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INTENDED USE
This device is intended to be used to aid in the percutaneous positioning and placement of needles or needlelike
therapeutic probes.
INDICATIONS FOR USE
Prostate - Diagnostic imaging and minimally invasive puncture procedures.
Surgical (Prostate) - Diagnostic imaging and puncture procedures.
PATIENT POPULATION
Template Grids are for use in adult male patients with suspected or diagnosed prostate cancer.
INTENDED USERS
Template Grids should be used by clinicians medically trained in ultrasound imaging. User groups may include, but
are not limited to: Physicists, Radiation Oncologists, Surgeons and Urologists.
PERFORMANCE CHARACTERISTICS
Template Grid accepts therapeutic probes up to 2.4mm (14 gauge) in diameter and consists of rows and columns
of holes spaced 3mm apart, providing percutaneous positioning and placement of needles and needlelike
therapeutic probes.
NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
Before use, you should be trained in cryotherapy. For instructions on preparation, safe operation and care
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of your transducer and cryotherapy system, see your system's user guide.
Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization may create a
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risk of contamination of the device, cause patient infection or cross-infection.
Users of this product have an obligation and responsibility to provide the highest degree of infection
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control to patients, co-workers and themselves. To avoid cross-contamination, follow infection control
policies established by your facility.
Product is packaged sterile and is intended for single use only.
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Product is sterilized using ethylene oxide.
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Do not use if integrity of packaging is violated.
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Do not use if expiration date has passed.
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Grid is designed and validated for use with CIVCO Steppers.
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Do not use grid if it appears to be cracked or broken.
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Grid cannot be resterilized after use.
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Ensure graphics on ultrasound monitor match graphics on grid.
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Take care when inserting needles into grid to avoid breaking needle.
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If the product malfunctions during use or is no longer able to achieve its intended use, stop using the
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product and call CIVCO.
Report serious incidents related to the product to CIVCO and the competent authority in your Member
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State, or appropriate regulatory authorities.
See your system's user guide for reprocessing transducer between use.
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NOTE: Product is not made with natural rubber latex.
NOTE: Grid to be used with 2.4mm therapeutic probe.
ASSEMBLING GRID
1. Using sterile technique, remove grid from package.
2. Configure guide for desired mode, one plate or two (Refer to illustrations).
3. Disengage clip to remove plate for Mode F only (Refer to illustration I).
4. Mount grid to platform (Refer to illustration II).
Template Grid - 14GA
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