Van Der Stahl MD-950 NanoPak Series Operating Instructions Manual

Van Der Stahl MD-950 NanoPak Series Operating Instructions Manual

Medical device pouch sealer
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Printed SEP 2018
4th Edition 4.02E
ME DI CAL DEVI CE P OU CH SEA LER
MD-950 NanoPak SERIES
OPERATING INSTRUCTIONS
www.vanderstahl.com

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Summary of Contents for Van Der Stahl MD-950 NanoPak Series

  • Page 1 Printed SEP 2018 4th Edition 4.02E ME DI CAL DEVI CE P OU CH SEA LER MD-950 NanoPak SERIES OPERATING INSTRUCTIONS www.vanderstahl.com...
  • Page 2: Table Of Contents

    ENGLISH MD 950 / NanoPak Contents INTRODUCTION ..............................4 ................................ 4 REFACE ............................4 MPORTANT NOTICE ................................5 EGEND ............................. 6 AFETY INSTRUCTIONS ............................... 7 LEANING ..............................8 ORRECT USE COMMISSIONING ..............................9 ........................ 9 OMMISSIONING THE SEALING DEVICE 2.1.1 Step 1 Inspection of the device ......................
  • Page 3 ENGLISH MD 950 / NanoPak Contents 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 ) ..........................
  • Page 4: Introduction

    ENGLISH MD 950 / NanoPak Introduction Chapter 1 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.
  • Page 5: Legend

    ENGLISH MD 950 / NanoPak Introduction Chapter 1 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.
  • Page 6: Safety Instructions

    ENGLISH MD 950 / NanoPak Introduction Chapter 1 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).
  • Page 7: Cleaning

    ENGLISH MD 950 / NanoPak Introduction Chapter 1 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.
  • Page 8: Correct Use

    ENGLISH MD 950 / NanoPak Introduction Chapter 1 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 Sealable pouches and reels in accordance with EN ISO 11607- 1/EN 868-5 of film and paper according EN 868-3...
  • Page 9: Commissioning

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2 Commissioning 2.1 Commissioning the sealing device 2.1.1 Step 1 Inspection of the device Sealing device After opening the packaging and the air- conditioning bag, check the device and its Power supply accessories for damage and completeness.
  • Page 10: Step 3 Connecting The Device

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2.1.3 Step 3 Connecting the device Insert the 24V cable of the power supply  into the device Top keyway   Insert the power cable into the power   supply ...
  • Page 11: Step 4 Turning On The Device

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 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.
  • Page 12: Step 4.1 Checking Of The Sealing Parameter Sensors

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 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.
  • Page 13: Step 5 Displays And Functions Of The Main Menu

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2.1.6 Step 5 Displays and functions of the main menu Symbol Function Note Displays the current sealing temperature °C Displays the current pressing force Displays the current throughput speed Value > 0 only when motor is running m/min Settings Checking the functions of heating, DMS –...
  • Page 14: Step 6 The First Sealing Process

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 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"...
  • Page 15: The Individual Levels Of The Device

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2.1.9 The individual levels of the device 2.1.9.1 Level 1 General Symbol Function Note Performing a routine test (see Chapter 2.2.1) Seal Check SealCheck, InkTest or peel test Login User login/logoff Recording of all process-related data, changes, errors and TraceLog settings made during operation Packaging List...
  • Page 16: Level 4 Standby

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2.1.9.4 Level 4 Standby Symbol Function Note After the selected time, the device reduces the heat output Standby and cools down to 80°C. After a selected time, a logged-in user is logged off ID-Standby automatically.
  • Page 17: The Sealing Seam Test

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 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).
  • Page 18: Locked Machine Due To Failed Seal Check

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 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.
  • Page 19: Printing Of The Test Parameters On A Package

    ENGLISH MD 950 / NanoPak Commissioning Chapter 2 2.2.2 Printing of the test parameters on a package Sealing temperature Sealing speed Serial number Date Time Contact pressure User name (when a password is entered) 2.2.3 Printing of the test parameters on a label ...
  • Page 20: Data Input

    ENGLISH MD 950 / NanoPak Data input Chapter 3 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.
  • Page 21: Entry Of User Data/Administrator Rights

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.2.2 Entry of user data/administrator rights   1. Activate ID-List menu  Enter new ID 3. Enter user name, e.g. "User", It is not possible to enter a name without a password. 4.
  • Page 22: Removing Administrator Rights

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.2.3 Removing administrator rights 1. Select a user name, e.g. "User" 2. Press the symbol to edit selected user data. 3. Remove the administrator data and confirm by pressing the key. Administrator rights inactive Exit this menu level 3.3 Packaging lists...
  • Page 23: The Settings Of A Packaging List

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.1 The settings of a packaging list A max. of twenty lists can be created for different types of packaging. These correspond to various "formulas" with different settings from the following table. Function Note Entering the packaging designation...
  • Page 24: The Printer Data Of A Packaging List

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.2 The printer data of a packaging list Selection ranges of the printer data Changing printer data 1 – 5 to 6 – 10 by swiping from left to right Max. 10 data selectable Data Note...
  • Page 25: Printer Data Selection

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.3 Printer data selection The individual printer data can be printed by pressing the desired free fields several times 1-5 or 6-10 can be set in the selection ranges.  Selectable data is shown and explained in Chapter 3.3.3. 3.3.4 Example of creating a packaging list Packaging parameters Parameter data...
  • Page 26: Enter The Package Designation And Determine An Identification Colour

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.4.1 Enter the package designation and determine an identification colour   1. Activate the Designation input 2. Enter packaging designation by pressing the input field 3. Press the button several times until the background colour of the packaging designation appears in the desired colour.
  • Page 27: The Settings Of The Internal Printer

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.4.3 The settings of the internal printer  The internal printer can be set individually for each packaging list. 3.3.4.3.1.1 The menu Function Note     FontMatic, character width 1, character width 2, character width 3 Character width...
  • Page 28 ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.4.3.2 The settings of the external label printer  The external label printer can be set individually for each packaging list! 3.3.4.3.2.1 The Packaging List create new list confirm Delete Exit menu level ...
  • Page 29: Display The Packaging List

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.3.4.4 Display the packaging list   1. Activate the Packaging lists menu 2. Select the packaging list  If no list has been created, this is displayed accordingly 3. Select and activate the packaging list activate delete a list Cancel/deactivate the packaging list...
  • Page 30: Data Lists

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.4 Data lists 3.4.1 The selection menu Function Example Note Length of user data: Name: 20 alphanumeric characters Password: 5 numbers List with user data Number of user entries: 50, individual entry or one after another Number would be overwritten after every List with LOT data Lot names, lot numbers...
  • Page 31: The Processing Menu

    ENGLISH MD 950 / NanoPak Data input Chapter 3 3.4.2 The Processing menu Example of an Info-List Function Re-enter a list text Delete a list text Delete a list text Confirm/activate Exit menu level Page GB 31 9.694.038 V 4.02...
  • Page 32: Device Configuration

    ENGLISH MD 950 / NanoPak Configurations Chapter 4 Device configuration 4.1.1 Counter 4.1.1.1 Counter functions Counting forwards Function Note 0 0 0 0 1 9 Displays the current value Switches the counter to forwards counting Sets the counter to 000000 Confirms the settings Counting backwards Function...
  • Page 33: Key Lock

    ENGLISH MD 950 / NanoPak Configurations Chapter 4 4.1.2 Key lock You can only lock the keys if a user list was created in which at least one person  in the list has the administrator right! Selecting or scanning data is not affected. Function Note All symbols stored on the home screen can be selected by users, but not...
  • Page 34: Data Recording

    ENGLISH MD 950 / NanoPak Data recording Chapter 5 Data recording 5.1 DataMatic If any formatted USB stick is plugged into a free USB slot and the stick is detected, a message will appear on the display indicating that the DataMatic has been activated, if it is confirmed with "yes".
  • Page 35: Configuring Datamatic Data

    ENGLISH MD 950 / NanoPak Data recording Chapter 5 5.1.2 Configuring DataMatic data Keys Data Note Date and time Sealing temperature Contact pressure Fixed recording data Throughput speed Unit counter TOTAL Device serial number Selected packaging Expiry date Optional recording data Info Process Sterilizer data...
  • Page 36: View The Recordings On The Usb Stick

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.1.3.2 View the recordings on the USB stick   1. Activate the TraceLog menu 2. Activate the USB memory data view Appears if not USB is plugged confirm 3. Select the USB slot where the stick was inserted confirm 3.
  • Page 37 ENGLISH MD 950 / NanoPak Changes Chapter 5 5. Select the day of the recordings, such as the tenth confirm 5. Select the serial number of the recordings, such as confirm Change display by swiping  Status of the event Date and time Event Temp.
  • Page 38: Show The Datamatic Data On A Pc

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.1.4 Show the DataMatic data on a PC USB stick directory with the recording data (for example: PC with Windows 7) Recording year 2017 Recording month Recording day Data file: Device number 496905.csv Display of a standard DataMatic recording, e.g.
  • Page 39: Tracelog (Logbook)

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.2 TraceLog (logbook) This logbook contains the temporary recording of various completed actions, events and faults that have occurred on the device. These recordings are only viewable while the device is switched on, however if a USB stick is connected for the DataMatic function, the data are stored as an add-on to the DataMatic data on it in the event of a date change and during the switch-off process.
  • Page 40: Data Designator (Prefix) - Symbol Or Text

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.4 Data designator (prefix) - Symbol or text  A text as a data designator is only possible for the internal printer! The data designator for different print data can be a symbol or text. If the text is selected as the data designator, this must be created beforehand The prefix is defined in the individual packaging lists See Chapter 3.3.2...
  • Page 41: Print Data As A Barcode

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.5 Print data as a barcode  The printing of data as a barcode is only possible if the language German or English has been set! This applies for the internal printer and the label printer! The following data are NOT printed as a barcode: Data Data...
  • Page 42: Direct Change Of The Process Parameters Of A Selected Packaging

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.6 Direct change of the process parameters of a selected packaging The sealing temperature or throughput speed of the packaging currently selected can be changed directly without calling up any menus. 5.6.1 Changing the sealing temperature 1.
  • Page 43: Udi Marking

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.7 UDI marking The marking is made using the HIBC coding system in accordance with the ANSI standard "ANS HIBC 2.5" embedded in the ISO standards for product and packaging marking ISO 22742, ISO 28219.
  • Page 44: External Keyboard For Data Entry

    ENGLISH MD 950 / NanoPak Changes Chapter 5 External keyboard for data entry A country-specific, external keyboard can be connected to enter packaging designations and the data for the various lists Insert the keyboard into a free USB slot 5.9 Display 5.9.1 Standby The display is darker and the device cools down to the default set Stand by is active, the sealing temperature decreases to...
  • Page 45: Maintenance Indicator

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.9.4 Maintenance indicator This symbol appears 30 days before the set maintenance cycle with information about the remaining days until the maintenance deadline or the days already exceeded after the maintenance deadline. Default setting: 12 months.
  • Page 46: The Display Of Control Center

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.9.7 The display of control center Tap the control center symbol Monitoring screen Symbol Display Checking of the temperature sensor positive Checking of the contact force sensor positive Checking of the throughput speed sensor positive Operating data button Page GB 46 9.694.038...
  • Page 47: Display Of Operating Data

    ENGLISH MD 950 / NanoPak Changes Chapter 5 5.9.8 Display of operating data Exit Symbol Display Device operating hours Device software version Device serial number Unit counter TOTAL Firmware version of the CPU PC board Date of the next maintenance Page GB 47 9.694.038 V 4.02...
  • Page 48: Special Functions

    ENGLISH MD 950 / NanoPak Special functions Chapter 6 6 Special functions Individual setting of the home screen 1. Activate the setting menu 2. Press and hold to select any symbol 3. The size of the symbol can be changed by activating the "size XL"...
  • Page 49 ENGLISH MD 950 / NanoPak Special functions Chapter 6 If the symbol in the home screen is to be deleted again or the position is to be changed, the respective symbol can be edited by holding it down for a long time. The position of the symbols can only be ...
  • Page 50: The Barcode Scanner (1.490.029)

    ENGLISH MD 950 / NanoPak Barcode scanner Chapter 7 7 The barcode scanner (1.490.029)  The barcode scanner is an optional accessory and not part of the sealing device scope of delivery! A connected barcode scanner that has not been approved by the device manufacturer can cause the device to fail! 7.1 Commissioning the barcode scanner 7.1.1 Step 1...
  • Page 51: Step 2 Connecting The Device

    ENGLISH MD 950 / NanoPak Barcode scanner Chapter 7 7.1.2 Step 2 Connecting the device 1. Switch off the device 2. Connect the barcode scanner's connection cable to a free USB slot 2. Switch on the device Page GB 51 9.694.038 V 4.02...
  • Page 52: Recording Data Using The Barcode Scanner

    ENGLISH MD 950 / NanoPak Barcode scanner Chapter 7 7.2 Recording data using the barcode scanner  The capture of data with a barcode scanner is only possible if the language German or English has been set! 7.2.1 Data of a created barcode list Only the print data of the internal printer of an activated packaging list can also be changed with a barcode scanner, provided they are activated in their print sequence.
  • Page 53: The External Printer

    ENGLISH MD 950 / NanoPak External printer Chapter 8 8 The external printer 1. Connect the external printer according to the instructions supplied with the printer and connect it to one of the USB slots on the back of the device. 2.
  • Page 54: Switch Off The Device

    ENGLISH MD 950 / NanoPak Switch off the device Chapter 9 9 Switch off the device Short press the Power button The device is switched off directly by holding the Power button Do not use if a USB stick is connected! Data loss! ≈5 s The colour of the Power button changes from...
  • Page 55: Troubleshooting And Maintenance

    ENGLISH Chapter MD 950 / NanoPak Troubleshooting and maintenance 10 Troubleshooting and maintenance 10.1 Troubleshooting checklist The malfunction corrections highlighted in grey may only be performed by  authorised service technicians Possible malfunction Malfunction Possible display Possible cause correction Open the front flap Front flap open display Close front flap Front flap sensor defective...
  • Page 56: Maintenance

    10.3 Service Your Van der Stahl customer service is available from Mon-Fri 8:00 to 17:00 at the following number: 1-800-550-3854 10.4 Spare parts service Conveniently order parts phone.
  • Page 57 Sender: E-mail: Fax no.: Your order No.: Date: Device type: Serial number:  Designation Art. No Qty. Device printer ink ribbon 6.813.104  Device printer ink ribbon, red 6.813.224         Signature _______________________ Page GB 57 9.694.038 V 4.02...
  • Page 58: Replacing The Sealing Device Ink Ribbon Cassette

    ENGLISH Chapter MD 950 / NanoPak Troubleshooting and maintenance 10.5 Replacing the sealing device ink ribbon cassette Switch off the device and DISCONNECT THE POWER SUPPLY Step 1 Sliding the infeed section forward and opening the front flap Step 2 Removing the ink ribbon cassette Press and hold down the lever Press the cassette clamping lever to the left...
  • Page 59 ENGLISH Chapter MD 950 / NanoPak Troubleshooting and maintenance Step 3 Installing a new ink ribbon cassette Insert a new ink ribbon cassette Press and hold down the lever The ink ribbon feed must not be Check to ensure that the cassette allowed to turn! is engaged Page GB 59...
  • Page 60: Technical Data

    ENGLISH Chapter MD 950 / NanoPak Technical data 11 Technical data 11.1 Specifications Connection data Mains connection [ V ] 100 - 240 Mains frequency [ Hz ] 50 / 60 Power consumption max. [ W] Mechanical system Dimensions Length [ mm ] Width Including...

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