ASAHI REXEED-A Serie Instrucciones De Uso

ENGLISH
HEMODIALYZER
1. INDICATION FOR USE
TM
Asahi REXEED -A series dialyzer (hereafter called REXEED-A) is
intended for use in hemodialysis (HD), hemodiafiltration (HDF) and
hemofiltration (HF) for the treatment of patients suffering from acute
or chronic renal failure.
2. CONTRAINDICATIONS
None known. In general, contraindications for HD, HDF and HF are
applicable.
3. ADVERSE REACTIONS
• Consult a responsible physician immediately whenever an adverse
reaction occurs.
• Some patients may experience hypersensitivity reactions during
treatment. Symptoms and signs include acute shortness of breath
with wheezing; respiratory arrest; itching; flushing; mood
discomfort; abnormal sweating; hives; generalized or localized skin
redness; edema of the face, hands, or feet; hypertension;
hypotension; elevated pulse rates; arrhythmia; ocular hyperemia;
hypoesthesia; fever; leukopenia; and thrombocytopenia.
• Side effects such as hypertension, hypotension, headache, chest pain,
stomachache, fatigue and nausea which may be associated with
hypovolemia or hypervolemia can usually be avoided by careful
management of the patient's fluid volume and electrolyte balance as
well as the blood flow rate and transmembrane pressure (TMP).
4. WARNINGS
Follow these instructions and those of the HD machine supplier.
Improper use could cause injury or death. The manufacturer will not be
responsible for patient safety if these instructions and the HD machine
supplier instructions are not followed. Make sure these instructions are
available to the operator at the treatment site.
 REXEED-A is intended for single use only. Reprocessing of
REXEED-A may lead to adverse reactions for the patient and/or
device failure.
 The user must use REXEED-A before the expiration date. Refer to
the REXEED-A product label for the expiration date.
 REXEED-A must be kept in a clean, dry environment away from
direct sunlight, heat, and humidity and at temperatures of 0-30°C
(32-86°F).
 REXEED-A, when shipped by the manufacturer, is filled with fluid.
This fluid must not be allowed to freeze. REXEED-A with frozen
fluid must never be used, even after the thawing of the fluid.
 REXEED-A is a plastic product, and must not be exposed to
vibration or impact during transportation, storage or handling.
 REXEED-A must not be exposed to organic solvents such as
alcohol to prevent cracking or deformation.
 Inspect each REXEED-A before use, and replace it if it shows signs
of damage, damage or improper sealing of the sterilization bag,
leakage of fluid from REXEED-A into the sterilization bag, or
misaligned or separated stoppers.
 Ensure that the dialysate and blood compartments of REXEED-A
are rinsed before use according to the priming procedure described
below.
 Use aseptic technique throughout priming and treatment.
 Do not remove the fluid before rinsing and filling the blood
compartment with saline to prevent any air from entering
REXEED-A.
 The saline must be a physiological solution that is sterile and
non-pyrogenic.
 Due to its high ultrafiltration coefficient, REXEED-A must only be
used with HD machines equipped with a UF controller (Refer to the
instructions of the HD machine).
 Dialysate must meet the regional or ISO water quality standards for
dialysis to minimize the risk of adverse reactions.
 The use of blood and dialysate port connectors (female) attached to
blood and dialysate lines that are designed in compliance with ISO
8637:2004 and ISO 8638:2004 is recommended.
 Ensure that the sensors, detectors and alarm system of the HD
machine are in proper operating condition including the venous air
sensor and the blood leak detector in accordance with the
instructions of the HD machine before starting treatment.
 Ensure that air is completely purged from REXEED-A and blood
lines during priming; failure in purging air may result in blood
clotting during treatment. Further, ensure that no air enters the
patient's blood vessel during blood return.
 During priming and treatment, verify that there is no leakage from
the dialyzer, blood lines, blood ports, and their connecting parts. If
leakage is observed, replace the dialyzer or the blood lines.
 If dialysate is to be used instead of saline or substitution fluid, care
must be taken to ensure that the purity of the dialysate is in
accordance with the applicable water quality standards (for example,
dialysate intended for infusion defined in ISO 11663:2009).
 In the event of a problem during treatment, such as blood leakage or
coagulation, immediately discontinue the treatment under the
direction of a physician and replace REXEED-A with a new primed
dialyzer.
 REXEED-A has multiple connection points. Failure to make the
INSTRUCTIONS FOR USE
TM
ASAHI REXEED -A SERIES DIALYZER
1
proper connections can result in compromised treatment, injury, or
death due to blood or therapy fluid leak.
 REXEED-A may remove medications given in the arterial blood
line. Give medications post dialyzer unless instructed otherwise.
 Do not permit the TMP to exceed 500 mmHg (66 kPa) with TMP
being defined as per ISO 8637:2004.
 The recommended ranges of the treatment parameters specified in
the APPENDIX should be considered when planning treatment for
patients.
 Dispose the used REXEED-A and the blood lines in strict
accordance with official and institutional standards for medical
waste disposal.
5. SPECIFICATIONS & PERFORMANCE
TM
Membrane, REXBRANE
Styrene-butadiene block copolymer; Stoppers, Polyethylene and
hydrogenated styrene-butadiene block copolymer; Potting material,
Polyurethane
Sterilized by gamma rays
Blood pathway is non-pyrogenic.
Refer to the APPENDIX for design specifications and in vitro
performance information regarding individual REXEED-A models. In
a clinical setting, the performance of REXEED-A may be different
from that in vitro; this performance may vary with the conditions and
duration of treatment.
6. ANTICOAGULATION
Anticoagulant requirements will vary with the patient's condition; the
type, quantity, and method of anticoagulant administration should be in
accordance with the directions by a physician who is familiar with the
patient's condition.
7. OPERATION
1. PRIMING
The order of procedures 2) and 3) can be reversed.
1) Place REXEED-A vertically in the holder, with the red header
(arterial end) down.
2) Connect the arterial blood line to the saline bag for infusion and fill
the arterial blood line completely with saline. Connect the arterial
and venous blood lines to the blood inlet and outlet ports. Be careful
not to introduce air into the hollow fibers and the blood lines. Rinse
the hollow fibers and the blood lines with at least 1000 mL saline at
approx. 100 mL/min. If any air is trapped in the dialyzer or blood
lines, introduce additional saline for rinsing while gently tapping the
dialyzer with one's hands or pinching and releasing the blood lines
until the air is completely removed. Do not attempt to remove the
air by tapping the dialyzer with hard instruments, such as forceps,
because this may damage the dialyzer.
3) Connect the dialysate lines to the dialysate ports. Allow the
dialysate to flow at approx. 500 mL/min for 2 min or more. For
HDF, connect the substitution line to the substitution port and prime
the line.
• For HF, different priming procedure can be obtained on request.
• Instead of saline, dialysate intended for infusion may be used for
priming and ending the treatment.
2. STARTING TREATMENT
1) Connect the arterial blood line to the patient's arterial cannula. Start
blood pump (approx. 100 mL/min) to displace saline.
2) Connect the venous blood line to the venous cannula.
• For HDF, the ultrafiltration flow rate should be monitored carefully
under the direction of a physician who is familiar with the patient's
condition. In some patients, for example, those with a high
hematocrit value, a high ultrafiltration flow rate may cause elevation
of the blood inlet pressure.
3. ENDING TREATMENT
1) Adjust the UF flow rate and stop the blood pump.
2) Remove the arterial cannula from the patient and connect the
arterial blood line to the saline bag. Feed 100-200 mL saline into the
hollow fibers and the blood lines by starting the blood pump slowly
to rinse back patient's blood.
3) Clamp the venous blood line and remove the venous cannula from
the patient.
8. WARRANTY AND LIMITED LIABILITY
• The manufacturer warrants that REXEED-A is manufactured in
accordance with its specifications and in compliance with ISO
9001:2008, ISO 13485:2003, applicable industry standards, and
regulatory requirements.
• If any defects caused during manufacturing or transportation are
brought to the attention of the manufacturer's representative, the
manufacturer will replace REXEED-A with a new one through the
representative.
• The manufacturer will not be liable for any damage caused by the
reuse of REXEED-A, misuse, improper handling, non-compliance
with warnings and instructions, damage caused by events occurring
after the product is released, failure to ensure the product is in proper
condition before use, or any warranty given by independent
distributors.
(Polysulfone / PVP); Housing and headers,