Merit Medical ReSolve Mini Gebrauchsanweisung Seite 2

Locking Drainage Catheter
I N S T R U C T I O N S F O R U S E
PRODUCT NAME
ReSolve Mini™ Locking Drainage Catheter
DESCRIPTION OF THE PRODUCT
The ReSolve Mini Locking Drainage Catheter with locking pigtail and
hydrophilic coating is a radiopaque catheter with multiple side holes
used for percutaneous drainage. The components of the catheter
allow for introduction and placement using a trocar stylette or over-
the-wire method.
The ReSolve Mini Locking Drainage Catheter may be packaged with
the following components:
• One (1) ReSolve Mini Locking Drainage Catheter with locking
pigtail (A), hydrophilic coating and pigtail straightener (B)
• One (1) Metal stiffening cannula (C)
• One (1) Flexible stiffening cannula (D)
• One (1) Trocar stylette (E)
• One (1) Repositioning Tool (F)
• One (1) Dead end cap (G)
• One (1) Marker band (H)
INDICATIONS FOR USE
The ReSolve Mini Locking Drainage Catheter with locking pigtail and
hydrophilic coating is intended for percutaneous drainage of fluid
from body cavities.
CLINICAL BENEFITS
Percutaneous drainage of fluid from body cavities.
CONTRAINDICATIONS
The ReSolve Mini Locking Drainage Catheter is contraindicated for use
where percutaneous drainage catheterization is unacceptable.
The ReSolve Mini Locking Drainage Catheter is contraindicated for
intravascular use.
MRI INFORMATION
MR CONDITIONAL
The ReSolve Mini Locking Drainage Catheter is MR Conditional
Non-clinical testing has demonstrated that the ReSolve Mini Locking
Drainage Catheter is MR Conditional. This device can be scanned
safely in a patient, immediately after placement under the following
conditions:
• Static Magnetic Field of 3 Tesla or less
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40
T/m)
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 4-W/kg in the First Level Controlled
Operating Mode of operation for the MR system
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MRI-RELATED HEATING
Under the scan conditions defined above, the ReSolve Mini Locking
Drainage Catheter is expected to produce a maximum
temperature rise of 2.3°C after 15 minutes of continuous
scanning.
ARTIFACT INFORMATION
The maximum artifact size as seen on the gradient echo pulse
sequence at 3-Tesla extends approximately 2-mm relative to the size
of the shape of the ReSolve Mini Locking Drainage Catheter.
The safety of the initial placement system including the metal
stiffening cannula has not been evaluated in the MR environment,
and therefore, these components should not be used within the MR
environment.
PRECAUTIONS
• Read manufacturer's instructions prior to use.
• Contents of unopened, undamaged package are sterile.
• For single patient use only. Do not reuse, reprocess, or resterilize.
Reuse, reprocessing, or resterilization may compromise the
structural integrity of the device and/or lead to device failure,
which in turn may result in patient injury, illness, or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness, or death of the patient.
• Follow universal precautions when inserting and maintaining this
device.
• Due to the risk of bloodborne pathogens, healthcare professionals
should always use standard blood and body fluid precautions in
the care of all patients.
• Sterile technique should always be followed.
• Do not use after expiration date.
• Store in a cool, dry place.
WARNINGS
• The ReSolve Mini Locking Drainage Catheter is not to be used to
deliver nutritional supplements.
P x Only Caution: Federal (U.S.A.) law restricts this device to sale by
or on the order of a physician trained and/or experienced in the use
of this device.
ADVERSE REACTIONS
• Septic shock
• Bacteremia
• Hemorrhage
• Superinfection
• Bowel transgression
• Pleural transgression
• Vascular injury
• Catheter dislodgement
• Catheter occlusion
INSTRUCTIONS FOR USE OPTION 1:
DIRECT PLACEMENT USING TROCAR STYLET
1. Remove the stiffening cannula and trocar stylette assembly from
catheter.
2. Wet the distal portion of the ReSolve Mini Locking Drainage
catheter prior to use with sterile water or saline. Keep the distal
portion of the catheter wet during placement.
WARNING: DO NOT wipe catheter with dry gauze or any solvents
because it may damage the catheter coating.
3. Flush catheter prior to use.
4. Ensure suture locking mechanism is in the proximal position.