English; Definition Of Expressions Used In This Manual; Intended Use / Indications; Product Description - baxter Prismaflex ST60 SET Gebrauchsanweisung

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014988
Designer: DEP
Colour Reference:
BLACK

ENGLISH

The Prismaflex ST60/ST100/ST150 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 ST60 / ST100 / ST150 set is a disposable, extracorporeal circuit
for use with the PrismaFlex control unit or with the PrisMax control unit (in
countries where PrisMax is cleared or registered).
• The Prismaflex ST60 / ST100 / ST150 set consists of a AN69 ST hollow fiber
hemofilter/dialyzer* and tubing lines ; refer to the control unit operator manual
drawing for details.
• The blood return line (blue-striped) is equipped with a Luer-lock connection near
the deaeration chamber, dedicated to the connection of authorized devices and
accessories described in the control unit operator's manual.
• All line connectors are compatible with the ISO 594-1 and ISO 594-2 international
standards concerning conical fittings.
• The fluid pathways of the Prismaflex set are guaranteed sterile and non
pyrogenic.
• The Prismaflex ST60 / ST100 / ST150 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 via the Prismaflex set must be prescribed by a
physician. The size, weight, state of uremia, cardiac status, and general physical
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):
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• inability to establish vascular access,
• severe hemodynamic instability,
• known hypersensitivity to any component of the Prismaflex set.

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 ST60 set should be restricted to patients with a body
weight greater than 11kg (24lb). The Prismaflex ST100 set and ST150 set
should be restricted to patients with a body weight greater than 30kg (66lb).
2. If the patient is not immediately connected to the Prismaflex set after priming
is complete, flush the set with at least 1 000 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.
3. 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.
4. 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.
5. 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. Once priming is complete the set's blood circuit will still contain heparinised
saline solution. Depending on the level of the patient's bleeding risk the
physician must decide if an additional priming using 500 mL non heparinised
saline solution is necessary.
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. Pay special attention to patients receiving ACE inhibitors and/
or having already shown similar allergic reactions (see "Hypersensitivity
Reactions" section).
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.
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