baxter prismaflex HP-X User Manual

The Prismaflex HP-X 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.
“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 HP-X set is a disposable, extracorporeal circuit for use with the
PrismaFlex control unit equipped with software 7.xx or later, or with the PrisMax
control unit (in countries where PrisMax is cleared or registered).
• The Prismaflex HP-X set consists in a tubing lines to which a blood purification
device chosen by the physician is connected ; 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 lines connectors are compatible with the ISO 594-1 and IS0 594-2 international
standards concerning conical fittings.
• The blood purification device connectors of both arterial and venous lines are
compliant to the ISO 8638 international standard concerning extracorporeal circuits.
• The fluid pathways of Prismaflex HP-X set are guaranteed sterile and non pyrogenic.
• The Prismaflex HP-X 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.
ADDITIONAL REQUIRED EQUIPMENT
In order to perform a blood purification treatment, following system components are
required:
• PrismaFlex control unit or PrisMax control unit (in countries where PrisMax is
cleared or registered).
• Blood purification device/cartridge holder.
• Prismaflex HP-X set.
• Blood purification device.
INTENDED USE
The Prismaflex HP-X set is a set of blood lines intended for extracorporeal circulation
of blood on the control unit and designed to be connected to blood purification devices.
Refer to the table in section “Instructions for use” and to control unit operator’s manual
to ensure the compatibility of the chosen blood purification device. Strict adherence to
the set instructions for use and to control unit operator’s manual is required.
INDICATIONS
Refer to the instructions for use of the chosen blood purification device for possible
indications and contraindications.
All treatments administered via the control unit must be prescribed by a physician. The
size, weight, cardiac status, blood volume 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):
• inability to establish vascular access,
• severe hemodynamic instability,
• known hypersensitivity to any component of the Prismaflex set.
NOTES, CAUTIONS AND WARNINGS
Notes
1. Refer to the control unit user interface and operator’s manual for additional cautions
and warnings.
2. Refer to the instructions for use of the chosen blood purification device 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 HP-X set blood volume plus
the blood volume of the blood purification device plus the blood volume of any
accessory or device if used (refer to “Specifications”).
2. If the patient is not immediately connected to the Prismaflex HP-X 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 and new priming collection bag.
3. When not using the pre blood pump infusion circuit, it is recommended to clamp this
circuit close to its connection to the access line; this will prevent the sedimentation
of blood into the pre blood infusion line.
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. Use the Prismaflex HP-X set only with blood purification device equipped with
connectors compliant to ISO 8637. The use of blood purification device equipped
with other connectors can result in patient injury or death.
4. Store the Prismaflex set in a dry place, between 0° C (32° F) and 30° C (86° F).
5. 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.
6. To prevent contamination, this Prismaflex set must be used as soon as its
packaging and sterilization caps are removed.
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.
Tightening Luer connections with an excessive force can damage the connectors.
10. During priming and operation, observe closely for leakage at joints and
connections within the set, notably the bags. Leakage can cause blood loss,
air embolism or fluid imbalance. If leakage cannot be stopped by tightening the
connections, replace the set.
11.
External blood leakage may not be immediately identified by monitoring
equipment and could result in significant blood loss. Check the blood purification
device and all connections of the disposable tubings during treatment to minimize
the risk of leakage.
12.
Use a 21-gauge or smaller needle to obtain blood/fluid samples or remove
trapped air from the Prismaflex HP-X set. Use of larger needles can cause holes
in the sample sites, resulting in external leak or air intake.
13.
In the case of patients who pose ahigh risk of haemorrhaging or heparin allergy, it
is recommended not to add heparin to the priming solution.
14.
Should acute allergic reactions (first-use syndrome) occur in patients receiving
treatments via the Prismaflex HP-X set do not return blood to the patient,
immediately stop the treatment and administer appropriate intervention. Refer
to the instructions for use of the chosen blood purification device for additional
information.
15.
The set must be changed after 3 days (72 hours). Continued use beyond this
time could result in rupture of the pump segments, with risk of patient injury
or death.
ENGLISH
9
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014868 Date: 16-JAN-20
Designer: E.M. Page: 9 of 48
Colour Reference:
BLACK
Proofread No.: P05

baxter prismaflex HP-X Specifications

General

Brand	baxter
Model	prismaflex HP-X
Category	Medical Equipment
Language	English