Hawo 3010 Manuale Uso

hm 3010 DC-V hm 3020 DC-V hm 3011 DC-V
Translation
Original – Instruction for use
9.694.013 V 2.05
ENGLISH
hm 3010 DC-V
hm 3020 DC-V Contents
hm 3011 DC-V
2.3.1 Installation
2.3.2 Commissioning
3.3.1 Sealing temperature and type of sterilization

3.3.2 Expiry date
3.3.3 Operator data, staff data
3.3.4 Quantity specification
3.3.5 Printer data Printer 1
3.3.6 Printer data Printer 2
3.3.7 Printer data External Printer
3.3.8 Selection of a catalog text in a print sequence
3.3.9 Entering a temporary text in a printing sequence
3.3.10 Representation of process data
3.5.1 Input menu selection

3.5.2 Entering sealing temperature
3.5.3 Entering the temperature switch-off tolerance
3.5.4 Entering the time
3.5.5 Entering the date
3.5.6 Entering the expiry date
3.5.7 Programming operator or staff data
3.5.8 Programming batch data
3.5.9 Programming item counter
3.5.10 Programming CE information
3.5.11 Programming text via the search function
3.5.12 Programming text via page number
3.5.13 Programming the sterilization type
3.5.14 Programming the order number
V 2.05 9.694.013 Page GB 2

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.1 Language selection

3.6.2 Date format
3.6.3 Unit of measurement
3.6.4 Selecting the device connection on the COM1 port
3.6.5 Identification
3.6.6 Barcode type
3.6.7 Baud rate
3.6.8 Display brightness
3.6.9 Display background colour
3.6.10 Signal tone
3.6.11 Key lock
3.6.12 Sterilization method ONLY hm 3010- I
3.7.1 Entry of print sequences
3.8.1 Display of device operating data
4.8.1 Activate service menu

4.8.2 Temperature control adjustment 75°C,125°C,175°C and 225°C
4.8.3 Adjustment of pressure
4.8.4 Adjusting the margin
4.8.5 Setting of sealing speed
4.8.6 Enter maintenance date
4.8.7 Enter the start of standby
4.8.8 Serial number, electronic modules
4.8.9 Delete memory
4.8.10 Acivate default settings function
4.8.11 Startup interlock password and automatic deletion
4.8.12 Batch counter on/off
5.1.1 Machine hm 3010 DC-V, hm 3011 DC-V

5.1.2 Machine hm 3010 DC- VI
5.1.3 Machine hm 3020 DC-V
Page GB 3 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
7.3.1 Validation schedule information
V 2.05 9.694.013 Page GB 4

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Introduction Section 1
hm 3011 DC-V
1 Introduction
1.1 Preface
First of all we would like to thank you for purchasing the sealing machine.
In these instructions you will find information about using the device, servicing and care as well
as process validation.
The sealing machine is a microprocessor controlled rotary sealer with printer for packaging
sealable pouches and reels (SBS1).
The sealing machine meets the requirements of DIN 58953-7, DIN EN ISO 11607-2 and the
resulting DGSV2 guideline for validating the sealing process.
Please read these operating instructions carefully before commissioning so that you
are familiar with the capabilities of the machine and you can make optimum use of
its functions.
 Always keep these instructions close to the machine.
1.2 Legend
The exclamation mark in the triangle draws your attention to important notes in
the operating instructions, which must absolutely be observed.

This warning sign refers to measures that could result in danger to human health
if they are not observed. It is compulsory to observe it.
 Tips with a hand symbol next to them, which relate to daily practice.
1
Sterile-Barriere-System
2
Deutsche Gesellschaft für Sterilgutversorgung e.V.
Page GB 5 9.694.013 V 2.05
ENGLISH
hm 3010 DC-V
hm 3011 DC-V
1.3 Important notice
In accordance with the intended use, the CE marking is displayed based on

the following EU directives:
2006/42/CE, 2011/65/CE and 2004/108/CE.
Medical device directive 93/42/CE is not applicable to sealing machine.
The limit values of IEC 60601-1 may not be applied in repeated electrical
inspections.
The manufacturer accepts no liability whatsoever for damage caused by tests

in accordance with standards not listed in the Conformity Declaration.
In the event of conversion work or interventions to the machine undertaken

without the express written permission of the manufacturer, the warranty
shall be deemed void and any liability for physical or material damage shall
be transferred to the operator.
Note
Because we are constantly improving our products, we
reserve the right to modify these operating instructions
and the functions described in them.
These operating instructions apply to products from
software version P240A01 onwards.
V 2.05 9.694.013 Page GB 6

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
1.4 Safety instructions
1. Our products left the plant in perfect safety condition.
 2. To maintain this condition, the content of these safety instructions as well as

type plates, labeling and safety instructions attached to the machine must be
observed while handling the device (transport, storage, installation,
commissioning, operation and maintenance).
3. This machine is suitable for processing laminated films in the heat-sealing

process. See also chapter 2.1 "Designated use".
4. Please check the packaging and lodge a complaint for any damage with the
carrier or parcel service immediately before installing the machine.
5. Before commissioning, ensure that the machine does not show any evidence
of damage. In case of doubt, contact the manufacturer or a service partner
authorized by the manufacturer.
6. Do not operate the machine if the power cable or the power plug is
damaged. Do not use the machine if it does not operate correctly or it is
damaged in any way. If the mains cable or the machine have been damaged,
the machine must be repaired by the manufacturer or by one of the
manufacturer's authorized service partners.
7. The machine must be connected using the mains cable included in shipment
to a protective contact socket with a stable voltage. Operation on IT networks
is not permitted.
8. Please place the machine on a stable base.
9. The machine must not be installed and operated in

explosive areas.
10. If the sealing machine is brought directly from a cold environment into a hot
environment, bedewing may occur. Wait until temperature equalization has
taken place.
Starting up the machine when it is bedewed causes danger to life!
11. Fuse changes and repairs must only be performed by the manufacturer or by
one of the manufacturer's authorized service partners.
12. Switch off the machine when it is not in use or remove the power plug from
the socket.
Page GB 7 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
13. Before cleaning: Disconnect from the mains! Clean the machine only with
a dry or damp soft cloth and a mild cleaning agent. Do not allow any water to
find its way into the machine. Caution! Never wet clean the machine!!
14. Do not insert pointed or flat items into the import slot of the machine. This
can result in damage to the machine and instruments.
15. Do not insert items into the louvers of the machine. You may receive an
electric shock or the machine could be damaged.
16. Do not use the machine if you have any doubts about machine safety.
17. The machine must not be installed or operated by persons under 16 years of
age.
18. The machine must not be operated unsupervised.
19. It is forbidden to operate the machine under the influence of drugs or alcohol.
20. Loose clothesm jewellery or long hair can be caught in moving parts.
21. Your appliance contains valuable materials which can be recovered or

recycled. Leave it at a local civic waste collection point. This appliance is
labeled in accordance with European Directive 2002/96 EC concerning used
electrical and electronic appliances equipment-WEEE).
The directive determines the framework for the return and recycling of used
appliances as applicable throughout the EU.
V 2.05 9.694.013 Page GB 8

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Before starting Section 2
hm 3011 DC-V
2 Before starting
2.1 Intended use
The machine is intended only for commercial and industrial use and may only be used for the
intended use and with following materials.
Sealable materials
Pouches and reels in accordance with EN 868-5 and EN ISO 11607-1*
Paper pouches in accordance with EN 868-4*
Uncoated HDPE (e.g. Tyvek™, 1059B, 1073B and 2FS)*
Aluminum laminate film
* also with side gusset
The correct sealing temperature must be identified by means of test sealings.

The machine output depends on the condition of the sealing material used.
Non-sealable materials
Polyethylene film
Soft PVC film
Hard PVC foils
Polyamide film
Polypropylene film
Page GB 9 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
2.2 Design and functions
Power switch
Line fuse
Power supply socket
Adjustment of
peel edge
0 – 30mm
Rear of machine
RS 232 interface RS 232 interface

PC Label printer or
Barcode Scanner
Sealing and printing process sequence
1. After the sterilization packaging has been inserted, the feed process is started
automatically by means of photoelectric cell.
2. The sterilization packaging is now fed and the sealing seam area is heated up to the set
sealing temperature by the heating units located at the top and bottom. The sealing
temperature is monitored.
3. The sealing seam, which is now heated, is pressed together by the sealing roller and
sealed. The contact pressure is monitored.
4. The printing process is triggered by means of a photoelectric cell when the pressure is
switched on and the activated print data is printed onto the sealed packaging.
5. The finished sterilization packaging is transported to the extraction side.
6. If no item to be sealed is fed in, the feed switches off after approximately 30 seconds.
7. The set parameters remain saved after the device is switched on or off, or after a power
failure. The date and time are updated automatically (Autosafe).
V 2.05 9.694.013 Page GB 10

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
2.3 Installation instructions and commissioning
Prior to installation, read the safety notices in chapter 1.4
2.3.1 Installation
Place the machine on a horizontal surface.
 Please do not lift the machine by the infeed section.
 The distance from the machine to a wall must be at least 200 mm.

200 mm

2.3.2 Commissioning
 Connect the mains cable to the

mains
Power switch
 Plug the mains plug into a socket
 Switch the machine on using the Power supply socket

power switch
To switch on the machine, press the power switch on the right-hand side.
After a short self-test and after the selected sealing temperature has been reached, the
machine is operational. You will see this on the display
Page GB 11 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Configuration of machine Section 3
hm 3011 DC-V
3 Configuration of machine
3.1 Putting into operation
Program
Serial Number version
Default settings
When the machine is switched on
for the very first time, the following
defaults must be undertaken:
Language
also refer to
page 34
Time and date

also refer to
page 25,26
Measurement unit Save entry

also refer to
page 34
V 2.05 9.694.013 Page GB 12

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Selection of a preset
sealing temperature, e.g. 180°C
The set sealing temperature

is reached after a short time.
The machine is ready for
operation
Login
In order to work with the machine,

the user must enter the personal
codeword programmed previously
(For programming, see 3.5.7)
If no personal codewords have

been programmed, the input is
omitted
Logout
If there is a change of user, the

previous codeword should be
deactivated by pressing the button!
Page GB 13 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.2 Display and keyboards

Display: Display: Display:
date + time pressure item counter
Display: Selection:
sealing temperature Sealing Speed
Selction: Selection:
sealing temperature Seal Check
Selection:
Quantity Selection:
Pack content input menu
Is only displayed if a Selction: Selection:

print order with quantity has expiry date print data
been selected
Selection: Selection:
Staff number Seal Check
Selection:
Special
characters
Selection:
upper case Entry confirmation with data
letters acceptance
V 2.05 9.694.013 Page GB 14

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3 Machine settings
3.3.1 Sealing temperature and type of sterilization
1. Selection of three preset temperatures e.g. 120°C
Press desired
temperature
Save selection
2. Selection of three preset sterilization types
Save selection
Page GB 15 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3.2 Expiry date
Selection of three Press desired expiry date

preset expiry dates.
Factory setting:
Date 1: 4 weeks
Date 2: 12 weeks
Date 3: 26 weeks
Save selection
3.3.3 Operator data, staff data
abc12
Selection of a name by
entering a defined
operator password
Enter password
e.g. A1B2C
See also page 28

Programming operator or staff data
Confirm entry
3.3.4 Quantity specification
If a printing sequence has

been selected which also
involves printing the quantity
that the package contains,
then the display shows a
quantity specification that can
be modified from 1-10 for each
package
Enter quantity
V 2.05 9.694.013 Page GB 16

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3.5 Printer data Printer 1 for hm 3010 DC-V, hm 3010 DC-VI, hm 3020 DC-V, hm 3011 DC-V
Selection from 5 print

sequences
See also page 39

Entries of print sequences
Save selection
3.3.6 Printer data Printer 2 ONLY hm 3020
Select
print sequences 1-5
Selection from 5 print
sequences Print sequence 6 =
PRINTER OFF
See also page 39
Entries of print sequences
Save selection
3.3.7 Printer data External Printer for hm 3010 DC-V, hm 3010 DC-VI, hm 3020 DC-V, hm 3011 DC-V
Select
print sequences 1-5
Print sequence 6 =
PRINTER OFF
selection
Number of labels to be printed 1 - 99
Page GB 17 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3.8 Selection of a catalog text in a print sequence
Press text selection key
1. Select text
Hospital
Save entry
V 2.05 9.694.013 Page GB 18

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3.9 Entering a temporary text in a printing sequence
1. Press text selection key
2. Select temporary text entry
Hospital
3. Enter temporary text
temp
Confirm
Save entry
Page GB 19 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.3.10 Representation of process data
00000436 Batch counter

08:19:43 Time
180°C Temperature
102N Contact pressure
10.0 m/min Rotary speed
After the sealing machine has Cursor
been switched on the
temperature, contact pressure
and rotary speed are recorded
during each sealing process.
The cursor can be moved over

the graphic gradients and the
corresponding measured
values applying to the absolute
Cursor ± 1
quantities are displayed.
Cursor ± 10
Y-axis selection Date of the

for the measured values: recording
T Temperature
F Contact pressure
v Rotary speed
V 2.05 9.694.013 Page GB 20

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.4 Sealing seam test – “Seal Check”

Testing of the critical process parameters temperature, contact pressure and sealing time with
"SEAL CHECK".
This test should be performed before and after the daily working process and/or before/after each
load and can be documented by routinely filing the printout (DIN EN ISO 11607-2).
The additional use of the SEAL CHECK sealing indicator in combination with the SEAL CHECK
function of the sealing machine is recommended.
Before the test, the device must be ready for use and the set temperature must have been reached.
 Date and time
T: Temperature
F : Pressure applied
v : Sealing time
: Name
: Machine serial number
Only hm 3020
: Machine serial number
Page GB 21 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5 Programming the machine data
3.5.1 Input menu selection
Press buttons in sequence
system configuration
printer setup
data input
Sealing temperature
device operating data
Packaging date
Expiry date 3. Select desired entry
Batch data
Staff data
Item counter
CE information
Texts
sterilization type
Order number
V 2.05 9.694.013 Page GB 22

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.2 Entering sealing temperature
Specify temperature
value to be changed
2. Enter new temperature

value and confirm entry
confirm entering
3. Select name of packaging

material
4. Enter name of packaging

and confirm entry
confirm entering
Page GB 23 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.3 Entering the temperature switch-off tolerance
1. Input the temperature value
Allocation of a temperature
tolerance limit which, if
violated, results in the motor
being stopped automatically.
Range ±2° to ±5°

Factory setting: ±5°
2. Select the tolerance value ±2° to ±5°
3. Confirm Entering
confirm entering
V 2.05 9.694.013 Page GB 24

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.4 Entering the time
Enter the hours
January January
M T W T F S S M T W T F S S
Enter the minutes
January 2006 January

Set seconds to 00
Press seconds
January
Page GB 25 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.5 Entering the date
Enter the day
January
M T W T F S S
Enter the month
January January Januar y Februar y

M T W T F S S March April
M T W T F S S
May June
July August
September October
November December
Enter the year

1. Select year on the calendar 2. Select new year from the list
February
February
M T W T F S S
M T W T F S S
Save entry
V 2.05 9.694.013 Page GB 26

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.6 Entering the expiry date
Select expiry date Enter day

1. Selct expiry dates to be changed 2. Select day on the calendar
January January
Enter the month

1. Select month field on the calendar 2. Select new month from list
January Januar y Februar y

January
March April
M D M D F S S M D M D F S S May June
July August
September October
November December
Enter the year

1. Select year field on the calendar 2. Select new year from list
Februar y February
Save entry
Page GB 27 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.7 Programming operator or staff data
1. Press name field
Enter 50 names
with password
Selection of 50 name
fields
2. Enter name with up to 20 characters
Miller
Confirm entry
3. Enter password with up to 5 characters
abc12
Confirm entry
V 2.05 9.694.013 Page GB 28

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.8 Programming batch data
Enter batch data
Enter alphanumeric text.

Up to 20 characters
Confirm entry
3.5.9 Programming item counter
Set counter. Up to 7 places
Set item counter to a

value.
If downward counter was selected

there is an acoustic signal for approx.
3 s, the counter reading is 0, the
counter display flashes red, and the Confirm entry
printer is switched off
The printer can be released after

resetting the counter or selecting Counter reading
upward counter
Selection Selection
Upward counter Downward counter
3.5.10 Programming CE information
Enter CE information

Up to 20 characters
Confirm entry
Page GB 29 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.11 Programming text via the search function
1. Select text page
Enter alphanumeric text

with the search function.
Scroll
Text memory: 2500 pages
Up to 20 characters
Select text page

2. Enter text
abcde
Confirm entry
V 2.05 9.694.013 Page GB 30

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.12 Programming text via page number
1. Activate entry of page number
Enter alphanumeric text

with the search function.
Text memory: 2500 pages

Up to 20 characters
2. Enter page number
3. Press text Field
4. Enter text
abcd
Confirm Entry
Page GB 31 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.5.13 Programming the sterilization type
1. Touch the label field
Entry of three different

sterilization types
2. Enter the label with a maximum of 20 characters
Plasma
Confirm entry
3.5.14 Programming the order number
Enter order number

Up to 20 characters
Confirm entry
V 2.05 9.694.013 Page GB 32

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6 Configuration of the machine

Configuration of the machine is only possible if the keyboard and input lock is deactivated
Configurations
Language
Date format
Baud rate
printer setup
data input
Key lock
Unit of
measurement
3. Select setting
Barcode type
Select device
connection on COM1
port
identification
Symbols / Text
Sterilization methode
ONLY hm 3010-I
Display Save configuration

background color
Display brightness
Signal Tone
off/on
Page GB 33 Signalton 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.1 Language selection
Portuguese, Turkish, Polish and Dutch
3.6.2 Date format
Save selection
3.6.3 Unit of measurement
Unit of measurement SI: Temperature [°C]

Pressure applied [N]
Throughput rate [m/min]
Unit of measurement fps: Temperature [°F]

Pressure applied [lbf]
Throughput rate [ft/min]
3.6.4 Selecting the device connection on the COM1 port
Label Printer hm 2000C
Serial Barcode Scanner hm 780 BR
V 2.05 9.694.013 Page GB 34

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.5 Identification
Package batch data

date
Identification for date, Staff ex Expiry date

expiry, batch, and operator are
printed as a symbol
as per EN 980 1. Select identification, e.g. date
Identification for date,

expiry, batch, and operator are
printed as freely selectable text
2. Enter text
Ster.on:
Confirm entry
3.6.6 Barcode type
Save selection
Page GB 35 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.7 Baud rate
Save selection
3.6.8 Display brightness
7-level brighness setting for the display
3.6.9 Display background colour
Select from 14 different background colours
3.6.10 Signal tone
Keystroke confirmed by signal tone
Keystroke without confirmation signal tone
V 2.05 9.694.013 Page GB 36

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.11 Key lock
1. Select lock
Entire keyboard
It is possible to lock the entire
keyboard
or the key of the
input menu. Input Menue
2. Enter password. Up to 5 places
The block can only be

cancelled by entering the
selected password again, or
using the "Delete memory"
function in the Service menu
Confirm entry
3. Activate key lock
or
Activate key lock
Page GB 37 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.6.12 Sterilization method ONLY hm 3010- I
Select the Sterilization method:
Steam or dry heat
Ethylen oxyde
Raditation
Save selection
Choice of text
V 2.05 9.694.013 Page GB 38

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7 Configuration of the printers

Configuration of the printers is only possible if the keyboard and input lock is deactivated
3.7.1 Entry of print sequences
3.7.1.1 Activate entry of print sequences
printer setup
data input
3. Entry of print sequences is activated
Page GB 39 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7.1.2 Select printer
Printer 1 / print line 1

hm 3010 / 3020 DC-V
hm 3010 DC-VI / 3011 DC-V
Printer 2 / print line 2

Only hm 3020 Select printer
External printer
hm 3010 / 3020 DC-V
hm 3010 DC-VI / 3011 DC-V
3.7.1.3 Select print sequence
One of five print sequences

can be selected
Selection of print
sequence 1, 2, 3, 4, 5
3.7.1.4 Create print sequence
Temperature Item counter

A print sequence
is comprised of up to 10 places
Pressure CE mark
One of the items of print
information shown can be Speed Sterilization method
activated at each place in the
print sequence. Serial Number Scanner data
Item counter TOTAL Choice of text
Date Text No. xxxx
Time Blanc space
Expiry date
Only hm 3010- I
Batch number
Reuse
Order number
Note
Staff data
V 2.05 9.694.013 Page GB 40

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7.1.5 Example of how to create print sequences
For printer 1 / print line 1

of the machine two print
sequences are created.
Print sequences 1: 2.
date, expiry date, Select print
sequence 1
staff data
1. Select printer 1
2. Select print sequence 1
3. Activate desired print

information for each place.
1.
Select printer 1
3.
Activate desired print
information
Page GB 41 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Print sequence 2:
date, expiry date,
staff data, batch data, 1.
text no. 22 Select print
sequence 2
1. Select print sequence 2
2. Activate desired print

information for each place.
2.
Activate desired print
information
Save Print sequences
External printer
When the external printer has been selected, a print sequence is created along the same lines.
Machine hm 3020 DC-V

When Printer 2 / Print Line 2 has been selected, a print sequence is created along the same
lines.
V 2.05 9.694.013 Page GB 42

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7.1.6 Print sequence with barcode
Select printer
2. Select print sequence 2.

Select print
sequence
3. Press barcode button
4. Select printing information that

you want to print as a barcode
1.
Select printer
22
Page GB 43 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7.1.7 Print format
1.
2.
printer setup
data input
Margin adjustment
4. Select configuration
Print direction
Print direction
Character width
Character width
Character pitch
Character pitch
Margin adjustment
Automatic
Character width Save entry
V 2.05 9.694.013 Page GB 44

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.7.1.8 Margin adjustment
Positioning the printout

on the package
0 – 50 mm from the edge 0 – 50 mm
of the package
3.7.1.9 Print direction
Representation of print format
3.7.1.10 Character size
Representation of characters in
4 different sizes
3.7.1.11 Character pitch
4 different pitches
between the individual
characters
3.7.1.12 Automatic Character width
Automatic adjustment of the The maximum desired width can be set via 3.7.1.10
character width acording to the
wide of the packaging
and the length of the print line
Page GB 45 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.8 Machine – operating data
3.8.1 Display of device operating data
1.
printer setup
2.
data input
3. Display of machine operating data
Operating data
Item counter TOTAL
Operating hours
Next maintence
deadline V173A07 13.03.2010
V 2.05 9.694.013 Page GB 46

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.9 IntelligentScan, connection of a barcode scanner
The following inputs and functions can be implemented using a hm 780 BR barcode scanner
(item number 1.421.006) connected to the "IntelligentScan" interface (see page 10), and
relevant barcode lists:
Inputs and functions using the barcode scanner
Inputs
Sealing temperature input Page 23
Entering the temperature switch-off tolerance Page 24
Setting of sealing Speed Page 64
Entering a temporary text in a printing sequence Page 19
Batch number input Page 29
Pack content quantity input Page 16
Sterilization type selection Page 15
Item counter preset Page 29
Expiry date selection Page 16
Character width selection Page 44
Print data selection Page 17
Functions
Log-in / Log-out Function Page 13
Switching the printer off or on Page 17
Switching the item counter off or on Page 69
Activating/deactivating standby function Page 66
Switching personal number Page 68
monitoring off or on
Seal check activation Page 21

The hm 780 BR barcode scanner (item number 1.421.006) is supplied with a
CD (item number 1.490.016) enclosed, facilitating the generation and recording of the
barcode lists on a PC.
For further information, please contact your authorized service partner or the hawo
service line: +49 (0) 6261 9770 0
Page GB 47 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
3.10 Operation and sealing process

 The material to be sealed must be sealed according to the manufacturer's instructions.
 Set the peel edge width:

After the locking device has been loosened, the peel edge can be set by shifting the infeed
section variably between 0 mm and 35 mm. A sufficient protrusion must be available
between the sealing seam and the reel interface given on the extraction side (in
accordance with DIN 58953-7 min. 10 mm).
 Sterilization packaging must be inserted from the left-hand side, always with the side to be
printed face down.
The drive is switched on automatically.
  Remove the sealed sterilization packaging and leave briefly to cool.
Sealable pouches and reels must only be filled to ¾ full (DIN 58953-7). The limited filling
prevents a load that is too large from being placed on the sealing seams.
The correct sealing temperature must be identified by means of sealing tests.

Sealing must be performed in such a way that the sealing seam meets the quality
characteristics requirements of EN ISO 11607-2, even with varying material
thicknesses. The following quality characteristics must be met:
 Intact sealing across the entire sealing seam width

 No channels or open seals
 No punctures or tears
 No delamination or material separation
hawotest SEAL CHECK is considered suitable for checking these quality

characteristics.* The hawotest SEAL CHECK seal indicators are available
separately.
* see the DGSV guideline for validation of the sealing process

V 2.05 9.694.013 Page GB 48
ENGLISH
hm 3010 DC-V
hm 3020 DC-V Troubleshooting and Maintenance Section 4
hm 3011 DC-V
4 Troubleshooting and Maintenance
4.1 Troubleshooting checklist
The trouble shooting suggestion marced with a * may only be carried of a service partner
authorised by the manucaftuer.
Malfunction Possible cause Remedy

Power supply Check power supply
Power cable not plugged in If necessary, plug into a different
power outlet.
Machine fails to switch on Power cable defective

No data on the display Replace power cable.
Line fuse
Replace line fuse!
If the fuse
blows again, it is imperative
to have the machine tested.
Control board
Color display Replace control board.
Change color display.
Set temperature is too low Increase set temperature
Temperature limitation activated Reset temperature limiter

by
pressing in the pin!
Machine fails to heat up If it still trips
it is imperative to have the
machine tested
Temperature sensor
Replace temperature sensor
Heating cartridge
Check heating cartridges
Replace if necessary
Control board
Replace control board.
No transport Motor sensor Replace light barrier
Front flap not closed Close front flap
Front flap sensor Replace front flap sensor
Transport belt Replace transport belt

damaged Check belt tension
Motor Replace motor
Control board Replace control board
Page GB 49 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V

Transport belt guide Replace PTFE tape on
die
Uneven material
feed Transport belt damaged. Replace transport belt
or Check belt tension
loud running noise
Motor Replace motor
Temperature too low Increased temperature
Pressure applied too low Readjust pressure of the

Sealed seam will not hold pressure roller
or replace pressure roller.
Distance between the

sealing dies too large Set distance of the sealing dies
to 0.5 mm
Pressure applied to high Readjust pressure of the
Sealed seam distorted pressure roller
or replace pressure roller.
Paper side of the package

is discolored or
side fold Temperature too high Reduce temperature
shrunk
No print Print information not activated Activate print information
Print incomplete Print start not set properly Reprogram print start
Ink ribbon
Print head Ink ribbon not inserted properly

Replace ink ribbon
Control board
Replace print head
Replace control board

Printing too faint Ink ribbon Replace ink ribbon
Print head Readjust print head
Paper pressure roller

Adjust paper pressure roller
Touch Screen does not work Color display Color display attachment
Change color display
Control board Replace control board
V 2.05 9.694.013 Page GB 50

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.2 Error diaplays

Sealing temperature out of
tolerance Temperature sensor Replace temperature sensor*
Flashes red
Control board Replace control board*
Temperature not calibrated Calibrate temperature*

(service mode) (4.8.2)
Contact pressure out of

tolerance DMS Modul defekt DMS Modul austauschen*
Flashes red
DMS module not calibrated Recalibrate DMS module* (4.8.3)

(service mode)
Sealing speed out of

tolerance Motor Replace motor*
Flashes red
Sealing speed not set Set the sealing speed (4.8.5)

(service mode)
4.3 Customer service

Your hawo customer service is at your disposal Monday through Friday
8:00 AM through 5:00 PM and by phone on +49 (0)6261-9770-31.
Please also feel free to send any questions you may have to the
following e-mail address: service@hawo.com
Page GB 51 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.4 Servicing / calibration
Like all technical devices, your machine is also subject to technical wear.
In order to guarantee continuous operational readiness, your device should be inspected
regularly by a competent person and serviced and calibrated at least once per year by
the manufacturer or by one of the manufacturer's authorized service partners.
Critical process
parameters
calibration
4.5 Parts Service
 Simply order parts by fax:

 Please copy the following pages according to the parts required.
Page 53: Parts required for maintenance and wear
Page 54: Replacement parts
 Enter machine number.

S/N: 123456
 Enter machine model
 Enter name, address, fax number and order number. Type: hm 3010 DC-V
 Mark items required
 Enter quantity required.
 Sign order.
 Fax order.
V 2.05 9.694.013 Page GB 52

To: Sender:
____________________________
____________________________
Your order no.: _________________ Date _______________
Machine model _________________ Serial number _______________
 Description Art.No. Qty.
 Ink ribbon 6.813.104
 PTFE tape Sealing die 6.105.285
hm 3010 DC-V, hm 3011 DC-V

 PTFE tape Guide rail 6.105.139
hm 3020 DC-V
 PTFE tape Guide rail 6.105.137
 Plastic pressure roller 2.230.008
hm 3010 DC-V, hm 3011 DC-V

 Toothed belt, drive 6.271.011
hm 3020 DC-V
 Toothed belt, drive 6.271.012
hm 3010 DC-V, hm 3011 DC-V

 Toothed belt Transport Sealing material 6.271.008
hm 3020 DC-V
 Toothed belt Transport Sealing material 6.271.006
 Heating cartridge 6.536.032
 Upper sealing die assembly 1.616.028
 Lower sealing die assembly 1.616.029
 Service dongle 1.561.002
Signature _____________________
To: Sender:
____________________________
____________________________
Your order no.: _________________ Date _______________
Machine model _________________ Serial number _______________
 Description Art.No. Qty.

hm 3010 DC-V, hm 3020 DC-V,
hm 3011 DC-V 1.653.002
 Print head
hm 3010 DC-VI
 Print head 1.653.003
hm 3010 DC-V
 Control board 1.410.046
hm 3010 DC-VI and hm 3020 DC-V

hm 3011 DC-V
 Color display with Touch Screen 1.410.048
 DMS module 1.410.018
 Optosensor 1.561.003
 Gear motor 1.212.018
 Ink ribbon, motor 1.212.012
 Temperature switch 6.564.018
 Temperature sensor 6.654.023
 Adapter USB/Ethernet 1.596.025
Signature _____________________
ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.6 Replacement parts order – allocation of article numbers
6.564.023 PTFE tape
6.105.285
6.564.018
2.301.027 hm 3010 DC-V

2.301.027 hm 3011 DC-V
2.301.063 hm 3020 DC-V
Upper guiding die
6.181.011
2.301.027 hm 3010 DC-V
2.301.027 hm 3011 DC-V
6.105.139 hm 3010 DC-V
6.105.139 hm 3011 DC-V 2.301.063 hm 3020 DC-V
6.105.137 hm 3020 DC-V
Lower guiding die
6.105.139 hm 3010 DC-V

6.105.139 hm 3011 DC-V
6.105.137 hm 3020 DC-V
2.301.027 hm 3010 DC-V
2.301.027 hm 3011 DC-V
2.302.063 hm 3020 DC-V
Page GB 55 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.7 Information about replacing wearing and spare parts
Replacing ink ribbon

! Please use only genuine replacement parts
 Switch off machine
 Open front flap
 Press lever for ink ribbon holder  down with left hand.
 Press holder for rink ribbon cassette  to side and remove cassette.
 Insert new ink ribbon cassette

Always ensure that the transport opening  in the cassette is attached to the transport
shaft .
 Press ink ribbon cassette toward rear until holder  catches

 Close front flap
 Switch on machine and check printing function after reaching nominal

temperature





V 2.05 9.694.013 Page GB 56

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Maintenance Information ! Please use only genuine replacement parts

Replacing PTFE strip on guide rail
 Switch off machine and DISCONNET POWER PLUG !

 Open housing
 Remove mounting screws  for upper guide rail and remove guide rail or
 Remove mounting screws for lower guide rail and remove guide rail
 Remove mounting screws  and detach PTFE strip
 Pull backing foil off of new PTFE strip and glue new PTFE strip on straight and without
wrinkles
 Fasten PTFE strip with screws 
 Install guide rail
When installing the upper guide rail before fastening, push the die down so that the
interval between the screw head and rail is 1 mm on both sides. This ensures the correct
 contact pressure for the guide rail.
 Close housing
Screw head – rail distance = 1 mm
  
 

Page GB 57 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Maintenance Information
Replacing PTFE strip for upper and lower heating die
 Switch off machine and DISCONNET POWER PLUG !

 Open housing
 Remove mounting screws  for upper guide rail and remove guide rail.
 
Disconnect electrical connections for
heating die
 Remove fastening screws 
 Remove top or bottom heating die
 Unscrew mounting screw  and
 detach PTFE strip
 Remove backing foil on new PTFE strip and glue new PTFE strip on straight and without
wrinkles
 Fasten PTFE strip with screw 
 Install heating die
 Fasten fastening screws  of the heating die
 Reconnect electrical connections to heating die

 Detach nuts 

 Set distance between the  
sealing dies to 0,5mm
 Faste nuts 
0, 5 mm
 
 Install guide rails

When installing the upper guide rail before fastening , push the die down so that the interval
between the screw head and rail is 1mm on both sides. This ensures the correct contact
pressure for the guide rail
Distance between screw head and rail = 1mm
 Close housing
V 2.05 9.694.013 Page GB 58

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Maintenance Information
Replacing pressure roller
 Switch off machine and DISCONNET POWER PLUG!
 Open housing
 Remove mounting screws  for upper guide rail and remove guide rail.
 Unscrew pressure adjustment screw  approx. 5 mm
 Loosen mounting screw  and pull pressure roller completely out of holder
 Detach snap ring  and remove pressure roller
 Install new pressure roller and fasten with snap ring 
 Position complete pressure roller in holder, center in relation to bottom roller and tighten
mounting screw 
 Adjust contact pressure by screwing in adjustment screw  according to calibration instructions
on page 62
  

 Install guide rail
 When installing the upper guide rail before fastening , push the die down so that the interval
between the srew head and rail is 1mm on both sides.
This ensures the correct contact pressure for the guide rail
Distance between screw head and rail = 1mm
 Close housing
Page GB 59 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8 Service settings
4.8.1 Activate service menu
Service Dongle
2. Open the housing cover
3. Remove service dongle

PC board
4. Plug service dongle into the
COM1 connector
(rear of machine)
5. Switch on machine
Adjustment
Temperature
Adjustment
Pressure
Adjustment
speed
Adjustment
Printer
Input
Maintenance date
Input
Standby start
Serial number
Electronic modules
Delete memory
Activate default settings
Password – activate /
deactivate starting lock
Item counter off
V 2.05 9.694.013 Page GB 60

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.2 Temperature control adjustment 75°C,125°C,175°C and 225°C
1. Introduce the temperature sensor between the sealing dies
2. Start adjustment for a set temperature of 75°C

Adjustment of temperature
control must always be
performed after replacing a
heating cartridge,
after replacing the temperature
sensor, and after replacing the 3. When the set temperature has reached 75°C and the counter
control board reading has reached 0 enter the corrected value
The temperatures
75°C , 125°C,175°C and
225°C are measured one after
another and the
difference between set value
and actual value is corrected.
After a set temperature has

been reached it is
stabilized for 120s.
When 120s have elapsed Confirm entry
the corrected value is input
Page GB 61 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.3 Adjustment of pressure
P1
1. Undo screw S
until measurement M
no longer changes
2. Using potentiometer P1
adjust measurement M to
5N
3. Set measurement M
to 100 N by turning screw S
clockwise
M
4. Press button
V 2.05 9.694.013 Page GB 62

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.4 Adjusting the margin
1. Introduce package, dimension > 150 mm,

and 2 vertical bars will be printed

Adjustment of margin setting
must
always be after conducted
replacing a print head and
after replacing the control
board
2. Measure distance 1 between the edge of the package and the

first bar and enter the measurement in mm x 10
Confirm entry
hm 3020 DC-V only ! 3. Measure distance 2 between the edge of the package and the
second bar and enter the measurement in mm x10
Confirm entry
Page GB 63 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.5 Setting of sealing speed
Setting the sealing speed of

5.0 m/min to 13.0 m/min in
steps of 0.5 m/min
Select speed
Confirm entry
V 2.05 9.694.013 Page GB 64

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.6 Enter maintenance date
Enter the day
Select day on calendar
Enter the month

1. Selct month field on calendar 2. Select new month from list
January January Januar y Februar y

M T W T F S S March April
May June
July August
September October
November December
Enter the year

1. Select year on calendar 2. Select new year from list
February
February
M T W T F S S
M T W T F S S
Page GB 65 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.7 Enter the start of standby
1. Enter the time for starting the standby function: 10 – 120 min
If no sealing operations take 20

place, the set sealing
temperature drops to 60°C,
provided standby is activated,
after the selected time has
elapsed.
2. Activate / deactivate standby function
20
Confirm entry
Activate
20
Confirm entry
Deactivate
V 2.05 9.694.013 Page GB 66

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.8 Serial number, electronic modules
View of serial numbers

of
CPU board,
DMS module
and display module
4.8.9 Delete memory
With this function

all the data entered is deleted.
The adjustment values, the

item counter total, the
operating hours meter,
maintenance date, and the
texts entered remain intact
4.8.10 Acivate default settings function
This function should be

activatet before the machine is
re-installed so that whenthe
device is switched on for the
very first timethe default
settings for
language
time and date
measurement unit
are run.
Page GB 67 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.11 Startup interlock password and automatic deletion
Enter time for starting automatic deletion:

1-60 min
5
Automatic deletion
If no sealing operations are

taking place and the entered
time is > 0 then the previous
personnel password is deleted
automatically after the entered
time has expired.
Activate startup interlock password

Startup interlock password
Activated: 5
The machine does not start if
no programmed personal
codeword I entered
Is this function is active
outlined in green
Activate
Deactivate startup interlock password

Deactivated
The machine starts without a
personnel password having 5
been entered
Deactivate
V 2.05 9.694.013 Page GB 68

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
4.8.12 Batch counter on/off

Dicplay batch counter
If the batch counter is switched

off then a display is no longer
activated and it is no longer
printed
If the batch counter is

switched on then the button
is outlined in green
Page GB 69 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Technical Data Section 5
hm 3011 DC-V
5 Technical Data
5.1 Circuit diagram and wiring diagram
5.1.1 Machine hm 3010 DC-V, hm 3011 DC-V
   

Com 1 Com 2
Fuse +24V 10 A SB Line fuse
 2 x 6.3 A SB
Motor Front flap 

Start
Printer
Start
 Color display 1.410.048

 Temperature sensor 6.564.023
 DMS module 1.410.018
 Gear motor 1.212.018
 Ink ribbon motor 1.212.012
 Temperature switch 6.564.018
 Heating cartridges 115V/200W 6.536.032
 Optosensors 1.561.003
 Print head 1.653.002
V 2.05 9.694.013 Page GB 70

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
5.1.2 Machine hm 3010 DC- VI
   

Com 1 Com 2
Fuse +24 V 10 A SB Line fuse
 2 x 6.3 A SB
Motor Front flap


Start
Printer
Start

 Ink ribbon mtor 1.212.012
Page GB 71 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
5.1.3 Machine hm 3020 DC-V
   

Com 1 Com 2
Fuse +24V 10 A SB Line fuse
 2 x 6.3 A SB
Motor Front flap 

Start
Printer
Start

 Ink ribbon motor 1.212.012
V 2.05 9.694.013 Page GB 72

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
5.2 Specifications
Connection data
Power connection [V] 230 /115 /100
Power frequency Hz ] 50 / 60
Power consumption max. [W] 500
Main fuse 100V – 240V [A] 6,3 T
Mechanic
Dimension Length [ mm ] 710 (hm 3010 DC-V, hm 3011 DC-V)
Width 830 (hm 3020 DC-V)
Height 250
240
Housing cover Steel AISI 304
Housing buttom Metal, coated
Weight [ kg ] 21 (hm 3010 DC-V, hm 3011 DC-V)
25 (hm 3020 DC-V)
Sealed edge infinitely adjustable [ mm ] 0 – 35
Sealing seam width [ mm ] 12
sealing system hawoflex™
Length of sealing seam [ mm ] unlimited
Sealing seam distance from [ mm ] >30
pack content ( DIN 58953-7:2003)
Process parameter / Sealing parameter
Sealing temperature max. [ °C ] 220
Tolerance limit motor stop [ °C ] ±2–±5
temperature (adjustable)
Temperature ranges 3
Temperature-tolerance [%] ±2
Pressure applied [N] 100
(70-130 N at service mode)
Tolerance limit motor stop [%] ±20
pressure
Throughput rate [ m / min ] 10
(5-13 at service mode)
Tolerance Throughput rate [%] ±10
Electronic und Communication
System Microprozessor
Serial Interfaces: Connector PC RS-232
USB
Ethernet (LAN)
Connector RS-232
Label printer hm 2000C
or
Barcode scanner hm 780 BR
Datea rate (Baudrate) 9600 - 11520
serial interface
Protection class 1
Environmental parameter
Heat dissipation [ kJ/s] 0,1
Noise intensity [ dB/ A ] <70
Page GB 73 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Declaration of Conformity Section 6
hm 3011 DC-V
6 Declaration of Conformity
6.1 EC- Declaration
V 2.05 9.694.013 Page GB 74

hm 3010 DC-V
hm 3020 DC-V
hm 3011 DC-V
6.2 DIN EN ISO 11607-2 / DIN 58953-7 Declaration of Conformity
Page GB 75 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3020 DC-V Validation Section 7
hm 3011 DC-V
7 Validation
7.1 General
Main purpose of every packaging system for medical products, which are sterilized during the final
packaging, is maintaining the sterility until use or until aseptic preparation at the patient. The
validation of packaging processes is crucial to ensure that sterile barrier system integrity is attained
and will remain so until opened by the users of sterile medical devices.
Within the scope of the preparation of medical products, the sealing process is considered to be
part of the process chain. This process is also to be validated in accordance with the Law on
Medical Products and with the Medical Devices Operator Ordinance.
The international standard EN ISO 11607 – Part 2 requires and describes the validation of
packaging processes. In order to implement it, the German Society for Sterile Supply (Deutsche
Gesellschaft für Sterilgutversorgung) issued a Guideline for the Validation of Sealing Processes
according to EN ISO 11607-2.
The machine meets the requirements of EN ISO 11607-2 and the resulting DGSV guideline for
sealing process validation.
The guideline can be downloaded from the www.dgsv-leitlinie.de website, or it can be requested
from the hawo Service Line on +49 (0) 6261 9770 0 (keyword: DGSV guideline).
Validation must always be performed by the user at the installation site.
7.2 Preparation
machine
machine
The manufacturer's calibration of hawo sealing machine 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 Line: +49 (0) 6261 9770 0
(keyword: servicing and calibration).
The manufacturer's calibration must be ordered separately (order number 9.079.035) and is not
included in shipment!
Furthermore, for the operational qualification you need the hawotest SEAL CHECK indicators. You
can obtain these from your supplier or directly from hawo (online at www.seal-check.de).
Using the original hawotest SEAL CHECK is recommended.
V 2.05 9.694.013 Page GB 76

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
7.3 Validation
We recommend that you perform validation in accordance with the DGSV* guideline for validation
(available from www.dgsv-leitlinie.de). In the following section you will find useful information,
which you will need to implement the DGSV guideline.
*German Society for Sterile Supply DGSV
7.3.1 Validation schedule information
7.3.1.1 Description of the sealing machine
Your sealing machine is a rotary sealer. The precise name and the serial number are written on
the type plate attached on a side of the machine.
The required disconnection tolerance (A) is +/- 5 °C (+/- 41°F) according to DIN 58953-7.
The temperature range of the packaging material will be required again later in the process. You
can get this information from your material supplier. If you do not succeed in getting this
information, you can take as a rule the following ranges:
Transparent packages according to EN 868-5: 170 – 190 °C (338 – 374.00 F)

Uncoated HDPE (Tyvek™): 130 – 140 °C (266 – 284.00 F)
(when using uncoated HDPE materials (e.g. Tyvek™) the
deactivation tolerance must be reduced if necessary)
7.3.1.2 Installation qualification information (IQ)
7.3.1.2.1 QM-system
You can get from hawo free of charge the necessary certificate for the quality management system
ISO 9001:2000.
Ask for it from info@hawo.com or call us on: +49 (0) 6261 9770 0 (keyword: QM certificate)
7.3.1.2.2 Type of machine: Rotary sealer

The machine has CE marking and complies with the EN ISO 11607-2 and DIN 58953-7 standards.
The corresponding conformity declarations can be found in chapter 6 and serve as certifying proof.
7.3.1.2.3 Service authorization

The service partner must be authorized by hawo in writing. Ask your service team for the
certificate.
Page GB 77 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
Safety features
Parameter required existing
Sealing seam width 6mm (0.24 in)* 12mm (0.47 in)
Distance from medical product 30 mm* 30 mm
Process cycle automatic automatic
* required in DIN 58953-7:2003
7.3.1.2.4 Process parameters

Parameter Disconnection tolerance preset adjustable
Sealing temperature +/- 5°C * (+/- 41°F) +/- 2 - 5°C (+/-35.6 - 41°F)***
contact pressure +/- 20% of the set value** not possible
* required in DIN 58953-7:2003
*** when using uncoated HDPE materials (e.g. Tyvek™), the required disconnection tolerance of +/- 5°C may not be
sufficient
These are controlled and monitored by the microprocessor system.
machine.
This prevents further working.
The process parameters must be routinely monitored. For this hawo offers the following
possibilities:
machine
2. ht 180 PT-USB
The new hawotest ht 180 PT-USB is a mobile process documentation system. This system
automatically receives data about the process parameters and additional relevant protocol data
(machine number, staff number, etc.). The data is stored on a USB stick and transferred to a
PC. Storage occurs by means of digitally signed PDF documents directly on the PC.
3. Batch documentation systems

The machine can be connected through an interface directly to the batch documentation
system. Ask the producer for the exact compatibilities.
V 2.05 9.694.013 Page GB 78

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
7.3.1.3 Operational qualification information (OQ)
According to standard EN ISO 11607-2, section 5.3.2 b, the quality characteristics of the
sealing are the following:
 Intact sealing across the entire sealing seam width

 No channels or open seals
 No punctures or tears
 No delamination or material separation
These quality characteristics must be checked and documented with a suitable method. Quality
characteristics can be checked in the best way using the hawotest SEAL CHECK indicators.
The SEAL CHECK reference card from hawo gives clear statements about their implementation.
For this purpose, a sealing must be made at the lower and upper limit value of the sealing
temperature. Quality characteristics are to be fulfilled in both sealings.
After that the sealing temperature is to be determined for daily practice. It is recommended to form
these from middle of the ACTUAL temperatures (during the test; e.g. a lower limit according to the
manufacturer of 170 °C (338 °F) and an upper limit according to the manufacturer of
190 °C (374 °F), mean value = sealing value 180 °C (356 °F).
7.3.1.4 Performance qualification information (PQ)
With the performance qualification it is to be furnished proof of a good understanding of the

process and of delivering of optimal closed sterile barrier systems - also after the sterilization.
The test is carried out using a seal seam resistance check according to DIN EN 868-5, Appendix
D. Packages must be sterilized before testing. Records (batch documentation) of sterilization
processes are part of the validation.
For the combinations determined in the validation schedule (see also Appendix E of the DGSV
guideline) 3 pouches of the same material must be sealed each time at the defined temperature
(T) and subsequently sterilized using the predefined sterilization program (reels must be sealed on
both sides). Each pouch is to be attributed to a different sterilization batch (if available) in order to
consider all influencing variables in the sterilization batches.
Seal seam resistance must be determined by a qualified validator (e.g. directly by hawo GmbH or
by an authorized service partner). Contact us now to ask us for the necessary documents and
checklists (order number 9.079.036).
Page GB 79 9.694.013 V 2.05

ENGLISH
hm 3010 DC-V
hm 3011 DC-V
7.3.1.5 Revalidation
As the manufacturer, we recommend annual periodic revalidation. If no changes have been made
to the sealing machine and the material has not been modified, a repetition of the performance
qualification (repeat of seal seam resistance determination) is sufficient for revalidation.
Seal seam resistance must be determined by a qualified validator (e.g. directly by hawo GmbH or
by an authorized service partner). Contact us now to ask us for the necessary documents and
checklists (order number 9.079.036).
machine
Servicing and calibration of hawo sealing machines 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 9770 0 (keyword:
servicing and calibration)
V 2.05 9.694.013 Page GB 80

Hawo 3010 Manuale Uso

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Hawo 3010 Manuale Uso

Uploaded by

Copyright:

Available Formats

hm 3010 DC-V hm 3020 DC-V hm 3011 DC-V

3.3.1 Sealing temperature and type of sterilization

3.5.1 Input menu selection

V 2.05 9.694.013 Page GB 2

3.6.1 Language selection

3.7.1 Entry of print sequences

3.8.1 Display of device operating data

4.8.1 Activate service menu

5.1.1 Machine hm 3010 DC-V, hm 3011 DC-V

Page GB 3 9.694.013 V 2.05

7.3.1 Validation schedule information

V 2.05 9.694.013 Page GB 4

 Always keep these instructions close to the machine.

1.3 Important notice

In accordance with the intended use, the CE marking is displayed based on

Medical device directive 93/42/CE is not applicable to sealing machine.

The manufacturer accepts no liability whatsoever for damage caused by tests

In the event of conversion work or interventions to the machine undertaken

V 2.05 9.694.013 Page GB 6

1.4 Safety instructions

1. Our products left the plant in perfect safety condition.

 2. To maintain this condition, the content of these safety instructions as well as

3. This machine is suitable for processing laminated films in the heat-sealing

8. Please place the machine on a stable base.

9. The machine must not be installed and operated in

Page GB 7 9.694.013 V 2.05

18. The machine must not be operated unsupervised.

21. Your appliance contains valuable materials which can be recovered or

V 2.05 9.694.013 Page GB 8

2.1 Intended use

* also with side gusset

The correct sealing temperature must be identified by means of test sealings.

Page GB 9 9.694.013 V 2.05

2.2 Design and functions

Power supply socket

RS 232 interface RS 232 interface

Sealing and printing process sequence

V 2.05 9.694.013 Page GB 10

2.3 Installation instructions and commissioning

Prior to installation, read the safety notices in chapter 1.4

Place the machine on a horizontal surface.

 Please do not lift the machine by the infeed section.

 Connect the mains cable to the

 Switch the machine on using the Power supply socket

Page GB 11 9.694.013 V 2.05

3.1 Putting into operation

Time and date

Measurement unit Save entry

V 2.05 9.694.013 Page GB 12

The set sealing temperature

In order to work with the machine,

If no personal codewords have

If there is a change of user, the

Page GB 13 9.694.013 V 2.05

3.2 Display and keyboards

Is only displayed if a Selction: Selection:

V 2.05 9.694.013 Page GB 14

3.3 Machine settings

3.3.1 Sealing temperature and type of sterilization

1. Selection of three preset temperatures e.g. 120°C

2. Selection of three preset sterilization types

Page GB 15 9.694.013 V 2.05

3.3.2 Expiry date

Selection of three Press desired expiry date