Durr Dental Hygopac View User manual

EN
Hygopac View
Installation and operating instructions
6024100132L02
*6024100132L02*
1906V003

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended purpose .. . . . . . . . . . . 4
2.2 Intended use .. . . . . . . . . . . . . . . 4
2.3 Improper use .. . . . . . . . . . . . . . . 4
2.4 General safety information .. . . . . 4
2.5 Specialist personnel .. . . . . . . . . 5
2.6 Electrical safety .. . . . . . . . . . . . . 5
2.7 Only use original parts .. . . . . . . . 5
2.8 Transport .. . . . . . . . . . . . . . . . . . 5
2.9 Disposal .. . . . . . . . . . . . . . . . . . 5
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 6
3.1 Scope of delivery .. . . . . . . . . . . . 6
3.2 Accessories .. . . . . . . . . . . . . . . . 6
3.3 Optional accessories .. . . . . . . . . 6
3.4 Consumables .. . . . . . . . . . . . . . 6
3.5 Wear parts and replacement
parts .. . . . . . . . . . . . . . . . . . . . . 7
4Technical data .. . . . . . . . . . . . . . . . . . . 8
4.1 Type plate .. . . . . . . . . . . . . . . . . 9
4.2 Declaration of conformity .. . . . . . 9
5 Operation .. . . . . . . . . . . . . . . . . . . . . . 10
5.1 Touch screen .. . . . . . . . . . . . . . . 11
5.2 VistaSoft Monitor (optional) .. . . . 11
Assembly
6Requirements .. . . . . . . . . . . . . . . . . . . 12
6.1 Installation/setup room .. . . . . . . 12
6.2 Setup options .. . . . . . . . . . . . . . 12
6.3 Information about electrical con-
nections .. . . . . . . . . . . . . . . . . . 12
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 12
7.1 Remove the transport locks .. . . 12
7.2 Electrical connections .. . . . . . . . 12
8 Commissioning .. . . . . . . . . . . . . . . . . . 13
8.1 Monitoring the unit via the net-
work .. . . . . . . . . . . . . . . . . . . . . 13
8.2 Handover of the device .. . . . . . . 14
9Configuring the unit .. . . . . . . . . . . . . . 14
9.1 Selecting the access level .. . . . . 14
9.2 Language selection .. . . . . . . . . . 14
9.3 Set the date and time. .. . . . . . . . 14
9.4 Adjusting the temperature .. . . . . 15
9.5 Set the speed for the belt trans-
port .. . . . . . . . . . . . . . . . . . . . . . 15
9.6 Set standby time .. . . . . . . . . . . . 15
9.7 Configuring the network .. . . . . . 15
9.8 Touch screen calibration .. . . . . . 16
Usage
10 Use of suitable sterile product pack-
aging .. . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.1 Recommendations for the sterile
product packaging .. . . . . . . . . . 17
11 Operation .. . . . . . . . . . . . . . . . . . . . . . 18
11.1 Switching the unit on/off .. . . . . . 18
11.2 Touch screen .. . . . . . . . . . . . . . . 18
11.3 Sealing the sterilisation packag-
ing .. . . . . . . . . . . . . . . . . . . . . . . 19
11.4 Start the transport belt manually .. 19
12 Monitoring the unit with VistaSoft
Monitor .. . . . . . . . . . . . . . . . . . . . . . . . 20
13 Adjustment of the adjustable stop .. . 20
14 Validation of the sealing process .. . . . 21
14.1 Validation steps .. . . . . . . . . . . . . 21
14.2 Daily function assessment .. . . . . 21
14.3 Annual Performance Qualifica-
tion .. . . . . . . . . . . . . . . . . . . . . . 21
15 Document the sealing process .. . . . . 22
Contents
6024100132L02 1906V003 1
EN

15.1 Securing the sealing log .. . . . . . 22
16 Cleaning and disinfection .. . . . . . . . . . 23
16.1 Unit surfaces .. . . . . . . . . . . . . . . 23
Troubleshooting
17 Messages .. . . . . . . . . . . . . . . . . . . . . . 24
17.1 "Caution" messages .. . . . . . . . . 24
17.2 "Fault" messages .. . . . . . . . . . . 24
17.3 "Note" messages .. . . . . . . . . . . 24
18 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 25
18.1 Displaying the sealing parame-
ters .. . . . . . . . . . . . . . . . . . . . . . 25
18.2 Fault on the unit .. . . . . . . . . . . . 25
18.3 Error messages on the touch
screen .. . . . . . . . . . . . . . . . . . . . 25
Appendix
19 Menu structure .. . . . . . . . . . . . . . . . . . 29
20 Sealing log .. . . . . . . . . . . . . . . . . . . . . 31
Contents
2 6024100132L02 1906V003
EN

Important information
1 About this document
These installation and operating instructions rep-
resent part of the unit.
If the instructions and information in these
installation and operating instructions are
not followed, Dürr Dental will not be able
to offer any warranty or assume any liabil-
ity for the safe operation and the safe
functioning of the unit.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translation of the original manual.
These installation and operating instructions are
the so-called "original operating instructions".
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
❯Follow these measures to avoid the
danger.
The signal word differentiates between four levels
of danger:
–DANGER
Immediate danger of severe injury or death
–WARNING
Possible danger of severe injury or death
–CAUTION
Risk of minor injuries
–NOTICE
Risk of extensive material/property damage
Other symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Observe the operating instructions.
CE labelling
Disconnect all power from the unit.
Manufacturer
On / off switch
Order number
Serial number
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Monitor ambient conditions
Fuses
Wear protective gloves.
Symbols in the display window
Menu
Start screen
1 step back
Enabled
Disabled
Important information
6024100132L02 1906V003 3
EN

1.2 Copyright information
All circuits, processes, names, software pro-
grams and units mentioned in this document are
protected by copyright.
The Installation and Operating Instructions must
not be copied or reprinted, neither in full nor in
part, without written authorisation from Dürr
Dental.
2 Safety
Dürr Dental has designed and constructed this
unit so that when used properly and for the
intended purpose it does not pose any danger to
people or property.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects on skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended purpose
The unit is intended to be used for the sealing of
sterilisation packaging.
2.2 Intended use
The unit is designed to provide validated thermal
sealing for sterilisation packaging in accordance
with EN ISO 11607‑1 (both bags and rolls) in the
medical sector, e.g. clinics, dental practices and
medical surgeries.
2.3 Improper use
Any use of this appliance / these appliances
above and beyond that described in the Installa-
tion and Operating Instructions is deemed to be
incorrect usage. The manufacturer cannot be
held liable for any damage resulting from incor-
rect usage. The operator will be held liable and
bears all risks.
Sterilisation packaging that does not comply with
EN ISO 11607-1 is not suitable.
2.4 General safety information
❯Always comply with the specifications of all
guidelines, laws, and other rules and regula-
tions applicable at the site of operation for the
operation of this unit.
❯Check the function and condition of the unit
prior to every use.
❯Do not convert or modify the unit.
❯Comply with the specifications of the Installa-
tion and Operating Instructions.
Important information
4 6024100132L02 1906V003
EN

❯The Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
2.5 Specialist personnel
Operation
Unit operating personnel must ensure safe and
correct handling based on their training and
knowledge.
❯Instruct or have every user instructed in han-
dling the unit.
❯Regularly train all operators who are responsi-
ble for use and maintenance of the device. As
part of this, the operators must also demon-
strate that they have understood everything
covered. Attendance lists of the training course
participants must also be kept.
Installation and repairs
❯Installation, readjustments, alterations,
upgrades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental.
2.6 Electrical safety
❯Comply with all the relevant electrical safety
regulations when working on the unit.
❯Never touch the patient and unshielded plug
connections on the device at the same time.
❯Replace any damaged cables or plugs immedi-
ately.
2.7 Only use original parts
❯Only use Dürr Dental parts or accessories and
special accessories specifically approved by
Dürr Dental.
❯Only use only original wear parts and replace-
ment parts.
Dürr Dental accepts no liability for dam-
ages or injury resulting from the use of
non-approved accessories or optional
accessories, or from the use of non-origi-
nal wear parts or replacement parts.
The use of non-approved accessories,
optional accessories or non-genuine wear
parts / replacement parts (e.g. mains
cable) can have a negative effect in terms
of electrical safety and EMC.
2.8 Transport
The original packaging provides optimum protec-
tion for the unit during transportation.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental will not accept any responsi-
bility or liability for damage occurring dur-
ing transportation due to the use of incor-
rect packaging, even where the unit is still
under guarantee.
❯Only transport the unit in its original packaging.
❯Keep the packing materials out of the reach of
children.
❯Screw in the transport protection (see "7.1
Remove the transport locks").
2.9 Disposal
Unit
The unit must be disposed of properly.
Within the European Union, the unit must
be disposed of in accordance with EU
Directive 2012/19/EU (WEEE).
❯If you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
Important information
6024100132L02 1906V003 5
EN

Product description
3 Overview
1
2
4
3
1 Hygopac View
2 Mains cable
3 SD card
4 Hygofol Set
3.1 Scope of delivery
The following items are included in the scope of
delivery:
Hygopac View .. . . . . . . . . . . . . . . 6024100001
– Hygopac View
– Mains cable
– SD card
– Hygofol Set
– Hygopac Sealcheck
– Installation and operating instructions
– Quick start instructions
– Handover protocol
– Guidelines for the handover and briefing of the
unit
– Information on the validation of the packaging
process
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
Hygofol transparent sterile product packaging
bags
7.5 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-061-00
10 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-062-00
15 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-063-00
Hygofol transparent sterile product packaging
rolled foil
5.0 cm x 100 m .. . . . . . . . . . . . . . 6020-050-50
7.5 cm x 100 m .. . . . . . . . . . . . . . 6020-051-50
10.0 cm x 100 m .. . . . . . . . . . . . . 6020-052-50
15.0 cm x 100 m .. . . . . . . . . . . . . 6020-053-50
25.0 cm x 100 m .. . . . . . . . . . . . . 6020-055-50
3.3 Optional accessories
The following optional articles can be used with
the unit:
Hygopac Sealcheck .. . . . . . . . . . . . 6022100027
Network cable .. . . . . . . . . . . . . . 9000-119-071
Hygofol Station .. . . . . . . . . . . . . . . 6022-600-00
Instrument table .. . . . . . . . . . . . . . 6022-700-00
Hygoprint .. . . . . . . . . . . . . . . . . . . 6020-080-50
3.4 Consumables
The following materials are consumed during
operation of the device and must be ordered
separately:
Hygopac Sealcheck .. . . . . . . . . . . . 6022100027
Hygofol transparent sterilisation packaging
bags
7.5 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-061-00
10 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-062-00
15 x 30 cm, 1 x 500 pcs .. . . . . . . 6020-063-00
Hygofol transparent sterilisation packaging
rolled foil
5.0 cm x 100 m .. . . . . . . . . . . . . . 6020-050-50
7.5 cm x 100 m .. . . . . . . . . . . . . . 6020-051-50
10.0 cm x 100 m .. . . . . . . . . . . . . 6020-052-50
15.0 cm x 100 m .. . . . . . . . . . . . . 6020-053-50
25.0 cm x 100 m .. . . . . . . . . . . . . 6020-055-50
Cleaning and disinfection
FD 322
rapid surface disinfection .. . . . . . CDF322C6150
FD 333
rapid surface disinfection .. . . . . . CDF333C6150
FD 350 Classic
disinfection wipes .. . . . . . . . . . . CDF35CA0140
Product description
6 6024100132L02 1906V003
EN

3.5 Wear parts and replacement
parts
Information about replacement parts is
available from the portal for authorised
specialist dealers at:
www.duerrdental.net.
Product description
6024100132L02 1906V003 7
EN

4 Technical data
Electrical data
Voltage V 230, 1~
Frequency Hz 50 - 60
Nominal current A 4
Power output, max. W 900
Fuse 2 x T 5.0 AH / 250 V~ (IEC 60127-2)
Type of protection IP 20
Protection class I
Degree of soiling (in accordance with EN
61010-1)
2
General data
Sealing temperature
(adjustable in 5 °C steps)
Tolerance of the adjusted sealing tempera-
ture
°C
100 - 210 (version 2.0 or higher)
+ / - 5
Heating performance W 2 x 400
Warm-up time approx. min 3
Rate of sealing
adjustable
m/min
5 - 7 - 9
Tolerance of the set throughput speed
Limit values
m/min + / - 1
min. 4, max. 10
Sealing seam:
Total width
Sealed width
mm
17
13
Pressing force, general range N 60 - 120
Duty cycle % 80 (S3, 30 min)
Noise level* dB(A) <70
Dimensions (W x H x D) cm 37 x 17 x 14
Weight kg 7.8
TFT touch screen " 2.8
*Noise level in accordance with ISO 3744
Ambient conditions during storage and transport
Temperature °C -10 to +60
Relative humidity % < 95
Ambient conditions during operation
Temperature °C +10 to +40
Relative humidity % < 70
Altitude above mean sea level m < 2000
Product description
8 6024100132L02 1906V003
EN

4.1 Type plate
The type plate is located on the rear side of the unit.
1
1 Type plate
4.2 Declaration of conformity
Name of manufacturer: DÜRR DENTAL SE
Address of manufacturer: Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Name of product: Hygopac View
We hereby declare that the above product meets all applicable requirements of the directives listed
below:
– Machinery directive 2006/42/EC in its current version.
Name of the person with responsibility for compiling all technical documentation:
F. Hatzfeld (Head of Development Equipment).
The address is identical to the address of the manufacturer.
– Low voltage guideline 2014/35/EU in its valid version.
– Electromagnetic Compatibility (EMC) Directive 2014/30/EU in its current version.
– Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and
electronic equipment in its current version.
Hygopac View REF 6024100001
F. Hatzfeld on behalf of Duerr Dental O. Lange on behalf of Duerr Dental
Head of Development Equipment Head of Quality Management
Product description
6024100132L02 1906V003 9
EN

5 Operation
4
5
10
6
1
2
3
79
8
1 On / off switch
2 Standby LED
3 Touch screen
4 Infeed
5 Adjustable stop
6 SD card slot
7 Mains connection
8 Fuse holder
9 Network connection
10 Outlet
The touch screen is used to display information, and settings can be entered here for operation of the
device.
Tapping the On/Off switch turns on the device. The device heats up, and both the target temperature
and the current actual temperature are shown on the touch screen.
The operator is reminded of the operational qualification every day. This is done after the device reaches
the target temperature for the first time at the start of working. To do this, a seam sealing test is per-
formed and then assessed, e.g. with Hygopac Sealcheck. If the seam sealing test is successful, this
must be confirmed by pressing a button, so that the device is released for operation. If the seam sealing
test is not successful, the target temperature must be corrected.
Product description
10 6024100132L02 1906V003
EN

In the area of the infeed there is a light barrier that is used to detect inserted sterilisation packaging and
start the transport. Then the transport belt runs for a maximum foil width of 75 cm. If a new foil is
quickly inserted afterwards but not placed against the adjustable stop, a foil can be picked up by the
transport belt without the light barrier being triggered. The infeed is designed so that only the thin sterili-
sation packaging can be fed into the unit. This ensures that no materials that are to be sterilised can be
damaged.
Within the unit, the sterilisation packaging is guided between two heating bars and heated. At the end
of the two heating bars there are two rollers that then seal the sterilisation packaging. The pressing force
of the rollers is continuously monitored. If the pressing force is outside the tolerance, this is shown on
the display window accordingly.
After the sterilisation packaging has been transported through the unit, the transport then switches off
after an afterrunning time. The unit is ready for the next sealing process.
The unit has a standby mode. If this is activated in the menu under System Settings -> Standby, the
unit will switch off automatically after the set time if it is not used. 30 minutes are preset.
The unit contains an SD card, on which the relevant sealing parameters are saved. The data can be
transferred to a computer using a card reader. Alternatively, the data can be transmitted via a continu-
ous network connection and read and edited using a suitable program.
5.1 Touch screen
The touch screen can be used to navigate through the device and to adjust settings (see "11.2 Touch
screen").
LOT: 12345610:0712.10.2018
Aufheizen auf 180°C
+ 80°C
Folientransport
Fig. 1: Start screen on the touch screen
5.2 VistaSoft Monitor (optional)
If the device is connected to the network then it can be monitored with the VistaSoft Monitor software.
VistaSoft Monitor shows the current status along with messages and faults on the device.
In addition, VistaSoft Monitor also helps with maintenance of the device – the software warns when
maintenance work is due.
For further information please refer to the VistaSoft Monitor manual (order number 2110300001).
Product description
6024100132L02 1906V003 11
EN

Assembly
6 Requirements
6.1 Installation/setup room
The room chosen for set up must fulfil the follow-
ing requirements:
– Closed, dry, well-ventilated room
– Should not be a room made for another pur-
pose (e. g. boiler room or wet cell)
Ambient and environmental conditions
must be taken into account. Do not oper-
ate the unit in damp or wet conditions.
WARNING
Risk of explosion due to ignition of
combustible materials
❯Do not operate the unit in any rooms in
which inflammable mixtures may be
present, e.g. in operating theatres.
6.2 Setup options
The following options are available for installation
of the device:
– On a stable, easily accessible surface (e.g.
work table).
Please note the following when setting up the
device:
– The device warms up during operation; keep a
good distance to heat-sensitive devices.
– A minimum gap equal to the width of the
packaging must be provided to the side to
allow insertion and removal of the sterile prod-
uct packaging that is to be sealed.
– Do not cover the ventilation slots.
6.3 Information about electrical
connections
The unit has no main power switch. The unit
must be set up so that the power outlet is easily
accessible and the unit can be unplugged from
the mains if necessary.
7 Installation
7.1 Remove the transport locks
❯Remove the transport protection.
❯Store the transport protection (see also
"2.8 Transport").
7.2 Electrical connections
12
1 Mains connection
2 Network connection
❯Before connecting the device, check that the
supply voltage matches the voltage specifica-
tion on the type plate.
❯Connect the mains cable to the unit and to the
power outlet.
Assembly
12 6024100132L02 1906V003
EN

❯Plug a network cable into the network connec-
tion on the unit (optional when using
e.g. Tyscor Pulse) and into the network socket.
8 Commissioning
❯Insert the SD card into the unit.
❯Switching on the unit:
Press the On/Off switch (blue LED lights
up).
❯A signal sounds, the blue LED flashes and the
device is heated to the pre-set temperature.
Once the selected temperature is reached, the
blue LED goes out and the device is ready for
operation.
❯Set up the basic settings for the device – e.g.
temperature, date and time. The firmware ver-
sion can be checked under Device Information
> Device Data. Refer to "9 Configuring the
unit"
The temperature of the device is pre-set
to 180°C for Hygofol transparent sterilisa-
tion packaging from Dürr Dental.
The speed of the belt transport is pre-set
to Medium.
❯Carry out a function check of the device.
❯Perform a sealing test.
If the test seal is not OK, adjust the tempera-
ture and/or speed as required.
8.1 Monitoring the unit via the
network
If the device is connected to the network then it
can be monitored with the VistaSoft Monitor soft-
ware.
VistaSoft Monitor shows the current status along
with messages and faults on the device.
In addition, VistaSoft Monitor also helps with
maintenance of the device – the software warns
when maintenance work is due.
For further information please refer to the
VistaSoft Monitor manual (order number
2110300001).
Assembly
6024100132L02 1906V003 13
EN

8.2 Handover of the device
A factory calibration is performed on the
device at the factory. A printout of these
test results is included in the supplied
documents. This factory calibration does
not replace the initial validation of the
sealing process after commissioning at
the place of installation. To do this, a per-
formance qualification of the sealing pro-
cess must be performed after commis-
sioning (see "14.3 Annual Performance
Qualification").
Correct handover and installation of the device
forms part of the validation process during the
Installation Qualification (IQ). This process must
be documented like every part of the validation.
Please use the enclosed handover record or
download and print it out from www.duerrden-
tal.com and then fill it in.
A new Installation Qualification always
needs to be carried out if major changes
are made to general conditions.
9Configuring the unit
9.1 Selecting the access level
The adjustment options depend on the selected
access level.
Only a qualified expert is permitted to
change the settings in the Service Techni-
cian access level.
Access level Rights
Operator – Querying device information
– Sealing parameters
Administrator In addition to the User rights:
– System settings (administra-
tive)
For operators, e.g. hygiene
officer
Service Tech-
nician
In addition to the Administrator
rights:
– System settings (all)
For qualified Service Techni-
cians
❯Tap System Settings > Access Level.
❯Select the access level.
❯Tap to go back.
9.2 Language selection
❯Tap System Settings > Language.
Language selection:
❯Select the language and tap Save. Tap
to go back.
9.3 Set the date and time.
The date and time must be set correctly on the
device in order for the batch documentation to
be correct.
You can manually set the date and time or, if the
device is connected to the Internet, you can
obtain the correct time and date from a time
server.
Manual adjustment
❯Tap System Settings > Date / Time.
Manual adjustment of date and time:
❯Tap Date.
❯Adjust the date and tap Save. Tap to go
back.
❯Tap Time.
Assembly
14 6024100132L02 1906V003
EN

❯Adjust the time and tap Save. Tap to go
back.
Automatic adjustment
In order to use automatic time setting,
DHCP must be activated (see "9.7 Con-
figuring the network").
❯Tap Time Zone.
❯Adjust the time zone and tap Save.
9.4 Adjusting the temperature
❯Tap Sealing Parameters > Temperature.
❯Adjust the temperature.
❯Tap Save .
Recommended sealing temperatures:
– 180 °C is recommended for Hygofol transpar-
ent sterilisation packaging.
– For sterilisation packaging from other manu-
facturers, the recommended sealing tempera-
ture should be checked with the relevant man-
ufacturer.
After adjusting the temperature, perform a
test sealing process.
9.5 Set the speed for the belt
transport
The speed of the belt transport can be adjusted
between Slow, Medium and Fast.
❯Tap Sealing Parameters > Speed.
❯Select the required speed, tap e.g. Medium.
❯Tap to go back.
❯Perform a sealing test, see "14.2 Daily function
assessment").
After changing the speed it may be nec-
essary to adjust the sealing temperature
(see "9.4 Adjusting the temperature").
9.6 Set standby time
❯Tap System Settings > Standby.
❯Tap +or -and adjust the time.
It is set to 30 minutes by default.
❯Tap Save .
9.7 Configuring the network
After the network settings have been
changed it is necessary to restart the
device. This saves the changed settings.
Requirements:
üAccess level Administrator or Service Techni-
cian selected.
If DHCP is activated then the settings are
applied automatically.
Deactivate DHCP if you wish to adjust the
settings manually.
❯Tap System Settings > Network.
❯Deactivate DHCP.
❯Tap IP Address, enter the data and tap Save.
❯Tap Net Mask, enter the data and tap Save.
❯Tap Gateway, enter the data and tap Save.
Syslog settings
If the unit is monitored using third-party docu-
mentation software for documentation of the
sealing processes, Syslog settings will still need
to be adjusted for it.
Syslog IP address: IP of the computer on which
the documentation software is running.
Syslog port: The port via which the units are
communicating (default setting: 514).
It is important that no other program is allowed to
access the same port on the computer on which
the documentation software is installed, as other-
wise that port will be blocked and the documen-
tation software will not be able to receive any
data.
❯Tap System Settings > Network > Syslog IP
Address, enter the data and tap Save.
❯Tap Syslog Port, enter the data and tap Save.
Syslog Heartbeat is activated at the fac-
tory, which allows the network stability to
be improved.
Assembly
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9.8 Touch screen calibration
The touch screen is calibrated at the factory.
However, if touch screen operation does not
work it is properly to calibrate the touch screen
on site.
Calibration after starting the device
The touch screen can only be calibrated
immediately after the device is switched
on.
Once the device has been switched on and as
soon as the start screen appears on the touch
screen:
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❯press the touch screen and keep pressing until
the symbol appears.
❯Press the centre of the circle and keep press-
ing until the colour changes (to green).
Drücken Sie in
die Mitte des Kreises
❯Repeat this process at three different points
(these are automatically chosen).
1.
2.
3.
❯The display then shows Calibration success-
ful.
❯Tap OK to confirm.
The calibration can be performed again if
you don't confirm by tapping OK.
Assembly
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Usage
10 Use of suitable sterile
product packaging
The following may be used:
Sterile product packaging in accordance with
DIN EN ISO 11607‑1 and the applicable parts of
EN 868, e.g. Hygofol from Dürr Dental.
– Recommended sealing temperature for
Hygofol: 180°C.
– Recommended sealing temperatures for other
foil brands must be obtained directly from the
relevant manufacturers.
The following materials must not be used:
Sterile product packaging with side gussets.
NOTICE
Device malfunctions or damage due
to use of incorrect materials
Incorrect materials can stick to the heat-
ing channel or to the press rollers. In
addition, these materials do not permit
the flow of air or steam in an autoclave.
❯Do not use any PE foil material
❯Do not use polyamide/nylon foil materi-
als
❯When using foils from the roll, it is pos-
sible for adhesive residue to be on the
start of the roll. Remove this part.
10.1 Recommendations for the
sterile product packaging
Here are various recommendations for working
with sterile product packaging:
– Select sufficiently large packaging.
– Only fill packaging to 75% of its capacity to
ensure that the sealing seams are tension-free.
– The distance between the sealing seam and
the sterilised material should be at least 3 cm.
– To the packaging from being cut or pierced,
sharp instruments should be covered with suit-
able protective equipment (e. g. protective
caps).
– When using multiple packaging, always place
the paper sides on top of each other to pro-
vide unhindered steam and condensate trans-
port. Select the exterior packing so that it is
sufficiently large. The criteria for sealing the
exterior packaging are the same as those for
the final packaging.
– Allow at least 2 cm foil distance to protrude to
the back behind the sealing seam. This
ensures unhindered peeling of the seam and is
used for applying the labels or stickers. Can be
set with adjustable stop.
– The sterilised material that is to be packaged
should be dry.
– The sterilised material must be free of contami-
nation.
– Clamps and blades loosely opened. Clamps,
max. first lock-in position.
Usage
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11 Operation
11.1 Switching the unit on/off
❯Switching on the unit:
Press the On/Off switch (blue LED lights
up).
❯A signal sounds, the blue LED flashes and the
device is heated to the pre-set temperature.
Once the selected temperature is reached, the
blue LED goes out and the device is ready for
operation.
11.2 Touch screen
Start screen
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1
43
2
1 Status bar (e.g. LOT, Time, Date)
2 Information area
3 Function for manual foil transport
4 Menu
Menu screen
Zugrisebene
Siegelparameter
Systemeinstellungen
Einstellungen
1
54
3
2
1 Context area
2 Menu items
3 Scroll bar, active if there are more than three
entries
4 1 step back
5 Start screen
Messages
The Messages view shows all currently active
messages. Here, the messages are divided into
the following categories:
Fault Unit will no longer function.
When the error has been
remedied, it may be neces-
sary to acknowledge the
error message.
Notice After acknowledgement
the unit will continue to
work, but only with limited
functions.
Note Important information for
the operator, e.g. about
the current status of the
device.
The unit continues to oper-
ate.
Information Information for the opera-
tor.
The unit continues to oper-
ate.
The messages Fault, Notice, Note and Informa-
tion are shown on the full screen.
Display of messages (see "Troubleshoot-
ing").
Operating the touch screen
NOTICE
Damage to the touch screen due to
incorrect handling
❯Only operate the touch screen using
your fingertips or the stylus.
❯Do not use a sharp instrument (e.g.
ballpoint pen) to operate the touch
screen.
❯Protect the touch screen against
water.
Usage
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