Merit Medical Prelude Gebrauchsanweisung Seite 3

2. Remove the Prelude Short Sheath Introducer components from package using proper aseptic
technique.
3. Flush all components with saline or suitable isotonic solution. The side port of the device has a
snap clamp; ensure that clamp is open during flushing.
4. After flushing side port, turn stopcock to off position to maintain flush in side port and prevent
bleed back upon insertion into the vessel. Close snap clamp on side port extension.
5. The side port of the device includes two removable indicators – red indicates arterial and blue
indicates venous use. Select the appropriate color and leave in place on the side port tubing;
remove and discard the other. If indicators are not necessary, remove and discard both.
6. Insert dilator into Prelude Short Sheath Introducer through hemostasis valve and snap into
place. Dilator must be securely snapped into place to avoid damage to the vessel.
7. Insert appropriate access needle into vessel. While holding the access needle, place the flexible
end or J end of the guide wire through access needle into vessel. Note – Refer to product
labeling for the guide wire size that is compatible with the system components.
WARNING: Do not advance the guide wire if resistance is met. Determine the cause of resistance
before proceeding.
NOTE: If a crossed catheter technique is utilized, the punctures should be greater than 11cm
apart. This distance ensures that during hemodialysis the Prelude Short Sheaths are sufficiently
separated for use as arterial and venous conduits.
8. Hold guide wire in place and remove access needle. Hold pressure at the site until the
introducer/dilator assembly is placed.
WARNING: If a needle with a metal cannula is used, do not withdraw the guide wire after it has
been inserted because it may damage the guide wire.
9. Insert the introducer/dilator assembly over the guide wire into the vessel. Using a rotating
motion, advance the introducer/dilator assembly through the tissue into the vessel. Grasp the
assembly close to the skin as it is being placed into the vessel to avoid buckling.
10. After introducer/dilator assembly has been placed into vessel, detach the dilator from the
introducer by bending the dilator hub down slightly (this will un-snap the dilator hub from
the introducer cap). While holding the sheath, carefully remove the dilator and guide wire
together, leaving the sheath introducer in the vessel.
11. Aspirate from the side port extension to remove any potential air. After aspiration, flush the
side port with a suitable solution. Stopcock should be turned off to maintain flush in side port.
In addition, ensure that clamp is closed to also maintain flush in side port.
12. Insert selected device(s) (wires, catheters, etc.) into Prelude Short Sheath Introducer.
NOTE: Hold the sheath in place when inserting, positioning, or removing the devices. Always
exchange or remove devices slowly through the sheath.
13. To temporarily suture the sheath in place, use the rotating suture ring.
14. REMOVAL
a. The sheath may be removed when clinically indicated. Compression on the vessel, above
the puncture site, should be started as the sheath is slowly removed. Discard the sheath
appropriately.
NOTE: Collected fibrin at the tip of the sheath may be aspirated via the side port tubing prior
to removal of the sheath.
b. Follow standard protocol for achieving hemostasis at the insertion site.
15. HEMODIALYSIS
a. If the sheath is to be used for temporary access for hemodialysis, aspirate from the side
port extension to remove any potential air. After aspiration, flush the side port with a
suitable solution. Stopcock should be turned off to maintain flush in side port. In addition,
ensure that clamp is closed to also maintain flush in side port.
b. Patient should be accompanied to dialysis center by appropriate personnel.
c. Following standard protocol, side port of sheath introducer can be connected to
hemodialysis circuit.
d. At conclusion of dialysis, refer to step 14 for sheath removal.
WARNING: After use, dispose of device in a manner consistent with standard protocols for
biohazard waste disposal.
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.
Caution
Do not use if package is damaged and consult instruction for use
Catalog number
Batch code
Medical Device
Unique Device Identifier
Single use
Do not resterilize
Consult Instructions for Use
For electronic copy scan QR Code, or go to www.merit.com/ifu and enter IFU
ID Number. For printed copy available within seven calendar days, call U.S.A.
or EU Customer Service.
Sterilized using ethylene oxide