precautions, Adverse Events
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Indications:
The VASOVIEW 5 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Contraindications:
The device is contraindicated in situations where minimally invasive surgery is contraindicated. The Harvesting Cannula is not intended for contraceptive coagulation of the fallopian tube but may be used to achieve hemostasis following transection of the tube.

Warnings and Precautions:
1. Read all instructions carefully. Failure to properly follow the instructions, warnings and cautions may lead to serious surgical consequences or serious injury to the patient.

2. Minimally invasive surgical procedures should be performed only by individuals adequately trained and familiar with such surgical techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.

3. Sterility: The product is sterile unless the package is opened or damaged. The product is designed for single use. Do not reuse or resterilize. The method of sterilization is irradiation.

4. Before endoscopic instruments and accessories from different manufacturers are employed in a procedure, verify compatibility and ensure that electrical isolation and grounding of these instruments is not compromised.

5. A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both the patient and operator(s) and damage to medical instrumentation.

6. For use with the bipolar outputs of electrosurgical generators only!

7. Do not exceed 35 watts in any mode.

8. Use generators listed in the required special mode setting only.

9. Do not use with Codman Mallis generators.

10. All exposed metal components at the distal end of the scissors may coagulate tissue. Ensure all exposed metal is within the field of vision and contacting the tissue intended for coagulation during the application of electrosurgical energy.

11. Handle the Endoscope carefully to avoid breakage. Regularly check the orientation of the camera before advancing.

12. Advance the cannula gently to avoid damage to delicate tissue.

13. Always advance the C-ring and bipolar scissors under endoscopic visualization. Ensure adequate visualization of bipolar scissor tips and surgical site prior to application of electrosurgical energy.

14. Always inspect the surgical site for hemostasis. If hemostasis is not present, appropriate techniques should be applied to achieve hemostasis.

15. In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approximately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension) and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.

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7 mm Extended Length Endoscope and Dissection Tip

The 7 mm Extended Length Endoscope with Dissection Tip is indicated for visualization of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Contraindications:
The device is contraindicated in situations where endoscopic techniques and minimally invasive surgery are contraindicated.

Warnings and Precautions:
1. Read all instructions carefully. Failure to properly follow the instructions, warnings and cautions may lead to serious surgical consequences or serious injury to the patient.

2. Endoscopic procedures should be performed only by physicians or surgical professionals having adequate training and familiarity with endoscopic techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.

3. The Endoscope is a reusable instrument that is supplied non-sterile. Thoroughly clean and sterilize the Endoscope prior to each use. Follow recommended cleaning and sterilization instructions as described in these Instructions for Use.

4. The Endoscope is a fragile instrument. Handle carefully to avoid breakage; bending of the shaft or dropping the Endoscope may damage the optics or other internal components, making the Endoscope inoperable. Sterilize and store in a protective tray whenever possible.

5. The Dissection Tip is sterile unless the package is opened or damaged. The Tip is designed for single use. Do not reuse or resterilize the Dissection Tip.

6. Whenever using endoscopic illumination equipment, ensure that the light cable connectors never rest on flammable materials such as surgical drapes, towels, etc.

7. Always inspect the surgical site for hemostasis. If hemostasis is not present, appropriate techniques should be applied to achieve hemostasis.

8. In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare but potentially serious complication that may occur (in approximately 1 in 10,000 cases). Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension), and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.

9. If Prevacuum or Gravity steam sterilization (autoclave) are used, the Endoscope may have a shorter life due to harsher sterilization environment. Inspect the Endoscope after each steam sterilization cycle for damage.

10. Do not cool a hot Endoscope after sterilization by rapidly exposing it to air or liquid. Sudden temperature changes may cause glass components to crack.

11. Do not "flash" steam sterilize (autoclave) the Endoscope. Flash (i.e., unwrapped) steam sterilization cycles introduce sudden temperature changes, which may cause glass components to crack.

12. Sterilization with liquid chemical sterilants (e.g., STERIS) may not convey the same sterility assurance as other sterilization methods.

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VASOVIEW Short Port Blunt Tip Trocar (BTT)

Important: These instructions for use are designed to assist in the use of the Short Port Blunt Tip Trocar (BTT). They are not a reference to endoscopic surgery or techniques. Indications: This product has applications for surgery in the leg for establishment of a port of entry for endoscopic instruments.

Indications:
This product has applications for surgery in the leg for establishment of a port of entry for endoscopic instruments.

Contraindications:
The device is contraindicated in situations in which minimally invasive surgery is contraindicated.

Warnings and Precautions:
1. Read all instructions carefully. Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences.

2. Minimally invasive surgical procedures should be performed only by persons having adequate training and familiarity with such surgical techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.

3. Sterility: The product is sterile unless the package is opened or damaged. The product is designed for single use. Do not reuse or resterilize. The primary method of sterilization is irradiation. The alternate method is ethylene oxide. For actual method used, see device label.

4. Before endoscopic instruments and accessories from different manufacturers are employed in a procedure, verify compatibility and ensure that electrical isolation and grounding of these instruments is not compromised.

5. A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both the patient and operator(s) and damage to medical instrumentation.

6. Balloon products must be treated with care. Damage to balloons by instruments used during insertion and in the course of a procedure may result in balloon rupture.

7. The balloon on the Short Port Blunt Tip Trocar contains a fully coated natural rubber latex and may affect patients with latex sensitivities if the coating becomes damaged.

8. Overinflation of the BTT Port balloon may result in balloon rupture. Do not inflate more than 25 cc.

9. In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approximately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension), and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.

Refer to the instructions for use for complete listing of indications, contraindications, warnings, and precautions.


 

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