Other Information - Toray HEMOFEEL CH Serie Instrucciones De Uso

English
Instructions for Use of HEMOFEEL CH Series
insing 4) Maintain a blood flow rate of 20 to 30 mL/min
until the entire priming solution in the blood
circuit is replaced. When the haemofilter and
es to
during circuit have become filled with blood, raise the
blood flow rate to 50 to 60 mL/min. Perform
haemoperfusion alone for at least 5 to 10
minutes after initiation for blank operation
nd no
without blood filtration.
d the
5) After at least 5 to 10 minutes after initiation of
t not haemoperfusion, confirm that haemoperfusion is
stable, and then initiate haemofiltration.
r than
6) Increase the blood flow rate gradually, and
akage
select an appropriate blood flow rate for
m the
extracorporeal circulation.
of an 7) Infuse anticoagulant continuously to prevent
blood from coagulating in the haemofilter while
d be
the product is in use. (Figure 7)
ician.
8) Remain vigilant regarding any difference in
g of
hould pressure between inlet and outlet of the
ncy to haemofilter – a large difference may be caused
by a clogged haemofilter due to blood clot
lation
formation etc.
olysis
priate
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ofilter,
ended
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oyed.
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東レ株式会社
ヘモフィールCH IFU使用説明書 P3
ヘモフィールCH_IFU使用説明書.indd 3
3. Completion of Haemofiltration
1) Circulate physiological saline solution or 5%
dextrose solution 100 to 200 mL at low flow rate
(approx. 50 mL/min) while monitoring the
patient's condition, and return the blood in the
haemofilter and blood circuit to the patient. If the
volume of physiological saline solution used for
retransfusion is insufficient, not all the blood
may be collected. At the final stage of blood
collection, natural pressure is recommended in
order to prevent air from becoming trapped in
the blood vessel.
2) Discard the haemofilter, the lines and other
disposables in the manner approved by your
institution.
X. WARRANTY AND LIMITATION OF LIABILITY
1) "HEMOFEEL"
accordance with its specifications and in
compliance with the GMP regulatory guidelines.
Toray
manufacturing defects free of charge. When
Authorized
Date of manufacture
Representative in the
(Sterilization date)
European Community
30˚C
(86˚F)
5˚C
(41˚F)
Keep Dry Temperature limit
CH is manufactured in
will replace a haemofilter with
Use by Lot No.
Caution:
For single
Refer to
use only
instructions
−3−
necessary, Toray will request return of the
haemofilter itself and all related packaging in
order to investigate the cause and to take
corrective actions, if applicable.
2) Toray is not responsible for any damages,
irrespective of product damages, patient injury
or any other problems caused by misuse,
improper handling, operation and storage by the
customer.
3) Toray is not responsible for any product
damages, patient injury or any other problems
caused by reuse of the haemofilter.
XI. OTHER INFORMATION
The following information is available on request.
1) Details of the test methods
2) In vivo performance characteristics
Gamma ray sterilized
Handle with Care
(Sterile fluid path)
Non-pyrogenic
(Blood side)
2020/07/13 19:18