baxter ADS201865 Manual De Instrucciones página 2

Initial Product Application:
8. Carefully approximate the distal end of the malleable tip to the
treatment site; use appropriate endoscopic instruments to bend the
malleable tip as required for application.
9. Pull the trigger of the EASYGRIP FLO-41 System to apply the
hemostatic agent per its instructions. Multiple pulls may be required to
apply desired amount of hemostatic agent.
NOTE: For ease of application, apply the hemostatic agent within two
(2) hours of reconstitution of the hemostatic agent.
Repeat Product Application (as needed):
1. If additional hemostatic agent is required during the same surgical
procedure:
• load remaining hemostatic agent, taking care not to depress trigger,
and fill the reservoir with additional product
-or-
• attach new syringe of hemostatic agent
Priming is not needed.
2. Repeat steps 8 and 9 for product application.
NOTE: Do not connect the empty syringe or use the saline prior to
complete application of the hemostatic agent.
Residual Product Application (optional):
1. If application of residual hemostatic agent is needed, fill the provided
1.5 mL syringe with non-heparinized saline.
2. Attach saline syringe to EASYGRIP FLO-41 System and fill the reservoir
with only 1.5 mL of non-heparinized saline.
3. Pull the trigger of the EASYGRIP FLO-41 System to apply residual
hemostatic agent.
4. If, after expelling all residual product from cannula, an additional
hemostatic agent application is required, the cannula must be removed
from the patient and purged of saline.
Straighten the malleable tip using appropriate endoscopic instruments
and remove the device from the trocar.
5. Perform steps 4-6 from the Assembly section.
NOTE: Priming after a saline purge will initially cause saline to be
expelled from the cannula; continued priming will fill the cannula with
hemostatic agent.
For Disposal:
1. After application of the hemostatic agent straighten the malleable
tip with appropriate endoscopic instruments prior to removing the
applicator from the trocar.
2. Dispose of the EASYGRIP FLO-41 System according to local regulations.
Do not resterilize.
Storage:
Store between 2°C (36°F) - 25°C (77°F). Store in original packaging.
Symbols Used in Labeling:
Symbol Symbol Title and Description
Consult instructions for use; Indicates the need for the
user to consult the instructions for use.
Do not use if package is damaged; Indicates a medical
device that should not be used if the package has been
damaged or opened.
Sterilized using irradiation; Indicates a medical device
that has been sterilized using irradiation.
Do not resterilize; Indicates a medical device that is not
to be resterilized.
Temperature limit; Indicates the temperature limits to
which the medical device can be safely exposed.
Do not re-use; Indicates a medical device that is intended
for one use, or for use on a single patient during a single
procedure.
Not made with natural rubber latex; Indicates no
presence of natural rubber or dry natural rubber latex as
a material of construction within the medical device or
the packaging of a medical device.
Catalogue number; Indicates the manufacturer's
catalogue number so that the medical device can be
identified.
Legal Manufacturer; Indicates the medical device
manufacturer, as defined in EU Directives 90/385/EEC,
93/42/EEC, and 98/79/EC.
Batch code; Indicates the manufacturer's batch code so
that the batch or lot can be identified.
Use-by date; Indicates the date after which the medical
device is not to be used.
Fragile, handle with care; Indicates a medical device that
can be broken or damaged if not handled carefully.
Keep away from sunlight; Indicates a medical device that
needs protection from light sources.
Keep dry; Indicates a medical device that needs to be
protected from moisture.
This way up; To indicate correct upright position of the
transport package.
U.S. Only: Rx Only
U.S. Only: 1-888-229-0001
Other Countries: Contact your local Baxter representative.
An affiliate of Baxter Healthcare S.A.:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015, USA
Legal Manufacturer
Baxter Healthcare S.A.
8010 Zurich
Switzerland
0123
Baxter, EASYGRIP FLO-41, FLO-41, and FLOSEAL are trademarks of Baxter
International Inc.
07-19-00-1986
Rev. Date: 2020-10-05
2
Symbol
Reference
ISO 15223-1:2016,
5.4.3
ISO 15223-1:2016,
5.2.8
ISO 15223-1:2016,
5.2.3
ISO 15223-1:2016,
5.2.6
ISO 15223-1:2016,
5.3.7
ISO 15223-1:2016,
5.4.2
ISO 15223-1:2016,
5.4.5 and Annex
B, Section B2
ISO 15223-1:2016,
5.1.6
ISO 15223-1:2016,
5.1.1
ISO 15223-1:2016,
5.1.5
ISO 15223-1:2016,
5.1.4
ISO 15223-1:2016,
5.3.1
ISO 15223-1:2016,
5.3.2
ISO 15223-1:2016,
5.3.4
ISO 7000 - 0623