Optiflux F180NR Quick Start Manual

GENERAL INFORMATION
Indications: Optiflux F180NR dialyzers are designed for single use acute and chronic
hemodialysis.
USA only: Federal law restricts this device to sale by or on order of a physician.
Contraindications: Specific contraindications for the dialyzer are unknown. Generally,
the contraindications for hemodialysis are applicable. The dialyzer should only be used
as directed by a physician.
Precautions: In the event of a blood leak during dialysis, the health care provider
should respond according to the facility's established protocol.
Air entering the extracorporeal circuit during dialysis can result in serious injury or death.
Check the integrity of all blood lines prior to the initiation of dialysis and periodically
during the treatment. The venous return line or drip chamber should be continuously
monitored with an air detector.
Warning: Due to the high water flux capability of high permeability membranes
with a KUF ≥ 8, it is necessary to use such dialyzers only in conjunction with
dialysis machines that are equipped with precise ultrafiltration control, such as
the Fresenius A2008 series. We recommend that dialyzers with a KUF ≥ 6 only be
used with such UF control machines. In any case, the safety instructions of the
manufacturer of the hemodialysis machine must be followed.
The user is cautioned to regularly monitor the patient's chemistry values using
quantitative measurements and analysis to ensure that the expected therapy is
delivered. The clinical parameters monitored should, at least, include: urea, hematocrit,
and serum albumin.
Dialyzers may leak, resulting in patient blood loss or contamination with dialysate.
Dialysate: The dialysate must meet AAMI standards for dialysis (RD5). The use of
bicarbonate-containing dialysate is recommended for short dialysis.
Side effects: In rare cases hypersensitivity reactions may occur during hemodialysis
treatment. A history of allergies is an indication for careful monitoring of hypersensitivity
reactions. Dialyzers of this type should not be used again on any patient exhibiting
a hypersensitivity reaction. With severe reactions, dialysis must be discontinued and
aggressive, first line therapy for anaphylactoid reactions must be initiated. The decision
to return the blood must be made by a physician.
Heparinization: It is recommended to systemically heparinize the patient by allowing
the prescribed loading dose of heparin to circulate for 3 to 5 minutes before beginning
extracorporeal circulation. In addition, the extracorporeal circuit may be heparinized,
taking care that the total amount of heparin to be delivered meets the prescription. During
dialysis, the dosage of heparin and the mode of administration are the responsibility of
the attending physician. The coagulation time should be checked regularly.
Sterile/Non-pyrogenic: The dialyzer blood pathway is sterile and non-pyrogenic if the
blood port caps are in place and undamaged. Sterilized with ethylene oxide gas. Do
not use if the dialyzer is damaged in any way. Use aseptic technique for all blood side
connections. Structural integrity of the hemodialyzer is warranted for the first use only
when prepared as directed.
Recommended storage: Between 5 and 30°C (41 and 86°F).
Dialyzer reuse: Optiflux F180NR dialyzers are NOT designed for reuse.
PREPARATION FOR DIALYSIS - DRY PACK
• Place the dry dialyzer in a vertical position, arterial end downward.
• Install the arterial and venous bloodlines on the hemodialysis machine. Note: Refer to
the manufacturer's instructions for the dialysate delivery machine.
• Remove any dialyzer blood port caps and aseptically connect the arterial and venous
blood lines to the dialyzer.
• Aseptically spike a 1 liter bag of 0.9% sterile normal saline with a clamped IV
administration set. Attach the IV administration set to the patient end of the arterial
bloodline.
• Open the clamp on the IV set. Prime the arterial bloodline, dialyzer, and venous
bloodline using a blood pump speed of approximately 150 mL/min. Discard the first
500 mL of solution. The drip chambers should be maintained about 3/4 full.
• Stop the blood pump. Clamp the arterial and venous bloodlines. Turn the dialyzer so
that the venous end is downward. Aseptically connect the patient ends of the arterial
and venous lines together in preparation for recirculation. Open the clamps on the
bloodlines.
• Verify that the dialysate is within the prescribed conductivity limits with a calibrated
external conductivity meter. To identify situations where the acetate or acid and
bicarbonate concentrates are not properly matched, use pH paper or a meter to verify
that the approximate pH is in the physiologic range.
• Attach the dialysate lines to the dialyzer. Fill the dialysate compartment. In order to
maximize the efficiency of the dialyzer, the dialysate flow must be countercurrent to
the blood flow.
• Rotate the dialyzer so that the arterial end is downward. Recirculate the blood side
at a flow rate of 300- 400 mL/min and a dialysate flow of 500 mL/min for a minimum
of ten to fifteen minutes and until all the air has been purged from the system before
connecting to the patient. Continue recirculation and dialysate flow until patient
connection.
• Ultrafilter or flush an additional 500 cc of 0.9% sterile normal saline so that the
extracorporeal circuit has been flushed with a minimum of 1 L of saline to minimize
sterilization residues.
Optiflux
F180NR
Hollow Fiber Dialyzers
NOT FOR REUSE
• If the dialysate delivery system was chemically disinfected or sterilized prior to patient
use, be sure to test for the absence of germicide residuals with a test intended for this
application, according to the test manufacturer's instructions.
INITIATION OF DIALYSIS
• Turn the blood pump off. Clamp the saline line and the arterial and venous
bloodlines.
• Aseptically attach the arterial bloodline to the patient's arterial access. Open the
arterial bloodline clamp.
• Place the venous bloodline in a drain container, making sure not to contaminate the
end of the bloodline. Open the clamp on the venous bloodline.
Warning: This step must be carefully monitored to prevent any possibility of
blood loss.
• Turn the blood pump speed up to 100 - 150 mL/min. Fill the extracorporeal circuit with
the patient's blood.
• Do not infuse the recirculated saline prime into the patient. If saline is required for
volume enhancement, discard the recirculated saline and fill the bloodlines with fresh
saline.
• Turn off the blood pump and clamp the venous bloodline.
• Aseptically attach the patient end of the venous bloodline to the patient's venous
access.
• Open the clamp to the venous access.
• Unclamp the venous bloodline and set the blood flow to the prescribed rate. Rotate
the dialyzer so that the venous end is downward.
• Set the prescribed ultrafiltration rate. A minimum ultrafiltration rate of 300 mL/hr during
dialysis treatment is recommended with Optiflux dialyzers.
DURING DIALYSIS TREATMENT:
• If a blood leak should occur during the treatment, the decision to attempt to allow the
leak to clot off by reducing the blood flow and ultrafiltration rate to minimum values is
a clinical decision. The decision whether or not to return the blood to the patient must
be made by a medical professional.
• Air entering the extracorporeal circuit during dialysis is very serious and should
be avoided. A routine check of all connections prior to initiation of dialysis and
periodically throughout the treatment is recommended. Constant monitoring of the
venous return line with an air detector is essential. Should air get into the venous
line during treatment, the dialysis must be discontinued without returning any of the
patient's blood that is mixed with air.
TERMINATION OF DIALYSIS
• When the dialysis treatment is completed, turn the blood flow rate to zero and UF rate
to recommended minimum.
• Clamp arterial bloodline and arterial access, and aseptically disconnect from the
patient's arterial access.
• Using the blood pump, rinse the patient's blood back using sterile 0.9% saline solution
at a slow rate. Do not allow air to enter the extracorporeal circuit.
• Once the blood has been returned, turn the blood pump flow rate to zero.
• Clamp the venous bloodline.
• Clamp the patient's venous access and aseptically disconnect the venous bloodline
from the patient's access.
• Discard the extracorporeal circuit in an appropriate biohazard waste receptacle.
References: 29CFR 1910.145, 1910.1030 (Code of Federal Regulations) and
appropriate state or local codes.
TECHNICAL DATA: These data represent typical in vitro performance. Actual in vivo
performance will differ.
Ultrafiltration coefficient
(in vitro, bovine blood, Hct 32%)
Clearance (Qb = 300 mL/min,
Qd = 500 mL/min)
Urea*
Creatinine
Phosphate
Vitamin B
Priming volume blood
Flow resistance blood
(Qb = 200 mL/min)
Flow resistance - dialysis fluid
(Qd = 500 mL/min)
Maximum TMP
Maximum blood flow
Maximum dialysate flow
Surface area
*Sodium used as a marker for Urea.
Note: Clearance tests performed using aqueous solutions of sodium, creatinine, phosphate, and
Vitamin B
Membrane material:
Inner diameter (nominal):
Housing:
Potting compound:
O-ring:
Blood connectors:
Dialysis fluid connectors:
®
F180NR
55
413
270
245
238
165
12
105
47
6.3
16
2.1
600
80
600
1000
1.8
12
Advanced Fresenius Polysulfone®
200 µm
Polycarbonate
Polyurethane
Silicone
DIN 13090 Part 3
DIN 58352 Part 2
mL/h/mmHg
mL/h/kPa
mL/min
mL/min
mL/min
mL/min
mL
mmHg
kPa
mmHg
kPa
mmHg
kPa
mL/min
mL/min
m
2
89-700-58 REV 06/16