Optiflux F18NR Quick Start Manual

GENERAL INFORMATION
Indications: Optiflux F18NR and F16NR 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: Adverse reactions such as hypertension, hypotension, headache, and
nausea may be associated with hypovolemia or hypervolemia and can usually be
avoided with careful management of patient fluid, electrolyte balance, blood flow rate,
and ultrafiltration rate.
In rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or
anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit,
may occur during hemodialysis. Hypersensitivity reactions may cause mild to severe
signs and symptoms, including: itching, flushing, hives, swelling, fever, leukopenia,
hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or
respiratory arrest.
Patients with a history of hypersensitivity reactions or patients who have a history
of being highly sensitive and allergic to a variety of substances should be carefully
monitored during treatment. With severe hypersensitivity reactions, dialysis must be
discontinued and aggressive first line therapy for hypersensitivity reactions must be
initiated. The decision to return the patient's blood in the event of a hypersensitivity
reaction is determined by the 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. 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. Electron beam sterilized. 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 F18NR and F16NR 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.
Optiflux
F18NR F16NR
Hollow Fiber Dialyzers
NOT FOR REUSE
• 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.
• Do not infuse the recirculated saline prime into the patient. Discard the recirculated
saline and fill the entire extracorporeal circuit with fresh saline prior to connecting to
the patient. The volume of fresh saline used to fill the extracorporeal circuit should be
equal to the volume of the dialyzer and blood tubing set in use.
INITIATION OF DIALYSIS
• T o initiate dialysis; stop the blood pump, clamp the dialysis priming set and the
arterial and venous bloodlines.
• A septically attach the patient ends of the bloodlines to the patient's arterial and
venous access. Open the arterial and venous bloodline clamps and the clamps
on the patient access.
• I ncrease the blood pump speed slowly to the prescribed blood flow rate. Be sure
to monitor the arterial and venous blood pressures carefully during this process
to note any possible flow restrictions or inappropriate pressure readings.
• O nce the prescribed blood flow rate has been achieved, set the prescribed
ultrafiltration rate.
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.
• Using a plastic clamp, clamp the arterial blood tubing just above the saline "T"
connection (between the saline "T" connection and the inlet of the blood pump
segment).
• Open the clamps on the saline line and saline "T" connection and allow the 0.9%
saline solution to rinse the blood between the saline "T" and the patient arterial access
connection back to the patient.
• Move the clamp from above the saline "T" connection to below the saline "T"
connection and clamp the patient's arterial access and close the main line clamp on
the arterial bloodline.
• Using the blood pump, slowly return the blood in the rest of the extracorporeal circuit
to the patient.
• 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 main line clamp on the venous bloodline.
• Clamp the patient's venous access.
• Aseptically disconnect the arterial and venous bloodlines from the patient's access.
• Discard the extracorporeal circuit in compliance with appropriate federal, state and
local requirements, which may require the use of medical waste and/or biohazard
receptacles. 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:
®
F18NR
12
90
265
236
188
113
12
103
53
7.1
11
1.5
600
80
600
1000
1.8
12
Advanced Fresenius Polysulfone®
200 µm
Polycarbonate
Polyurethane
Silicone
DIN 13090 Part 3
DIN 58352 Part 2
F16NR
10 mL/h/mmHg
75 mL/h/kPa
262 mL/min
228 mL/min
175 mL/min
100 mL/min
84 mL
56 mmHg
7.5 kPa
14 mmHg
1.9 kPa
600 mmHg
80 kPa
500 mL/min
1000 mL/min
1.5 m 2
89-700-84 REV 06/16