Toray HEMOFEEL CH-W Série Mode D'emploi page 2

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Instructions for Use of HEMOFEEL CH Series
Read these instructions carefully before using
the "HEMOFEEL" CH series haemofilter.
I. DEVICE DESCRIPTION
"HEMOFEEL" CH is a haemofilter, designed for the
continuous replacement of the main activity of the
kidneys by removing water and toxins at a slow and
steady rate (i.e., continuous renal replacement
therapy [CRRT]). Haemofilters are devices intended
to perform haemofiltration. Haemofiltration is a
process whereby extracorporeal blood is slowly and
continuously passed through a system to allow for
the removal of toxins and/or the replacement of
electrolytes. The device functions with dialysate
solution for the transfer of substances by diffusion
and convection.
II. INTENDED USE
"HEMOFEEL" CH is a single-use haemofilter
designed for the continuous replacement of the main
activity of the kidneys by removing water and toxins
at a slow and steady rate (i.e., continuous renal
replacement therapy [CRRT]). The haemofilter
should be used only on the direction of a physician.
III. INDICATIONS
"HEMOFEEL" CH haemofilter is used for patients
who have acute kidney failure, with conservative
treatment consisting of volume, electrolyte and
acid–base homeostasis management, and specific
drug management.
IV. CONTRAINDICATIONS
Special contraindications for "HEMOFEEL" CH are
unknown. Generally, the contraindications
haemofiltration are applicable.
V. STERILIZATION
"HEMOFEEL" CH haemofilters are gamma-ray
sterilized and nonpyrogenic (blood side).
VI. PERFORMANCE AND SPECIFICATIONS
Refer to the attached technical data.
VII. ADVERSE EVENTS
1) Patients should be carefully monitored during
and after haemofiltration. In particular, patients
with a history of allergy and hypersensitivity
should be carefully monitored. If anaphylactoid
reactions should occur, haemofiltration should
be discontinued and the attending physician
should decide whether or not to return the blood
in the extracorporeal circuit to the patient.
Symptoms or signs of anaphylactoid reaction
includes flushed face, angioedema, urticaria,
etc.
2) Disequilibrium syndrome may appear especially
during haemofiltration treatment at high flow
rates. Appropriate treatments,
discontinuation of haemofiltration, should be
taken, if the following symptoms or signs of
disequlibrium syndrome
headache, nausea, vomiting, consciousness
disturbed, decrease of blood pressure or
convulsion.
3) Appropriate treatments, including discontinuation
of haemofiltration, should be taken, if the
following symptoms, which
occasionally in usual haemofiltration,
observed: Dyspnoea, chest pain, blood pressure
decreased, blood pressure
thrombocytopenia, headache, nausea, vomiting,
abdominal pain, low back pain, leukopenia,
palpitation, pyrexia, chills, sweating abnormal,
muscle cramp, hypoproteinaemia,
hypoalbuminaemia. Patient body fluid and
electrolyte levels should be monitored.
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, haemofiltration 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 haemofiltration machine
or a procedural error in its use, such as blood
loss, blood overheating, hemolysis, excessive
ultrafiltration and electrolyte imbalance. Refer to
the instructions for the machine to avoid such
complications.
VIII. WARNINGS AND PRECAUTIONS
1. General warnings and precautions
1) Reuse
"HEMOFEEL" CH 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
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contamination, adverse reactions caused by
residual reprocessing agents and/or blood
components, etc.).
2) Rinse
"HEMOFEEL" CH haemofilters are filled with
sterile water. Before starting haemofiltration, the
blood side of the haemofilters must be flushed
with sterile physiological saline, and the
dialysate side must be flushed with sterile
physiological saline or dialysate to avoid
hemolysis, etc.
3) Machine
Since "HEMOFEEL" CH haemofilters have a
high ultrafiltration rate, they should be used in
conjunction
equipped with an ultrafiltration rate controller.
4) Storage
"HEMOFEEL" CH should be stored and
transported at temperatures between 5°C (41°F)
and 30°C
environmental
excessive humidity, wetness, dryness, freezing
temperature) should be avoided.
5) Handling
"HEMOFEEL" CH is made from various plastic
components. Excessive vibration or mechanical
shock should be avoided during handling and
operation. Avoid tapping the haemofilter header
with a clamp or other metal object to remove air
bubbles or to return the blood.
6) Chemicals
Strictly avoid contact between the device and
alcohol (sterilant) or other organic solvents.
Such contact may lead to distortions or cracks of
for the device.
7) Blood line
Some of blood lines have manufacturer's
original connectors which do not fit to the
dialysis ports of "HEMOFEEL" CH. In that case,
use suitable adaptors available in the market.
8) Special care
Since the product has high ultrafiltration
performance, start with a low blood flow rate and
a low water removal rate in the following
patients. [If an inappropriate filtrate flow
rate/supplementary liquid flow rate is selected,
such symptoms as blood-pressure lowered etc.
may occur.]
•Patients with hypotension or in shock
•Patients with low body weight or elderly
patients
•Patients in whom a dialyzer with a smaller
membrane area was used prior to the use of
this product
•Patients who use antihypertensive agents
•Patients who require rapid water removal
within a short period
•Patients who experienced blood-pressure
including lowered etc. due to blood purification therapy
9) Application to elderly patients
Since physiological
are observed: deteriorates in elderly patients, carefully monitor
the patient when using this product.
10) Application to pregnant women or pediatric
patients
Since the safety of the product has not been
established in pregnant women, use in pregnant
may occur women and women of child-bearing potential
are should be limited to cases where the therapeutic
benefits outweigh possible risks.
increased, While the product has been used for pediatric
patients, the population is not large enough to
establish safety.
2. Precautions to be taken before haemofiltration
1) The haemofilter must not be used if it appears to
be damaged or its package is torn.
2) The haemofilter must not be used if there
storage during 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
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
avoid detachment of connection, saline or blood
leakage, or breakage of the blood ports.
4) The extracorporeal circuit with the connectors
conforming to ISO8638 is recommended for this
haemofilter.
5) Connect the dialysate connectors of blood line
to the dialysis ports by pushing the line with
appropriate force to ensure a tight fitting to avoid
detachment of connection, dialysate/filtrate
leakage or breakage of the dialysate port.
6) When the connectors of blood line do not fit to
the dialysis port of haemofilter, use appropriate
commercially available adaptors to connect the
blood line to dialysis ports. Ensure tight fittings
between connectors of blood line with the
adaptor and between the adaptor and the
microbiological dialysis ports of haemofilter.
with haemofiltration machines
(86°F). Exposure to severe
conditions (direct sunlight,
IX. HAEMOFILTRATION PROCEDURE
function generally
−2−
7) The haemofilter should be used just after rinsing
and priming.
8) 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 haemofiltration
1) Confirm that there is no blood leakage and 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
haemofilter connectors.
3) The administration method and dose of an
anticoagulant such as heparin should be
determined for each patient by a physician.
Special cares, including monitoring
coagulation time during haemofiltration, should
be taken for patients who have a tendency to
haemorrhage or who have a coagulation
disorder.
4) If air bubbles, a blood leak, clotting or hemolysis
are observed during haemofiltration, appropriate
treatments, including discontinuation
haemofiltration or replacing the haemofilter,
should be taken promptly.
5) When the administration of drugs is intended
before or during haemofiltration, consider
various conditions such as route, timing and
dose, because haemofiltration may remove
them or modify their effects. Special cares are
recommended for patients
angiotensin-converting enzyme inhibitors.
6) When completing haemofiltration, 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 haemofilter vertically and
rotating it around its axis, if necessary.
Use protective gloves and an aseptic technique to
prevent contamination of patient's blood when
connecting the blood line to the haemofilter,
collecting blood, or returning the blood from the
extracorporeal circuit.
The following procedure is an example.
1. Preparation for Haemofiltration
1) Introduce physiological saline solution into the
end of the arterial side (inlet: Side A in the
figure) blood circuit. Avoid air bubbles becoming
trapped in the header, and connect the circuit to
the arterial side header. Air bubbles in the
header must be eliminated by introducing
physiological saline solution into the syringe
barrel in advance.
2) Connect the venous side (outlet: Side V in the
figure) header with the venous side blood circuit.
(Figure 1)
3) Turn the haemofilter upside down so that the
arterial side is facing downwards. (Figure 2)
4) Use at least 500 mL of physiological saline
solution for CH-1.3W, and wash in the order of the
arterial side blood circuit, inside of the hollow fibers
(blood side), and the venous side blood circuit.
(Figure 3) (Use at least 900 mL for CH-1.8W.)
5) Turn the haemofilter upside down, remove the
stopper of the filter-side haemofilter, and
connect the filter side nozzle near the arterial
side to the filter pressure monitor. (Figure 4)
6) Turn the haemofilter upside down, clamp the
venous side with forceps, drain at least 500 mL
of physiological saline solution from the
blood-side through the haemofilter to remove air
bubbles in the filter-side and wash. (Figure 5)
7) Turn the haemofilter upside down, and fix it into
the holder of the device. (Figure 6)
8) Prime the haemofilter and blood lines with more
than 500 mL of anticoagulant-added
physiological saline, or 5% dextrose solution
and confirm that there are no air bubbles
remaining in the haemofilter.
2. Haemofiltration
1) Connect the blood circuit to the patient's blood
removal side catheter. Pay due attention to
prevent blood contamination when connecting
the blood circuit to the catheter.
2) Operate the blood pump slowly; let a small
amount of priming solution in the circuit flow and
discard the solution while monitoring the
patient's condition. When air bubbles in the end
of blood return side circuit have been removed,
connect the circuit immediately to the patient's
blood return side catheter.
3) Start haemoperfusion, and add anticoagulant to
the blood circulating in the circuit before it enters
the haemofilter.
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