baxter ADS201865 Manual De Instrucciones

ADS201865
EASYGRIP FLO-41
Precision MIS Delivery System
INSTRUCTIONS FOR USE
Device Description:
The EASYGRIP FLO-41 Precision MIS Delivery System ("EASYGRIP FLO-41
System")
is a sterile, single-use device that consists of two components:
• 1 x applicator device with a 41cm long cannula (5mm outer diameter)
• 1 x empty 1.5 mL syringe.
The EASYGRIP FLO-41 System is compatible with FLOSEAL Hemostatic Matrix
(hemostatic agent).
Sterile and non-pyrogenic. Sterilized using irradiation.
Not made with natural rubber latex.
Indications:
The EASYGRIP FLO-41 System is indicated for delivering FLOSEAL
Hemostatic Matrix to bleeding sites through a 5mm or larger trocar.
Intended Purpose / Intended Use:
The EASYGRIP FLO-41 System is intended for delivering FLOSEAL
Hemostatic Matrix to bleeding sites through a 5mm or larger trocar.
Contraindications:
None
Warnings:
• Single use only. Do not reuse. Do not resterilize. Reuse or
reprocessing of a single use device may lead to contamination and
compromised device function or structural integrity.
• Do not use the EASYGRIP FLO-41 System if the packaging is damaged
or open, or if the applicator is damaged, as this could lead to
compromised device function.
• Do not use air as a propellant to extrude hemostatic agent from the
EASYGRIP FLO-41 System.
• Do not use the EASYGRIP FLO-41 System to manipulate or retract
organs or tissue.
• Do not bend the malleable tip against organs or tissue.
Precautions:
Read the hemostatic agent's instructions prior to using this device.
How Supplied:
The EASYGRIP FLO-41 System is supplied sterile in a sealed plastic tray
packed in a
product box. The tray contains one (1) applicator device and one (1) empty
1.5 mL syringe. One (1) shipping carton contains six (6) EASYGRIP FLO-41
Systems
NOTE: The provided syringe is used for optional residual product application;
do not use prior to complete application of hemostatic agent.
Malleable tip
Cannula
Fill port
Reservoir
Trigger
Syringe
Directions for Use:
Assembly:
1. Prepare the hemostatic agent per its instructions for use.
2. Inspect the integrity of the EASYGRIP FLO-41 System packaging. If the
tray, tray seal, or contents have been opened or damaged, do not use.
3. Using aseptic technique, open tray lid where indicated and transfer
contents into the sterile field.
4. Attach the hemostatic agent syringe to the EASYGRIP FLO-41 System
fill port, taking care to not overtighten.
5. Taking care not to pull the device trigger, fill the reservoir completely
with
hemostatic agent.
NOTE: Syringe may be removed if desired.
6. Prime cannula by repeatedly pulling trigger (approximately 2-3 pulls)
until hemostatic agent is visible in clear malleable tip. The EASYGRIP
FLO-41 System is now ready to use.
NOTE: Once primed, take care not to depress trigger prior to
application.
7. Ensure the malleable tip is straight before introducing the cannula into
a trocar.
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