EX3™ Stepper English
EX3™ STEPPER
Symbol Title of Symbol Description of Symbol
Manufacturer
(ISO 15223-1, 5.1.1)
Indicates the medical device manufacturer.
Authorized Representative in the European
Community (ISO 15223-1, 5.1.2)
Indicates the Authorized Representative in the European Community.
Date of manufacture
(ISO 15223-1, 5.1.3)
Indicates the date when the medical device was manufactured.
Batch code
(ISO 15223-1, 5.1.5)
Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalog number
(ISO 15223-1, 5.1.6)
Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Serial number
(ISO 15223-1, 5.1.7)
Indicates the manufacturer's serial number so that a specific medical device can be identified.
Type B applied part
(IEC 60417, 5840)
Indicates a type B applied part complying with relevant section of the technical standard IEC
60601-1 for safety of medical electrical equipment.
Electrical equipment waste
(BS EN 50419)
Identifies product that is subject to the European Union's Waste Electrical and Electronic
Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment.
Consult instructions for use
(ISO 15223-1, 5.4.3)
Indicates the need for the user to consult the instructions for use.
European Conformity
(EU MDR 2017/745, Article 20)
Indicates manufacturer declaration that the product complies with the essential requirements of
the relevant European health, safety and environment protection legislation.
Medical Device
(MedTech Europe Guidance: Use of Symbols
to Indicate Compliance with the MDR)
Indicates the product is a medical device.
Quantity
(IEC 60878, 2794)
To indicate the number of pieces in the package.
GENERAL EQUIPMENT INFORMATION
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
n
Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see your system's user guide.
n
Prior to use, read and understand all instructions and warnings.
n
Prior to use inspect device for signs of damage, if damage is evident do not use.
n
Equipment is not to be modified without CIVCO authorization.
n
Stepper is designed and validated for use with CIVCO accessories. For stabilizers, template grids, drapes, and other accessories, visit
www.CIVCO.com.
n
Stepper is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure stepper is properly cleaned and disinfected before
each use. See reprocessing section for instructions on how to properly clean and disinfect.
n
For illustration purposes only, equipment may be shown without a drape. Always place a drape over the equipment to protect patients and users from
cross-contamination.
n
If the product malfunctions during use or is no longer able to achieve its intended use, stop using the product and contact CIVCO.
n
Report serious incidents related to the product to CIVCO and the competent authority in your Member State, or appropriate regulatory authorities.
INTENDED USE
The equipment is intended to hold and manipulate ultrasound imaging probes, and report position, during prostate brachytherapy, cryotherapy,
transperineal template-guided biopsy, and/or fiducial marker placement procedures (including volume determination of the prostate gland), and/or the
application of radionuclide source(s) into the body during brachytherapy.
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.
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