vascular: thaw & rinse instructions thaw & rinse instructions (cannulated) cryovein®...
TRANSCRIPT
Vascular: Thaw & Rinse Instructions(cannulated)
CryoVein® Saphenous Vein
CryoVein Femoral Vein
CryoArtery® Femoral Artery
Other Vascular Allograft included (not pictured): CryoVein Saphenous Vein, Double Graft Pack
Cardiac: Thaw & Rinse InstructionsAortoiliac Artery: Thaw & Rinse Instructions
(non-cannulated)
CryoValve® Aortic Human Heart Valve
CryoValve SGPulmonary HumanHeart Valve
CryoPatch SGPulmonary Human Cardiac Patch (Trunk and Branch)
CryoGraft®
Descending Thoracic Artery
CryoPatch® SG Pulmonary Human Cardiac Patch (Hemi-Artery)
CryoArtery Aortoiliac Artery
Other Cardiac Allografts included (not pictured): CryoValve Pulmonary Valve, CryoPatch, CryoGraft Ascending Thoracic Artery, CryoPatch Pericardial Sheet, and CryoGraft Pulmonary Artery.
L7092.003 (06/2015) 1/8
Vasc
ular
: Tha
w &
Rin
se In
stru
ctio
nsTo
tal E
stim
ated
Tim
e: 4
5 m
inut
es
Oth
er V
ascu
lar A
llogr
aft i
nclu
ded
(not
pic
ture
d): C
ryoV
ein
Saph
enou
s Ve
in, D
oubl
e G
raft
Pac
k
Requ
ired
Supp
lies:
Non
-Ste
rile:
•
Larg
e ba
sin (5
lite
rs)
• Th
ree
(3) l
iters
of w
ater
or s
alin
e at
98
° to
108°
F (3
7° to
42°
C)•
Sciss
ors
• Pa
ck o
f tow
els
• In
sula
ted
glov
es•
Prot
ectiv
e ey
ewea
r•
Ther
mom
eter
Requ
ired
Supp
lies:
Ster
ile:
• O
ne (1
) lite
r of 5
% D
extro
se in
La
ctat
ed R
inge
r’s (D
5/LR
; at r
oom
te
mpe
ratu
re)
• La
rge
basin
(5 li
ters
)•
Two
(2) s
mal
l bas
ins (
0.5
to 1
lite
r)•
60cc
Lue
r-Lok
® sy
ringe
•
Sciss
ors
• M
arki
ng p
en
• H
epar
inize
d La
ctat
ed R
inge
r’s
solu
tion
(mix
ing
ratio
is a
t su
rgeo
n’s d
iscre
tion)
(can
nula
ted
allo
graf
ts)
Cryo
Vein
Sap
heno
us V
ein
Cryo
Vein
Fem
oral
Vei
n
Cryo
Arte
ry F
emor
al A
rtery
2/8
Stric
t adh
eren
ce to
this
prot
ocol
is a
crit
ical
fact
or to
a su
cces
sful
out
com
e.
Non
-Ste
rile
Fiel
d
Step
1:
• Al
logr
aft M
UST
be th
awed
or
stor
ed (a
t or b
elow
-135
°C)
prio
r to
the
ship
per t
ime/
date
st
amp
othe
rwise
DO
NO
T US
E•
Han
dle
allo
graf
t with
car
e•
DO
NO
T US
E if:
- Allo
graf
t is e
xpire
d
- Allo
graf
t is d
ropp
ed a
t cr
yoge
nic
tem
pera
ture
s•
If th
e Cr
yoSa
fe® p
acka
ging
sy
stem
is c
ompr
omise
d, se
e In
stru
ctio
ns fo
r Use
(IFU
)•
Refe
r to
the
IFU
to re
view
ot
her p
reca
utio
ns
Step
2:
Wea
r eye
pro
tect
ion.
Usin
g in
sula
ted
glov
es o
r tow
els,
gent
ly p
lace
Cr
yoSa
fe p
acka
ging
syst
em o
n a
flat s
urfa
ce
and
rem
ove
from
car
dboa
rd sl
eeve
. (D
O
NO
T al
low
tiss
ue to
slip
off
surfa
ce).
Not
e th
e st
art t
ime.
Air
thaw
for 3
min
utes
.
Step
3:
Fill
larg
e ba
sin w
ith th
ree
(3)
liter
s of w
arm
wat
er o
r sal
ine
and
conf
irm
with
ther
mom
eter
the
tem
pera
ture
is 9
8°
to 1
08°F
(37°
to 4
2°C)
. It i
s not
nec
essa
ry to
m
aint
ain
this
elev
ated
tem
pera
ture
.
Step
4: G
ently
pla
ce C
ryoS
afe
pack
agin
g sy
stem
in la
rge
basin
and
fu
lly su
bmer
ge b
y pl
acin
g to
wel
s on
top.
DO
NO
T m
anip
ulat
e al
logr
aft
durin
g th
awin
g. N
ote
the
star
t tim
e.
Rem
ove
Cryo
Safe
pac
kagi
ng sy
stem
fro
m b
asin
whe
n ic
e cr
ysta
ls ar
e no
t pr
esen
t. Ap
prox
imat
e th
aw ti
me:
25
min
utes
.
Step
5:
Whe
n al
logr
aft i
s co
mpl
etel
y th
awed
, dry
the
outs
ide
of
the
Cryo
Safe
pac
kagi
ng sy
stem
with
to
wel
. Ope
n th
e ou
ter p
ouch
with
sc
issor
s (D
O N
OT
cut t
he m
iddl
e an
d in
ner p
ouch
es).
Rem
ove
the
mid
dle
pouc
h an
d th
e Im
plan
t Sum
mar
y Ca
rd.
3/8
Ster
ile F
ield
Step
6:
Usin
g a
ster
ile m
arki
ng p
en, l
abel
the
two
(2) s
mal
l bas
ins:
“Disc
ard”
and
“he
parin
ized
Lact
ated
Rin
ger’s
”. N
on-s
teril
e te
am
mem
ber s
houl
d as
eptic
ally
pou
r hep
arin
ized
Lact
ated
Rin
ger’s
into
the
corre
spon
ding
mar
ked
basin
in th
e st
erile
fiel
d.
Step
7:
Non
-ste
rile
team
mem
ber
shou
ld in
trodu
ce th
e in
ner p
ouch
to
the
ster
ile te
am m
embe
r by
asep
tical
ly
peel
ing
back
the
mid
dle
pouc
h.
Step
8:
Ster
ile te
am m
embe
r sh
ould
use
ster
ile sc
issor
s to
open
th
e in
ner p
ouch
. Gen
tly p
our t
he
cont
ents
into
the
disc
ard
basin
.
Step
9:
Not
e w
hich
end
cap
and
can
nula
e co
rresp
ond
to th
e in
flow
and
out
flow
bef
ore
rem
ovin
g ca
ps
(see
Lege
nd).
Rem
ove
the
end
caps
from
the
allo
graf
t can
nula
e.
NO
TE: T
he C
ryoV
ein
Saph
enou
s Vei
n, D
oubl
e G
raft
Pack
has
a
conn
ecto
r tha
t allo
ws t
he tw
o al
logr
aft s
egm
ents
to b
e rin
sed
simul
tane
ously
.
4/8
Lege
ndVe
rsio
n 1:
Sa
phen
ous V
ein,
Fem
oral
Ve
in, a
nd F
emor
al A
rtery
Caps
:Bl
ue =
Inflo
w
Red
= O
utflo
wBl
ue =
Inflo
w
Red
= O
utflo
w
Blue
= In
flow
Re
d =
Out
flow
Cann
ulae
:
Vers
ion
2:
Saph
enou
s Vei
n an
d Fe
mor
al
Arte
ryCa
ps:
Can
nula
e:
W
hite
= In
flow
Cle
ar =
Out
flow
Vers
ion
3:
Fem
oral
Vei
n Caps
:Bl
ue =
Inflo
w
Red
= O
utflo
w
Can
nula
e:
Cl
ear =
Inflo
w C
lear
= O
utflo
w
Oth
er C
ardi
ac A
llogr
afts
incl
uded
in th
is p
roto
col (
not p
ictu
red)
: Cry
oVal
ve P
ulm
onar
y Va
lve,
Cry
oPat
ch, C
ryoG
raft
Asc
endi
ng
Thor
acic
Art
ery,
Cry
oPat
ch P
eric
ardi
al S
heet
, and
Cry
oGra
ft P
ulm
onar
y A
rter
y.
Step
10:
Non
-ste
rile
team
mem
ber s
houl
d po
ur o
ne li
ter o
f D5/
LR in
to th
e st
erile
five
lite
r ba
sin. G
ently
pla
ce th
e al
logr
aft i
n la
rge
basin
w
ith D
5/LR
. Usin
g th
e Lu
er-L
ok sy
ringe
, gen
tly
flush
60c
c of
the
D5/
LR fo
r a to
tal o
f thr
ee
(3) t
imes
. Let
allo
graf
t pas
sivel
y rin
se fo
r 15
min
utes
.
Step
11:
Usin
g th
e Lu
er-L
ok sy
ringe
, the
su
rgeo
n sh
ould
gen
tly fl
ush
the
allo
graf
t with
60
cc o
f hep
arin
ized
Lact
ated
Rin
ger’s
and
ch
eck
for l
eaks
. Sur
geon
shou
ld li
gate
the
allo
graf
t as n
eede
d. T
he th
aw a
nd ri
nse
are
com
plet
e.
Step
12:
Disc
ard
the
segm
ents
of a
llogr
aft i
n co
ntac
t with
the
cann
ulae
(inc
ludi
ng th
e co
nnec
tor f
or
the
Cryo
Vein
Sap
heno
us V
ein,
Dou
ble
Gra
ft Pa
ck).
The
allo
graf
t(s) i
s/ar
e re
ady
to im
plan
t.
NO
TE: I
f mor
e th
an 3
0 m
inut
es a
re
expe
cted
to e
laps
e be
fore
the
allo
graf
t(s)
is/ar
e im
plan
ted,
pla
ce th
e la
rge
basin
co
ntai
ning
the
D5/
LR a
nd a
llogr
aft(s
) on
ice
and
cove
r with
ster
ile d
rape
unt
il re
ady
for
use
by th
e ph
ysic
ian.
Flu
sh w
ith h
epar
inize
d La
ctat
ed R
inge
r’s p
rior t
o im
plan
tatio
n.
NO
TE: D
O N
OT
allo
w a
llogr
aft(s
) to
dry
out.
Keep
the
surfa
ce o
f the
allo
graf
t(s)
moi
st b
y w
ettin
g it
with
hep
arin
ized
Lact
ated
Rin
ger’s
if p
art o
f it i
s out
side
the
body
dur
ing
impl
anta
tion.
Non
-Ste
rile
Fiel
dSt
ep 9
: Com
plet
e an
d re
mov
e th
e Im
plan
t Sum
mar
y Ca
rd-P
atie
nt C
opy
and
prov
ide
to p
atie
nt. C
ompl
ete
the
rem
aini
ng
porti
on o
f the
Impl
ant S
umm
ary
Card
and
m
ail t
o Cr
yoLi
fe.
1655
Rob
erts
Bou
leva
rd, N
W, K
enne
saw,
Geo
rgia
, 301
44, U
nite
d St
ates
1-
800-
438-
8285
(Uni
ted
Stat
es a
nd C
anad
a) •
+1-
770-
419-
3355
(Int
erna
tiona
l) •
+1-7
70-5
90-3
753
(Fax
), w
ww.
cryo
life.
com
(Web
site)
Th
e AA
TB A
ccre
dite
d In
stitu
tion
logo
is a
regi
ster
ed tr
adem
ark
of th
e Am
eric
an A
ssoc
iatio
n of
Tiss
ue B
anks
and
is u
sed
with
per
miss
ion
of th
e AA
TB.
Luer
-Lok
is a
regi
ster
ed tr
adem
ark
of
Bect
on, D
icki
nson
and
Com
pany
Cor
pora
tion.
All
othe
r tra
dem
arks
are
ow
ned
by C
ryoL
ife, I
nc. ©
2015
Cry
oLife
, Inc
. Al
l rig
hts r
eser
ved.
5/8
Card
iac:
Tha
w &
Rin
se In
stru
ctio
nsA
orto
iliac
Art
ery:
Tha
w &
Rin
se In
stru
ctio
nsTo
tal E
stim
ated
Tim
e: 3
5 m
inut
es
Cryo
Valv
e Ao
rtic
Hum
an
Hea
rt Va
lve
Cryo
Valv
e SG
Pulm
onar
y H
uman
Hea
rt Va
lve
(Hem
i Arte
ry)
Cryo
Patc
h SG
Pulm
onar
y H
uman
Car
diac
Pa
tch
(Tru
nk
and
Bran
ch)
Cryo
Gra
ftD
esce
ndin
g Th
orac
ic A
rtery
Cryo
Patc
h® S
G
Pulm
onar
y H
uman
Ca
rdia
c Pa
tch
(H
emi-A
rtery
)
Cryo
Arte
ry
Aorto
iliac
Arte
ry
Requ
ired
Supp
lies:
Non
-Ste
rile:
•
Larg
e ba
sin (5
lite
rs)
• Th
ree
(3) l
iters
of w
ater
or
salin
e at
98°
to 1
08°F
(37°
to
42°
C)
• Sc
issor
s•
Pack
of t
owel
s•
Insu
late
d gl
oves
• Pr
otec
tive
eyew
ear
• Th
erm
omet
er
Requ
ired
Supp
lies:
Ster
ile:
• O
ne (1
) lite
r of 5
% D
extro
se
in L
acta
ted
Ring
er’s
(D5/
LR;
at ro
om te
mpe
ratu
re)
• La
rge
basin
(5 li
ters
)•
Smal
l bas
in (0
.5 to
1 li
ter)
• 60
cc L
uer-L
ok sy
ringe
• Sc
issor
s
Oth
er C
ardi
ac A
llogr
afts
incl
uded
in th
is p
roto
col (
not p
ictu
red)
: Cry
oVal
ve P
ulm
onar
y Va
lve,
Cry
oPat
ch, C
ryoG
raft
Asc
endi
ng
Thor
acic
Art
ery,
Cry
oPat
ch P
eric
ardi
al S
heet
, and
Cry
oGra
ft P
ulm
onar
y A
rter
y.
(non
-can
nula
ted
allo
graf
ts)
6/8
Stric
t adh
eren
ce to
this
prot
ocol
is a
crit
ical
fact
or to
a su
cces
sful
out
com
e.
Non
-Ste
rile
Fiel
d
Step
1:
• Al
logr
aft M
UST
be th
awed
or
stor
ed (a
t or b
elow
-135
°C)
prio
r to
the
ship
per t
ime/
date
st
amp
othe
rwise
DO
NO
T US
E•
Han
dle
allo
graf
t with
car
e•
DO
NO
T US
E if:
- Allo
graf
t is e
xpire
d
- Allo
graf
t is d
ropp
ed a
t cr
yoge
nic
tem
pera
ture
s•
If th
e Cr
yoSa
fe® p
acka
ging
sy
stem
is c
ompr
omise
d, se
e In
stru
ctio
ns fo
r Use
(IFU
)•
Refe
r to
the
IFU
to re
view
ot
her p
reca
utio
ns
Step
2:
Wea
r eye
pr
otec
tion.
Usin
g in
sula
ted
glov
es o
r tow
els,
gent
ly p
lace
Cr
yoSa
fe p
acka
ging
syst
em o
n a
flat s
urfa
ce a
nd re
mov
e fro
m
card
boar
d sle
eve.
(DO
NO
T al
low
tiss
ue to
slip
off
surfa
ce).
N
ote
the
star
t tim
e. A
ir th
aw
for 3
min
utes
.
Step
3:
Fill
larg
e ba
sin w
ith
thre
e (3
) lite
rs o
f war
m w
ater
or
salin
e an
d co
nfirm
with
th
erm
omet
er th
e te
mpe
ratu
re
is 98
° to
108°
F (3
7° to
42°
C). I
t is
not n
eces
sary
to m
aint
ain
this
elev
ated
tem
pera
ture
.
Step
4: G
ently
pla
ce C
ryoS
afe
pack
agin
g sy
stem
in la
rge
basin
and
fu
lly su
bmer
ge b
y pl
acin
g to
wel
s on
top.
DO
NO
T m
anip
ulat
e th
e po
uch.
N
ote
the
star
t tim
e. R
emov
e Cr
yoSa
fe
pack
agin
g sy
stem
from
bas
in w
hen
ice
crys
tals
are
not p
rese
nt. A
ppro
xim
ate
thaw
tim
e: 2
5 m
inut
es.
Step
5:
Whe
n al
logr
aft i
s tha
wed
, dr
y th
e ou
tsid
e of
the
Cryo
Safe
pa
ckag
ing
syst
em w
ith to
wel
. Ope
n th
e ou
ter p
ouch
with
sciss
ors (
DO
N
OT
cut t
he m
iddl
e an
d in
ner
pouc
hes).
Rem
ove
the
mid
dle
pouc
h an
d th
e Im
plan
t Sum
mar
y Ca
rd. F
or
Syne
rGra
ft® ti
ssue
, the
labe
l adh
ered
to
the
Impl
ant S
umm
ary
Card
con
tain
s a
Uniq
ue D
evic
e Id
entif
ier (
UDI).
If n
ot
alre
ady
scan
ned,
the
end-
user
has
the
oppo
rtuni
ty to
scan
the
UDI a
t thi
s tim
e.
7/8
Oth
er C
ardi
ac A
llogr
afts
incl
uded
in th
is p
roto
col (
not p
ictu
red)
: Cry
oVal
ve P
ulm
onar
y Va
lve,
Cry
oPat
ch, C
ryoG
raft
Asc
endi
ng
Thor
acic
Art
ery,
Cry
oPat
ch P
eric
ardi
al S
heet
, and
Cry
oGra
ft P
ulm
onar
y A
rter
y.
Ster
ile F
ield
Step
6:
Non
-ste
rile
team
mem
ber s
houl
d in
trodu
ce th
e in
ner
pouc
h to
the
ster
ile
team
mem
ber b
y as
eptic
ally
pee
ling
back
th
e m
iddl
e po
uch.
Step
7:
Ster
ile
team
mem
ber s
houl
d us
e st
erile
sciss
ors
to o
pen
the
inne
r po
uch.
Gen
tly p
our
the
cont
ents
into
the
disc
ard
basin
.
Step
8:
Non
-ste
rile
team
mem
ber
shou
ld p
our o
ne li
ter o
f D5/
LR in
to st
erile
fiv
e lit
er b
asin
. G
ently
pla
ce th
e al
logr
aft
in th
e la
rge
basin
with
the
D5/
LR. L
et
allo
graf
t pas
sivel
y rin
se fo
r 5 m
inut
es.
The
thaw
and
rins
e ar
e co
mpl
ete.
The
al
logr
aft i
s rea
dy to
impl
ant.
NO
TE: I
f mor
e th
an 3
0 m
inut
es a
re
expe
cted
to e
laps
e be
fore
the
allo
graf
t is
impl
ante
d, p
lace
the
larg
e ba
sin c
onta
inin
g D
5/LR
and
the
allo
graf
t on
ice
and
cove
r w
ith st
erile
dra
pe u
ntil
read
y fo
r use
by
the
phys
icia
n.
NO
TE: D
O N
OT
allo
w th
e al
logr
aft t
o dr
y ou
t. D
urin
g im
plan
tatio
n, u
se a
60c
c Lu
er-L
ok sy
ringe
to w
et th
e su
rface
of t
he
allo
graf
t with
D5/
LR a
nd k
eep
it m
oist
.
Step
9: C
ompl
ete
and
rem
ove
the
Impl
ant S
umm
ary
Card
-Pat
ient
Cop
y an
d pr
ovid
e to
pat
ient
. Com
plet
e th
e re
mai
ning
po
rtion
of t
he Im
plan
t Sum
mar
y Ca
rd a
nd
mai
l to
Cryo
Life
.
1655
Rob
erts
Bou
leva
rd, N
W, K
enne
saw,
Geo
rgia
, 301
44, U
nite
d St
ates
1-
800-
438-
8285
(Uni
ted
Stat
es a
nd C
anad
a) •
+1-
770-
419-
3355
(Int
erna
tiona
l) •
+1-7
70-5
90-3
753
(Fax
), w
ww.
cryo
life.
com
(Web
site)
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e AA
TB A
ccre
dite
d In
stitu
tion
logo
is a
regi
ster
ed tr
adem
ark
of th
e Am
eric
an A
ssoc
iatio
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anks
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sed
with
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ion
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e AA
TB.
Luer
-Lok
is a
regi
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ark
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Bect
on, D
icki
nson
and
Com
pany
Cor
pora
tion.
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othe
r tra
dem
arks
are
ow
ned
by C
ryoL
ife, I
nc. ©
2015
Cry
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