Van Der Stahl MD-950 NanoPak Series User manual

www.vanderstahl.com
Printed SEP 2018
4th Edition 4.02E
MEDICAL DEVICE POUCH SEALER
MD-950 NanoPak SERIES
OPERATING INSTRUCTIONS

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1INTRODUCTION ..................................................................................................................................................4
1.1 PREFACE ........................................................................................................................................................4
1.2 IMPORTANT NOTICE ..........................................................................................................................................4
1.3 LEGEND..........................................................................................................................................................5
1.4 SAFETY INSTRUCTIONS .....................................................................................................................................6
1.5 CLEANING .......................................................................................................................................................7
1.6 CORRECT USE .................................................................................................................................................8
2COMMISSIONING ................................................................................................................................................9
2.1 COMMISSIONING THE SEALING DEVICE ................................................................................................................9
2.1.1 Step 1 Inspection of the device............................................................................................................9
2.1.2 Step 2 Setting up the device ................................................................................................................9
2.1.3 Step 3 Connecting the device ............................................................................................................10
2.1.4 Step 4 Turning on the device .............................................................................................................11
2.1.5 Step 4.1 Checking of the sealing parameter sensors ........................................................................12
2.1.6 Step 5 Displays and functions of the main menu...............................................................................13
2.1.7 Change menu level 1 till 7 by “Swiping”..............................................................................................13
2.1.8 Step 6 The first sealing process ........................................................................................................14
2.1.9 The individual levels of the device ......................................................................................................15
2.1.9.1 Level 1 General...............................................................................................................................15
2.1.9.2 Level 2 Printer.................................................................................................................................15
2.1.9.3 Level 3 Print Data ...........................................................................................................................15
2.1.9.4 Level 4 Standby ..............................................................................................................................16
2.1.9.5 Level 5 Monitoring...........................................................................................................................16
2.1.9.6 Level 6 Special Features ................................................................................................................16
2.1.9.7 Level 7 System Configuration .........................................................................................................16
2.2 THE SEALING SEAM TEST ................................................................................................................................17
2.2.1 Locked machine due to failed Seal Check..........................................................................................18
2.2.2 Printing of the test parameters on a package .....................................................................................19
2.2.3 Printing of the test parameters on a label ...........................................................................................19
3DATA INPUT ......................................................................................................................................................20
3.1 CREATING DATA FOR DIFFERENT LANGUAGES ...................................................................................................20
3.2 THE ID-LIST..................................................................................................................................................20
3.2.1 The menu ...........................................................................................................................................20
3.2.2 Entry of user data/administrator rights ................................................................................................21
3.2.3 Removing administrator rights ............................................................................................................22
3.3 PACKAGING LISTS ..........................................................................................................................................22
Menu ..................................................................................................................................................................22
3.3.1 The settings of a packaging list ......................................................................................................23
3.3.2 The printer data of a packaging list ................................................................................................24
3.3.3 Printer data selection .......................................................................................................................25
1-5 OR 6-10 CAN BE SET IN THE SELECTION RANGES. ......................................................................................25
3.3.4 Example of creating a packaging list..............................................................................................25
3.3.4.1 Enter the package designation and determine an identification colour ..........................................26
3.3.4.2 Select the sealing temperature .......................................................................................................26
3.3.4.3 The settings of the internal printer ..................................................................................................27
3.3.4.4 Display the packaging list ...............................................................................................................29
3.4 DATA LISTS ...................................................................................................................................................30
3.4.1 The selection menu ..........................................................................................................................30
3.4.2 The Processing menu.......................................................................................................................31
4DEVICE CONFIGURATION ...............................................................................................................................32
4.1.1 Counter ..............................................................................................................................................32
4.1.1.1 Counter functions............................................................................................................................32
4.1.2 Key lock .............................................................................................................................................33
5DATA RECORDING ...........................................................................................................................................34
5.1 DATAMATIC ..................................................................................................................................................34
5.1.1 Activating DataMatic ...........................................................................................................................34
5.1.2 Configuring DataMatic data ................................................................................................................35

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5.1.3 Show the DataMatic data on the device display .................................................................................35
5.1.3.1 The display menu............................................................................................................................35
5.1.3.2 View the recordings on the USB stick .............................................................................................36
5.1.4 Show the DataMatic data on a PC......................................................................................................38
5.2 TRACELOG (LOGBOOK) ..................................................................................................................................39
5.2.1.1 The display menu............................................................................................................................39
5.2.1.2 Interpretation of entries ...................................................................................................................39
5.3 DATA READOUT VIA ETHERNET........................................................................................................................39
5.4 DATA DESIGNATOR (PREFIX)-SYMBOL OR TEXT................................................................................................40
5.5 PRINT DATA AS A BARCODE.............................................................................................................................41
5.6 DIRECT CHANGE OF THE PROCESS PARAMETERS OF A SELECTED PACKAGING.......................................................42
5.6.1 Changing the sealing temperature......................................................................................................42
5.6.2 Changing the throughput speed .........................................................................................................42
5.7 UDI MARKING................................................................................................................................................43
5.7.1 The Processing menu .........................................................................................................................43
5.8 EXTERNAL KEYBOARD FOR DATA ENTRY ...........................................................................................................44
5.9 DISPLAY .......................................................................................................................................................44
5.9.1 Standby...............................................................................................................................................44
5.9.2 Counter status 0 .................................................................................................................................44
5.9.3 Display of the set test interval.............................................................................................................44
5.9.4 Maintenance indicator.........................................................................................................................45
5.9.5 RS 232 data interface active display ..................................................................................................45
5.9.6 Display of password startup interlock .................................................................................................45
5.9.7 The display of control center...............................................................................................................46
5.9.8 Display of operating data ....................................................................................................................47
6SPECIAL FUNCTIONS ......................................................................................................................................48
7THE BARCODE SCANNER (1.490.029)............................................................................................................50
7.1 COMMISSIONING THE BARCODE SCANNER.........................................................................................................50
7.1.1 Step 1 Unpacking the barcode scanner.............................................................................................50
7.1.2 Step 2 Connecting the device ............................................................................................................51
7.2 RECORDING DATA USING THE BARCODE SCANNER .............................................................................................52
7.2.1 Data of a created barcode list .............................................................................................................52
7.2.2 General barcode data .........................................................................................................................52
7.2.2.1 Assignment of general barcode data ..............................................................................................52
8THE EXTERNAL PRINTER................................................................................................................................53
9SWITCH OFF THE DEVICE ...............................................................................................................................54
10 TROUBLESHOOTING AND MAINTENANCE................................................................................................55
10.1 TROUBLESHOOTING CHECKLIST.......................................................................................................................55
10.2 MAINTENANCE...............................................................................................................................................56
10.3 SERVICE .......................................................................................................................................................56
10.4 SPARE PARTS SERVICE...................................................................................................................................56
10.5REPLACING THE SEALING DEVICE INK RIBBON CASSETTE ....................................................................................58
11 TECHNICAL DATA ........................................................................................................................................60
11.1 SPECIFICATIONS ............................................................................................................................................60

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1 Introduction
1.1 Preface
First of all we would like to thank you for purchasing this sealing device.
In these instructions you will find information about using the device, servicing and care as well
as process validation.
The sealing device is a microprocessor controlled rotary sealer with a printer for packaging
sealable transparent pouches and reels (SBS = sterile barrier system).
The sealing device meets the requirements of DIN 58953-7, DIN EN ISO 11607-2 and the
resulting DGSV (German Society for Sterile Supply) guideline for validating the sealing
process.
Always keep these instructions close to the device.
1.2 Important notice
In accordance with the intended use, the CE marking is displayed based on
the foll
owing EU directives:
2006/42/EC, 2014/30/EU and 2011/65/EU.
Medical device directive 93/42/EEC is not applicable to sealing devices.
The limit values of IEC 60601-1 must 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 declaration of conformity.
Please read these operating instructions carefully before commissioning so that
you are familiar with the capabilities of the device and you can make optimum use
of its functions.
Note
We are constantly improving our products, therefore we
reserve the right to modify these operating instructions
and the functions described in them.
These operating instructions apply to products from
software version V4.02.00 onwards


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1.3 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.
Ahand symbol indicates important information.
Select function
Press the button
Press and hold down the button
Press the button several times
Select data by swiping up or down

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1.4 Safety instructions
Our products are in a flawless condition in terms of safety technology when
they leave the plant.
To maintain this condition, the contents of these safety instructions as well
as type plates, labelling and safety instructions attached to the device must
be observed while handling the device (transport, storage, installation,
commissioning, operation and maintenance).
This device is suitable for processing laminated films in the heat-sealing
process. See also chapter 1.6 "Intended use".
Please check the packaging, and lodge a complaint for any damage with the
carrier or parcel service immediately, before installing the device.
Before commissioning, ensure that the device does not show any evidence
of damage. In case of doubt, contact the manufacturer or a service partner
authorised by the manufacturer.
Do not operate the device if the power cable or the power plug is damaged.
Do not use the device if it does not operate correctly or it is damaged in any
way. If the mains cable or the device have been damaged, the device must
be repaired by the manufacturer or by one of the manufacturer's authorised
service partners.
The device must be connected using the mains cable included in the scope
of delivery to a protective contact socket with a stable voltage. Operation on
IT networks is not permitted.
Place the device on a stable base.
The device must not be installed or operated
in potentially explosive areas.
If the sealing device is brought directly from a cold environment into a warm
environment, condensation may form. Wait until temperature equalisation
has taken place.
Repairs and the replacement of spare parts must be performed only by the
manufacturer or by one of the manufacturer's authorised service partners.
Switch off the device when it is not in use, or remove the power plug from
the socket.
Do not insert pointed or flat items into the import slot of the device. This can
result in damage to the device and instruments.
Do not insert items into the louvres of the device. You might receive an
electric shock or the device could be damaged.
Do not use the device if you have any doubts about its safety.

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The device must not be installed or operated by persons under 16 years of
age.
The device must not be operated unsupervised.
It is forbidden to operate the device under the influence of drugs or alcohol.
Keep hair, clothing and gloves away from moving parts.
Loose clothing, jewellery or long hair can be caught by moving parts.
The device contains valuable materials that can be recycled and reused.
The device should therefore be disposed of at a public disposal facility near
you.
The device has been labelled in accordance with Directive 2012/19/EU
(WEEE) on waste electrical and electronic equipment.
This directive governs the return and recycling of scrap equipment within the
EU.
1.5 Cleaning
Before cleaning, disconnect the mains plug from the socket and disconnect the device from the
power supply with the plug.
Clean the device only with a dry or damp soft cloth and a mild cleaning agent.
(E.g.: isopropanol, spirit, etc.)
Do not allow any water to find its way into the device.
Caution! Never wet clean the device!

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1.6 Correct use
The device is intended only for commercial and industrial use, and must be used only for the
intended purpose and with the following sealable materials.
SEALING MATERIALS
Sealable paper pouches in accordance with EN ISO 11607-1/EN
868-4
x
Sealable pouches and reels in accordance with EN ISO 11607-
1/EN 868-5 of film and paper according EN 868-3
x
Sealable pouches and reels according ISO 11607/EN 868-5 of
film and uncoated nonwoven materials of polyolefines according
EN 868-9
1
x (approval and/or tests necessary)
Aluminium-laminate film
x (approval and/or tests necessary)
Sealable PA/PE on request
on request
NON - SEALABLE MATERIALS
Polyethylene films
Soft PVC films
Hard PVC films
Polyamide films
Polypropylene films
Coated HDPE
The correct sealing temperature for the packaging materials being used must be identified by
means of test sealing’s (DIN 58953-7).
The device output depends on the condition of the sealing material used.
1Not applicable for sealable pouches and reels according EN ISO 11607-1/EN 868-5 of plastic and uncoated
nonwoven materials of polyolefins according EN 868-10.

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2 Commissioning
2.1 Commissioning the sealing device
2.1.1 Step 1 Inspection of the device
After opening the packaging and the air-
conditioning bag, check the device and its
accessories for damage and completeness.
Sealing device
Power supply
Power cable
Operating instructions
Test report(s)
Replacement ink ribbon
2.1.2 Step 2 Setting up the device
Set up the device on a flat surface and make
sure that there is at least a 200 mm spacing
between the device and the wall.
200 mm

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2.1.3 Step 3 Connecting the device
Insert the 24V cable of the power supply 
into the device
Insert the power cable into the power
supply 
and
insert the mains plug into the socket
Top keyway





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2.1.4 Step 4 Turning on the device
Press the Power button
The colour changes from red to green.
The device operating system is loaded.
When the device is turned on for the first
time, the date, time, date format and
languages can be reset.

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2.1.5 Step 4.1 Checking of the sealing parameter sensors
After switch-on, the device heats up to the
default sealing temperature of 190°C. The
sealing parameters temperature, contact
pressure and throughput speed are checked.
If their safe function is guaranteed, the main
menu is displayed and the device heats up to
the default set value. This is also indicated
by an alternating display in the temperature
display.
Once the sealing temperature has been
reached, the device is ready for operation.

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2.1.6 Step 5 Displays and functions of the main menu
Symbol
Function
Note
189°C Displays the current sealing temperature
100 NDisplays the current pressing force
0.0 m/min
Displays the current throughput speed Value > 0 only when motor is running
Settings
Control center Checking the functions of heating, DMS –module and motor
as well as the device informations
Display of the preselected languages
For better operation, the device can be switched to different
languages using the three buttons during operation. A
change is possible at any time via the Settings / System
configuration / Language level. (See data input Chapter 3)
Displays the current counter / the adjusted counter
2.1.7 Change menu level 1 till 7 by “Swiping”
To change to another menu level, swipe across the display in the desired direction.
To level 2
To level 4

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2.1.8 Step 6 The first sealing process
The default sealing temperature is 190°C and the throughput speed is 10 m/min. This ensures
pouches and reels are sealed in accordance with EN 868-5 and EN ISO 11607-1.
The internal printer is "active" in delivery mode, but without print data.
The material to be sealed must be sealed according to the manufacturer's instructions.
Sealable pouches and reels must only be filled to ¾ full (DIN 58953-7). The limited
filling prevents too great a load being placed on the sealing seams.
Setting the peel edge
After releasing the locking device, the peel edge can be steplessly adjusted by between
0 mm and 35 mm by moving the infeed section.
A sufficient overhang must be present between the sealing seam and the reel interface
on the extraction side (in accordance with DIN 58953-7 min. 10 mm).
Sterilisation 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 sterilisation packaging and leave briefly to cool.
The correct sealing temperature must be identified by means of test sealings.
(DIN 58953-7).
Sealing must be performed in such a way that the sealing seam meets the quality
characteristics required in 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



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2.1.9 The individual levels of the device
2.1.9.1 Level 1 General
Symbol
Function
Note
Seal Check Performing a routine test (see Chapter 2.2.1)
SealCheck, InkTest or peel test
Login User login/logoff
TraceLog Recording of all process-related data, changes, errors and
settings made during operation
Packaging List Selecting packaging lists that have already been created
Counter Setting the counter for counting up/down
Printer Switching the internal printer on/off
External printer Switching the external printer on/off
2.1.9.2 Level 2 Printer
Symbol
Function
Note
Packaging lists Creation of packaging lists
Prefixes Changing data names for print data
External Printer Configuration Creating, editing and deleting formulas for external printer data
2.1.9.3 Level 3 Print Data
Symbol
Function
Note
ID-List Creating, editing and deleting ID lists
LOT Creating and deleting LOT numbers
Sterilizer Creating, editing and deleting steriliser data
CE-List Creating, editing and deleting CE lists
Reference-List Creating, editing and deleting reference numbers
Info-List Creating, editing and deleting stored information
Expiry-Date Adjust the expiry date

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2.1.9.4 Level 4 Standby
Symbol
Function
Note
Standby After the selected time, the device reduces the heat output
and cools down to 80°C.
ID-Standby After a selected time, a logged-in user is logged off
automatically.
2.1.9.5 Level 5 Monitoring
Symbol
Function
Note
Test-Intervals
Setting different intervals for Seal Check, InkTest and peel
test.
DataMatic
Selection of individual DataMatic data.
Fixed data: Date/time, temperature, contact pressure, speed,
counter total and serial number
2.1.9.6 Level 6 Special Features
Symbol
Function
Note
Scanner Data
Assign the scanned data to other functions.
The scanner data is assigned to the batch number by
default (see Chapter 7.2.2)
ValiUp
Determining the ideal sealing temperature for the material
used by means of an aid

Not activated until unlock
Key lock Locks the settings on the home screen so that data can only
be selected but not deleted or edited.
UDI Creating, editing and deleting UDI data
Not activated without special dongle
2.1.9.7 Level 7 System Configuration
Symbol
Function
Note
Date/time Setting the current date and time
Date formats
Changing date formats
dd.mm.yyyymm.dd.yyyyyyyy.mmmm.yyyyyyyy
Jan.dd.yyyy
Measurement Unit
Conversion of the units of measurement from
si T[°C] F[N] v[m/min]
fps T[°F] F[lbf] v[ft/min]
Default Resetting the device to default settings
(Password-protected settings)
Language
Setting the three languages that can be preselected via the
start menu
The printout of country-specific characters is only
possible with a 24 stylus print head! (special equipment)
IP Password-protected menu level for setting the
IP address
Config Password-protected menu level for service purposes
Update Performing software updates via USB stick
(for more details see technical data)

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2.2 The sealing seam test
Testing of the critical process parameters temperature, contact pressure and sealing time by
means of the sealing seam test. This test should be performed and documented before and
after the daily work process and/or before/after each lot (EN ISO 11607-2).
The sealing parameters are displayed during the tests.
Activating and starting the sealing seam test
1. If a user has been created in the user list, an user
code must be entered before a test is carried out.
Otherwise this is not necessary.
2. Activate the sealing seam test
3. Select the type of sealing seam test
3.1 Seal check
Cannot be used for packages with a side fold!
Place the indicator strips inside the package.
3.2 Ink test
Place the disposable cartridge inside the package
3.3 Peel test
Cut out the test strips after sealing
4. Insert the sterilisation packaging, width min. 200 mm.
This key is used to cancel the function

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2.2.1 Locked machine due to failed Seal Check
As soon as the Seal Check has been done twice without passed result, the machine asked for
lock function.
Seal Check result confirmation Message in the screen if two Seal Check result hasn´t been
passed.
If the screen is locked due to failed Seal Check, you can unlock it by using the lock password.
(see technical information on page 60)

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2.2.2 Printing of the test parameters on a package
2.2.3 Printing of the test parameters on a label
ONLY with the label printer connected!
If the ValiPrint label printer is connected and switched
on, a label is also printed with each test selected
Date and time
Sealing temperature
Contact pressure
Sealing speed
User name (when entering password)
Serial number
23.08.2017 12:00
190
100
10.1
U1
123.456
Approval:
Date Time Contact pressure User name
(when a password is entered)
Sealing temperature Sealing speed Serial number


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3 Data input
3.1 Creating data for different languages
When entering data, it should be noted that lists, names and all freely editable texts are only printed
correctly after a packaging list has been selected if they have been created in the selected language.
The corresponding language in the start menu must also be selected.
This means that a text created in Japanese, for example, can only be printed correctly in a packing list if
the language in the start screen has been changed to Japanese and the Japanese keyboard has been
used to enter the text.
The same applies to all other languages.
3.2 The ID-List
The names and passwords of users who will be operating the device are entered into the user list. The
users on the list can/must log in to the device before starting their task via the password entered into the
list, i.e. they can also log out when their task is complete.
If the User standby function was activated in the Settings menu, the user is automatically logged out
after a set time after which no sealing process has taken placed.
A logged in user name is automatically printed on the packaging when using the "Test"
function.
It is possible to record the user name with each sealing process using the DataMatic function.
You can activate the printout of a logged in user name on the packaging in a packaging list.
3.2.1 The menu
Key
Function
Note
Delete an entry Only visible when the user has already been created.
Re-enter an entry
Length of user name:
max. 8 alphanumeric characters
Length of a password:
max. 5 digits
Number of user names:
max. 50, individual entry or one after another
Activate or deactivate administrator right
A so-called administrator right can be assigned to one or more
users. This authorises him/her to block or release certain
functions.
Exit menu level
Edit created user data Only visible when the user has already been created.
