Related Manuals for Exact Imaging EV9C
Summary of Contents for Exact Imaging EV9C
- Page 1 Care, Cleaning and Use Guide for EV9C Transrectal Transducer Part Number 6138 Revision 2.1...
- Page 2 Operation and Safety Manual for ExactVu™ High Resolution Micro-Ultrasound System. Version information System: ExactVu™ High Resolution Micro-Ultrasound System Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1, original instructions Exact Imaging Page 2 of 31...
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Page 3: Table Of Contents
Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 Table of Contents Chapter 1 Introduction ..........................4 Chapter 2 General Information ........................5 Transducer Safety ............................5 General ............................... 5 Electrical Safety ..........................5 Interference ............................5 Acoustic Safety ..........................6 Bio-safety ............................ -
Page 4: Chapter 1 Introduction
The materials used in the construction of the EV9C transducer meet the applicable requirements of ISO 10993-10 Biological evaluation of medical devices. It is important to use this Care, Cleaning and Use Guide for EV9C Transrectal Transducer in conjunction with other instructions for using the ExactVu system. -
Page 5: Chapter 2 General Information
Chapter 2 General Information 1 Transducer Safety The EV9C transducer meets FDA’s Track 3 Requirements, per Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers and the requirements of IEC 60601-2-37. -
Page 6: Interference
Revision 2.1 1.3 Interference 1.3.1 Electromagnetic (EMC) WARNING Do not activate the EV9C transducer outside the patient’s body if it would not EN-W17 comply with electromagnetic compliance requirements. It may cause harmful interference with other nearby equipment. 1.4 Acoustic Safety Safety information for the ExactVu micro-ultrasound system is provided in Operation and Safety Manual for ExactVu™... -
Page 7: Transducer Parts, Accessories, Consumables
If the sheath is punctured by the needle, discard it and re-prepare the transducer as described in Chapter 3, section 1.3 on page 11. 2 Transducer Parts, Accessories, Consumables Figure 1 identifies parts of the EV9C transducer (Exact Imaging Catalog Reference EV-9C). Imaging surface (lens) -
Page 8: Civco® Disposable Endocavity Needle Guide
Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 2.1 CIVCO® Disposable Endocavity Needle Guide For biopsy procedures using the EV9C transducer, only use the CIVCO Disposable Endocavity Needle ® Guide. It is manufactured by CIVCO, and may be ordered from CIVCO or one of its distributors. It is available in a 24-pack configuration (CIVCO catalog reference 610-1274-24). -
Page 9: Latex-Free Sheath
Discard the component and its packaging according to internal clinical procedures for safe disposal. 2.2 Latex-free Sheath For biopsy procedures using the EV9C transducer that require the use of a latex-free sheath, use one of the following options from CIVCO or one of its distributors. •... -
Page 10: Chapter 3 Preparing For Imaging
Refer to Chapter 2, section 2.2 on page 9 for information about recommended latex-free sheaths. 1.1 Exam Type Each transducer is associated with a specific exam type. Details for the EV9C transducer are specified in the following table: Exact Imaging... -
Page 11: Presets
1.3 Preparing the Transducer These instructions are applicable to: • Preparing the EV9C transducer for imaging-only procedures (i.e., imaging procedures without biopsy) • Preparing the EV9C transducer for biopsy procedures WARNING EN-W28 Always wear gloves when handling sterile items. -
Page 12: Connecting The Transducer To The Exactvu System
Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 CAUTION EN-C13 It is important to prevent air bubbles from forming inside the sheath near the imaging surface of the transducer to avoid interfering with image quality. To prepare the EV9C transducer for imaging-only procedures: •... - Page 13 Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 To connect the transducer to the ExactVu system: On the transducer connector, turn the lock knob to its unlocked position (refer Figure 4: Transducer Locked Icon Figure 5: Transducer Unlocked...
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Page 14: Performing A Biopsy Procedure
Discard surgical gloves used during the procedure according to internal clinical procedures for safe disposal. Wipe off any material or gel from the EV9C transducer using a damp, soft cloth. CAUTION Use caution to prevent damaging the transducer during cleaning and to avoid EN-C24 scratching the transducer’s imaging surface (i.e., the lens). -
Page 15: Disconnecting The Transducer
Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 Verify that the supply of consumables for upcoming procedures is adequate. Replacement needle guides and sheaths may be ordered from your local distributor. Refer to Appendix A for contact information. -
Page 16: Chapter 4 Transducer Reprocessing
• After every use, follow proper procedures for cleaning and waste disposal. • Follow the procedure in this section for cleaning and disinfecting the EV9C transducer, and observe all warnings, cautions and notes. WARNING The use of damaged transducers may cause the reprocessing procedure in this EN-W80 chapter to be ineffective. -
Page 17: Preparation For Transducer Reprocessing
2 Preparation for Transducer Reprocessing 2.1 Required items Several items are required to perform the reprocessing procedure for the EV9C transducer: • Cleaner and disinfectant (For a list of cleaning agents and disinfectants approved by Exact Imaging for use in this procedure, refer to Approved Chemicals List for ExactVu Transducers) •... -
Page 18: Surface Cleaning For The Ev9C Transducer
It is applicable to: • The parts of the EV9C transducer that do not come into contact with the sheath during a TRUS procedure, or in other words, the part of the transducer that is above the soak level (refer to Figure 11). -
Page 19: Cleaning And Disinfecting The Ev9C Transducer
It is applicable to: • The parts of the EV9C transducer that come into contact with the sheath during a TRUS procedure, or in other words, the part of the transducer that is on or below the soak level (refer to Figure 11). - Page 20 The cleaning solution may be prepared in advance of cleaning the transducer. • Fill the cleaner container with a sufficient volume of cleaning solution for the EV9C transducer to be immersed to the soak level indicated in Figure 11. •...
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Page 21: High-Level Disinfection Of The Ev9C Transducer
Do not exceed the duration of exposure recommended in the instructions for use provided by the manufacturer of the high-level disinfectant. Fill the rinse container with a sufficient volume of sterile water or tap water for the EV9C transducer to be immersed to its soak level. -
Page 22: Inspecting The Ev9C Transducer After Reprocessing
Gently dry the EV9C transducer with a soft, clean cloth. 5 Inspecting the EV9C Transducer after Reprocessing Inspect the EV9C transducer for signs of deterioration due to cleaning and disinfection after every application of the cleaning and disinfecting procedure. Imaging... -
Page 23: Storing The Ev9C Transducer After Reprocessing
Over time, cleaning and disinfecting the EV9C transducer may cause discoloration. Discoloration does not affect the performance of the EV9C transducer; however, if considerable discoloration is observed over a period of approximately six months, contact Technical Support using the contact information in Appendix A. -
Page 24: Caring For The Ev9C Transducer
Caring for ExactVu transducers includes careful handling, maintenance, reprocessing (as described in Chapter 4). 1 Careful Handling of the EV9C Transducer In order to prevent damage, the EV9C transducer must be handled carefully at all times. This includes: • During use •... - Page 25 2.1.2 Checking the EV9C Needle Guide Alignment The procedure to check the alignment of the EV9C needle guide consists of comparing the alignment of the biopsy needle in the needle guide with the needle guide overlay displayed on the ExactVu system’s imaging screen.
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Page 26: Storing The Ev9C Transducer
Chapter 4 must be performed prior to using the transducer in a procedure. 2.2 Storing the EV9C Transducer EV9C transducers may be stored in the transducer holders on the front of the ExactVu system cart. WARNING Before putting a reprocessed transducer into the transducer holder on the... - Page 27 Follow the complete procedure for cleaning and disinfecting the EV9C transducer provided in provided in Chapter 4. Follow the instructions provided above for storing the EV9C transducer in its shipping package. Seal the shipping package with packing tape. Contact Technical Support using the contact information in Appendix A to obtain an RMA (Return Material Authorization) number.
- Page 28 Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 CAUTION EN-C37 To prevent damage, Exact Imaging recommends securely packaging transducers during transportation. Exact Imaging Page 28 of 31...
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Page 29: Service And Repair
Service and Repair 1 Working Life of ExactVu Transducers The EV9C transducer, when used with proper care, is designed for a working lifetime of whichever comes first of 5 years or 2500 reprocessing cycles. The working lifetime for Exact Imaging transducers is based on their ability to withstand the effects of cycles of the reprocessing procedure without degrading functionality or compromising safety. -
Page 30: Chapter 7 Disposal
When the EV9C transducer reaches the end of its working life, national rules for discarding/recycling the relevant material in each individual country must be followed. The EV9C transducer is designed for a working lifetime of 5 years, when used with proper care. The ExactVu system is designed for a working lifetime of 5 years. -
Page 31: Appendix A Contact Information
Care, Cleaning and Use Guide for EV9C Transrectal Transducer Revision 2.1 Appendix A Contact Information For Technical Support Region Phone number Email address All regions except North America – contact +33(0)472 153 150 ccc@edap-tms.com EDAP TMS North America (US, CA, MX) – contact EDAP +1 (512) 852-9685 service@edap-usa.com...
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