Cartiva, Inc
Recommend
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Cycle Num
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Sterilizatio
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INSTRUCTIO
Instructions f
The instructio
preparing no
reprocessor
and materia
trained in or
routine mon
instructions
consequence
REFERENCE
1. AA
for
ma
2. ISO
by
3. WH
Tra
CONTACT IN
C
6
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+
Cartiva
®
is a
c. Document #L2
ded Sterilization Pa
am sterilize using
nd to demonstrate
ximum load configu
mber
e Type
on
ure
Time
Drying Time
rilizers vary in des
uld be verified a
cific sterilizer and lo
en sterilizing multip
sterilizer manufact
ing time may vary
es).
ruments must be a
ch instruments duri
rilized, packaged
ess area that is we
ects, vermin, and te
rilized instrument p
ure that there has b
NCE
ubrication is neede
card blunt, damage
ONS FOR USE
for use are provide
ons provided abov
on-sterile instrumen
to ensure that rep
ls, and that perso
rder to achieve th
nitoring of the pr
should be properl
es.
ES
AMI TIR12:2004. D
r reprocessing in
anufacturers
O 17664: 2004. St
the manufacturer f
HO/DCS/CSR/APH
ansmissible Spong
NFORMATION
Cartiva, Inc.
6120 Windward Par
Alpharetta, GA 300
+1-770-754-3800
MDSS
G
Schiffgra
30175
H
German
registered tradema
20-0275, Rev E
rameters
one of the three fo
e a sterilization a
urations described a
1
Gravity
270°F/132°C
(+5°F / +3°C)
25 minutes
30 minutes
ign and performan
gainst the steriliz
oad configuration b
ple instruments in o
urer’s maximum loa
according to load
adequately cooled
ng the cooling proc
instruments shou
ell ventilated and p
emperature/humidit
packages should b
been no loss of pac
ed.
ed, severely corrode
d with Cartiva
®
Syn
e have been valida
nts for initial use o
processing is perfo
onnel in the repro
he desired result.
rocess. Any devia
y evaluated for e
Designing, testing,
n health care fa
terilization of medic
for the processing
H/2000.3, WHO
giform Encephalopa
rkway, Suite 220
005, USA
GmbH
aben 41
Hannover
ny
ark of Cartiva, Inc.
ollowing steam cyc
assurance level (S
above (AAMI TIR12
2
Pre-Vacuum
270°F/132°C
(+5°F / +3°C)
4 minutes
20 minutes
nce characteristics,
zer manufacturer’s
being used.
one steam sterilizat
ad is not exceeded
size (larger loads
after removal from
cess.
ld be stored in a
provides protection
y extremes.
be examined close
ckage integrity.
ed or severely disc
nthetic Cartilage Im
ated by Cartiva, Inc
or re-use. It is the
ormed using the a
ocessing facility ha
This normally re
ation by the rep
ffectiveness to av
, and labeling reus
cilities: A guide
cal devices —Infor
of resterilizable me
Infection Cont
athies, March 1999
cles. Each has be
SAL) of 10
-6
for
2:2004):
3
Pre-Vacuum
273°F/134°C
(+5°F / +3°C)
3 minutes
20 minutes
, so cycle paramet
s instructions for
tion cycle, ensure t
d.
require longer dry
m the sterilizer. Do
a designated, lim
n from dust, moistu
ely prior to opening
colored instruments
mplant.
c. as being capable
e responsibility of
appropriate equipm
ave been adequa
equires validation a
rocessor from th
void potential adve
sable medical devi
for medical dev
rmation to be provid
edical devices
trol Guidelines
.
een
the
)
ters
the
that
ying
not
ited
ure,
g to
s.
e of
the
ment
tely
and
ese
erse
ces
vice
ded
for
SYMBOL
LS USED IN LABE
ELING
Do not re-use
Consult instructio
Non-sterile
Catalogue numb
Batch code
Date of manufac
CE mark. The pr
Medical Device D
Authorized repre
Manufacturer
ons for use
er
cture
roduct meets the es
Directive 93/42 EEC
esentative in the Eu
Page 2
ssential requiremen
C.
uropean Community
2 of 12
nts of
y