16. Destroy this set after single use, using aseptic technique for potentially
contaminated equipment and following local regulation for disposal. Do not
resterilize. The Prismaflex HP-X set is intended for single use only. Re-using
the Prismaflex HP-X set may cause serious damage to the product resulting
in patient injury or death.
17.
Use only drugs compatible with plastics listed in the specifications section.
Some plastics can be incompatible with drugs when in contact with solutions
with pH > 10.
SPECIFICATIONS
Prismaflex HP-X set materials
Tubing material : Plasticized polyvinyl chloride (PVC)
Support plate : PolyEthyleneTerePhtalateglycol (PETG)
Note: the types and amounts of residue from the sterilization process are
available from the manufacturer upon request.
Note: the Prismaflex set is not made with natural rubber latex.
Note: all fluid pathways in direct or indirect blood contact are DEHP-free.
INSTRUCTIONS FOR USE
PARAMETERS Prismaflex HP-X set
Blood flow rate:
- Minimum recommended
- Maximum allowed
Maximum blood pressure
Blood volume in HP-X set
Connectors of access/return lines
Maximum duration of use
50 mL/min
450 mL/min
500 mmHg (66,6 kPa)
108 mL
in compliance with ISO 8638
72 hours
Note: use the set by following the detailed on-line instructions provided by the control
unit. Additional information is available in the control unit operator’s manual.
Load Set
Install the set onto the control unit using the photographs on the inside cover as a
guide - the same procedure applies for both PrismaFlex and PrisMax control units
(in countries where PrisMax is cleared or registered).
Prepare and Connect Solutions
Hang bag of priming saline or alkaline solution (pH ≥ 7.3) with or without heparin
added (5000IU heparin/liter, correctly homogenized) according to usual institutional
practice, on priming hook. Connect access (red) line to priming solution bag.
Prime Set
Refer to the instructions for use of the chosen blood purification device for minimum
volume of priming fluid recommended for priming.
Note: A minimum of 1000 mL is required to carefully deaerate and rinse the
Prismaflex HP-X set.
Anticoagulation Considerations
Refer to the instructions for use of the chosen blood purification device for
additional information.
Treatment monitoring
Refer to on-line instructions and to the instructions for use of the chosen blood
purification device for additional information.
The decision regarding the duration of ahemopurification treatment has to be
made by the physician in charge according to the individual needs of the patient.
SPECIAL PROCEDURES
INCASEOFCOMPLICATION
External Blood Leaks
Note: see Warning no. 11.
If an external blood leakage is observed, immediately stop the blood pump. Initiate
corrective action by securing connections or replacing the Prismaflex HP-X set and
blood purification device.
If necessary, administer adequate replacement solution to the patient to compensate
for
blood loss.
Hypersensitivity Reactions
Note: see Warning no. 14.
Should acute allergic reactions (first use syndrome) occur within the first few minutes
of the treatment, it is important to react immediately by discontinuing the session and
administering appropriate treatment.
Adverse reactions may occur due to the complex interaction between blood and the
artificial surfaces of the entire extracorporeal circuit. These reactions may also be
precipitated and/or exacerbated by other external factors involved with the individual
patient’s specific disease process and the treatment. Certain types of adverse reaction
may occur due to operational factors associated with the treatment. Therefore, proper
management of electrolyte balance, anticoagulation and blood flow rate as well as
monitoring of the overall treatment parameters are essential to avoid side-effects.
Should an adverse reaction occur, it is important to react immediately by discontinuing the
session and administering appropriate treatment. Blood in the extracorporeal circuit must
not be returned to the patient.
Extra care must be taken when treating patients who have exhibited possible hypersensitivity
symptoms during previous treatments, or patients who have a history of being highly
sensitive and allergic to a variety of substances. A physician must be consulted to evaluate
the risk and prescribe the appropriate precautions if a possible sensitivity is suspected.
The following factors are considered essential to minimize the risk of hypersensitivity
reaction and other side effects:
• Strict adherence to the set-up, priming and rinsing procedures detailed in the
manufacturer’s instructions for use.
• Setting up and monitoring the treatment operating parameters according to
the manufacturer’s recommendations specified for Prismaflex HP-X set and the
chosen blood purification device, as well as to the patient's needs and tolerance.
• Strict adherence to all WARNINGS and CAUTIONS given by the manufacturer
in the instructions for use.
WARRANTY AND LIMITATION OF LIABILITY
a) The manufacturer warrants that the Prismaflex HP-X set has been manufactured
in accordance with its specifications and in compliance with good manufacturing
practices, other applicable industry standards and regulatory requirements.
If provided with the lot/serial number of the defective product, the manufacturer will,
by replacement or credit, remedy manufacturing defects in the Prismaflex HP-X set
becoming apparent before the expiration date.
b) The warranty under paragraph a) above is in lieu of, and to the exclusion of, any
other warranty, whether written or oral, express or implied, statutory or otherwise,
and there are no warranties of merchantability or other warranties, which extend
beyond those described in paragraph a) above. The remedy set out above for
manufacturing defects is the sole remedy available to any person due to defects in the
Prismaflex HP-X set and the manufacturer shall not be liable for any consequential
or incidental loss, damage, injury or expense arising directly or indirectly from
the use of the Prismaflex HP-X set, whether as a result of any defect therein or
otherwise.
c) The manufacturer shall not be liable for any misuse, improper handling,
non-compliance with warnings and instructions, damage arising from events after
the manufacturer’srelease of the Prismaflex HP-X set, failure or omission to inspect
the Prismaflex HP-X set before use in order to ensure that the Prismaflex HP-X set
is in proper condition, or any warranty given by independent distributors or dealers.
d) The manufacturer is GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883
MEYZIEU CEDEX, FRANCE.
e) GAMBRO Industries is not responsible for the blood purification device chosen nor
the utilization of this blood purification device.
10
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014868 Date: 16-JAN-20
Designer: E.M. Page: 10 of 48
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