Download Operating Instructions

hm 780 DC hm 780 DC-V
F-t-l-t-tE-F-r-t:rJ
OperatingInstructions
9.694.026
ENGLISH
hm 78ODG
hm 78ODG-V
Gontents
Eß ENGLISH
2
2.2
2.3
...............
CovtpostroA
N N DF U N C I o N
ANDcoMMtssroNrNG...............
rNsrRUcroNs
lNsrALLATroN
2.3.2
3
.............8
BEFORESTARTTNGUP...........
........10
Commissioning................
...........11
OF DEVICE
GONFIGURATION
3.2
LrcHT
FUNcloNs...,.........
lNspEcroN
3.4.1
3.4.2
3.4.3
input.............
Sealingtemperature
printer
Switch
off and on................
Personal
codeinput...
3.4.5 Printdataselection.....
Viewof sealingparameterscontactpressureand sealingspeed.........
3.4.6
connectionof a barcodescanner.
lntelligentScan,
3.4.7
PRocEss
ANDSEALING
3.5 OpeRnloru
CHECK"
SEAM
TEsr- "SEAL
3.6 SEALTNG
4
AND SERV|C|NG..........
TROUBLESHOOTING
4.1
T n o u e L e s H o o l NccH E c K l r s r . . . . . . . . . . . . . .
D|SPIAYS
ANDERRoR
4.3 ALRRrvr
FUNCIoNS
4 . 3 . 1 A l a r mf u n c t i o n s
4.3.2
..................
/ cALTBRATIoN
4.4 SenvrcrHc
NUMBERS
ALLocATtoN
oF ARTICLE
oRDERS4.6
RepuceveruTPART
- CotvtpuETE
ovERVtEW
.................
oRDERtnc
4.7 SpnnePART
ANDsPARE
PARTS..........
wEARING
ABourREPLAcING
4.8
lruroRuerton
ADJUSTMENT
4.9 PnocesspARAMETERS
control.........
4.9.1 Temperature
4.9.2 Contactpressure ONLy hm 78ADC-Vdevice
Motormonitoringconfiguration ONLY hm 780 DC-V device
4.9.3
rate (baudrate)of the serialinterface
Settingthe transmission
4.9.4
5.1
5.2
Wrntruc
Dncnnu HM780 DC-V............
Crncurrnruo
Dncnnm HM780 DC...............
CrncurrANDWtRtNG
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14
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.. ..........1.5
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..'...40
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hm 78ODG
hm 78ODG-V
6
Gontents
OF CONFORM|TY........
DECLARATTONS
6.1
6.2
6.3
CEDecnnnroNoFCoxroRurrv
/ DIN58953-7
ENISO11607-2
Coruponurry
DECLARAToN
HM780DC-V...
DIN58953-7
Decuennrron
nu 780DC...............
CoruroRn/lrry
Validation
scheduleinformation.
7.3.1
Pano
GR
?
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hm 78ODG
hm 78ODG-V
lntroduction
Section I
1 Introduction
1.1 Preface
Firstof allwe wouldliketo thankyoufor purchasing
thesealingdevice.
you
andcareas well
information
using
the device,servicing
find
about
In theseinstructions will
as processvalidation.
rotarysealerwithprinterfor packaging
controlled
Thesealingdeviceis a microprocessor
sealablepouchesand
reels(SBS').
of DIN58953-7,DINEN ISO 11607-2andthe
Thesealingdevicemeetsthe requirements
process.
guideline
for
validating
the
sealing
resulting
DGSV'
so that
carefullybeforecommissioning
Pleasereadtheseoperatinginstructions
you
use
can
make
optimum
youarefamiliarwiththe capabilities
the
device
and
of
of itsfunctions.
G=
Alwayskeep these instructionscloseto the device
1.2 Legend
A
The exclamationmark in the triangledrawsyour attentionto importantnotesin
whichmust absolutelybe observed.
the operatinginstructions,
thatcouldresultin dangerto human
Thiswarningsignrefersto measures
is
compulsory
to observeit.
not
lt
observed.
healthif theyare
e
Tipswitha handsymbolnextto them,whichrelateto dailypractice.
' Steril-Barriere-System
' Deutsche
e.V,
für Sterilgutversorgung
Gesellschaft
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hm 78ODG
hm 78ODG-V
Introduction
Section {
{.3 lmportantnotice
withthe intended
In accordance
use,the CE markingis displayed
basedon
following
EU
directives:
the
108/CE.
20061
421CE,2006/95CE
and 20041
Medicaldevicedirective
93l42lCEis notapplicable
to sealingdevices.
The limitvaluesof IEC60601-1maynotbe appliedin repeatedelectrical
inspections.
whatsoever
for damagecausedby tests
The manufacturer
acceptsno liability
in accordance
withstandards
notlistedin the Conformity
Declaration.
Note
Becausewe are constantlyimprovingour products,we
reservethe rightto modifytheseoperatinginstructions
a n d t h e f u n c t i o n sd e s c r i b e di n t h e m .
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hm 78ODG
hm 78ODG-V
lntroduction
Section {
1.4 Safety instructions
Our productsleft the plantin perfectsafetycondition.
To maintainthis condition,the contentof these safetyinstructionsas well as
type plates, labelingand safety instructionsattachedto the device must be
observedwhile handlingthe device(transport,storage,installation,
operationand maintenance).
commissioning,
J.
This deviceis suitablefor processinglaminatedfilms in the heat-sealing
process.See alsochapter2.1 "Designated
use".
4.
Pleasecheckthe packagingand lodgea complaintfor any damagewith the
carrieror parcelserviceimmediatelybeforeinstallingthe device.
5.
Beforecommissioning,
ensurethat the devicedoes not show any evidence
of damage.ln case of doubt,contactthe manufactureror a servicepartner
authorizedby the manufacturer.
o.
Do not operatethe deviceif the powercableor the power plug is damaged.
Do not use the device if it does not operatecorrectlyor it is damaged in any
way. lf the mainscableor the devicehave been damaged,the devicemust
authorized
be repairedby the manufactureror by one of the manufacturer's
servicepartners.
The devicemust be connectedusingthe mainscableincludedin shipment
to a protectivecontactsocketwith a stablevoltage.Operationon lT
networksis not permitted.
Pleaseplacethe deviceon a stablebase.
a
The devicemust not be installedand operatedin
explosiveareas.
1 0 . lf the sealingdeviceis broughtdirectlyfrom a cold environmentinto a hot
environment,bedewingmay occur.Wait untiltemperatureequalizationhas
taken place.
Starting up the device when it is bedewed causes danger to life!
PageGB 6
11.
Fuse changesand repairsmust only be performedby the manufactureror
authorizedservicepartners.
by one of the manufacturer's
12.
Switchoff the devicewhen it is not in use or removethe powerplugfrom the
socket.
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hm 78ODG
hm 78ODG-V
lntroduction
Section I
1 3 . Beforecleaning:Disconnectfrom the mains!Cleanthe deviceonlywitha
agent.Do not allowanywaterto
dry or dampsoftclothanda mildcleaning
finditswayintothe device.Caution!Neverwet cleanthe device!!
14
Do not insertpointedor flatitemsintothe importslotof the device.Thiscan
resultin damageto thedeviceandinstruments.
1 5 . Do not insertitemsintothe louversof the device.You mayreceivean
electdcshockor the devicecouldbe damaged.
16.
Do not usethe deviceif youhaveanydoubtsaboutdevicesafety.
17.
or operatedby personsunder16yearsof
Thedevicemustnot be installed
age.
1 8 . Thedevicemustnotbe operated
unsupervised.
19.
PageGB 7
of drugsor alcohol.
to operatethe deviceunderthe influence
It is forbidden
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hm 78ODG
hm 780DG-V
Before Starting Up
Section 2
2 Beforestarting Up
2.1
lntended use
use and may only be usedfor the
The deviceis intendedonlyfor commercial
and industrial
intendeduse and with followingmaterials.
Sealablematerials
Pouchesand reels in accordancewith EN 868-5and EN ISO 11607-1*
Paperpouchesin accordancewith EN 868-4.
HDPE(e.9.TyvekrM,10598,10738and 2FS)*
Aluminumlaminatefilm
* alsowith side gusset
The correctsealingtemperaturemust be identifiedby meansof test sealings.
The deviceoutputdependson the conditionof the sealingmaterialused.
Non-sealablematerials
Polyethylene
film
Soft PVC film
Hard PVC foils
Polyamide
film
film
Polypropylene
P a g eG B B
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hm 78ODG
hm 78ODG-V
Section 2
Before Starting Up
2.2 Compositionand function
Temperature
Controller
Serial interfaces
RS 232
IntelligentScan
PC/ ht 180
(Barcode
scanner) hm 780DC-V
only
Adjustable
sealingedgesetting
Powerconnection I Mainsfuses
Sealing and printing process sequence
1. After the sterilizationpackaginghas been inserted,the feed processis started
by meansof photoelectric
cell.
automatically
packaging
is now fed and the sealingseam area is heatedup to the set
2. The sterilization
sealingtemperatureby the heatingunitslocatedat the top and bottom.The sealing
temperatureis monitored.
3. The sealingseam,which is now heated,is pressedtogetherby the sealingrollerand
sealed.
With the hm 780 DC-V device,besidestemperature,contactpressureand sealing
speedare monitoredas well.
cell when the pressureis
4. The printingprocessis triggeredby meansof a photoelectric
switchedon and the activatedprintdata is printedonto the sealedpackaging.
5. The finishedsterilizationpackagingis transportedto the extractionside.
6. lf no item to be sealedis fed in, the feed switchesoff afterapproximately30 seconds.
7. The set parametersremainsavedafterthe deviceis switchedon or off, or aftera power
(autosafe).
failure.The date and time are updatedautomatically
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hm 78ODG
hm 78ODG-V
Before Starting Up
Section 2
2.3 Installationinstructionsand commissioning
Priorto installation,readthe safetynoticesin chapter1.4
2.3.1 Installation
Placethe device on a horizontalsurface.
o
Pleasedo not lift the deviceby the in feed section.
@
The distancefrom the deviceto a wall must be at least200 mm.
2.3.2 Commissioning
To switchon the device,pressthe powerswitchon the left-handside,
After a shortself{est and afterthe selectedsealingtemperaturehas been reached,the device
is operational.
You will see thiswhenthe "okay"indicatorlighthas stoppedflashing
( s e ec h a p t e 3
r .1).
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hm 78ODG
hm 780DG-V
Gonfiguration
Section 3
3 Configuration of device
3.1 Basicffunctions
Switch on the device
The self test runs for approx.5
seconds(see Chapter2.3)
Indicator lights and
display test
Software version indicator
The"okay"indicatorlightflashes "okay"inspectionlightflashes
is
untilthe settemperature
Currentactualtemperature
reached,
afterabout3 - 4
minutes
display
After reachingthe set
the indicatorlight
temperature,
remainspermanentlyon
'okav"
insna..tinn lioht On
Selected actual temperature is
reached
The device is ready for use
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hm 78ODG
hm 78ODG-V
Gonfiguration
Section 3
3.2 Inspectionlight functions
Function
Deviceswitchedon
Warm-uoohase
Sealingtemperature
=t5o
hm 780 DC-V
Contactpressure
= t2lo/o
flashes
off
off
off
on
off
on
off
off
on
off
on
off
on
off
on
flashes
off
off
on
Sealing
speed
= t 10ok
Sealing
temperature
<>t5'
hm 780 DC-V
Contactpressure
<> +200
Sealing
speed
<> t 10Vo
Standby
warmingup after
standbyor changein set
temoerature
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hm 78ODG
hm 78ODG-V
Gonfiguration
$ection 3
3.3 Buttonfunctions
Menulevell
Switchprinter
offlon
Personalidentification
input
"Seal check"activation
Temperaturevalue +
1
Temperature
value-1
Confirminput
Menu level 2 activation
Press for 3 s
Menu level 3 activation
Press for 7 s
M e n ul e v e l 2
Sealingtemperatureinput
Menu level3
3.1
parameters
view
Sealing
3.2
Printdataconfiguration
3.3
Datainput
P a g eG B 1 3
Switchover
3.1-3.2-3.3
I
on
Switchover
3 . 1- 3 . 2 - 3 . 3
lnputvalue+1
I n p u tv a l u e - 1
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Confirminput
off
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ENGLIS}I
hm 78ODG
hm 78ODG-V
Gonfiguration
Section 3
3.4 Devicesettings
3.4.1 Sealing temperature input
Display
for1s
I
I
Pressbuttonfor 3s
t-t-l
Currenttemperature
setvaluedisplay
tll
il-l
Changeset value
rA.ä
v
\Y-l
Confirminput
I
I
3.4.2 Switch printeroff and on
(y
Pressbutton
Display
for 1s
tll
t-t*l-llCurrentsettingdisplay
Printerswitchedon
I
I
I
Switchprinteroff or on
tlt
ll
Printerswitched off
I
I
l*t
P a g eG B 1 4
t*
I
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Confirminpul
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hm 78ODG
hm 78ODG-V
Gonfiguration
Section 3
3.4.3 Personalcode input
@ In thi. disptay
an alphanumeric
code has been
inputby barcodescanner
Displayfor 1s
Pressbutton
Currentpersonalcode display
Selectnew code
rAaä
v
\Y-l
P a g eG B 1 5
Confirminput
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hm 78ODG
hm 780DG-V
Gonfiguration
Section 3
Datainput
ll
l-t*l
Pressbuttonfor 7s
to datainput
Switchover
rAaa
\-/
\Y-l
tl
( <----t )
Select data
aAra
\=/
\Y-l
Keylock
active
Input 1 - 9999
Confirmselection
t_t-ll_
inactive
Input0
( <---,
)
Confirm selection
Confirminout
rAaa
\7
\Y_/
P a g eG B 1 6
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hm 780DG
hm 78ODG-V
Dateand time
Gonfiguration
Section 3
I
*tI
I
Confirmselection
I
I
I
Dayinput
(r\)(v)
/;\
\_-/
\Y-l
_t
Confirminput
I
Month input
(a)(v)
til_
t*l*
/t;\
\:-,/
\_-/
Yearinput
()e,
/f
t
Confirminout
*tlll_:
Confirm
input
tlrl
Hourinput
rAaä
\Y-l
5/
Confirminput
Minuteinput
r/\)(v)
\y-l
Confirminput
[]/
ll
tl
tl
I
Expirydate
Confirmselection
tI
Dayinput
(l\)(v)
\_-/
\:-/
Monthinput
I
I
Confirminput
I
I
rAaa
\-/ \Y_/
lll_
tlll
[ <
r )
Confirminput
Yearinput
/7\ /3
(J !Y/
P a g eG B 1 7
_l
lrl
til*
9.694.026
Confirminput
ENGLISH
hm 78ODG
hm 78ODG-V
Gonfiguration
Section 3
I
l*il*
Batch
Input 0000 - 9999
w In thisdisplay
an alphanumeric
codehasbeen
inputby barcodescanner
/;\
|
/\
\
/
\-----7
t / \ / l, \/
\_/
\:-/
tl
tl
\
l
I
I
Pack content quantity
Input0 - 99
/r\A\
e/ \Y/
Sterilization type
ttl
-,
,-
ltlt
Sterilizationtype selection
rAaä
5/
\Y-l
,-
t*
Confirmselection
Steam
ll
ll
I
t*l
I
Ethyleneoxide
l*
I
Formaldehyde
I
Confirmselection
Plasma
I
I
P a g eG B 1 8
t
I
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hm 78ODG
hm 78ODG-V
Configuration
Batchcounter
Input0 - 9999
I
ll
Confirmselection
lt
ttttl
rAaa
5/
Section 3
Confirminput
\Y-l
Counting direction selection
Countingdirectionup
tl
t-
lf countingdirectiondown has been
selected.an alarmsoundswhenthe
value 0 is reached
Countingdirectiondown
I
-il-il
I
il*
Confirmselection
Switchoff batch counter
Switch off batch counter
Standby
Input 0 - 60min
til_t_
til
l
I
t
I
ll
I
A\
Confirminput
9\Yl
lf the motor was not started before
reachingthe set time,thenthe
temperatureis set automaticallyto
50"c | 122"F.
The brief insertionof a packagecausesthe
temperatureto resetto its previousset value.
Once this has been reached.the deviceis
again readyfor use
I
I
Operating data
View of the operatinghours
and the absolutebatch counter
View selection
aAra
\-/
Confirmselection
I
Operatinghours
-il*l
\Y-l
t il*
Confirmselection
Absolutebatch counter
*il
P a g eG B 1 9
Confirmselection
tl
I
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hm 78ODG
hm 78ODG-V
Gonfiguration
Unitsof measurement
t*
Confirmselection
ill
Unitsof measurement
selection
rAaä
\7 \Y/
Europe
Section 3
Unitsof measurement
Europe
Confirmselection
Unitsof measurement
USA
tlt*
ltl
Temperature
in'G
hm 780 DC-V
Contactpressurein N
Sealingspeed in mlmin
USA
Temperaturein "F
hm 780 DC-V
Contactpressurein lbf
Sealingspeedin in inch/mm
t*
Character width
Confirmselection
tl
| /\
\ I 17
\ / \ / \ \/
\--l
\:_/
Input0 - 2
\
I
I
I
Confirminpul
In accordancewith the setting
selected,the charactersare printed
in variouswidths
lnputA
Automaticsettingof the character
width,dependingon the width of the
packagingand the lengthof the print
line.
t-----l
F**I
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hm 78ODG
hm 780DG-V
Monitoring
Personalnumber
Input0 - 60min
Configuration
ttl
rAaä
U/
\Y-l
Confirmselection
Confirminput
When inputtinga time > 0
monitoring
of the personalnumberis
activeand the motor can onlv be
startedif the value of the
personalnumberis 1-9999
Once the set time is reached,the
personalnumberis automatically
set
to0
lf the personalnumberis 0000and a
packageis inserted,a command
promptappears
By inputtinga personalnumberof
1-9999,the lock of the drive motor is
disabledand the commandprompt
disappears
P a g eG B 2 1
Ghapter 3
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hm 78ODG
hm 78ODG-V
Section 3
Gonfiguration
3.4.5 Print data selection
llrtl
l-ll-t*
Pressbuttonfor 7s
1l
t-
to printdata
Switchover
tttl
rAaä
E/ \Y-l
t-r
Select data to be printed
(v a,
/3
The print sequenceis
predefined.
date
Sterilization
Activatedprintdata is alwaysprinted
in this sequence
Sterilization date
Time
Expiry date
Batch counter
Personal identification
Batch counter
Sterilization type
Pack content quantity
Text
(withbarcodelist
and attachedbarcode
scanner)
Confirmselection
t-
1
*ll*l
ill
I
II
I
t----*l
@@@
+-l
Ir*rr-r-l
Time
I
@@@
il-|*
Expirydate
ll
I
I
I
I
I
I
@@@
tl
Batchnumber
r_rr rl ä\,
I
r-----1-l-l \?/@
tt trl l
ttl
Personalidentification
I r*r- r-l
@
I
I
l-lr-
@@@
llllrl
@@o
Batchcounter
t
Sterilization
r----*_:l
r_rI rl
I
ä\z
€i@
r--t:Tt
Ir_rr-:-l
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hm 78ODG
hm 78ODG-V
Gonfiguration
Pack content quantity
I
I
Ghapter 3
T---*-l]
fr-I
I r_r-r-l
t----:_:l
t_rI rl
Text
I
t-----l-r-:l
I
I
A\,
E'@
@
/n\.s
(Y\Y
/1\
\:2
Ir_rr*r-l
Example
Printingthe sterilizationdate and the expirydate
Pa g eG B2 3
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hm 78ODG
hm 78ODG-V
Ghapter 3
Configuration
3.4.6 View of sealingparameterscontactpressureand sealingspeed
only hm 780DC-Vdevice
Activate
1
I
(s)
Confirmselection
Pressbuttonfor 7s
ContactDressure
Select view
rArä
\7\Y-l
Sealingspeed
tI t t l
I
tl
rl
tt
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hm 78ODG
hm 78ODG-V
Gonfiguration
Ghapter 3
3.4.7 lntelligentScan,
connectionof a barcodescanner
Thefollowing
inputsandfunctions
canbe implemented
usinga hm 780 BR barcodescanner
(itemnumber1.421.006)
connected
to the "lntelligentScan"
interface(seepage9), and
relevantbarcodelists:
lnputsand functionsvia the controlleror usingthe barcodescanner
Inputs
Sealingtemperature
input
codeinput
Personal
Batchnumberinput
Packcontentquantityinput
Sterilization
typeselection
Batchcounterpreset
Character
widthselection
Printdataselection
P a g e1 4
P a g e1 5
P a g e1 8
P a g e1 8
P a g e1 8
P a g e1 9
Page 20
Page22
Functions
Switching
the printeroff or on
Activating/deactivating
standbyfunction
personal
Switching
number
monitoring
off or on
Sealcheckactivation
Page14
P a g e1 9
Page21
Page26
lnputs and functions only with the barcodescanner
Inputs
personalcode
alphanumeric
Inputof a 1O-digit
batchdesignation
Inputof a 1O-digit
alphanumeric
text
lnputof an alphanumeric
Expirydatesin 1, 3, 6, 9, 12, 24 and60 months
Functions
Switchingthe batch counteroff or on
g
is suppliedwith a
The hm 780 BR barcodescanner(itemnumber1.421.006)
generation
(item
and recordingof the
facilitating
the
1.490.016)
enclosed,
number
CD
barcodelistson a PC.
For further information, please contact your authorized service partner or the hawo
service line: +49 (0) 6261 9770 0
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hm 78ODG
hm 78ODG-V
3.5
Gonfiguration
Ghapter 3
Operation and sealing process
o
The materialtobe sealedmust be sealedaccordingto the manufacturer'sinstructions.
o
Set the peel edge width:
After the lockingdevicehas been loosened,the peel edge can be set by shiftingthe in
feed sectionvariablybetween0 mm and 35 mm. A sufficientprotrusionmust be available
betweenthe sealingseam and the reel interfacegivenon the extractionside (in
with DIN 58953-7min. 10 mm).
accordance
.
packagingmust be insertedfrom the left-handside, alwayswith the side to be
Sterilization
printedface down.
The drive is switchedon automatically.
a
Removethe sealedsterilizationpackagingand leavebrieflyto cool.
e
Sealablepouchesand reelsmust only be filledto % full (DlN 58953-7).The limited
fillingpreventsa loadthat is too largefrom beingplacedon the sealingseams.
The correctsealingtemperaturemust be identifiedby means of sealingtests.
Sealingmust be performedin such a way that the sealingseam meetsthe quality
requirementsof EN ISO 1 1607-2,even with varyingmaterial
characteristics
must be met:
thicknesses.The followingqualitycharacteristics
.
.
.
.
Intactsealingacrossthe entiresealingseam width
No channelsor openseals
No puncturesor tears
No delamination
or materialseparation
hawotestSEAL CHECKis consideredsuitablefor checkingthese quality
The hawotestSEAL CHECKseal indicatorsare available
characteristics."
separately.
see the DGSVguidelinefor validationof the sealingprocess
PageGB 26
9.694.026
v 1.Q2
ENGLISH
hm 78ODG
hm 78ODG-V
Gonfiguration
Ghapter 3
3.6 Sealingseamtest - "SealCheck"
pressure
parameters
process
andsealing
timewith
temperature,
contact
Testing
of thecritical
''SEALCHECK''.
This test shouldbe performedbeforeand afterthe dailyworkingprocessand/orbefore/after
filingthe printout(DlN EN ISO 116A7-2).
each loadand can be documentedby routinely
withthe SEALCHECK
The additional
use of the SEALCHECKsealingindicatorin combination
functionof the sealingdeviceis recommended.
Beforethe test, the devicemust be readyfor use and the set temperaturemust have been
reached.
Device ready for use
Specified set temperature
has been reached
t_t_tt_l
trl
l
packaging,
Sterilization
minimumwidth 200 mm and
insertSEALCHECKIndicator
stripsif necessary
I. u{te-tz-zoos12:31r='tzs"cF=I00Nreg.grntnin
\ ttzz +gztqt
Sealingtime
I Serialnumber
(hm 780 DC-V only)
Name
Pressingon pressure
PageGB 27
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
and servicing
4 Troubleshooting
4.1 Troubleshootingchecklist
The troubleshootingsuggestionmarcedwith a * may only be carriedof a servicepartner
authorisedby the manucaftuer.
Possible cause
Malfunction
Mainsconnection
- Mainscablenot pluggedin
Devicedoes not switchon
No data in the display
Troubleshootinq
Checkmainsconnection
and connectto anothersocket
if necessary
- Mains cable defective
Reolacemainscable
Mainsfuse
Replacemainsfuse*
! In case of repeatedfailure
you must have the device
fuse checked
Temperaturecontrollerdefective ReplaceTemperaturecontroller"
too low
Settemperature
lncreaseset temperature(see page 13)
Temoerature
limitation
active
Resetthe temperaturelimiterby
pushingdown the pin
! In case of repeatedactivation
you must havethe device
checked
Temperaluresensor
Replacetemperaturesensor*
Heatingelement
Checkheatingelementand replaceif
necessary'
Devicenotheatingup
Temperaturecontrollerdefective ReplaceTemperaturecontroller
No feed
PageGB 28
SST Moduledefective
Conveyorbelt
- damaged
- no feed
ReplaceSST Module*
Frontflap not closed
Close front flap
Motor- sensor
Replacelightbarrier"
Frontflaps- sensor
Replacefront flap sensor*
Motor
Reptacemotor*
Temoeraturecontrollerdefect
ReolaceTemoeraturecontroller"
9.694.026
Replaceconveyorbelt
Checkbelttension
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Malfunction
Unevenmaterialfeed
or
loudrunningnoise
Sealingseamdoes not hold
Possiblecause
ReplacePTFE belt on guide
unit (see pages 25-26)
Conveyorbelt
- damaged
Replaceconveyorbelt
Checkbelttension
Motor
Temperaturetoo low
Reolacemotor*
Increasetemperature
Contactpressuretoo low
Adjustthe contactpressureof the sealing
rolleror replacethe sealingroller*
- nofeed
Sealingunit
- Distance between
sealinqunitstoo larqe
Contactpressuretoo high
Paperside of the packaging
Temperature
toohigh
discolored
or sidegusset
shrunk
lmprinttoo weak
Troubleshootinq
Conveyorbeltguide
Sealingseamdistorted
No imprint
or
imprintincomplete
Section 4
Set sealingunit clearance
to 0.5mm*
Adjustsealingseal rollercontactpressure
or replace
sealinqroller"
Reducetemperature(see page 13)
Programthe printingstartmarginagain
Programming
- Printingstart marginincorrectly (see page 12)
set
Ribbon
Ribbon not insertedcorrectly
Replaceribbon.(see page24)
Printercontrol
Replaceprintercontrol*
Switched- mode powersupply
defective
Ribbon
Replacepowersupply"
Printhead
Adjustprinthead again
Paoer- oressureroller
Paper- adiustpressureroller
Replaceribbon.
4.2 Customerservice
E
PageGB 29
Your hawo customer serviceis at your disposal Mondaythrough Friday
8:00 AM through 5:00 PM and by phone en +49 (0)6261-9770-31.
Please also feel free to send any questions you may have to the
following e-mail address: [email protected]
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.3 Alarm functions and error displays
4.3.1 Alarmfunctions
Batchcounter,set to count
down,has reachedthe
value0
Cancelinqthe Alarm
Setbatchcounter
to a value> 0
or
Setbatchcounterdirection
to up
PageGB 30
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 780DG-V
Troubleshooting and servicing
Section 4
4.3.2 Errordisplays
t\
:.}
The troubleshootingsuggestionmarcedwith a * may only be carriedof a servicepartner
authorisedby the manucaftuer.
Sealingtemperature
outside
tolerance
Possiblecause
Temperaturesensordefective
Replacetemperaturesensor*
TemperatureControllerdefective
Replacecontroller*
SST moduledefective
Onlyhm 780DC-V
Gontactpressureoutside
tolerance
l:-l:i
Possiblecause
DMS modulenot adjusted/
calibrated
Adjust/ calibrateDMS moduleagain*
DMS moduledefective
Only hm 780 DC-V
Sealingspeed outside
tolerance
Troubleshootin
PageGB 3'l
9.694.026
v 1.02
ENGLISH
hm 780DG
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.4 ServicingI calibration
yourdeviceis alsosubjectto technical
devices,
wear.
Likealltechnical
yourdeviceshouldbe inspected
guarantee
readiness,
In orderto
operational
continuous
personandserviced
regularly
by a competent
andcalibrated
at leastonceperyearby
authorized
or by oneof themanufacturer's
servicepartners.
themanufacturer
Maintenance
chart
Ink ribbon
PTFE strip
for guide
die
Pressure
roller
Toothedbelt
At leastevery
3 months
q, q, q, q
Depending
on
use, at least once
annualy
d? d? & €?
Sealingdie
interval
Critical process
parameters
calibration
ffi
Legend:
d?
Reprace
Measure
4.5 PartsService
g
Simplyorder parts by fax:
o Pleasecopy the followingpages accordingto the parts required.
and wear
Page31: Partsrequiredfor maintenance
Page 32: Replacementparts
a
r
a
a
a
o
a
Entermachinenumber.
Entermachinemodel
Entername,address.fax numberand ordernumber.
Markitemsrequired
Enter quantityrequired.
Signorder.
Fax order.
PageGB 32
9.694.026
No.: 123456
Type:hm 780DC-V
v 1.02
Sender:
Fax No.
Yourorderno.:
Date
Machinemodel
Seralnumber
V
Designation
PartNo
tr
lnk ribbonblack
6.813.104
D
lnk ribbonred
6.813.224
D
PTFEstripfor upperguiderail
6.105.178
D
PTFEstripfor lowerguiderail
6.105.177
D
Pressurerollerplastic
2.230.008
n
Toothedbeltdrive
6.271.018
D
Toothedbelt,materialtransport
6.271.019
tr
Heatingcartridge
6.536.024
tr
Uppersealingdie complete
1.616.049
tr
Lowersealingdie complete
1.616.050
fl
Print head
1.653.002
fl
Reed Contact
6.543.011
tr
tr
Signature
qtv
Sender:
FaxNo.
Yourorderno.:
Date
Machine Model
Serial number
g
Designation
Part No
n
Temperature
control
tr
Printercontrol
1.461.013
!
DMS Module Only hm 780 DC-V
1.410.018
n
SSTModule
1.461.014
tr
-modepowersupply
Switched
6.533.001
tr
Lightbarrier
1.561.003
100- 245V
6.564.042
hm 780DC
n
tr
u
Gearmotor 230V
Gearmotor 115V
Gearmotor 100V
1.212.026
1.212.027
1.212.028
hm 780DC-V
tr
tr
tr
Gearmotor 230V
Gearmotor 115V
Gearmotor 100V
1.212.420
1.212.021
1.212.022
I
Motorinkribbon
1.212.012
il
Temperaturelimit switch
6.564.018
tr
Thermocouple
6.564.023
tr
Fan24Y
6,212.028
Signature
qty
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.6 Replacementpart orders-allocationof articlenumbers
Heating die
6.564.018
Upperguiderail
6.181.012
PTFEstrip6.105.178
lower guide rail
PTFEstrip6.105.{77
SeiteGB 35
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 780DG-V
Troubleshooting and servicing
Section 4
4.7 Sparepart ordering- Completeoverview
Pressurerollerplastic
2.230.008
Toothedbelt,materialtransport
6.271.019
Powerswitch
6.562.009
SSTModule
1.461.O14
powersupply 6.533.001
Printercontrol
1 . 4 6.10 1 3
hm 780 DC-V
DMSModule
1.410.018
@
-
Temperature
Controller
6.564.042
Fan6.212.028
hm 780 DG
hm 780 DG-V
SeiteGB 36
9.694.026
Gearmotor 230V
Gearmotor 115V
Gearmotor 100V
Gearmotor 230V
Gearmotor 115V
Gearmotor 100V
1.212.026
1.212.027
1.212.028
1.212.020
1.212.021
1.212.022
v 1.02
ENGLISH
hm 780DG
hm 78ODG-V
Troubleshooting
4.8 Informationaboutreplacing
wearingand spare parts
I
and servicing
Section 4
parts
Pleaseuseonlygenuinereplacement
Replacing
ink ribbon
)
Switch off machine
.
.
r
.
Open front flap, set in feed sectionto 0 if appropriate
Pressleverfor ink ribbonholder O downwith left hand.
Pressholderfor rink ribboncassette@ to sideand removecassette.
lnsertnew ink ribboncassette
Alwaysensurethat the transportopening I in the cassetteis attached to the transport
shaft @.
.
.
i
towardrearuntilholder@catches
Pressinkribboncassette
Closefrontflap
Switch on machine and check printing function after reachingnominal temperature
SeiteGB 37
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
MaintenanceInformation
I
Section 4
parts
Please
useonlygenuinereplacement
ReplacingPTFEstrip on guide rail
) Switch off machine and DISCONNETPOWERPLUG !
o
o
o
o
o
Open housing
Removemountingscrews O for upperguiderailand removeguiderail or
Removemountingscrews€) for lowerguiderailand removeguiderail
RemovemountingscrewsO and detachPTFEstrip
Pullbackingfoil off of new PTFE stripand glue new PTFEstripon straightand without
wrinkles
o FastenPTFE strip with screws I
o lnstallguide
rail
r€P
.:
e
When installingthe upperguiderail beforefastening,pushthe die down so that the
intervalbetweenthe screwheadand rail is 1 mm on bothsides.This ensuresthe correct
contactpressurefor the guiderail.
Closehousing
\ lEltr+
Distance
between
screwheadandrail= 1 mm
\./
IJ
-r
a)
a)
PTFEstrip
€) r*'-.
SeiteGB 38
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Information
Maintenance
Section 4
parts
! ,,uu.uuseonlygenuinereplacement
Replacingpressureroller
) Switchoff machineand DISCONNET
POWERPLUG!
a
a
a
a
a
a
a
O p e nh o u s i n g
RemovemountingscrewsO for upperguiderailand removeguide rail.
Unscrewpressureadjustmentscrew @ approx.5 mm
Loosenmountingscrew O and pull pressurerollercompletelyout of holder
Detachsnap ring G)and removepressureroller
Installnew pressurerollerand fastenwith snap ring ()
Position
completepressurerollerin holder,centerin relationto bottomrollerand tighten
mountingscrewI
Adjustcontactpressureby screwingin adjustmentscrew @ accordingto calibrationinstructions
o n p a g e4 1
.-o
.
Installguide
rail
screws0, pushthediedownso thatthe
theupperguiderailbeforefastening
Wheninstalling
thescrewheadandrailis 1mmon bothsides.
intervalbetween
fortheguiderail
Thisensuresthecorrectcontactpressure
fF
.w
\ l.E!
.
trL
screwheadandrail= 1mm
Distance
between
CO
oo
oo
o
Closehousing
SeiteGB 39
9.694.026
v 1.42
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.9 Processparametersadjustment
g
After adjustment,the deviceshouldremainswitchedon for a further 10 seconds!
4.9.1 Temperature
control
120 oGand 200 "C are measuredconsecutively
The temperatures
the
and
differencebetweenset and actual value corrected.
Thetemperature
control
adjustment
shouldalwaysbe
this is stabilizedfor 120 s.
After reachingthe set temperature,
a
carriedoutafterreplacing
At the end of 120s, the temperaturevalue
heating
element,
measuredwiththe temperaturegaugeis input
afterreplacing
thetemperature
the
sensorandafterreplacing
temperature
control
Process
measuring
device
Insertthetemperature
sensorof a temperature
thesealingunits
fromtheinflowsideon theleft,between
and switchon the device.
Pressbothbuttonssimultaneously
PowerSwitch
SeiteGB 40
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
-il*l ill-il*
Select temperature
adjustment
/I\/O\
I
I
e/v
I
Thesettemperature
of the
to
deviceis set automatically
120"C
Afterreachingthattemperature
timestarts
thestabilizing
Confirmselection
I
tl
lt
lI It
ilt
l*tl
I
I
Afterexpiryof thattime
inputthetemperature
measured
device
withthemeasuring
/-;\
{/\
_ll
\/r--7\
t_t*
\/\/\\/1
\_-/
\:-/
Thesettemoerature
of the
to
deviceis setautomaticallv
200"c
input
Confirm
Afterreachingthattemperature
timestarts
thestabilizing
t
I
I
t
'
Afterexpiryof thattime
measured
inputthetemperature
device
withthemeasuring
rAa;)
\7
\Y-l
tlllll
r: r: r_l*l
SeiteGB 41
9.694.026
Confirminput
v 1.02
ENGLISH
hm 78ODC
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.9.2 Contactpressure ONLY hm 780 DC-Vdevice
Pressbothbuttonssimultaneously
andswitchon thedevice
Settingof the contactpressure
shouldalwaysbe done after
replacingthe temperature
control,after replacingthe
DMS moduleand after
replacingthe pressureroller.
Only then is the contact
pressuremonitoringactive
ttl
l
t*lt-l-ll*
Selectcontactpressuresetting
/;\,a\
ta)t\//
\:-/
\_-/
SeiteGB 42
t_l
ttl
9,694.026
Confirmselection
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting
and servicing
Section 4
Process
TurnscrewS to the leftuntil
doesnot
thevaluedisplayed
changeanymore
Pl,
Usingthepotentiometer
setthezeropointof the
DMSmoduleto 005
II
ByturningthescrewS
clockwise,
setthecontact
pressure
to 100N
Confirminput
SeiteGB 43
9.694.026
ENGLISH
hm 78ODG
hm 780DG-V
Troubleshooting and servicing
Section 4
configurationONLYhm 780DC-Vdevice
4.9.3 Motormonitoring
Pressbothbuttonssimultaneously
and switchon thedevice
Motormonitoring
shouldalwaysbe
configuration
done afterreplacingthe
temperaturecontrol,
after replacingthe
motor and after replacingthe
tachogenerator
Onlythen is the motor
monitoringactive
PowerSwitch
tl
-t
It
I
Select motor monitoring
configuration
@@
Process
The motoris started
andfor 5s themeasured
sealingspeedis displayed
-
ttl
rtl
tt
Confirmselection
I
motorhm780DC-V
Display
r l l_il_l
tillll
Displaymotorhm 780 DC
tt
ill
SeiteGB 44
l
ill
_t.r_l
9.694.026
v 1.a2
ENGLISH
hm 78ODG
hm 78ODG-V
Troubleshooting and servicing
Section 4
4.9.4 Settingthe transmissionrate(baudrate)of the serial interface
Pressbothbuttonssimultaneously
and switchon the device
PowerSwitch
till
-lt-r-ltSelect baud rate setting
l_ t*il
tillIl
Select baud rate
1 _l
Confirmselection
Examole:Baudrate576008d
12008d- 576008d
t_
ll
tt
II
SeiteGB 45
I
9.694.026
Confirmselection
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Technical Data
Section 5
5 TechnicalData
5.1 Circuitand WiringDiagramhm 780DC-V
ao
o
@
o
Mainfuse230V
2AT
Mainfuse115/100V
5AM
Heatingelementsconnectionat 1151100
V
o
o
@
0
@
0
@
o
@
0
@
oo
oa
o0
Printhead
Lightbarrier
Gearmotor 230V
Gearmotor115V
Gearmotor 100V
DMS-Module
Heatingcartridge
Temperature
limitswwitch
SSTModule
Printercontrol
Motorink ribbon
Fan
Switched-mode power supply
Reed contact
Temperature
control
Thermocouple
SeiteGB 46
1.653.002
1.561.003
1.212.020
1.212.021
1.212.022
1.410.018
6.536.024
6.564.018
1.461.014
1.461.013
1.212.012
6.212.028
6.533.001
6.543.011
6.564.042
odsoooaQ
6.564.023
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Technical Data
Section 5
5.2 Circuitand Wiring Diagram hm 780 DC
o o
@
0
Mainfuse230V
2AT
Maintuse1151100V
5AM
Heatingelementsconnectionat 115/100V
o
o
o
Printhead
Lightbarrier
Gearmotor 230V
Gearmotor 115V
Gearmotor 100V
1.653.002
1.561.003
1.212.026
1.212.027
1.212.028
Heatingcartridge
Temperature
limitswwitch
SSTModule
Printercontrol
Motorinkribbon
Fan
powersupply
Switched-mode
Reedcontact
Temperature
control
Thermocouple
6.536.024
0
@
I
@
o
@
0
@
oo
oa
o0
SeiteGB 47
6.564.018
1.461.014
1.461.013
1.212.012
6.212.028
6.533.001
6.543.011
oooo9066
6.564.042
6.564.023
9.694.026
v 1.02
ENGLISH
hm 78ODG
hm 78ODG-V
Technical Data
Section 5
5.3 Specifications
Connectiondata
Po w e r c o n ne cti o n
Powerfrequencv
Powerconsumptionstandard
IVI
I Hzl
tWI
Powerconsumption max.
tW I
M a i nf u s e2 30 V (1 1 0 V/ 1 1 5 U
Mechanic
Dimension
Length
width
Heiqht
Housinqcover
Housinqbuttom
tAI
Weioht
Sealededoe infinitelvadiustable
Sealinoseamwidth
I ko I
I mm I
I mm I
sealinqsvstem
Lenothof sealinqseam
from
Sealing
seamdistance
packcontent
/ S ea
Process a
Sealinqtemperaturemax.
Tolerance
limitmotorstop
temoerature
Temoerature
ranoes
Temoerature-tolerance
hm 780DC-V
Pressureaoolied
limitmotorstop
Tolerance
Dressure
Throuqhputrate
ToleranceThrouqhputrate
[mm ]
230 t115/100
50/60
390
2 T
500
(5M)
555
250
145
S t e e l A l S l3 0 4
S t e e l A l S l3 0 4
14
0-35
12
hawoflexrM
I mm I
Imm ]
unlimited
>30
( DIN58953-7:2003)
meter
[ "C I
[ "C ]
+5
220
I o/oI
1
!2
INI
lYoI
!20
[m/min]
I o/o1
110
100
10
Electronicund Communication
Microprozessor
Svstem
Seriallnterfaces: RS-232connectorfor PC
RS-232connectorfor
bar code scanner
USB with adapter
Ethernet(LAN)with adapter
Datearate (Baudrate)
[Bd ]
hm 780 DC-Vonly
yes
optionalavailable
(Art.-Nr.:1.596.024)
ootionalavailable
1200- 57600
RS 232 PC
RS 232 Bar Code Scanner9600
4t
Protection
class
mental
Heat dissipation
I kJ/s]
0,1
Noiseintensitv
t dB/A I
<70
SeiteGB 48
9.694.026
v 1.o2
ENGLISH
hm 78ODG
hm 780DG.V
Declarations of Gonformity
Section 6
6 Declarationsof Conformity
of Gonformity
6.1 CE Declaration
- i.J::rl,1l;:ir1l
KilüI{rmil;:lts!"klärrrr.:
r)f ll'rl,:rr; :7
lJixl,r.nlro. C[' d* rirtinrüriF
llscl*it...taon dr ,l*r'lnfmrd&1 ce :.r {i.t
alr'r:!t,1lf!,n,.1taln
llrnlrlrrrrrnr, dr .,rialnf*. l; -' J.4lefnar.trn
9.694.CI26C
.'i*i!r
li3r:tsG
f lt{:.tilrt *tt.l;r-r1r ,t!rl, iJ.:rxi rJ D iirli*! r'-"t.irfi: !1}i' ;,:,r..rlri'ir.l
l11r,1si1f',.,,11 i::t:;:: ittt.! ll'i!:
F;r
1 , . .i ;: , , i r : r ' ; ' r ,
l':,: r"|]il rliir:llL'i,.) i:l
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ir::li:r.Iir!
f::,r il ;::.i.:tfj'.i:i .;,]'l;l:.',jrt:i,. ;:]-;:r1.1::fl-:r!:tt"tn;: taftll,:l:)iJ':.ü;i i'i,:ttit,t-l.
l " ' i , " ':l ; ' : :; t t t | . ] ,: : : .t : i , - l1 : , r : i . , , : : .' 1. : : ' , ,i r , : ,: i ] i t : : . l i t 1 1 :t i : ' : , , i . i l t i ;: . : : r : i ' r . r i i i
i r ' r ; 1 i , 1 i , 1 . n l , : : i i . t r ' : f , 1 , : l : : r : r r l t r ! : : ' . : : ' ' : j J , l - l r - : al i.i : a , 1 . : : , : , 1 1 1. - t : : . ' : J t ' r . t : : : . i. -i . ' i l :
h m 7 8 0D C ,h m 7 8 0P C - V
il;l|r1l1ll.,1t;;1Ü::'l}':]..i||r.:]]1,jj|:;'-'.!ii;':i||.-l]].'i;.l.j.']t]'.|i.tl'!.|].,|,-|:;,|:.:'.]ll]!.'..''..l.:,|1...:|'.l:|
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SeiteGB 49
9.694.026
v 1.02
DEUTSCH
hm 78ODG
hm 78ODG-V
Declarations of Conformity
Section 6
6.2 EN ISO fi607-2 / DIN58953-7ConformityDeclarationhm 780 DC-V
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SeiteGB 50
9.694.026
v 1.o2
ENGLISH
hm 78ODG
hm 78ODG-V
Declarations
of Gonformity
Section 6
6.3 DIN58953-7ConformityDeclarationhm 780 DC
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SeiteGB 51
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ENGLISH
hm 78ODG
hm 78ODG-V
7
Validation
Section 7
Validation
7.1 General
Main purposeof every packagingsystemfor medicalproducts,which are sterilizedduringthe
final packaging,is maintainingthe sterilityuntiluse or untilasepticpreparationat the patient.
The validationof packagingprocessesis crucialto ensurethat sterilebarriersystemintegrityis
attainedand will remainso untilopenedby the usersof sterilemedicaldevices.
Withinthe scope of the preparationof medicalproducts,the sealingprocessis consideredto
be part of the processchain.This processis also to be validatedin accordancewith the Law
on MedicalProductsand with the MedicalDevicesOperatorOrdinance.
standardEN ISO 11607- Part2 requiresand describesthe validationof
The international
packagingprocesses.In orderto implementit, the GermanSocietyfor SterileSupply
(DeutscheGesellschaftfür Sterilgutversorgung)
issueda Guidelinefor the Validationof
to
EN
ISO
11607-2.
SealingProcessesaccording
The sealingdevicemeetsthe requirementsof EN ISO 11607-2and the resultingDGSV
guidelinefor sealingprocessvalidation.
website,or it can be
The guidelinecan be downloadedfrom the www.dgsv-leitlinie.de
requestedfrom the hawo ServiceLineon +49 (0) 6261 9770 0 (keyword:DGSVguideline).
Validationmust alwaysbe performedby the user at the installationsite.
7.2 Preparation
Your sealingdevicehas alreadybeen calibratedbeforedelivery(seetest report).
beforeeach re-validation
The sealingdeviceshouldbe re-calibrated
The manufacturer's calibration of hawo sealing devices may only be performed by hawo
GmbH or by one of hawo's authorized service partners. For further information, please
contact your authorized service partner or the hawo Service Hotline: +49 (0) 6261 97700
(keyword: servicing and calibration).
calibrationmust be orderedseparately(ordernumber9.079.035)and is
The manufacturer's
not includedin shipment!
you needthe hawotestSEAL CHECKindicators.
Furthermore,for the operationalqualification
your
supplieror directlyfrom hawo (onlineat uruiry.seal-check.de).
You can obtainthese from
Using the original hawotest SEAL CHECKis recommended.
SeiteGB 52
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hm 78ODG
hm 78ODG-V
Validation
Section 7
7.3 Validation
We recommend
thatyouperformvalidation
in accordance
withthe DGSV*guideline
for
(available
validation
fromwww.dqsv-leitlinie.de).
In thefollowing
sectionyouwillfinduseful
information,
whichyouwillneedto implement
the DGSVguideline.
GermanSocietyfor SterileSupply DGSV
7.3.1 Validation schedule information
7.3.1.1 Descriptionof the sealingdevice
Your sealingdeviceis a rotarysealer.The precisename and the serialnumberare writtenon
the type plateattachedon a side of the machine.
The requiredsealingtemperaturetoleranceis +/- 5'C (+^ 9'F) accordingto DIN 58953-7.
The temperaturerangeof the packagingmaterialwill be requiredagain later in the process.
You can get this informationfrom your materialsupplier.lf you do not succeedin gettingthis
information,you can take as a rule the followingranges:
Transparentpackagesaccordingto EN 868-5.
HDPE(TyvekrM):
170- 190 "C ( 338 - 374 "F )
130- 140 "C ( 266 - 284 "F )
7.3.1.2 Installationqualificationinformation{lQ}
7.3.1.2.1 QM-system
You can get from hawo free of chargethe necessarycertificatefor the qualitymanagement
systemISO 9001:2000.
or call us on: +49 (0) 6261 977AO (keyword:QM certificate)
Ask for it from [email protected]
7.3.1.2.2 Typeof device:Rotarysealer
The devicehas CE markingand complieswith the EN ISO 11607-2and DIN 58953-7
standards.The correspondingconformitydeclarationscan be found in chapter6 and serveas
certifyingproof.
7.3.1.2.3 Serviceauthorization
The servicepartnermust be authorizedby hawo in writing.Ask your serviceteam for the
certificate.
SeiteGB 53
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hm 78ODG
hm 78ODG-V
Validation
Section 7
7.3.1.2.4 Safetyfeatures
reouired,
6 mm*
Distancefrom medicalproduct 30 mm*
Parameter
Sealinoseamwidth
automatic
*
existino
12mm
30 mm
automatic
requiredin DIN 58953-7:2003
7.3.1.2.5 Processparameters
Parameter
Sealingtemperature
contactpressure
hm 780DC-Vonlv
*
Disconnection
tolerancepreset adiustable
+l- 5"C (+/- 9"F) *
not possible
+l- 20o/oof the set value**
not possible
required
in DIN58953-7:2003
and monitored
by the microprocessor
Thesearecontrolled
system.
limitvalues
which,in caseof deviation
of the predetermined
Systemshavebeenintegrated
andstopthe device.
fromthe criticalprocessparameters,
displaywarnings
Thisprevents
furtherworking.
Forthishawooffersthefollowing
mustbe routinely
monitored.
The processparameters
possibilities:
1. SEALCHECKfunction
withthe SEALCHECKfunction(seealso
Dailyprintoutof the sealingparameters
3.10).
Section
hm 780DC-Vonly
2. ht 180PT-USB(ordernumber0.712.005)
system.This
The newhawotestht 180PT-USBis a mobileprocessdocumentation
andadditional
receives
dataaboutthe processparameters
systemautomatically
number,staffnumber,etc.).The datais storedon a
relevantprotocoldata(machine
to a PC.Storageoccursby meansof digitallysignedPDF
USBstickandtransferred
directlyon the PC.
documents
systems
3. Batchdocumentation
directlyto the batchdocumentation
throughan interface
Thedevicescanbe connected
for theexactcompatibilities.
system.Ask the producer
SeiteGB 54
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hm 78ODG
hm 78ODG-V
Validation
Section 7
7.3.1.3 Operationalqualificationinformation(OQ)
Accordingto standardEN ISO 11607-2,section5.3.2b, the qualitycharacteristics
of the
sealingare the following:
.
'
Intactsealingacrossthe entiresealingseam width
No channelsor openseals
: N:!:t.,l'T:illtffit","i"rseoaration
Thesequalitycharacteristics
mustbe checkedanddocumented
witha suitablemethod.Quality
characteristics
canbe checkedin the bestwayusingthe hawotest
SEALCHECKindicators.
Thefreeof chargeSEALCHECKreference
cardfromhawogivesclearstatements
abouttheir
implementation.
Forthispurpose,a sealingmustbe madeat the lowerandupperlimitvalueof the sealing
temperature.
Qualitycharacteristics
areto be fulfilledin bothsealings.
Afterthatthe sealingtemperature
is to be determined
for dailypractice.lt is recommended
to
(duringthe test;e.g.a lowerlimit
formthesefrommiddleof theACTUALtemperatures
according
to the manufacturer
of 170'C (338"F) andan upperlimitaccording
to the
'C
manufacturer
of 190 (374 "F),meanvalue= sealing
value180"C (356'F).
qualification
(PQ)
7.3.1.4 Performance
information
proofof a goodunderstanding
qualification
it is to be furnished
of the
Withthe performance
processandof delivering
of optimalclosedsterilebarriersystems- alsoafterthe sterilization.
checkaccording
to DINEN 868-5,
Thetestis carriedout usinga sealseamresistance
beforetesting.Records(batchdocumentation)
of
mustbe sterilized
AppendixD. Packages
processes
sterilization
are partof the validation.
(seealsoAppendixE of the DGSV
in thevalidation
schedule
Forthe combinations
determined
guideline)
pouches
be
timeat the defined
of
same
material
must
sealed
each
3
the
program(reels
predefined
(T)andsubsequently
sterilized
usingthe
sterilization
temperature
to a differentsterilization
batch
mustbe sealedon bothsides).Eachpouchis to be attributed
batches.
(if available)
variables
in the sterilization
in orderto considerall influencing
validator(e.g directlyby hawoGmbH
by a qualified
mustbe determined
Sealseamresistance
partner).
documents
now
ask
us for the necessary
Contactus
to
service
or by an authorized
(order
andchecklists
number9.079.036).
testingdeviceht
Youcaneasilyperformthistestyourselfusingoursealingseamresistance
1 5 0S C D .
SeiteGB 55
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ENGLISH
hm 78ODG
hm 78ODG-V
Validation
Section 7
7.3.1.5 Revalidation
Sinceevensmallchangescanfrequently
compromise
status,the processes
thevalidation
periodically
mustbe revalidated
if changeshavebeenmadeto the sealingdeviceor if the
packaging
materialhasbeenchanged.
As the manufacturer,
we recommend
annualperiodicrevalidation.
lf no changeshavebeen
madeto thesealingdeviceandthe materialhasnot beenmodified,
a repetition
of the
performance
qualification
(repeatof sealseamresistance
determination)
is sufficient
for
revalidation.
Sealseamresistance
(e.9.directlyby hawoGmbH
mustbe determined
by a qualified
validator
or by an authorized
servicepartner).
Contactus nowto askus for the necessary
documents
(ordernumber9.079.036).
andchecklists
Youcaneasilyperformthistestyourselfusingoursealingseamresistance
testingdeviceht
1 5 0S C D .
Thesealingdevicemustbe servicedanddemonstrably
calibrated
beforeperiodicrevalidation.
(seeDINEN ISO11607-2
5.2.5)
Servicingand calibrationof hawosealingdevicesmay only be performedby hawo
GmbHor by one of hawo'sauthorizedservicepartners.For further information,please
contactyour authorizedservicepartneror the hawoServiceHotline:+a9(0) 626197700
(keyword:servicingand calibration)
SeiteGB 56
9.694,026
v 1.02