Intended Purpose - mediglobe SonoTip II EBUS Gebrauchsanweisung

1 9
GB
The SonoTip

Intended Purpose

®
The SonoTip II EBUS-TBNA Needle System is intended for Ultrasonically Guided
Fine Needle Aspiration, (FNA) of submucosal and extra-luminal lesions of the
Tracheobronchial Tree and Gastrointestinal Tract.
! The presence of a cytologist during extra-luminal EBUS guided TBNA may
reduce the number of fine needle aspiration passes required from each lesion.
*FDA/CDRH/ODE/DREAD – M. Cornelius
Warning !
The user of this equipment should be thoroughly trained in the applicable
procedure. Furthermore, failure to read and thoroughly understand the contents of
this instruction manual may result in serious injury to the patient and/or user. It is
essential to follow the instructions enclosed, as well as instructions found in other
instruction manuals, infection control requirements and current hospital protocols for
usage, cleaning and sterilization.
! Possible complications from the extra-luminal endobronchial ultrasound-guided
TBNA may include but are not limited to infection, hemorrhage, perforation and
tumor seeding.
! Failure to follow these instructions may result in instrument malfunction and/or
damage!
Storage
Please store the instrument between a range of temperature of 5°C to 30°C and
between a humidity range of 30% to 60%. Keep dry and avoid exposure to sunlight
and chemical fumes.
General Safety Instruction
 Wear protective garments (i.e., gloves, protective eyewear, gowns, etc.) to
assist in the protection against cross-contamination and injury.
 Do not use this instrument if it does not function properly. If the device has any
physical defect(s), replace the instrument with a new and/or functioning
instrument.
 Check the endoscope‟s working channel diameter prior to introducing the
instrument into the endoscope. The working channel of the endoscope must be
at least "0.2 mm" larger than the SonoTip
! Never use instruments which do not comply with the technical specifications.
 Do not force an instrument down the working channel of the endoscope. This
could result in endoscope and/or instrument damage.
 Do not under any circumstances make any modifications to the instrument or
components described in this manual.
Warning !
®
II EBUS-TBNA Needle System is for SINGLE USE ONLY.
Resterilization of this product is prohibited!
®
II EBUS outer diameter.
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