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Instructions for Use of FILTRYZER B3, BK-U, BK-F Series
Read these instructions carefully before using
the "FILTRYZER" B3, BK-U, BK-F series dialyzer.
I. INTENDED PURPOSE
"FILTRYZER" dialyzers are artificial kidney (hollow
fiber dialyzer) which removes uremic toxins and
water from the blood through hemodialysis to
ameliorate conditions of a patient with renal
insufficiency.
II. INDICATIONS
"FILTRYZER" dialyzers are indicated for SINGLE
USE in acute or chronic hemodialysis. These
dialyzers should be used only on the direction of a
physician and used by trained medical personnel or
by
trained
patient/caregiver
physician.
III. CONTRAINDICATIONS
Special contraindications for "FILTRYZER" are
unknown.
Generally,
the
contraindications
hemodialysis are applicable.
IV. STERILIZATION
"FILTRYZER" dialyzers are gamma-ray sterilized
and nonpyrogenic (Blood side).
V. PERFORMANCE AND SPECIFICATIONS
Refer to the attached technical data.
VI. ADVERSE EVENTS
1) Patients should be carefully monitored during
and after dialysis. In particular, patients with a
history of allergy and hypersensitivity, patients
who
have
experienced
decreasing by hemodialysis, patients whose
immune function is accelerating, and patients
using "FILTRYZER" for the first time should be
carefully monitored. Appropriate treatments,
including discontinuation of dialysis, should be
taken, if the symptoms or signs of adverse
reactions are observed.
2) Disequilibrium syndrome may appear especially
during the introductory period of dialysis
treatment, when applying to patients with low
body weight, elderly patients, or patients in need
of rapid water removal in a short period of time,
or when changing dialyzer to one which is more
efficient or has a larger effective surface area.
Appropriate
treatments,
discontinuation of dialysis, should be taken if the
following symptoms or signs of disequilibrium
syndrome are observed: headache, nausea,
vomiting,
consciousness
pressure decreased or convulsion.
3) Loss of proteins such as albumin may increase
depending on the treatment conditions.Observe
the patient's condition and serum albumin values.
4) Appropriate treatments, including discontinuation
of dialysis, should be taken, if the following
symptoms, which may occur occasionally in
usual dialysis, are observed: dyspnea, chest
pain, blood pressure decreased, blood pressure
increased, loss of consciousness, hypoxemia,
shock,
palpitation,
tachycardia,
hypersensitivity, anaphylactoid reactions, white
blood cell decreased, platelet decreased,
eosinophilia, pruritus, edema (eyelid, throat,
intraoral, face, etc.), malaise, fatiguability,
headache, vertigo, back pain, abdominal pain,
lumbar pain, diarrhea, queasy, vomiting, chest
discomfort, discomfort, eczema, rash, redness,
urticaria, flushed face, pyrexia, rigors, abnormal
sweating, muscle cramp, cough, hoarseness,
tinnitus, yawning, abnormal vision, taste peculiar,
strange smell sensation or hemolysis.
5) Improper
handling
or
transportation or operation (mechanical shock,
excessively high or freezing temperature, etc.)
may increase the risk of blood leakage. When
blood leakage is found, hemodialysis should be
discontinued and appropriate actions should be
taken. The attending physician should decide
whether or not to return the blood in the
extracorporeal circuit to the patient.
6) Other complications may occur caused by
malfunction, a defect of dialysis machine or a
procedural error in its use, such as blood loss,
blood
overheating,
hemolysis,
ultrafiltration and electrolyte imbalance. Refer to
the instructions for the machine to avoid such
complications.
7) In case of a serious incident related to this
dialyzer, it should be reported to the manufacturer
and the competent authority in which the user
and/or patient is established.
VII. WARNINGS AND PRECAUTIONS
1. General warnings and precautions
Consult the physician if any abnormalities are
found during and/or after the use of the dialyzer.
1) Reuse
"FILTRYZER" is a medical device intended for
SINGLE USE ONLY. Its reuse might cause
product damages (blood leakage, performance
changes, etc.) and also induce patient injury
(infection caused by microbiological contamination,
adverse reactions caused by residual reprocessing
agents and/or blood components, etc.).
2) Special care
Special care is recommended for elderly,
pregnant or pediatric patients.
3) Rinse
"FILTRYZER" dialyzers are filled with sterile water.
Before starting dialysis, the blood side of the
dialyzers must be flushed with sterile physiological
saline or dialysate, and the dialysate side must be
flushed with dialysate to avoid hemolysis.
4) Dialysis machine
Since "FILTRYZER" dialyzers have a high
ultrafiltration rate, they should be used in
authorized
by
a
conjunction with dialysis machines equipped
with an ultrafiltration rate controller.
5) Storage
"FILTRYZER" should be stored and transported
at temperatures between 5°C (41°F) and 30°C
for
(86°F). Exposure to severe environmental
conditions (direct sunlight, excessive humidity,
wetness, dryness, freezing temperature) should
be avoided.
6) Handling
"FILTRYZER" is made from various plastic
components. Excessive vibration or mechanical
shock should be avoided during handling and
operation. Avoid tapping the dialyzer header
with a clamp or other metal object to remove air
bubbles or to return the blood.
7) Chemicals
Strictly avoid contact between the device and
alcohol (sterilant) or other organic solvents.
blood
pressure
Such contact may lead to distortions or cracks of
the device.
8) Dialysate quality control
Follow the standards of each country. Use clean
dialysate since dialysate may come into patient
blood stream through the mechanisms of
backfiltration and /or backdiffusion.
2. Precautions to be taken before dialysis
1) The dialyzer must not be used if it appears to be
damaged or its package is torn.
2) The dialyzer must not be used if there appears
to be a water leak such as, drops of water in the
package, improper cap fitting over either blood
or dialysate port or an accumulation of a large
quantity of air in the blood or dialysate
including
compartment.
3) Connect the Luer lock connectors of the blood
line to the blood ports by inserting at a correct
angle and twisting to ensure a tight fitting to
disturbed,
blood
avoid detachment of connection, saline or blood
leakage, or breakage of the blood ports.
4) The dialyzer should be used just after opening
the package, rinsing and priming.
5) Take special care not to allow air bubbles to
remain in or enter the blood compartment during
the rinsing and priming procedure.
6) The BK-F series dialyzer must not be used for
HDF (hemodiafiltration) or HF (hemofiltration)
due to the higher permeability of proteins such
as albumin.
allergy,
3. Precautions during dialysis
1) Confirm that there is no fluid leakage at the
blood connection and the dialysate connection
sites.
2) Transmembrane pressure (TMP) must not
exceed 66 kPa (500 mmHg). TMP higher than
66 kPa (500 mmHg) could cause blood leakage
or disconnection of the blood lines from the
dialyzer connectors.
3) The performance of the dialyzer could be
diminished if the device is used below the
recommended flow rate or in orientations other
storage
during
than indicated.
4) The administration method and dose of an
anticoagulant such as heparin should be
determined for each patient by a physician.
Special
coagulation time during dialysis, should be
taken for patients who have a tendency to
hemorrhage or who have a coagulation
disorder.
5) If air bubbles, a blood leak, clotting or hemolysis
are observed during dialysis, appropriate
treatments, including discontinuation of dialysis
excessive
or replacing the dialyzer, should be taken
promptly.
6) When the administration of drugs is intended
before or during dialysis, consider various
conditions such as route, timing and dose,
because dialysis may remove them or modify
their effects. Special cares are recommended
for patients receiving angiotensin- converting-
enzyme inhibitors.
7) When completing dialysis, air rinsing of
remaining blood should not be employed.
Return the patient's blood by rinsing with saline,
returning as much of the patient's blood as
possible by holding the dialyzer vertically and
rotating it around its axis, if necessary.
VIII. DIALYSIS PROCEDURE
Use protective gloves and an aseptic technique to
cares,
including
monitoring
— 2 —
prevent contamination of patient's blood when
connecting the blood line to the dialyzer, collecting
blood samples, or returning the blood from the
extracorporeal circuit. The extracorporeal circuit with
the connectors conforming to ISO8638 or ISO8637-2
is recommended for this dialyzer.
The following procedure is an example.
1. Preparation for Dialysis
1) Take the dialyzer out of the package and place it
on the dialyzer holder.
2) Hang a container of sterile physiological saline
(1000 mL or more) on an IV pole, and connect
the arterial infusion line to the container.
3) Fill the arterial blood line with physiological
saline, first the vascular access connector side
and then the dialyzer connector side. Clamp
both ends of the arterial line. (Fig. 1)
4) Connect the venous line to the venous port of
the dialyzer. (Fig. 2)
5) Carefully connect the arterial line filled with
physiological saline to the arterial port taking
care so as not to allow air to enter the dialyzer. If
some air bubbles are observed in the arterial
port, remove them by squeezing the venous drip
chamber. (Fig. 3)
6) Rinse the blood side of the dialyzer and the
blood line with more than 1000 mL of
physiological saline at about 100 mL/min. (Fig.
4)
7) Connect the dialysate lines to the dialysate ports
so that the dialysate flows countercurrently to
the blood flow. Remove any air bubbles and
rinse the dialysate side with dialysate flowing at
about 500 mL/min. (Fig. 5) Let the dialysate flow
for at least 5 minutes. Avoid any ultrafiltration
during this procedure.
8) Prime the dialyzer and blood lines with more
than 500 mL of heparinized physiological saline,
and confirm that there are no air bubbles
remaining in the dialyzer by flushing repeatedly.
If massive air bubbles appear from fibers,
replace the dialyzer. (Fig. 6)
9) Confirm that the venous bubble trap is about 3/4
full.
10) Clamp the venous line near the distal end.
2. Dialysis
1) Flow dialysate after setting filtration rate at 0
mL/h if dialysate hasn't flowed.
2) Connect the arterial line to the patient's arterial
cannula.
3) Open the clamps of both the arterial and venous
lines and start the blood pump at 50-100
mL/min. When blood reaches the end of the
venous line, stop the blood pump and connect
the venous line to the venous cannula.
4) Gradually increase the blood flow rate and the
ultrafiltration rate to the levels required for each
patient.
5) As for the confirmation of dialysis machine's
alarm function prior to dialysis treatment, follow
the machine manufacturer's instructions.
3. Completion of Dialysis
1) Reduce pressures in both the blood and
dialysate sides as much as possible and stop
the blood pump after 5 minutes of perfusion
without ultrafiltration.
2) Connect a container containing 300 mL or more
of physiological saline to the infusion line.
3) Using gravity, let physiological saline flow into
the arterial blood access side to return in-line
blood. Clamp the end of the line and aseptically
withdraw the arterial cannula.
4) Remove the arterial blood line from the blood
pump.
5) Using gravity and physiological saline, start
blood return from the dialyzer and the blood
lines.
6) Clamp the end of the line and aseptically
withdraw the venous cannula.
7) Discard the dialyzer, the lines and other
of
disposables in the manner approved by your
institution.
IX. WARRANTY AND LIMITATION OF LIABILITY
1) "FILTRYZER" is manufactured in accordance
with its specifications and in compliance with the
GMP regulatory guidelines. Toray will replace a
dialyzer with manufacturing defects free of
charge. When necessary, Toray will request
return of the dialyzer itself and all related
packaging in order to investigate the cause and
to take corrective action, if applicable.
2) Toray is not responsible for any damages,
irrespective of product damages, patient injury
or any other problems caused by misuse,
improper handling, operation and storage by the
customer.
3) Toray is not responsible for any product
damages, patient injury or any other problems
caused by reuse of the dialyzer.
X. OTHER INFORMATION
The following information is available on request.
1) Details of the test methods
2) In vivo performance characteristics
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