English; Intended Use / Indications; Product Description; Cautions And Warnings - baxter prismaflex HF 20 SET Folleto De Utilización

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014990
Designer: CDS
Colour Reference:
BLACK

ENGLISH

The Prismaflex HF20 set is manufactured by GAMBRO Industries,
7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCE.
Caution: Federal law (USA) restricts this device to sale by or on the order of
a physician.
DEFINITION OF EXPRESSIONS
USED IN THIS MANUAL
In this document :
"Warning" indicates a hazardous situation which, if not avoided, could result
in death or serious injury.
"Caution" indicates a hazardous situation which, if not avoided, could result
in minor or moderate injury.
"Note" to give additional information.
SCUF: Slow Continuous UltraFiltration.
CVVH: Continuous Veno-Venous Hemofiltration.
CVVHD: Continuous Veno-Venous HemoDialysis.
CVVHDF: Continuous Veno-Venous HemoDiaFiltration.
Predilution: addition of replacement fluid to the blood stream upstream to the filter.
Postdilution: addition of replacement fluid to the blood stream downstream to the filter.
"Control unit" refers to the PrismaFlex control unit, or to the PrisMax control unit
(in countries where PrisMax is cleared or registered).

PRODUCT DESCRIPTION

• The Prismaflex HF20 set is a disposable, extracorporeal circuit for use with the
PrismaFlex system or with the PrisMax system (in countries where PrisMax is
cleared or registered).
• The Prismaflex HF20 set consists of a PAES hollow fiber hemofilter/dialyzer*
and tubing lines; refer to the control unit operator manual drawings for details.
• The Prismaflex HF20 set is compatible with the sleeve blood warmers, which
should be installed on the return line. Refer to the specific instructions for use.
• All line connectors are compatible with the ISO594-1 and ISO594-2
international standards concerning conical fittings.
• The fluid pathways of the Prismaflex set are guaranteed sterile and non pyro-
genic.
• The Prismaflex HF20 set is sterilized by ethylene oxide (EtO). Deaeration is
such that EtO residuals comply with the standards in ISO 10993.
• Expiration date: please refer to product label.
* In this document the hemofilter/dialyzer will be referred to as "filter".

INTENDED USE / INDICATIONS

The Prismaflex set is indicated for use only with the PrismaFlex control unit or
with the PrisMax control unit (in countries where PrisMax is cleared or registered)
in providing continuous fluid management and renal replacement therapies. The
system is intended for patients who have acute renal failure, fluid overload, or
both.
This set is intended for use in the following veno-venous therapies: SCUF; CVVH;
CVVHD; CVVHDF.
All treatments administered with the Prismaflex set must be prescribed by a
physician. The size, weight, metabolic and fluid balance, cardiac status, and
general clinical condition of the patient must be carefully evaluated by the
prescribing physician before each treatment.
CONTRAINDICATIONS
There are no known absolute contraindications to continuous renal replacement
therapies.
For the following conditions a careful assessment of the individual risk/benefit
ratio has to be made by the treating physician (relative contraindications):
• inability to establish vascular access,
• severe hemodynamic instability,
• known hypersensitivity to any component of the Prismaflex set.
Date: 19-NOV-2020 Proofread No.: 1
Page: 14 of 84

CAUTIONS AND WARNINGS

Note: refer to the control unit user interface and operator's manual for additional
cautions and warnings.
Cautions
1.
Particular attention must be paid to extra corporeal blood volume with respect
to patient size. Consider the sum of the Prismaflex set blood volume (refer
to "Specifications") plus the blood volume of any accessory or device if used.
The Prismaflex HF20 set should be restricted to patients with a body weight
greater than 8kg (18lb).
2. When not using the pre blood pump infusion line, it is recommended to
clamp this line close to its connection to the access blood tubing line; this will
prevent the sedimentation of blood into the pre-blood pump infusion line.
3.
If citrated blood is used for the priming of the extracorporeal circuit before
patient connection, it is recommended that the pH of this blood be verified
and buffered at a value between 7.3 and 7.5. The ionized calcium should be
adjusted at a value > or = 1.0.
4. If the patient is not immediately connected to the Prismaflex set after priming
is complete, flush the set with at least 500 mL priming solution [saline or
alkaline solution (pH ≥ 7.3), with or without heparin added according to usual
institutional practice] prior to connecting the patient. This requires use of a
new bag of priming solution.
5. Using the Prismaflex set with blood flow rates lower than the recommended
minimum values (see "Operating Parameters" section) may impair filter
performance due to hemoconcentration, or to increased risk of coagulation.
6. Since drugs can be removed by the membrane of the filter, the dosage
of associated drug treatments may need to be adjusted for patients on
continuous renal replacement therapy. Monitoring of blood drug levels of
relevant compounds should be performed. The removal of other water-
soluble compounds (e.g. vitamins, trace elements) during therapy also
requires clinical consideration.
Warnings
1. Carefully read these instructions for use and the control unit operator's
manual before using this product.
2.
The use of operating procedures other than those published by the
manufacturer or the use of accessory devices not recommended by the
manufacturer can result in patient injury or death.
3. Store the Prismaflex set in a dry place, between 0° C (32° F) and 30° C (86° F).
4. Do not use this set if the packaging is damaged, if the sterilization caps are
missing or loose, or if any of the lines in the set are kinked.
5. To prevent contamination, this Prismaflex set must be used as soon as its
packaging and sterilization caps are removed.
6. Do not try to remove the filter from the cartridge plate.
7. Use aseptic techniques when handling all blood and fluid lines in the set.
8. Prismaflex sets are compatible with the usual disinfection agents used for
aseptic setup; however solvents and other chemicals, if used in contact with
the product, could damage the set.
9. During priming and operation, observe closely for leakage at joints within the
set, and connections to other approved accessories and bags. Leakage can
cause blood loss, fluid imbalance or air embolism. If a leakage is detected at
a Luer connection and cannot be stopped by tightening the connections, or
if leakage occurs at any other location, replace the set.
10. Tightening Luer connections with an excessive force can damage the connectors.
11. In the case of patients with a high risk of hemorrhage it is recommended not
to add heparin to the priming solution.
12. Do not allow air to enter the blood compartment of the filter after priming is
started. If a large amount of air enters, the set must be replaced.
13. Should acute allergic reactions (first-use syndrome) occur in patients
receiving treatment, immediately stop the treatment and administer
appropriate intervention.
14. Use a 21-gauge or smaller needle to obtain blood/fluid samples or remove
trapped air from the Prismaflex set. Use of larger needles can cause holes in
the sample sites, resulting in external leak or air intake.
15. External blood leakage may not be immediately identified by monitoring
equipment and could result in significant blood loss. Check the filter and all
connections of the disposable tubings during treatment to minimize the risk
of leakage.
16. To assure adequate filter performance, it is recommended that the set be
changed every 24 hours of use. However, the set must be changed after 3
days (72 hours). Continued use beyond this limit could result in rupture of the
pump segments, with risk of patient injury or death.
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