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Micro-Touch® Stabilizer
MI C R O- T OUCH®S T A B I L I Z E R
Symbol
Title of Symbol
Manufacturer
(ISO 15223-1, 5.1.1)
Authorized Representative in the European
Community (ISO 15223-1, 5.1.2)
Date of manufacture
(ISO 15223-1, 5.1.3)
Batch code
(ISO 15223-1, 5.1.5)
Catalog number
(ISO 15223-1, 5.1.6)
Serial number
(ISO 15223-1, 5.1.7)
Consult instructions for use
(ISO 15223-1, 5.4.3)
European Conformity
(EU MDR 2017/745, Article 20)
Medical Device
(MedTech Europe Guidance: Use of Symbols
to Indicate Compliance with the MDR)
(IEC 60878, 2794)
GENERAL EQUIPMENT INFORMATION
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 ultrasonography. For instructions on the use of your transducer, see your system's user guide.
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Prior to use, read and understand all instructions and warnings.
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Prior to use inspect device for signs of damage, if damage is evident do not use.
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Equipment is not to be modified without CIVCO authorization.
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Stabilizer is designed and validated for use with CIVCO accessories. For CIVCO Steppers and other accessories, visit www.CIVCO.com.
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Stabilizer is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure stabilizer is properly cleaned and disinfected
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before each use. See reprocessing section for instructions on how to properly clean and disinfect.
For illustration purposes only, equipment may be shown without a drape. Always place a drape over the equipment to protect patients and users
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from cross-contamination.
If the product malfunctions during use or is no longer able to achieve its intended use, stop using the product and contact CIVCO.
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Report serious incidents related to the product to CIVCO and the competent authority in your Member State, or appropriate regulatory authorities.
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INTENDED USE
The equipment is intended to provide fixation, support and manipulation of transrectal ultrasound imaging probes during insertion and final placement.
INDICATIONS FOR USE
Prostate - Diagnostic imaging and minimally invasive puncture procedures.
Surgical (Prostate) - Diagnostic imaging and puncture procedures.
PATIENT POPULATION
Equipment is for use in adult males with suspected or diagnosed prostate cancer.
INTENDED USERS
Equipment 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
Stabilizer features stable single-arm fixation with a single-point locking mechanism to instantly fix the stabilizer in the desired position.
NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.
Indicates the manufacturer's serial number so that a specific medical device can be identified.
Indicates manufacturer declaration that the product complies with the essential requirements of
Quantity
Indicates the medical device manufacturer.
Indicates the Authorized Representative in the European Community.
Indicates the date when the medical device was manufactured.
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Indicates the manufacturer's catalogue number so that the medical device can be identified.
Indicates the need for the user to consult the instructions for use.
the relevant European health, safety and environment protection legislation.
Indicates the product is a medical device.
To indicate the number of pieces in the package.
1
Description of Symbol
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