Medical Device - Merit Medical Resolve Mini Gebrauchsanweisung

CATHETER EXCHANGE, REPOSITIONING OR REMOVAL
1. Disconnect catheter from drainage bag, tubing or dead end cap.
2. To release the pigtail loop choose one of the following options:
Option 1:
• Using the Repositioning Tool align the opening of the round
section of the Repositioning Tool in line with the handle of the
suture locking mechanism.
• Bring the flat back of the Repositioning Tool around the catheter
hub.
• Gently squeeze together.
• Remove the Repositioning Tool and rotate the suture locking
mechanism to the most proximal position.
Precaution: Do not rotate the suture locking mechanism beyond
the point of resistance. Rotating the suture locking mechanism
beyond the point of resistance will not release the suture to
allow the pigtail to straighten upon removal.
Option 2:
For exchange or removal only, cut the hub off the drainage catheter
and sever suture. This will release the suture and the pigtail loop.
WARNING: The suture will no longer be secured to the catheter. Take
care to remove both the suture and catheter.
3. For catheter exchange or if access is to be maintained, advance
appropriate guide wire through catheter; using diagnostic
imaging to confirm guide wire placement. Guide wire will
maintain access to drainage site. To ease guide wire placement, a
stiffening cannula may be used
WARNING: When long-term use is indicated, it is recommended
that indwelling time not exceed 90 days. The ReSolve Mini
Locking Drainage Catheter should be evaluated by a physician
on or before 90 days post placement.
4. Carefully remove the ReSolve Mini Locking Drainage Catheter.
Proceed with either catheter exchange or skin closure.
5. Dispose of explanted catheter following standard blood and
body fluid precautions per applicable hospital protocols.
ATTENTION ATTENDING PHYSICIAN: IF PATIENT WILL NOT BE
FOLLOWED UP BY YOU, IT IS RECOMMENDED THAT THE "INSTRUCTIONS
FOR USE" OR THE SECTION ON HOW TO REMOVE THE CATHETER BE
ATTACHED TO THE PATIENT'S CHART.
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician.
Caution: Consult accompanying documents.
Single use.
Do not resterilize
Non-pyrogenic
Do not use if package is damaged
Sterilized using ethylene oxide
Maximum diameter guide wire
Catalog number
Batch code
MR Conditional
Date of Manufacture: YYYY-MM-DD
Use by date: YYYY-MM-DD
Consult Instructions for Use

Medical Device

Sterile Package Sterile Package
In the EU, any serious incident that has occurred in relation to the
device should be reported to the manufacturer and the competent
authority of the applicable Member State.