aquapheresis therapy
Contraindications
There are no known contraindications
to Aquadex system therapy.
The intended use and contraindication of pharmacological
therapy used in conjunction with the Aquadex system must be individualized
by physician and deemed appropriate for each patient.
Warnings and Cautions
• Standard diurectic therapy should
be considered prior to Aquapheresis with the Aquadex system.
• Aquadex System circuit use beyond eight (8) hours should
be used in a hospital setting.
• Do not use the Aquadex system circuit beyond 24 hours. Extended
use could be associated with an increased risk of blood loss and
exposure to blood by the health professional.
• Extracorporeal blood circulation may be associated with
a risk of blood loss and air embolism.
• Blood in the ultrafiltrate bag may indicate a health hazard
to the patient.
• Check for the presence of blood in the ultrafiltrate bag
when the blood leak detector is disabled.
• To avoid the risk of blood loss, inspect the Blood Circuit
Set closely for leakage at joints and connections during priming
and operation. Replace the circuit if tightening the connections
does not stop any leaks.
• Because the system may not always detect blood leakage from
the Blood Circuit Set, it is important to monitor the system and
patient environment
for blood leaks throughout treatment.
• It is the clinician’s responsibility to monitor parameters
that are not detected by the Aquadex system under special conditions,
including:
• Blood Circuit Set disconnection and air detection, which
are disabled during Manual mode.
• Blood leak detection during Run mode, if blood leak detection
is disabled.
• The extended length catheter is intended for peripheral
use only with the Aquadex system. Do not place the extended length
catheter in a central vein.
• All operation and maintenance procedures must be performed
by trained and qualified personnel as described in this manual.
The manufacturer
cannot be responsible for patient safety under other circumstances.
• The Aquadex system should only be used by those trained
in the clinical operation of extracorporeal fluid management therapies
in a setting where appropriate responses can be delivered should
problems develop in
catheter care and/or fluid management.
• Anticoagulation therapy may cause bleeding.
• Do not use heparin for anticoagulation in patients with
intolerance or allergy to heparin.
• Aquadex system treatment may be associated with a risk of
hypovolemia and hypotension.
• Aquadex system treatment may be associated with a risk of
electrolytic imbalance and/or loss of protein.
• Aquadex system treatment has not been tested for use in
patients with uncontrolled hypertension.
• Rapid volume depletion as a result of ultrafiltration may
cause irreversible damage to renal function in patients with baseline
compromise in
glomerular filtration rate (GFR).
• To avoid the risk of patient injury or death, do not use
unauthorized tubing sets, hemofilters, or other accessories.
• To avoid possible infection, do not use the Blood Circuit
Set with damaged packaging.
• ELECTRIC SHOCK HAZARD. Do not open the case of this device.
Operate this device only with all covers, panels, and knobs properly
installed.
• To avoid the risk of fire, do not operate this device in
the presence of flammable anesthetics or other flammable gases.
• The Aquadex system includes air and blood leak detectors.
To ensure correct operation, the Blood Circuit Set must be properly
inserted into both detectors at all times during setup and use.
• To minimize the introduction of air into the patient, do
not connect the patient until Blood Circuit Set priming (when the
air detector is disabled) is complete.
• Ensure that the Blood Circuit Set is free of air at the
end of priming.
• To prevent air from entering the patient, monitor the Blood
Circuit Set closely when turning the blood pump by hand.
• Monitor patient for clinical signs of hypovolemia and hypotension
as appropriate.
• Rapid rates of fluid removal can result in life-threatening
hypotension and/or tachycardia during treatments.
• The Aquadex system has not been tested in patients with
a hematocrit higher than 53%.
• The safety and effectiveness of the Aquadex system has not
been established in patients:
• With recent infection that required parenteral antibiotics.
• Who are Hepatitis B surface antigen positive.
• Having a previously known history of hypercoagulable states
such as a known history of phospholipid syndrome or history of recurrent
documented thromboembolic events.
• Who are pregnant.
• Access to peripheral circulation for therapy with the Aquadex
system may be difficult or impossible in patients with poor veins
or inadequate circulation.
• Access to central venous circulation should be limited to
areas within the
hospital that routinely manage patients with central venous access
catheters.
• It is important for the clinician to balance the risks of
anticoagulation with the potential benefit when deciding to use
anti-coagulation therapy (for example, heparin) in conjunction with
Aquadex system therapy.
• To reduce the risk of extravasation and infiltration, monitor
the patient during catheter insertion, at the start of therapy,
and during therapy as appropriate.
• Use aseptic technique throughout treatment to minimize the
risk of infection.
• To prevent contamination, use the Blood Circuit Set immediately
after removing its packaging and caps. Do not use the Blood Circuit
Set if the package is damaged, if the components are missing or
loose, or if the lines are kinked.
• The Blood Circuit Set has not been tested for more than
twenty four hours of use.
• The Aquadex system has not been designed for use with access
using an arterio-venous fistula.
• This Equipment or System should not be used adjacent to
or stacked with other equipment. If this is necessary, the Equipment
or System should be observed to verify normal operation in the configuration
in which it will be used.
• Set the Hct Limit on the Crit-Line Monitor when setting
a Hct Limit on the Aquadex Console. This provides an audible and
visual alarm independent of the Aquadex.
• The use of the Hct Limit option on the Aquadex System is
an adjunct to patient care and is not a replacement for standard
medical care for assessing patient response to fluid removal.
•All electrical installations must comply with all applicable
local electrical code and the manufacturer’s specifications.
Use potential equalization
(ground post) in accordance with national requirements.
• Do not tamper with pumps or attempt to run pumps with protective
knobs removed.
• Do not modify the Aquadex system in any way.
• All operation and maintenance procedures must be performed
by trained
and qualified personnel as described in this manual.
• Grounding reliability can only be achieved when the equipment
is connected to an equivalent receptacle marked HOSPITAL ONLY or
HOSPITAL GRADE.
• Refer to Instructions for Use; Medical Electrical Equipment
may need special precautions regarding EMC and must be installed
and put into service according to the information contained in the
Instructions for Use.
• Portable and Mobile RF Communications equipment can affect
Medical
Equipment, take precautions for adequate separation.
• Use only approved cables and accessories. Use of accessories,
transducers, and cables other than those specified may result in
increased emissions or decreased immunity.
• Use only the data key supplied with the circuit. Keys are
not interchangeable between circuits.
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