VeriDoc2C GB V 11.02
VeriDoc2C GB V 11.02
VeriDoc2C GB V 11.02
VeriDoc 2c
OPERATING INSTRUCTIONS
www.vanderstahl.com
ENGLISH
ENGLISH
1 INTRODUCTION ............................................................................................................................................... 3
1.1 FOREWORD .................................................................................................................................................. 3
1.2 EXPLANATION OF SYMBOLS.......................................................................................................................... 5
1.3 GENERAL SAFETY INSTRUCTIONS ................................................................................................................ 6
1.4 CORRECT USE OF THE DOCUMENTATION SYSTEM ....................................................................................... 7
2 BEFORE YOU BEGIN ...................................................................................................................................... 8
2.1 COMMISSIONING THE VERIDOC 2C DOCUMENTATION SYSTEM ................................................................. 8
2.1.1 Connector assignment and accessories for the Printbox ............................................................ 8
2.1.2 Connector assignment and accessories for the ValiPrint printer ................................................ 9
2.1.3 Connection of the Printbox ............................................................................................................. 10
2.1.4 Connections between the Printbox and the ValiPrint printer ..................................................... 11
2.1.5 Commissioning ................................................................................................................................. 13
2.1.6 IntelligentScan, connection of the barcode reader ..................................................................... 14
2.1.7 Recording the process data using the USB stick ........................................................................ 15
2.2 LABEL DATA ................................................................................................................................................ 16
2.2.1 Standard labels ................................................................................................................................ 16
2.2.2 SealCheck label data ...................................................................................................................... 18
3 BASIC FUNCTIONS ....................................................................................................................................... 19
3.1 LANGUAGE SELECTION ............................................................................................................................... 19
3.2 ENTERING THE PRINT DATA ........................................................................................................................ 20
3.2.1 LOT number ...................................................................................................................................... 20
3.2.2 Expiry date or final sterile goods storage date ........................................................................... 21
3.2.3 Date and time .................................................................................................................................. 22
3.2.4 Date formate ..................................................................................................................................... 22
3.2.5 Staff identifier .................................................................................................................................... 23
3.2.6 Text .................................................................................................................................................... 24
3.2.7 Sterilisation method ........................................................................................................................ 24
3.2.8 Volume of the package contents .................................................................................................. 25
3.2.9 Seal Check........................................................................................................................................ 25
3.3 PRINTER SETTINGS..................................................................................................................................... 26
3.3.1 Number of printed labels ................................................................................................................. 26
3.3.2 Selection of label size ..................................................................................................................... 27
3.4 CONTENT OF THE INFORMATION FIELD ...................................................................................................... 28
4 TROUBLESHOOTING ................................................................................................................................... 29
4.1 ERROR DISPLAYS ON THE PRINTBOX ......................................................................................................... 29
4.2 DETERMINING THE SOFTWARE VERSION AND DEVICE TYPE ...................................................................... 29
4.3 ERROR DISPLAYS ON THE PRINTER ............................................................................................................ 30
5 MAINTENANCE .............................................................................................................................................. 31
5.1 PARTS SERVICE .......................................................................................................................................... 31
5.2 REPLACING THE ROLL OF LABELS .............................................................................................................. 33
5.3 REPLACING THE INK RIBBON ...................................................................................................................... 36
6 TECHNICAL DATA......................................................................................................................................... 39
6.1 PRINTER SPECIFICATIONS .......................................................................................................................... 39
7 DECLARATIONS OF CONFORMITY .......................................................................................................... 40
7.1 CE DECLARATION OF CONFORMITY PRINTBOX ......................................................................................... 40
7.2 CE DECLARATION OF CONFORMITY PRINTER............................................................................................ 41
7.3 CE DECLARATION OF CONFORMITY BARCODE READER............................................................................. 42
1 Introduction
1.1 Foreword
First of all, we would like to thank you for making this purchase.
VeriDoc 2C is a stand-alone labelling and documentation system that can be used for all
preformed sterile barrier systems available in clinical practice.
Examples include:
The system, comprising either one or two label printers and a barcode reader, allows users to
print customised labels in order to label sterile barrier systems.
A program included with the barcode reader enables corresponding barcode lists to be created.
These lists can contain information such as the name of the packager, the designation of the
medical device, the set or the reusable container.
This information is scanned in using the barcode reader and assigned to the label.
After a visual inspection of the sterile barrier system, a decision is made whether it
can be approved or not.
Depending on this decision, the barcode is scanned in as "sterile barrier system approved" or
"sterile barrier system not approved"
and the corresponding label is then printed automatically.
The labels are duplex labels and are equipped with class 1 process indicators, which change
colour after sterilisation.
Once sterilisation is complete, the final approval of the sterilised sterile barrier system can be
documented with a signature in an optional approval area on the label.
After treatment, the label can be removed from the packaging and stuck in the patient's folder
for documentation purposes.
Corresponding attachments for the patient folder are included in the scope of delivery.
Number of labels /
Type of label Sterilisation method Article number
roll
LABEL STEAM Steam LABEL L 6.812.070
1000
LABEL XL 6.812.064
LABEL STEAM / FORM Steam / formaldehyde 6.812.067 1000
LABEL STEAM / ETO Steam / ethylene oxide 6.812.068 1000
LABEL H2O2 Hydrogen peroxide 6.812.069 1000
The indicators on the labels comply with the ISO 11140-1 Type 1 standard.
Please read these operating instructions carefully before commissioning so that you
are familiar with the properties of the documentation system and can make optimum
use of its functions.
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. These instructions must always be followed.
Important notice
In accordance with the intended use, the CE marking is displayed based on
the following EU directives:
2006/42/CE, 2006/95CE and 2004/108/CE.
The European Medical Device Directive 93/42/EEC and the German Law on
Medical Products (MPG) are not applicable to documentation systems.
The limit values of IEC 60601-1 must not be applied in repeated electrical
inspections.
repeated electrical inspections.
Note
Because we are constantly improving our products, we
reserve the right to modify these operating instructions
and the functions described in them.
1
LABEL XL is currently only available for steam sterilisation
Page GB 5 9.693.020 Version 1.02
ENGLISH
Please check the packaging and lodge a complaint for any damage with the
carrier or parcel service immediately before installing the documentation
system.
Before commissioning, ensure that the equipment 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 equipment if the power cable or the power plug are
damaged. Do not use the equipment if it does not operate correctly or it is
damaged in any way. If the mains cable or a device have been damaged, the
device must be repaired by the manufacturer or by one of the manufacturer's
authorised service partners.
Switch off the equipment when it is not in use or remove the power plug from
the socket.
Do not insert objects into the equipment. You may receive an electric shock
or the equipment could be damaged.
Do not use any of the equipment if you have any doubts about its safety.
The equipment contains valuable materials that can be recycled and reused.
The equipment should therefore be disposed of at a nearby public refuse
facility.
The equipment bears labels as required by the European Directive
2002/96/EC (WEEE) on electrical and electronic equipment.
This directive regulates the return and recycling of old equipment within the
EU.
Connector assignment
Accessories
1x 1x
Connector assignment
Accessories
Voltage supply 1. Connect the printer and Printbox with a power cable
Printbox
ValiPrint printer
Data connection 1. Connect the printer and Printbox with the data cable
Printbox
ValiPrint printer
Connect the voltage supply 1. Connect the mains plug on the voltage supply to a mains socket
to a mains socket
2.1.5 Commissioning
Red
Red
2. Switch on printer 1
Green
Red
3. Switch on printer 2
Green
Green
Data connection 1. Connect the data cable on the barcode reader to the Printbox
Printbox
Voltage supply 2. Insert the connector of the power cable on the reader power supply to
the data connector on the barcode reader
3. Insert the mains cable on the reader power supply to the mains socket
The ValiScan barcode reader (item number 1.421.018) is supplied with a CD (item number
1.490.028), with which individual barcode lists can be easily created and documented on a
PC.
For further information, please contact your authorised service partner or the hawo Service
Hotline: +49 (0) 6261 9770 0
Using a USB stick, the label data can be recorded for every finished label.
The data is written in *.csv format to the USB stick, and is displayed using a text editor such as
the Windows text editor or Windows WordPad, or using
a spread sheet program such as Windows Excel.
Display example:
State Date and Time User LblCnt Charge Text S/N Sterilizer
OK 28.10.14 10:04 Moon 1022 113A test 444555 Steri 3A5
OK 28.10.14 11:15 Moon 1023 113A test 444555 Steri 3A5
OK 28.10.14 11:15 Sun 1024 114B test 444555 Steri 3A5
OK 28.10.14 13:31 Sun 1025 116C test 444555 Steri 3A5
OK 28.10.14 13:31 Sun 1026 116C test 444555 Steri 3A5
Printbox
STEAM=BROWN
STEAM=BROWN
13-000001 13-000001
hawo 1234
STERILE STEAM
1
Text 1
Nomenclature
Warning field
Steam indicator
Information field
Indicator field
*
LABEL XL is currently only available for steam sterilisation
Page GB 16 9.693.020 Version 1.02
ENGLISH
Standard printout
U1-U9, no printout with U0
Factory setting
STEAM
STERILE Sterilisation method
Setting with the barcode reader
Factory setting
1
Signature(Factory setting
Signature approving the sterile barrier system
Information field
QR code
Batch. Use-by date, date of production, staff ID, steriliser ID,
text
Blank
Process indicator Reference to
STEAM=BROWN
ISO 11140-1 Type 1 indicator colour change
28.06.2013 13:56h
Approval:
Seal
Check
hawo 1234
SN 405060
Nomenclature
Test date and time Is always updated even with the Printbox switched off
Approval:
Signature field for approval
of the test
Staff identification
3 Basic functions
3.1 Language selection
For the text in the warning field on the label
Factory setting:
German German
English
French
Italian
Spanish
Portuguese
Chinese
Japanese
Korean
Russian
Arabic
Note By default, the current year number and label counter are displayed, e.g.
13-00001.
The counter increases automatically with each new label
3.2.2 Expiry date or final sterile goods storage date LABEL L LABEL XL
1 month
24 months
60 months
Note On delivery of the documentation system, the current date and time (CET)
are set
The date and time are updated automatically even when the Printbox is
switched off.
Function key If it becomes necessary to enter a new date and time, the software included
hs 980 BR 2D software with the barcode reader should be used, via the button shown, to generate
a barcode for the date and time and this should be scanned in via the
barcode reader.
DD.MM.YYYY
MM.DD.YYYY MM.DD.YYYY
YYYY.MM
MM.YYYY
YYYY YYYY.MM.DD
Jan.DD.YYYY
MM.YYYY
YYYY
Jan.DD.YYYY
Example:
U0 No printout The designation "U" stands for
U1 Katja User.
U2 Ms. Mayer
U3 Dr. Dental
You will find the list that can be displayed in the practice in Appendix 1 of these
instructions
U0 U1
U2 U3
U4 U5
U6 U7
U8 U9
Function key
hs 980 BR 2D software 2. Generate a corresponding barcode using the
software included with the barcode reader via the button shown and
scan it in using the barcode reader
Note
Create a text, for example the name of a medical product, using the button
Function key shown, via the software included with the barcode reader and scan it in
hs 980 BR 2D software
using the barcode reader
Factory setting:
STEAM FORM
Formaldehyde
VH2O2
Plasma
IRRAD
Ionising radiation
DRY
Dry heat
1 2
Volumes of between
1-10
can be selected
Factory setting: 1 3 4
7 8
9 10
Note Create a list containing the serial numbers of the sealing devices used and
use the Seal Check function via the keys shown using the software included
with the barcode scanner and scan this in via the barcode scanner
Function key
hs 980 BR 2D software
Quantities of between
1-10
can be set
1 2
Factory setting: 1
3 4
5 6
7 8
9 10
STEAM=BROWN
55 mm x 33 mm 13-000001
(LABEL L)
Factory setting 17.08.2013 Approved:
18.02.2013
STEAM=BROWN
(LABEL XL)
17.08.2013
18.02.2013 13:56h
hawo 1234
STERILE
1
Text 1
17.08.2013 Approved:
18.02.2013
Approval:
QR Code
Blank
4 Troubleshooting
4.1 Error displays on the Printbox
The current software version and type designation are printed onto a label
Your hawo customer service team is happy to help you from Monday to Friday
between 8 a.m. and 5 p.m. by phone on +49 (0)6261-9770-00.
5 Maintenance
5.1 Parts service
Fax No.
Ink ribbon for ValiPrint printer 6.813.300
Signature ____________________
ENGLISH
Step 1
Open the housing
Pull the lateral locks forwards
and fold the upper section of the housing
backwards
Step 2
Open the label guide
Step 3
Insert the roll of labels
Step 4
Close the label guide
Pull the backing strip forward by 4 label lengths
Push the lever on the label guide backwards and
adapt the label guide to the width of the backing
strip
Step 5
Open the individual dispenser
Push the individual dispenser upwards
and fold it forwards
Step 6
Introduce the backing strip
Step 7
Close the individual dispenser
Step 8
Close the housing
Step 9
Test label
Switch on the printer
If the control light is green, press the "Feed"
button
once.
Step 1
Open the housing
Step 2
Opening the ink ribbon holder
Step 3
Fold out the ink ribbon holder
Step 4
Insert the ink ribbon
Step 5
Insert an empty reel core
Step 6
Secure the ink ribbon on the empty reel core
as shown in the figure over
Pull the ink ribbon
the print head and secure with the cable tie to
the empty reel core .
Step 7
Close the housing
6 Technical data
6.1 Printer specifications
Connection data
Mains connection [V] 100-240
Mains fuse [A] 2 AT
Mains frequency [ Hz ] 50/60
Power consumption [W] 40
Mechanical system
Dimensions [ mm ]
Width 128
Depth 235
Height 173
Weight approx. [ kg ] 1.6
Electronics and communication systems
System Microprocessor
Serial interfaces: RS-232 connection
Transfer speed (baud rate) [ Bd ] 9600
Electrical protection class 1
Environmental parameters
Heat emissions [ kJ/s] 0.1
Noise intensity acc. to Machinery Directive <70
2006/42/EC Appendix I 1.7.4.2 u.) [ dB/ A ]
Ambient temperature [ °C ] 0-35
Relative humidity [%] 30-80 non-condensing
7 Declarations of conformity
VeriDoc 2C Appendix 1
VeriDoc 2C Appendix 1
U1 ______________________________________
U2 ______________________________________
U3 ______________________________________
U4 ______________________________________
U5 ______________________________________
U6 ______________________________________
U7 ______________________________________
U8 ______________________________________
U9 ______________________________________
U0 Log Out
VeriDoc Appendix 2
10
VeriDoc Appendix 3
1 Month
3 Month
6 Month
9 Month
12 Month
24 Month
60 Month
VeriDoc Appendix 4