Publicité
Les langues disponibles
Les langues disponibles
English
Instructions for Use of TORAYLIGHT NS Series
Read these instructions carefully before using
the "TORAYLIGHT" NS series dialyzer.
I. INDICATIONS
"TORAYLIGHT" NS dialyzers are indicated for
SINGLE USE in acute or chronic hemodialysis.
These dialyzers should be used only on the direction
of a physician.
II. CONTRAINDICATIONS
Special contraindications for "TORAYLIGHT" NS
are unknown. Generally, the contraindications for
hemodialysis are applicable.
III. STERILIZATION
"TORAYLIGHT" NS dialyzers are gamma-ray
sterilized and nonpyrogenic (blood side).
IV. PERFORMANCE AND SPECIFICATIONS
Refer to the attached technical data.
V. 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 blood pressure decreasing by
hemodialysis, patients whose immune function is
accelerating, and patients using "TORAYLIGHT"
NS 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, including discontinuation
of dialysis, should be taken, if the following
symptoms or signs of disequilibrium syndrome
are observed: headache, nausea, vomiting,
consciousness
disturbed,
decreased or convulsion.
3) 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,
eosinophilia, pruritus, edema (eyelid, throat,
intraoral, face, etc.), malaise, fatigueability,
headache, vertigo, back pain, abdominal pain,
lumbar pain, diarrhea, queasy, vomiting, chest
discomfort, discomfort, eczema, rash, redness,
urticaria, flushed face, pyrexia, rigors, sweating
abnormal, muscle cramp, cough, hoarseness,
tinnitus, yawning, abnormal vision, taste peculiar,
strange smell sensation or hemolysis.
4) 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.
5) 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.
VI. WARNINGS AND PRECAUTIONS
1. General warnings and precautions
1) Reuse
"TORAYLIGHT" NS 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
microbiological
contamination,
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
Before starting dialysis, the blood side of the
dialyzers
must
be
flushed
physiological saline, and the dialysate side must
be flushed with dialysate to avoid hemolysis.
4) Dialysis machine
Since "TORAYLIGHT" NS dialyzers have a high
ultrafiltration rate, they should be used in
conjunction with dialysis machines equipped
with an ultrafiltration rate controller.
5) Storage
"TORAYLIGHT" NS should be stored and
transported at temperatures between 5ºC (41ºF)
and
environmental
excessive humidity, wetness, dryness, freezing
temperature) should be avoided.
6) Handling
"TORAYLIGHT" NS 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. Especially when
the coupler has been connecting to the dialysate
port, breakage or cracking of the dialysate port
might be caused by tapping or inverting the
dialyzer forcibly.
7) Chemicals
Strictly avoid contact between the device and
alcohol (sterilant) or other organic solvents.
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 an improper cap fitting over either blood or
dialysate port.
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
blood
pressure
avoid detachment of connection, saline or blood
leakage, or breakage of the blood ports.
4) The dialyzer should be used just after 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.
3. Precautions during dialysis
allergy,
1) Confirm that there is no fluid leakage at the
blood connection and the dialysate connection
platelet
decreased,
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
than indicated.
storage
during
4) The administration method and dose of an
anticoagulant such as heparin should be
determined for each patient by a physician.
Special cares, including monitoring of coagulation
time during dialysis, should be taken for patients
who have a tendency to haemorrhage 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
or replacing the dialyzer, should be taken
promptly.
excessive
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
caused
by
rotating it around its axis, if necessary.
adverse
VII. DIALYSIS PROCEDURE
Use protective gloves and an aseptic technique to
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 is
with
sterile
recommended for this dialyzer.
30ºC
(86ºF).
Exposure
to
conditions
(direct
sunlight,
— 3 —
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
severe
both ends of the arterial line, and connect it to
the arterial port of the dialyzer. Then connect the
venous line to the venous port of the dialyzer.
(Fig. 1)
4) Rinse the blood side of the dialyzer and the
blood line with more than 500 mL of
physiological saline at about 100 mL/min. (Fig.
2)
5) 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. 3) Let the dialysate flow
for at least 5 minutes. Avoid any ultrafiltration
during this procedure.
6) Prime the dialyzer and blood lines with more
than 500 mL of physiological saline at about 200
mL/min, and confirm that there are no air
bubbles remaining in the dialyzer by flushing
repeatedly. (Fig. 4) If massive air bubbles
appear from fibers, replace the dialyzer.
7) Prime the dialyzer and bloodlines with more
than 500 mL of heparinized physiological saline.
8) Confirm that the venous bubble trap is about 3/4
full.
9) 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 less than 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
disposables in the manner approved by your
institution.
VIII. WARRANTY AND LIMITATION OF LIABILITY
1) "TORAYLIGHT"
accordance with its specifications and in
compliance with the GMP regulatory guidelines.
Toray will replace the damaged dialyzer caused
by manufacturing with new one 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.
IX. OTHER INFORMATION
The following information is available on request.
1) Details of the test methods
2) In vivo performance characteristics
NS
is
manufactured
in
Publicité
