Tornier AEQUALIS - Storage, Handling, Packaging, and Sterilization; Storage and Handling Instructions; Packaging and Sterilization Procedures

operativ
part of t
h
biomec
h
the oper
the bon
e
of sizes
• Intra
o
The cor
r
and the
p
The use
The pro
s
have un
d
The im
p
used ac
c
deterior
a
cement
e
• Posto
The sur
g
- pre
c
- the
pro
s
The Ae
q
for safe
t
Reverse
d
MR env
i
It is rec
o
early si
g
b
e take
n
time of
i
deterior
a
progra
m
8. Stor
a
I MPLA
N
STORA
G
EXPOSE
D
TEMPE
R
HANDL
E
9. Pac
k
The im
p
steriliza
t
An imp
l
passed
m
Every p
r
the imp
l
Ancilla
ry
For ha
n
ancillar
y
should
n
For an
y
instructi
e technique of the
h
e pre-operative e
x
h
anical or other fa
c
ation and the post
o
e
is satisfactory en
o
must be available
o
peratively:
r
ect selection of t
h
p
ositioning of the
of trial pieces all
o
s
theses must not b
d
ergone shock, ab
r
p
lants coated with
h
c
ording to the rec
o
a
tion of the coatin
g
e
d.
peratively:
g
eon must inform
p
c
autions to take in
fact that their wei
g
s
thesis,
q
ualis Adjustable
t
y and compatibi
l
d
shoulder prosth
e
ironment.
o
mmended that a
r
g
ns of wear, loose
n
n
. Normal wear of
i
ts design cannot i
n
a
tion in the chara
c
m
must be designe
d
a
ge and handli
n
N
TS MUST BE ST
O
G
E PLACE MUST
B
D
TO DIREC
T
R
ATURES NOR P
A
E
D WITH CARE TO
k
aging and ster
i
p
lants are suppli
e
t
ion and integrity
o
l
ant whose packa
g
m
ust not be used.
r
ecaution must be
l
ant and during im
p
r
y instruments ma
y
n
dling and steriliz
y
instruments ins
t
n
ot be sterilized.
y
other informati
ons provided for
t
product which is
x
amination, the s
u
c
tors are present t
h
o
perative period.
H
o
ugh to support t
h
at the time of the
h
e type and size o
f
implant are extre
m
o
ws for the proper
e used if their fun
c
r
asion, or other d
e
h
ydroxylapati
t
e (
H
o
mmendations of t
h
g
. The implants c
o
p
atients about:
daily life to guar
a
g
ht and level of a
c
Reversed Should
e
l
ity in the MR e
n
e
ses have not bee
n
r
egular postoperat
i
n
ing of the prosth
e
the implant in res
p
n
any way be con
s
teristics of the im
p
d
and implemente
d
n
g:
O
RED IN THEIR
O
B
E AWAY FROM
H
T
SUNLIGHT ,
A
RTICULAR CO
N
PRESERVE THE I
N
i
lization:
e
d sterile (gamm
a
o
f the packaging
m
g
ing is open or d
t
aken to ensure s
t
p
lantation.
y
be supplied steri
l
ation of non-ster
i
t
ructions. The te
m
on regarding th
e
h
is purpose.
available from th
e
u
rgeon must chec
k
h
at will affect the
c
H
e must also chec
k
h
e implantation. A
n
o
peration.
the implant appr
o
m
ely important.
size selection of t
h
c
tional surfaces h
a
e
terioration.
H
A) must be hand
l
h
e surgical techni
q
o
ated with hydrox
y
a
ntee maximum i
m
c
tivity can affect t
h
e
r prostheses hav
e
n
vironment. The
A
n
tested for heatin
g
i
ve follow-up is u
n
e
sis, etc., and to c
o
p
ect of the state o
f
s
idered to constitu
t
p
lant. A suitable r
e
d
specific to the p
a
O
RIGINAL SEALE
D
H
UMIDITY . I MPL
A
I
ONIZING RAD
I
N
TAMINATION . I
M
N
TEGRITY OF TH
E
a
radiation). The
m
ust be checked.
amaged or whos
e
t
erility when open
l
e.
i
le ancillary instr
u
m
plates are supp
e
ancillary instru
m
e
manufacturer. A
s
k
that no biologica
l
c
orrect conduct o
f
k
that the quality
o
n
appropriate ran
g
o
priate to the patie
n
h
e implants.
a
ve been damaged
l
ed with care and
b
q
ue to avoid
y
lapatite must not
m
plant survival,
h
e life span of the
e
not been evalua
t
A
equalis Adjusta
b
g
or migration in
t
n
dertaken to detec
t
o
nsider the action
t
f
knowledge at the
t
e a dysfunction o
r
e
habilitation
a
tient.
D
PACKAGING . T
H
A
NTS MUST NOT
I
ATION , EXTRE
M
M
PLANTS MUST
E
PACKAGING .
expiration date
e
expiration date
h
ing the packaging
u
ments, refer to
t
lied non-sterile
a
m
ents, refer to
t
s
l
,
f
o
f
g
e
n
t
or
b
e
be
t
ed
b
le
t
he
t
t
o
r
H
E
BE
M
E
BE
f
or
h
as
of
t
he
a
nd
t
he
SYMB
O
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M
A
NUFA
C
TORNIE
10801 Ne
Bloomin
g
USA
Tel: (952
)
Fax: (952
)
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TURER :
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sbitt Avenue Sou
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921-7100
) 236-4007
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