English; Definition Of Expressions Used In This Manual; Product Description; Contraindications - Gambro Prismaflex HF 20 SET Gebrauchsanweisung

ENGLISH

The Prismaflex HF20 set is manufactured by GAMBRO Industries,
7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCE.
DEFINITION OF SYMBOLS USED
ON LABELING OF PRODUCT
Manufacturing batch number
Sterilized by ethylene oxide (EtO)
Expiration date of the product
Product for single use only
Read instructions before using the product
Manufactured by
Date of production
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.

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
4
en