Optiflux F180NR - User Manual

89-700-58 REV 06/16
Optiflux
®
F180NR
Hollow Fiber Dialyzers
NOT FOR REUSE
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.
•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.
F180NR
Ultrafiltration coefficient
(in vitro,bovineblood,Hct32%)
55
413
mL/h/mmHg
mL/h/kPa
Clearance (Qb = 300 mL/min,
Qd = 500 mL/min)
Urea*
Creatinine
Phosphate
VitaminB
12
270
245
238
165
mL/min
mL/min
mL/min
mL/min
Primingvolumeblood 105 mL
Flow resistance blood
(Qb = 200 mL/min)
47
6.3
mmHg
kPa
Flow resistance - dialysis fluid
(Qd = 500 mL/min)
16
2.1
mmHg
kPa
MaximumTMP 600
80
mmHg
kPa
Maximum blood flow
Maximum dialysate flow
Surface area
600
1000
1.8
mL/min
mL/min
m
2
*Sodium used as a marker for Urea.
Note: Clearance tests performed using aqueous solutions of sodium, creatinine, phosphate, and
VitaminB
12
Membranematerial: AdvancedFreseniusPolysulfone®
Inner diameter (nominal): 200 µm
Housing: Polycarbonate
Pottingcompound: Polyurethane
O-ring: Silicone
Bloodconnectors: DIN13090Part3
Dialysisfluidconnectors: DIN58352Part2

Optiflux F180NR Specifications