Merit Medical ReSolve Mini Gebrauchsanweisung Seite 3

5. Slide pigtail straightener along distal portion of catheter to
straighten curve prior to placing metal stiffening cannula into
the catheter. Place the metal stiffening cannula into the catheter
and tighten the Luer lock fittings. See Figure 1.
Caution: To prevent catheter damage fully seat cannula in the
catheter tip before removing the paper spacer and inserting the
trocar stylette.
6. Remove the paper spacer from the trocar stylette. Advance the
trocar stylette through the metal stiffening cannula and tighten
the Luer lock fittings. See Figure 2.
7. Remove pigtail straightener from catheter prior to insertion.
8. Place the catheter/cannula/trocar assembly into the fluid
collection site using standard insertion technique.
Note: Placement should be confirmed with diagnostic imaging.
9. After placement is confirmed, remove the trocar stylette and
stiffening cannula.
10. To engage the suture locking mechanism: Pull the suture until
desired pigtail is formed. Rotate the suture locking mechanism
distally to hold the suture in place. See Figure 3.
Note: If the catheter needs to be repositioned, unlock the suture
locking mechanism by rotating the arm proximally to the point
of resistance.
Precaution: When unlocking, 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.
11. Once placement is confirmed, and the suture locking mechanism
has been rotated to the most distal position, press the suture
locking mechanism into the hub to secure it. The suture locking
mechanism is now locked into position. See Figure 4.
12. The ReSolve Mini Locking Drainage Catheter is now ready to be
connected to appropriate drainage bag, tubing or dead end cap.
WARNING: If using alcohol to clean the catheter hub, allow
sufficient time for alcohol to dry before connecting the drainage
tubing or dead end cap.
WARNING: DO NOT over tighten the connection between the
drainage catheter and drainage tubing or dead end cap.
Note: A flush regimen should be designed for the circumstances
of each patient and the protocol of the physician.
Note: Instruct patient or other healthcare personnel in
appropriate device function and/ or maintenance.
INSTRUCTIONS FOR USE OPTION 2:
SELDINGER ENTRY TECHNIQUE OR GUIDE WIRE EXCHANGE
1. Remove the stiffening cannula and trocar stylette assembly from
catheter.
Figure 1
Figure 2
Figure 3
Figure 4
2. Ensure that the distal portion of the catheter is wet prior to
placement. 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.
5. Slide pigtail straightener along distal portion of catheter to
straighten curve prior to placing the stiffening cannula into
the catheter. Place the stiffening cannula into the catheter and
tighten the luer lock fittings. See Figure 5.
6. Remove pigtail straightener from catheter prior to insertion.
7. Place catheter/cannula assembly over appropriate guide wire and
advance into the fluid collection site. The catheter accommodates
a 0.038" (0.97 mm) wire. See Figure 6.
Note: Placement should be confirmed with diagnostic imaging.
8. After placement is confirmed, remove the stiffening cannula and
guide wire.
9. To engage the suture locking mechanism: Pull the suture until
desired pigtail is formed. Rotate the suture locking mechanism
distally to hold the suture in place. See Figure 7.
Note: If the catheter needs to be repositioned, unlock the suture
locking mechanism by rotating the arm proximally to the point
of resistance.
Precaution: When unlocking, 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.
10. Once placement is confirmed, and the suture locking mechanism
has been rotated to the most distal position, press the suture
locking mechanism into the hub to secure it. The suture locking
mechanism is now locked into position. See Figure 8.
11. The ReSolve Mini Locking Drainage Catheter is now ready to be
connected to appropriate drainage bag, tubing or dead end cap.
WARNING: If using alcohol to clean the catheter hub, allow
sufficient time for alcohol to dry before connecting the drainage
tubing or dead end cap.
WARNING: DO NOT over tighten the connection between the
drainage catheter and drainage tubing or dead end cap.
Note: A flush regimen should be designed for the circumstances
of each patient and the protocol of the physician.
Note: Instruct patient or other healthcare personnel in
appropriate device function and/ or maintenance.
Figure 5
Figure 6
Figure 7
Figure 8