CARDIOVASCULAR SYSTEMS INC. EX1000 Manuales de usuario

Tabla de contenidos

• System Description

  1
• System and Component Descriptions

  1
• Indications for Use

  9
• Contraindications

  9
• Restrictions

  10
• Warnings

  10
• Precautions

  11
• Storage and Handling

  13
• Adverse events

  13
• Clinical Trials Summary

  14
• Equipment, Setup, and Test

  14
• OAS Directions for Use

  22
• Specifications

  32
• OAS Pump Declaration of Conformity

  34
• EMC Declaration

  34
• FCC

  37
• Disclaimer of Warranty

  37
• Appendix A. System Troubleshooting

  39
• Appendix B. Introducer, Guide Sheath, or Guide Catheter Size

  44
• Appendix C. Maximum Orbit and Resulting Lumen Diameter

  46
• Appendix D. Orbit Performance

  48