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TECCHNICAL SPECIFICATION

Na
arrow T-MMax Mid Range Sterilizer Series (A
AB)

ATURE SUMMARY
FEA EVICE PIC
DE CTURE
Chhamber volum me from 310 to o 700 liters
SttU capacity 4 to t 10
Working
W pressure meets PED D and ASME requirements
Teemperature range 105 C (2 221 F) to 137 C (279 F)
Electrical steam m generator or external steam source
Usser friendly control system withw touch scre een display
20
0 preset cycle programs
Buuilt-in printer
PCC connection p port for direct PC access
Inddependent pre essure gaugess on front panel
316L stainless ssteel chamberr and door
Chhamber has a mirror-like finish
Sttainless steel piping
p
Coonforms to Me edical Device Directive
D 93/4
42 EEC
Coonforms to standards: EN E 285, EN N13445, ASM ME,
AAAMI/ANSI-ST8 8, UL, EN 610 010-1 & EN 61010-2-040,
Coompany appro oved for ISO 9001:2000, ISO 13485:2003
(M
Medical Device es) and 21 CFR 820
Opptional configu urations availaable

PRO
ODUCT DE
ESCRIPTIO
ON
This autoclave
a serries is design
ned to cover a large field
d of
appliccations for hosspitals, CSSD and medical centers.
c

The autoclave
a series has a cha
amber volume
e range from 310
3
liters to
t 706 liters.

The autoclave
a operrates with saturated steam as the sterilizzing
agent with a tempeerature range from
f 105 C (221F) to 1377 C Narrow T-Max
T Mid Range Sterilizer
(279 F)
and a working pressure that meets PED and AS SME
requirrements. The autoclave is equipped
e with a 24 kW / 32 kW
/ 36 kW / 63 kW W electrical steeam generato or. These ste eam
generrators supply the necessa ary steam forr the sterilization
process. The sterilizer may also be steam fed from an external
m source.
steam

APP
PLICATION
NS
Centra Supply Department (CSSD)
al Sterilizing S
Operaating Theater
Out Patient Clinic

Info
ormation furnished
d by Tuttnauer is believed to b be accurate and reliable.
How d by Tuttnauer for its use.
wever, no responssibility is assumed

Thiss specification is subject


s to change without notice.

Rev. 20-08-2012
2 Tuttnauer - Your Sterilization
S & Infection Control Partners
P Page 1 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)

PRO
ODUCT SP
PECIFICAT
TION VO
OLTAGE SUPPLY
Three phase or one
o phase ele
ectricity supplyy is available.
CHAM
MBER VOLU
UME & SIZE
E
415V 3 Phasse with Neutraal
CHA
AMBER DIMEN OLUME StU
NSIONS VO U 380V / 400V 3 Phase with h Neutral
MO
ODEL
(mm) (lliter) Capac
city 230V 3 Phasse with Neutraal
Widtth Height Depth 208V 3 Phasse without Neutral
220V / 230V 1 Phase *
T-M
Max 4 705 3
310 4
110V / 115V 1 Phase *
T-M
Max 6 990 4
430 6 * Must have building steam supply
s and vaccuum by ejecttor
660
0 660
T-M
Max 8 1295 5
565 8 Fre
equency: 50
0 Hz or 60 Hzz

STEAM G
GENERATOR
R
T-Ma
ax 10 1620 7
700 10 MOD
DEL
POW
WER (kW)
T-Ma
ax 4 24

DOOR SELECTIO
ON T-Ma
ax 6 32
Single door T-Ma
ax 8 36
Do
ouble door (pa ass through) T-Max
x 10 63
Au
utomatic verticcal sliding (con
ntrol on top)
Cu
ustomized electrical specifications are available
a (add
ditional
utomatic doorrs have a rob
All au bust hydraulicc mechanism for
cosst).
operaating doors.
LA
ANGUAGE
anguages including:
The operator diisplay is available in 23 la
SERV
VICE ACCES
SS English, Spanish
h, German, Duutch, Russian,, Chinese, Ara
abic.
From loading side a
and left or righ
ht side.
ST
TANDARDS AND CODE
ES
INST
TALLATION SELECTION
NS Tutttnauer prod
ducts meet the followin
ng provisions
s and
sta
andards:
Ins
stalled in a wa
all [Sing
gle Door]
Caabinet enclosuure [Sing
gle Door] Eu
urope:
Caabinet enclosuure through on
ne wall [Douuble Door] EN
N 285:2006 forr Large Autoclaves
Ins
stalled through two walls [Douuble Door] US
SA:
ST
T8 Hospital Sterilizers
S

ELEC
CTRICAL CO
OMPONENT
TS Dirrectives & Gu
uidelines:
The fo
ollowing parts are located in
n the electric boxes:
b Me
edical Device Directive
D MD
DD 93/42 EECC
Preessure Equipm
ment Directivees PED 97/23 EEC
Thhe Solid State e Relays for the command d of the vacu uum EN
N 13445
pu
ump, and the w water pump. Loww Voltage Dire
ective 73/23
3 EEC
Thhe Circuit Brea
akers for prote
ection of all po
ower circuits. EM
MC Directive 89/336
8
Thhe power supp plies for powe
ering of electroonic circuitry and WEEE & RoHS Directives 200 02/95, 96
so
olenoid valves. FD
DA Clearance
Ann overload swwitch is used to protect the device from high h
ov
verload currents. Safety and EMC C Standards:
Thhe connectio on elements (sockets, plugs, p etc) and IEC
C/UL/EN 6101 10-1:2001, IECC/UL/EN 61010-2-041
co
omponents have a degree of o protection conforming
c to the IEC
C/EN 61010-2 2-040:2005 Auutoclave Safetyy
IP44 protection n level and conform to o the IEC605 529 ENN 61326 EMC
andard.
sta Inte
ernational Pro
otection Level IPx4
ENN 50082-1:97 (EMC) Immu unity Compatibility

Pre el and Steam Generator Construction


essure Vesse
Sta
andards:
AS
SME Code, Seection VIII, Divvision 1, unfired pressure ve
essels
AS
SME Code, Seection I, for boiilers

Goood Practice Standards:


S
ISO
O 17665-1 Validation and Routine
R Contro
ol
STT79 Sterility As
ssurance in He
ealthcare Facilities

Quuality System Standards:


ISO
O 9001:2000 (Quality
( Syste
ems)
ISO
O 13485:20033 (Quality Systtems for Mediccal Devices)
21 CFR 820

Rev. 20-08-2012
2 Page 2 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)
CHAM
MBER CONSTRUCTION
N
Materrials Safety Valves: Both chamb ber and jacket are equippeed with
The sterilizer
s cham
mber is constrructed from solid,
s high qua
ality preessure relief safety valvess. If the pre essure exceed
ds the
materrials. Chambeer and door thiickness is no less
l than 6 mm
m. allo
owed limit then the safety va
alves will discharge.

dard Configura
Stand ation Materialss: Buuilt-in Steam Generator Safety: A water w level control
c
Chammber + Door: 316L stainless steel sysstem maintain ns a constan
nt water level that ensures safe
opeeration of the heaters. Furthermore, a sensor
s ensure
es that
Jacke
et: 304L stainless steel the
e heater does not operate without
w a minim
mum water inta
ake.

nal Materials ((Stainless Ste


Option eel): Emmergency Shu ut-Off: Easily y accessible emergency
e sw
witches
Chammber + Door: 316Ti for immediate cyycle shut-off.
Jacke
et: 316L or 316Ti
ouble Indepen
Do ndent Monito oring: The coombined digittal and
me
echanical monnitoring systemms provide a cross-referenc
c ce and
Cham mber Design
gua
arantee accurrate monitoring
g of temperatu
ure and pressuure.
The chamber
c is fully jacketed. The chambe er floor is slig
ghtly
slopedd towards an internal drrain to facilitate drainage. A
stainle
ess steel meesh strainer protects the drain port frrom
blockaage by debriis. The cham mber is moun nted on a steel WA
ATER RING VACUUM PUMP
P
frameework which is height adjustable. The vacuum pum mp effectively removes morre than 99% air
a from
e chamber. Th
the he pump is mounted on a damping
d mech
hanism
Door Gasket to minimize
m vibra
ation.
Manual hinged doo or gasket: a silicone
s gaske
et is permane
ently
fixed in
i the door. Duuring vacuum action
a the flow
w path of the fluids is throu
ugh the
conndenser (heatt exchanger) and the vacu uum pump/ejector to
matic sliding door
Autom d gasket: a silicone gassket is fixed in a dra
ain. This prrotects the vacuum
v syste
em from exc cessive
groove in the door frame and the gasket is seealed against the tem
mperatures.
door by
b means of steam pressure e.

Surfaace Treatmentt PIP


PES & COM
MPONENTS
A passsivation layer is applied to the
t internal su urface through
h an The piping systeem of the autoclave consistss of air-operated ball
electro
o-chemical tre
eatment which h results in a smooth
s and sh
hiny vallves, which co
ontrol the cond
densate and stteam flow in and
a out
stainle
ess steel. Thhe resultant su urface is polisshed to less than of the
t chamber, operates the vacuum,
v and tthe air inlet va
alve.
0.8 m
which is highly proteccted against corrosion. The T
internal corners are
e rounded to aid
a cleaning. andard configu
Sta uration:
Pip
ping and fitting
gs: d stainless steel
304 threaded
Chammber Heating Co
omponents*: Brass
The fully
f b steam in the
jacketed chamber is pre-heated by
jackett. ptional configuration (stainle
Op ess steel):
Insulaation Primary piping & fittings **: 316 + triclamp fittings
The sterilizer jackett and door are
e completely innsulated with a 1" Primary compon nents: 316 triclampss or 316 threa
aded
de free glass wool thereby keeping the autoclave
chlorid a cool on
the outside. Custo omized thickeer insulation is
i optional. The
T * Components Manual valvve, non-returnn valve,
ation is comple
insula etely enclosedd within a stain
nless steel cov
ver. gulator, pneum
pressure reg matic valves, steam trap, etcc.

nsulation redu
The in uces the energ
gy consumptio
on by keeping the ** Primary pipin
ng system thatt connects to tthe chamber
heat inside the jackket and chamb
ber. up to and inc
cluding the firsst valve.

SAFE
ETY FEATUR
RES PR
RESSURE GAUGES
G
Door Safety Syste ems: The single door configuratio on has two pressure
p gaugges
loccated on the front
f panel (lo
oading side) that
t indicate the
t
A pneumatic safety comp ponent (pressure switch) is
preessure in the chamber
c and jacket. The ppressure gaug ges
stalled in the autoclave which
ins w preventss opening of the
for the door ga asket and th he steam gen nerator line are
a
dooors until prressure in the t chamber reaches ro oom
loccated on the autoclave's side
e panel.
pressure.
Chhamber doorr cannot be opened wh hen chamberr is All pressure gau oved to the front
uges can be optionally mo
pressurized. pannel.
Stteam is not allowed
a into th
he chamber when
w the dooor is
oppen. The double door configuration
n has two add ditional pressu
ure
A cycle cannott start if the door is open n or not properly uges on the unloading
gau u sidee that indicate
e the pressuree in
cked.
loc the
e chamber and
d the pressure in the gaske et of the secoond
doo
or.
Thhe sliding door movementt will stop im mmediately if an
obbject is detecte
ed in the way of the closing door.
Doouble door saffety is implemented through h interlocks wh
hich
prevent both do oors from being g opened simultaneously.

Rev. 20-08-2012
2 Page 3 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)
VALIDATION PO
ORTS CIT
TY TAP WA
ATER CONSU
UMPTION
The chamber
c is pro
ovided with tw
wo 1" threadedd connections s for Average Con nsumption
M
Model
optionnal vacuum/pressure gaug ges and testt sensors. The T (liters/c
cycle)
Valida ation Ports aree each found on
o the right an
nd left side of the T-Max 4 160
0
sterilizzer from the co
ontrol side. T-Max 6 210
0
T-Max 8 210
0
AIR FILTER
F T-Max 10 260
0
A disp posable micro obiological air filter is provid
ded to filter all air No
ote: Tuttnauerrs optional wa ater recycling system (men
ntioned
entering the sterilizer chamber. The air is use ed to equalize the on page 9) signifficantly reduce
es water usagge.
chamber pressure to atmospherric pressure a at the end of the
sterilizzation cycle.
CO
ONTROL SYSTEM
S (
(ALLEN-BRADLEY)
or a particle sizze of 0.2 m.
The filter is rated fo The controls sysstem is based
d on the Allen Bradley MicrroLogix
11000 PLC platfo
form, and con ntrols and moonitors the phhysical
parrameters of the sterilization process, and perform ms the
opeeration seque
ence of the maachine, accord
ding to the se
elected
STE
EAM SUPP
PLY pro
ogram, and feaatures:
The autoclave
a is su
upplied with either
e a steam
m generator orr an Data acquisittion from 10 digital
d inputs: four
f PT100 se ensors,
option
n to connect to
o building stea
am supply. A combined option four 4-20mA A analog in nputs, and tw wo 010V analog
a
of stea
am generator and building steam
s supply is also availab
ble. inputs
Digital inputss and outputs for
f sterilizer coontrol
Additional specializzed steam sup
pply configurattions are listed
d in Analog inputss from multiplee temperature e and pressure e
pecial Optionss and Accesso
the Sp ories section below.
b Measures chamber
c presssure, jackett pressure, steam
generator prressure, door gasket presssure, and refe erence
Steamm Generator: supplies stea am for the sterrilization proce
ess. temperature
The stainless
s steel steam gene erator is an electrically hea ated Communicattion via a se erial port or ana Ethernet 10/100
type generator
g equ
uipped with immersion he eaters, divided d in communication port (on so ome configura ations)
three--phases. The electrical system of the ste eam generato or is Analogue sensor calibratio on
locate
ed in a separatte electric boxx. Fo mode
Barcode read ding
Waterr to the steamm generator isi supplied byy a single-phase FLASH mem mory and rea al-time clock backup store e cycle
pump, from a wate er reservoir, which
w is conne
ected to a sou
urce data for at least 5 years ev
ven if there is a power failurre
neral-free wate
of min er.
The system inc cludes an addditional memmory device which
conntains: the updated
u softwa
are, offset an
nd gains, and in the
STEA
AM GENERA
ATOR WATE
ER QUALITY
Y casse of software or controll error will reload the so oftware
Variou us water systems can be e used to sup pply mineral-ffree auttomatically.
water to the steam generator such as Reverse Osmosis (R RO),
ed water, etc. Water sup
distille pplied to the steam genera ator The control sysstem controls s all system functions, mo onitors
should d be in com mpliance with the EN 285 standard wh hich sysstem operationns, both visua
ally and audibly alerts the op
perator
includdes the followin
ng hardness and
a conductiviity requiremennts: of cycle malfu unctions and,, on demand, provides visual
Ha ardness < 0.1 mmol/l dication of the chamber temperature and pressure.
ind
Co onductivity < 5
50 S/cm

Note: Soft water shhould not be used


u since its use may result in TE
EMPERATUR
RE AND PRE
ESSURE SE
ENSORS
sion of the steam generatorr and chamberr.
corros The temperaturre and pressure measurin ng circuits are
e both
line
ear and desig
gned with com
mponents having a high pre
ecision.
The PT100 se ensors conforrm to Class A of the IE EC751
STEA
AM GENERA
ATOR WATE
ER CONSUM
MPTION staandard.

Whhen the exh haust tempe


erature increaases above 40C
Consumption
del
Mod (measured by a PT100 senso aust drain) then tap
or at the exha
(liters/cycle)
ater is mixed with
wa w the exhaust to drain.
T-Ma
ax 4 24
T-Ma
ax 6 36 The control sysstem allows fo
or the calibra
ation of tempe
erature
T-Ma
ax 8 54 and pressure to be performed
d digitally.
T-Ma
ax 10 60 Each sensor cirrcuit is calibra ated with individual consta
ants to
corrrect the devia
ation in manuffacturing and aging.
a

The system uses FLASH mem mory in which


h the offset an
nd gain
VACU
UUM AND D
DRAIN COOL
LING WATE
ER QUALITY
Y datta of the sens
sors are stored
d. This data may
m be entere ed into
City ta
ap water supp ply: the
e system, throough program mming or through the autoclaves
Ha ardness betwe een 0.7 and 2 mmol/l tou
uch screen con ntrol panel.
Th he tap water pressure sh hould be in tthe range off
3 5 bar (40 - 7
72 psi)
Re ecommended temperature: 15C

Rev. 20-08-2012
2 Page 4 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)
CONT
TROL PANE
EL AL
LARMS
Contrrol and Monittoring The autoclave usesu both auddible and visu
ual alarm indic
cators.
Automatic proce ess checking and
a failure detection are provided
The control
c system
m is operated via an easy to
t use full colour by the control system.
s In th
he event of a failure durinng the
touch screen (7 TFFT LCD) founnd on the operator control side
s steerilization cycle
e, the system enters an alaarm phase which will
(loading side). saffely end the process auto omatically. Th
he range of alarms
a
inccludes:
ouch screen ccontrol panel supports
The to s 23 lan
nguages.
Temperature e & pressure sensor
s failure
Twelvve password a access levels (0-12) are prrovided to con ntrol Phase time-o outs
accesss/operation o of the mach hine preventinng unauthorized Door(s) not properly
p closed
d
accesss. These accessa levelss are custommizable. Acccess Power failuree
contro
ol can be appllied to the following functions operated frrom No water in the
t water rese ervoir
the co
ontrol panel: Optional utilitty alarms: noo water / no steam
s / no air
run nning test cyccles
se ensor calibratioon, service and maintenancce
cycle selection, cycle start, cu ustomizing cyccle parameterss CY
YCLE DOCU
UMENTATION - PRINTER
R
18 8 preset sterilizzation program ms and 2 preset test programs hich prints a detailed
The autoclave iss equipped witth a printer wh
do oor control hisstory of each cycle performmed by the instrument. Various
V
tessting inputs an nd outputs typ
pes of printeers are listedd in the Sp pecial Options and
Accessories secction towards the
t end of thiss document.
With the standard d factory con nfiguration, ca
alibration of the
tempe erature circuitts and calibra
ation of the pressure circcuits The printing format is 24 characters per line. The folllowing
requirre an access ccode. ormation and
info d set param
meters are printed when the
ste
erilization cycle
e begins:
Doublle door autoclaves are provvided with two status indicattors
on the
e unloading sid
de. Autoclave se erial number, lo
oad no., namee
Software verrsion
The operators
o conttrol panel (TFT
T LCD) is found at the load
ding Real time
side of
o the sterilizerr. Selected program
Sterilization temperature,
t pressure,
p and time
Dry time
Alarms

Thereafter, the autoclave sta arts performinng the sequence of


opeerations of the cycle. The measured values of tempe erature
andd pressure arre printed at fixed
f time inte
ervals, accord
ding to
varrious phases of the steriliization processs: 4 minute e time
inte
erval for vacuum, 1 minute time interval for sterilizatio
on, and
the
e start and ennd time of the drying phase e. All interval times
cann be user deffined. Furtherrmore, the cusstomer may re equest
cusstomized timee intervals prior to order delivvery.

The data is printted from the bottom


b up, beg
ginning with th
he date
d ending with
and h O.K. for a complete cyccle or FAIL for an
abo
orted cycle.

OP
PTIONAL LOADING
G EQUIPMENT
Tw
wo Pull Out Trrays
Operators
O Control Panel (To
ouch Screen) Sta
ainless steel trays equipped
d with tracks for
f easy loadin ng and
unlloading. The tracks are deesigned to preevent the trayys from
rollling over.
ollowing inform
The fo mation is displayed:
Loading Cart an nd Transfer Carriage
C
Te emperature, ch hamber pressure and jacke et pressure
The loading cartt rolls off the trransfer carriag
ge onto the ch
hamber
Do oor status
raills for easy han
ndling of heavvy loads.
Stterilization time
e count down
Au utoclave statu us: standby, ready, pre-vvacuum, heatting, The transfer carriage
c usess heavy dutyy revolving wheelsw
ste
erilization, exh
haust, dry time
e, air inlet, cyccle ended astors) to ma
(ca aximize mobility in limited space, and wheel
Dissplay of inpu uts and outp puts with oth her maintenance braakes to prevennt rolling. The ere is a lock to
o prevent the lo
oading
fun
nctions carrt from slidinng. The legss of the tra ansfer carriagge are
Vieew of alarmss history and general hiistory log (2000 adjjustable to match
m the heigght of the loading cart with the
rea
adings) tracks in the sterrilizer chambeer.
dooor/s status
cycle graph disp play with zoomm Both the loading
g cart and transfer carriage are
a made of durable
d
cycle name, cyccle parameterss SI 304 or AISI 316 stainlesss steel.
AIS
usser messages
See Special Opttions and Acce
essories sectio
on for more op
ptions.

Rev. 20-08-2012
2 Page 5 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)

STE
ERILIZER D
DOCUMEN
NTATION Proogram 8, 9, 10 with Slow 121: 1
A nummber of copiess of the manua als are provided. Operator and Maaterials which h require a slow
s pressurre exhaust inn open
servicce manuals arre in selected language. Otther manuals are or closed conta ainers (not se ealed).
in Engglish. Manualss include elecctrical and piping diagram. For loads which its manufactu urer declares to be in comp
pliance
witth the following
g sterilization conditions:
ermore, a CD is provided co
Furthe ontaining the following:
f
Sterilization
n temperature 121 C
Op perators manu ual
Sterilization
n time 15 minu
utes (programss 8 and 9)
Te echnical manu ual
Sterilization
n time 30 minu
utes (program 10)
Se erial number foor specific auttoclave
Slow exhau ust
XP PCS software for calibration n and softwaree download
Slow discha arge of pressu
ure
Fa actory test rep
port prior to shipping
Op ptional - techn
nical specificattions for comp
ponent, etc.
TE
EST CYCLE PROGRAMS
S
Proogram 11: Bo owie & Dick Test
T
STE
ERILIZATIO
ON PROGRAMS This program iss intended to test the efficiency of air re
emoval
The autoclave
a is su
upplied with 20
2 sterilization
n programs an nd 2 from within the chamber.
c
test programs. An authorized us ser can change the parametters
of eacch program cyycle. The vacu uum pulses (nnumber of pulsses, Test parameterss:
the depth and heiight of each pulse, and the pulse pro ofile: Sterilization temperature 134
1 C
negative pulse, possitive pulse, orr mixed negattive and positiv
ve), Sterilization time 3.5 minu
utes
the attmospheric prressure value, and the pre essure profile are Fast exhausst
also programmable
p e. There are 6 selectable exhaust mod des. Drying time of 2 minutes
The cycle programss are summarized as followss:

Progrram 1 with Fa ast 121: Proogram 12: "A Air Leakage Test
T (Vacuum m Test)
Unwrrapped rigid (instruments)), etc. This program is intended to te
est air leakage from the ch
hamber
oads which its manufacturer declares to be in compliance
For lo ough the do
thro oor seal or any
a other seeals. This test
t is
with th
he following stterilization con
nditions: perrformed during
g the vacuum phase.

Sterilization tem
mperature 121
1 C
Sterilization tim
me 15 minutes
Fast exhaust
Drying
D time 1 mmin
MA
AINTENAN
NCE / SER
RVICE PLA
AN
A global netwo ork of skilled service speccialists can provide
p
perriodic inspections and adju ustments to help assure loow-cost
pea ak performancce. A detailedd service and maintenance plan is
Progrram 2 and 3 with
w Fast 134:
inccluded in the operator
o manu ual.
Unwrrapped rigid (instruments)), etc.
oads which its manufacturer declares to be in compliance
For lo
with th
he following stterilization con
nditions:

Sterilization tem
mperature 1344 C PA
ACKAGING FOR SH
HIPMENT
Sterilization tim
me 3 minutes The sterilizer is packed d in a w
wooden crate
e for
Fast exhaust shiipping/transpo
ortation.
Drying
D time 1 mmin

Progrram 4 and 5 with


w Dry 134: W
WARRANTY
Y
Wrapped materials s (instrumentts), porous lo
oad, etc. Tutttnauer warra
ants that ea ach device is carefully tested,
t
oads which its manufacturer declares to be in compliance
For lo insspected and that it leavess the factory in proper working
w
with th
he following stterilization con
nditions: con ndition.
Sterilization tem
mperature 1344 C Tutttnauer certifie
es that the devvice is guaran
nteed to be fre
ee from
Sterilization tim
me 7 minutes deffects in material and wo orkmanship, forf one yearr from
Fast exhaust insstallation date but not more e than 18 mo onths from sh hipping
Drying
D time 15 min datte, against fa aulty compon nents and assembly. Exttended
waarranty periods s are optional.
Progrram 6 with Drry 121: The warranty do oes not includde and does not replace routine
r
Wrapped materials s (instrumentts), porous lo
oad, etc. treatment and preventive maintenance to be perfformed
oads which its manufacturer declares to be in compliance
For lo acccording to "Preventive and Period dical Mainten
nance"
with th
he following stterilization con
nditions: insstructions men
ntioned in the device's
d accom
mpanying mannual.
Sterilization tem
mperature 121
1 C The user must ensure that all utilities used,
u includin
ng the
Sterilization tim
me 15 minutes ater, meet all
wa a the spec cifications mentioned
m in the
Fast exhaust operator manua
al.
Drying
D time 15 min
The user is subjject to the fulll warranty sta
atement found in the
doccumentation delivered
d with the equipmen nt.

Rev. 20-08-2012
2 Page 6 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)

UTIL
LITY DATA
A / REQUIREMENTS
S
Exterrnal Steam So ource Minneral-Free Fe eed Water forr Steam Gene erator
1. 97 100 % dry ssaturated stea am 1. Water intend ded for the ste
eam generatorr must have a water
2. Preessure 4 to 6 Bar quality in acccordance with EN285/ISO 17665.
3. Finnal steam pipe e to the autoclave at least pipe 1" 2. Install 1/2" piipe with a shut-off valve at its end
4. Insstall a shut-offf valve at end of
o steam pipe 3. Regulations may require a Back-Flow prrotection devicce
5a. T-Max
T 4 steam
m rate (water supply) 30 Kg//hour 4a. T-Max 4 min neral-free wate
er supply 30 liiters/hour
5b. T-Max
T 6 steam
m rate (water supply) 46 Kg//hour 4b. T-Max 6 min neral-free wate
er supply 46 liiters/hour
5c. T-Max 8 steam m rate (water supply) 46 Kg//hour 4c.. T-Max 8 min neral-free wate
er supply 46 liters/hour
5d. T-Max
T 10 steam m rate (water supply) 80 Kg g/hour 4d. T-Max 10 mineral-free
m wa
ater supply 80 liters/hour

Electrrical Tap Water


With generator
g (all models) 1. Intended for vacuum pump p and cooling
3-Phase, 208 / 2 220 / 230 / 380 / 400 / 415 Volt,
V with or 2. Install 3/4" piipe with shut-o
off valve at its end
without neutral, 24 kW / 32 kWW / 36 kW / 63 3 kW 3. 1 4 bar preessure supply at approximattely 15C
4. Local regulattions may requ uire a Back-Fllow protection
Witho
out generator ((all models) device
Note: must have bu uilding steam supply 5. Hardness (fre ee of alkaline earth ions) shhould be betwe
een
3-Phase, 208 / 220 / 230 0 / 380 / 4 400 / 415 Volt,
V 0.7 mmol/l and 2.0 mmol/ll
with or without n
neutral, not les
ss than 10 A 6. Supply: app proximately 17 7 l/min
1-Phase, 110 / 115 / 220 / 230 2 Volt, with neutral, not less
l
an 10 A, vacuum by ejectorr
tha

Additional customizzable electrica ns are available.


al specification Coompressed Aiir
1. At least 3/8" hose to supply the compresssed air
2. The compres ssed air suppply line cominng from the building
b
Drainage (Sewage e) must have a shut-off valve e
1. Att least 2" sewa
age pipe. 3. Pressure: 5 to 8 bar, frree from liquid water, filte ered to
2. Thhe sewage shall be ab ble to withsttand continuous 25 m, free from
f oil drople
ets greater tha
an 2 m
temmperature of 880 C and for short time perriods at 100 C
C.
3. Ea
ach autoclave will have a se eparate sewag ge line conneccted
to a vertical ven
nt pipe. Vertical pitch is 100
00 mm. Am
mbient Tempe erature
Pla
ant room temp
perature shoulld be in the ra
ange from 5 to
o 40 C
Note: Local national regulations
s may require that the drain
n be and
d 85% RH (relative humidityy).
tapped and ventedd, and not con nnected to other drains whhich
may cause
c back prressure or obstruct flow. AAn air break may
m Flo
oor
also be
b necessary. The unit mass sh hall be considered no less than
t 10000 N//m
2

acccording to the DIN 58949-7:2004 standarrd.


Ventilation
10 air replacementss per hour

ERALL EX
OVE XTERNAL DIMENSIO
D ONS
DOOR CO ONFIGURATION EXTERNAL DIMENSION
NS (mm)
MODEL
Door
D Type N of Doors
No. Width
W Height Depth
h
1 1030
0
T-Max 4 Verrtical Sliding 9
999 1980
2 1050
0
1 0
1400
T-Max 6 Verrtical Sliding 9
999 1980
2 1310
0
1 1690
0
T-Max 8 Verrtical Sliding 9
999 1980
2 1682
2
1 2100
0
T-Max 10 Verrtical Sliding 9
999 1980
2 1950
0

Note:
Upon requ
uest Tuttnaueer can provid
de special configuration so that the autoclave will fit through na
arrow
passage-w
ways / elevators during transportation in and out of buildings.
Dimensions may chan nge from time dated drawings are availa
e to time - upd able

Rev. 20-08-2012
2 Page 7 of 9
TECH
HNICAL SPECIFICA
S ATION
T-M
Max Mid R
Range Steerilizer Series (AB
B)

PRO
OGRAM CY
YCLE DAT
TA Note: All
A 20 program cycles are cus stomizable. Number of pulsess, the depth & height of each pulse,
and pullse profile (neg
gative pulse, po
ositive pulse, or
o mixed negattive & positive)) can be config
gured.

Progra
am 1 with Fast 121 Unwrapped rigid (instrume
ents), etc.
Parameters Units Range Factory Seetting
Par 1, 2 1. Sterilization Temperature C
C 105 - 137 121
2. Sterilization Time min 1 - 99 15
3. Exhaust Mod de 1-6 1 (fastt)
4. Drying Time (Post-Vacuum) min 0 - 99 1
Notes:
Par 3, 4
Residual air is displaced by 4 va
acuum pulses (dowwn to 25 kPa) andd 3 steam pulses up
u to 160
Atmosspheric
kPa. When the e pressure reache
es atmospheric pre
essure, the vacuuum pump is activatted until
Pressu
ure
the pressure drrops to 25kPa.
Progra
am 2 and 3 with
h Fast 134 Unwrapped rigid (instrume
ents), etc.
Parameters Units Range Factory Seetting
P 1, 2
Par 1. Sterilization Temperature C
C 105 - 137 134
2. Sterilization Time min 1 - 99 3
3. Exhaust Mod de 1-6 1 (fastt)
4. Drying Time (Post-Vacuum) min 0 - 99 1
Notes:
Par 3, 4 Residual air is displaced by 4 va
acuum pulses (dowwn to 25 kPa) andd 3 steam pulses up
u to 160
Atmosspheric
kPa. When the e pressure reachess atmospheric pre
essure the vacuumm pump is activateed until
Pressu
ure the pressure drrops to 25 kPa.
Progra
am 4, 5 and 7 w
with Dry 134 Wrapped ma
aterials (instruments), porous
s load, etc.
Parameters Units Range Factory Seetting
P 1, 2
Par 1. Sterilization Temperature C
C 105 - 137 134
2. Sterilization Time min 1 - 99 7
3. Exhaust Mod de 1-6 1 (fastt)
4. Drying Time (Post-Vacuum) min 0 - 99 15
5. Dryvac Time e min 0 - 99 5
Notes:
Par 3, 4, 5 Residual air is displaced by 4 va
acuum pulses (dowwn to 25 kPa) andd 3 steam pulses up
u to 160
Atmosspheric
kPa. When the e pressure reachess atmospheric pre
essure the vacuumm pump is activateed until
Pressu
ure
the pressure drrops to 25 kPa.
Progra
am 6 with Dry 1
121 Wrapped ma
aterials (instruments), porous
s load, etc.
Parameters Units Range Factory Seetting
P 1, 2
Par 1. Sterilization Temperature C
C 105 - 137 121
2. Sterilization Time min 1 - 99 15
3. Exhaust Mod de 1-6 1 (fastt)
4. Drying Time (Post-Vacuum) min 0 - 99 15
5. Dryvac Time e min 0 - 99 5
Notes:
Par 3, 4, 5 Residual air is displaced by 4 va
acuum pulses (dowwn to 25 kPa) andd 3 steam pulses up
u to 160
Atmosspheric
kPa. When the e pressure reachess atmospheric pre
essure the vacuumm pump is activateed until
Pressu
ure
the pressure drrops to 25 kPa.
Progra
am 8, 9, 10 with
h Slow 121 Liquids: slo
ow pressure ex
xhaust for open
n or closed con
ntainers
Parameters Units Range Factory Seetting
Par 1, 2 1. Sterilization Temperature C
C 105 - 137 121
2.a Sterilization
n Time (program 8 and 9) min 1 - 99 15
2.b Sterilization
n Time (program 10)
1 min 1 - 99 30
Par 3 3. Exhaust Mod de 1-6 4 (sloww)
Notes:
Residual air is displaced by 1 vaacuum pulse (down to 25 kPa). A slow exhaust is use ed to
discharge presssure from the cha amber very slowly. Exhaust time is dependent on loa ad
Atmospheric
volume and configuration of containers. This prog gram is not design
ned in accordance e with the
Pressu
ure
EN285 and mu ust not be used forr routine sterilization of medical devvices.
Progra
am 11 Bowie & Dick Test Efficiency te
est of air remov
val from within
n the chamber
Facctory
Units Ra
ange
Parameters Settting
P 1, 2
Par 1. Sterilization Temperature C - 134
2. Sterilization Time min - 3
3.5
3. Exhaust Mod de - 1 (fast)
(
4. Drying Time (Post-Vacuum) min - 2

Notes:
Par 3, 4 Residual air is displaced by 4 va
acuum pulses (dowwn to 25 kPa) and d 3 steam pulses up
u to 160
Atmospheric kPa. Drying is performed during g a "low-pressure" phase. When the e pressure reachees
Pressu
ure atmospheric prressure the vacuum pump is activatted until the presssure drops to 25 kPa. Only
the number and d type of vacuum pulses can be moodified.
Progra
am 12 Air Leakage/Vacuum Test
T Air leakage ttest to chambe
er through doo
or and other seals
Parameters Units Range
e Factory Setting
S
Atmospheric 1. Stabilizing Time
T m
min - 5
ure
Pressu 2. Test Time m
min - 10
Par 1,
1 2
Notes:
Chamber vacuum is brought to 10
1 kPa. Thereafte er all valves and motors
m are closed for 5
minutes enabling pressure stabilization. The acce
eptable pressure change
c over the fo
ollowing
5 min 10 min 10 minutes is 1.3
1 kPa.

Rev. 20-08-2012
2 Page 8 of 9
TECH
HNICAL SSPECIFICA
ATION
T-M
Max Mid RRange Steerilizer Series (AB
B)

SPE
ECIAL OPT
TIONS AND ACCESSORIES ADVANCED OPERATION
O N FEATURES
Multipurpose Valve
V
ADVA
ANCED CON
NTROL FEA
ATURES Coompressed air operated con ntrol valve dra
ains the water//steam
10 TFT (LCD) Tou uch Screen an
nd releases prressure in ord der to open thee chamber if a cycle
Upgra
ade from 7 to 10.4 touch screen. failure occurs due to electric power failure.

Indeppendent Cycle e Documenta ation ual Steam So


Du ource Valve
Pa anel printer To pply and backup steam generator.
o connect central steam sup
Tw wo probes P PT1000 and PT100 allow w detection of
te
emperature da ata so that they y can be printed out. oot Pedal to Open
Fo O Door
HA ACCP function n key Th
he foot pedal feature
f allowss one to open the
t door by fo
oot.
Tw wo digital inpu
uts for starting
g, storing and d terminating the
t
cyycle program Au
utomatic Res start and Shu utdown
Re eal Time clockk Fe
eature enable es a preprogrrammed resta art and/or complete
RS S232/RS485/T TTl serial interrfaces sh
hutdown of utiilities at cycle end or set tim
me, closing alll utility
9 tot 40 VDC pow wer inputs va
alves, returning chamber an nd jacket to am
mbient temperature.

Superrvisory Contrrol and Data Acquisition


A S
Software
Comp plete superviso ory control an
nd data acquisition. Provid des ADVANCED STEAM
S REL
LATED OPTIONS
superv vision control, data logger and remote control
c of up to Auutomatic Blow Down
16 auutoclaves. The e software creeates an electtronic file (SN
NP) Auutomatic drain
nage can be accomplished
a tthrough the usse of a
accesssible with su uitable data software succh as Microssoft prrogrammable timer
t .
accesss and SQL to show real tim me data. Possibility to produuce
reportts monthly or per cycle. The price incluudes a standa ard Seeparate Connnection to Jac cket and Cha amber
PC with
w Windows license and all the softw ware install anda Ennables reaching sterilizatio
on at a fasterr rate and imp proved
tested
d in the factoryy. temperature control when wo orking with liquids, especiallly with
050C and less. This feature
10 e is vital for cle
ean steam sys
stems.
Two Color
C Printer
Printeer IDP3550 Se erial dot impa
act, two colorss black/red, hiigh
speed d printing 3.6 lines/sec, 7 X 9 matrix 40 columns, 76m mm ACCESSORIE
ES
roll pa
aper, paper auuto loading. Aiir Compressoor
Fo
or operating the pneumattic valves and automatic door/s
RS Loogic500 (Softtware) (m
must be orderred if there is
s no local sou
urce of compressed
The software
s licensse provides acccess for trou
ubleshooting and
a air).
PLC code
c modificaation. This item is aimed at a an authoriz
zed
dealerr technician off the dealer to allow timeoutt access. Ho
otwell
Th
he hotwell he eats water to about 80-90
0C to remove
e non-
Graph hic Printer - D
DPU 414 co
ondensable gases
g prior to
o being pummped to the steam
The DPU-414 is a silent hig gh-quality prin
nter that prinnts ge
enerator or ste
eam-to-steam generator.
characters and high h-density grap
phics. The DPU-414
D printss a
ed history of each
detaile e cycle perrformed by the
e instrument. Biio Shield Frame
Thhe sterilizer is
s surrounded by a frame which serves s as a
Chartt Recorder (Inndependent Microprocess
M sor Control) prreparation for a cross-conta
amination seal made of Neo oprene
A high
h-speed chart recorder, withh independentt microprocesssor sh
heet that is attached betweeen the frame a
and the wall att site.
contro
ol and power supply, is su uitable for ind
dependent cycle
docummentation. Th his multi-range
e input recorde
er can record 12 Water Recyclin
W ng System
points
s at once fro om RTDs and d DC voltage e input signaals, Thhis system reccycles water necessary
n for the heat exch
hanger
producing analog trend record ds and printt-outs. Simp
ple to cool down the steam exha aust from the chamber.
c Thee water
operation with an easy-to-view display allow ws one to keyy-in aving system recycles the water and reu
sa uses it. Tuttn
nauer's
us items of set data. The unit
variou u operates independentlyy of waater saving syystem saves more than 50 0% of the tapp water
the au
utoclave (oblig
gatory for meeeting EN285). ussed.

Back--Up Cycle His story


Flash memory can produce a da aily file which includes a log
g of C
CONTACT INFORMA
ATION
every 20 seconds. The device contains
c view
wer software and
a
In
nternational Sales
S and Marrketing
installation instructiions. It can store
s an immeense amount of
E--mail: info@tu
uttnauer-hq.co
om
cycle data.
W
Website: www..tuttnauer.com
m

Tu
uttnauer Euro ope b.v.
Paaardeweide 36 6, 4824 EH,
P..O.B. 7191, 48
800 GD Breda a
Th
he Netherland ds
Te
el: +31 (0) 765
5 423 510 Fa ax: +31 (0) 765
5 423 540
E--mail: info@tu
uttnauer.nl

Tu ur Sterilization & Infection Control Partnerrs


uttnauer - You

Rev. 20-08-2012
2 Page 9 of 9

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