CompoGuard Technical Manual Software version: 1.06X Edition: 4/04.07 Part no.: M63 689 1 Table of Contents 1 2 3 4 Donationmaster NT/Net Important Information ...................................................... 1-1 1.1 Organization of the Technical Manual..................................................................................... 1-1 1.2 How to Use the Technical Manual............................................................................................ 1-2 1.3 Precautions for Working on the Device .................................................................................. 1-3 1.4 Addresses .................................................................................................................................. 1-4 Initial Start-Up ................................................................................................................................. 2-1 2.1 2.1.1 Initial Start-Up CompoGuard .................................................................................................... 2-1 Start-up Report for the CompoGuard .......................................................................................... 2-4 2.2 2.2.1 2.2.2 Initial Start-Up Donationmaster NT/Net ................................................................................... 2-6 System Requirements ................................................................................................................. 2-6 Donationmaster NT/Net Start Options......................................................................................... 2-8 2.3 2.3.1 CompoGuard Network Installation (Radio) ............................................................................. 2-9 Operating Steps on the CompoGuard Mixer ............................................................................... 2-9 2.4 2.4.1 Installation of the CompoGuard Cable Network................................................................... 2-11 Operating Steps on the CompoGuard Mixer ............................................................................. 2-11 2.5 2.5.1 Operating Steps on the Donationmaster NT/Net .................................................................. 2-13 Additional Settings..................................................................................................................... 2-15 Service Program / Alarm Codes......................................................................................... 3-1 3.1 3.1.1 3.1.2 3.1.3 Service Program ........................................................................................................................ 3-1 Installing the Cable Network........................................................................................................ 3-1 HyperTerminal Program .............................................................................................................. 3-2 Service Program.......................................................................................................................... 3-5 3.2 3.2.1 3.2.2 Alarm Codes ............................................................................................................................ 3-11 Operation Alarms....................................................................................................................... 3-11 System Alarms .......................................................................................................................... 3-12 Setup / Repair .................................................................................................................................. 4-1 4.1 Opening the Device ................................................................................................................... 4-1 4.2 Assembling the Device ............................................................................................................. 4-1 4.3 4.3.1 4.3.2 4.3.3 4.3.4 Safety Clamp.............................................................................................................................. 4-2 Removal/Installation .................................................................................................................... 4-2 Exchanging the Tension Spring................................................................................................... 4-3 Test.............................................................................................................................................. 4-3 Calibrating the Safety Clamp....................................................................................................... 4-4 Fresenius Kabi CompoGuard TM 4/04.07 0-1 4.4 4.4.1 4.4.2 Swing Unit .................................................................................................................................. 4-8 Removal/Installation .................................................................................................................... 4-8 Calibrating the Swing Unit ......................................................................................................... 4-10 4.5 4.5.1 4.5.2 4.5.3 Weighing Sensor ..................................................................................................................... 4-12 Removal/Installation .................................................................................................................. 4-12 Test............................................................................................................................................ 4-14 Calibrating the Weighing Sensor ............................................................................................... 4-15 4.6 4.6.1 RF Generator............................................................................................................................ 4-16 Removal/Installation .................................................................................................................. 4-16 4.7 DECT Module ........................................................................................................................... 4-17 4.8 4.8.1 4.8.2 Display...................................................................................................................................... 4-18 Removal/Installation .................................................................................................................. 4-18 Test............................................................................................................................................ 4-19 4.9 5 Simulating a Donation Process............................................................................................ 4-20 4.10 4.10.1 4.10.2 4.10.3 4.10.4 4.10.5 Hand Sealer.............................................................................................................................. 4-22 Spark Detector........................................................................................................................... 4-22 Cleaning the Hand Sealer ......................................................................................................... 4-22 Disassembling the Hand Sealer ................................................................................................ 4-23 Reassembling the Hand Sealer................................................................................................. 4-24 Adjusting the Hand Sealer......................................................................................................... 4-25 4.11 4.11.1 4.11.2 Sealing Test ............................................................................................................................. 4-27 Sealing Test 1............................................................................................................................ 4-27 Sealing Test 2............................................................................................................................ 4-29 4.12 Autosense Scanner ................................................................................................................. 4-30 Functional Description ............................................................................................................. 5-1 5.1 Block Diagram ........................................................................................................................... 5-2 5.2 Position and Wiring Diagram ................................................................................................... 5-3 5.3 P.C.B. LP 1085 Control Board .................................................................................................. 5-4 5.4 P.C.B. LP 1086 Connection Board ........................................................................................... 5-6 5.5 P.C.B. LP 1087 Accumulator Contact Board........................................................................... 5-8 5.6 P.C.B. LP 1088 Gooseneck ....................................................................................................... 5-9 5.7 P.C.B. LP 1089 DECT Module ................................................................................................. 5-10 5.8 P.C.B. LP 1300 Sensor ............................................................................................................ 5-11 5.9 Hand Sealer.............................................................................................................................. 5-12 6 CompoGuard Maintenance Checklist ............................................................................ 6-1 7 Spare Parts Catalog .................................................................................................................... 7-1 7.1 Fresenius Kabi CompoGuard Bottom Tray ....................................................................................................... 7-2 CompoGuard TM 4/04.07 0-2 8 9 7.2 CompoGuard Upper Tray.......................................................................................................... 7-4 7.3 Gooseneck (Optional) ............................................................................................................... 7-6 7.4 CompoGuard Hand Sealer (Optional)...................................................................................... 7-8 7.5 Printed Circuit Boards ............................................................................................................ 7-10 7.6 Accessories – Options............................................................................................................ 7-12 7.7 Test Equipment........................................................................................................................ 7-14 Software Update ............................................................................................................................ 8-1 8.1 Software Update of Donationmaster NT/Net........................................................................... 8-2 8.2 8.2.1 8.2.2 8.2.3 8.2.4 Software Update of CompoGuard............................................................................................ 8-4 Saving Data ................................................................................................................................. 8-4 Software Update with Flash-Master ............................................................................................ 8-6 Software Update with FlashPro4 ................................................................................................. 8-9 Final Inspection and Testing...................................................................................................... 8-12 8.3 Programming the Flash-Master.............................................................................................. 8-13 Appendix ............................................................................................................................................. 9-1 9.1 9.1.1 9.1.2 9.1.3 9.1.4 Concept of the Data Interface Between Donationmaster NT/Net and the Blood Bank Information System ....................................... 9-1 Introduction.................................................................................................................................. 9-1 Physical Connection .................................................................................................................... 9-1 Logical Connection ...................................................................................................................... 9-1 Exceptions ................................................................................................................................... 9-2 9.2 9.2.1 9.2.2 9.2.3 9.2.4 Description of the Interface Files............................................................................................. 9-3 Order File..................................................................................................................................... 9-3 Order Error File............................................................................................................................ 9-4 Donation Results ......................................................................................................................... 9-6 Barcode Check Lists.................................................................................................................. 9-13 9.3 9.3.1 9.3.2 9.3.3 9.3.4 Donationmaster NT/Net Requirements to be Met by the BIS .............................................. 9-14 Introduction................................................................................................................................ 9-14 System Requirements ............................................................................................................... 9-14 What does the Customer Have to Do?...................................................................................... 9-14 Issues to be Noted..................................................................................................................... 9-14 Fresenius Kabi CompoGuard TM 4/04.07 0-3 0-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 1: Donationmaster NT/Net Important Information 1 Donationmaster NT/Net Important Information 1.1 Organization of the Technical Manual Page identification The page number 1-3 refers to chapter 1, page 3. Editorial information The editorial information 4/04.07, for example, refers to: 4th edition, April 2007. In case of updates, the pages concerned will be replaced. Changes Changes to the Technical Manual will be released as new editions or supplements. In general, this manual is subject to change without notice. Fresenius Kabi CompoGuard TM 4/04.07 1-1 Chapter 1: Donationmaster NT/Net Important Information 1.2 How to Use the Technical Manual Purpose This Technical Manual is intended for service technicians. It can be used both for first studies (to acquire a basic knowledge) and for reference purposes (for TSC, maintenance and repair). The Technical Manual, however, does not replace the training courses offered by the manufacturer. Requirements Knowledge of the current Operating Instructions of the respective system. Background experience in mechanics, electrical and medical engineering. Specifications For the specifications of the respective device, refer to the current Operating Instructions. Component layouts The identification on the PCB permits the operator/technician to verify if the component layout matches the PCB actually installed in the system. Explanation of the Note and Caution symbols used Note Informs the operator that in case of a failure to follow the steps as described, a specific function will be executed incorrectly or will not be executed at all, or will not produce the desired effect. Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on operators and patients. 1-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 1: Donationmaster NT/Net Important Information 1.3 Precautions for Working on the Device Authorized persons Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him. Test equipment and accessories The activities described in the Technical Manual require the availability of the necessary technical test equipment and accessories. Precautions When working on the open system, the following precautions must be respected: – Protect the components against ingress of fluids. – Do not touch live parts. – Before removing the plug connectors on the printed circuit boards, carefully lift them using a small screw driver. – Remove or mount the plug connectors in the device only after having removed all power supplies (PSU and battery). ESD precautions When repairing the device and when replacing spare parts, observe the applicable ESD precautions (e.g. EN 100 015-1). Fresenius Kabi CompoGuard TM 4/04.07 1-3 Chapter 1: Donationmaster NT/Net Important Information 1.4 Addresses Please address any inquiries to: Manufacturer Fresenius Kabi D-61346 Bad Homburg v.d.H. Phone: 0049 (0) 06172 / 608 - 0 Local service: National service 1-4 Fresenius HemoCare GmbH Technischer Service Pfingstweide 53 D-61169 Friedberg Germany International Service Hotline (08:30 - 17:00) Phone: +49 6172 / 608 8469 Fax: +49 6172 / 608 8539 E-mail: technical_support_medical_device@fresenius-kabi.com Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up 2 Initial Start-Up 2.1 Initial Start-Up CompoGuard A suitable site for the installation of the CompoGuard system must be determined. The CompoGuard should not be exposed to direct sunlight. The electrical connection must be free from electrical interference. Caution To ensure a correct weighing result, the CompoGuard must be operated in horizontal position. This requires that all four device supports are resting on a firm and vibration-free base. Nothing must be jammed between the inline tray and the housing. The inline tray must move freely, i.e. its movement may not be obstructed by cables, etc. Before starting the initial start-up, check that all parts have been accounted for. The initial start-up may only be performed by persons authorized to do so. Caution If transported from a cool room to a warmer one, the CompoGuard must first reach its operating temperature before initial start-up. Fresenius Kabi CompoGuard TM 4/04.07 2-1 Chapter 2: Initial Start-Up Scope of delivery Name CompoGuard Complete CompoGuard Data CompoGuard Seal CompoGuard Basic CompoGuard X X X X Operating Instructions X X X X AC adapter X X X X Gooseneck X X X + Autosense Scanner + + + + Hand sealer with cable X Donationmaster NT/Net + + DECT fixed part for radio transmission network + + Network converter + + O O Y-piece + + O O Network cable, 5m + + O O Transport case for CompoGuard + + + + Transport case with charging option + + + + Powerpack for CompoGuard X + X + Multicharger for CompoGuard + + + + X + O X Contained in the scope of delivery Comprised as an option Comprised as an option; the software mode High is also required General external checks Check the CompoGuard on the outside for possible damage in transit or other damage. Connections Connect the AC adapter to the CompoGuard and insert it in the wall outlet. Connect the hand sealer (option) Insert the Powerpack (option) into the battery charging compartment Connect the scanner (option) When using a DECT radio module, the address of the fixed part must be scanned via the menu Setup menu / Common Setup / DECT FP Address, using the CompoGuard barcode scanner. Charging the Powerpack 2-2 When using the optional Powerpack, connect the device to the external power supply for two hours before start-up, in order to charge the batteries. Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up Turning the device power on Press the On/Standby key for 2 seconds to switch the CompoGuard on. The System Check is performed. The following messages are displayed: 1 3 2 4 5 1 Software version 2 Serial number 3 Software Mode: High indicates that data management is possible Software Mode: Standard indicates that data management is not possible 4 UID: Indicates the date and the time when the last transmitted donation program was saved in Donationmaster NT/Net. YYMMDDHHMMSS In our example: 020514152941, i.e. 14.05.02 at 15:29:41 5 Set language The LEDs of the donation-relevant keys are lit for approx. 2 seconds. The safety clamp is opened and closed again. A mixing movement is made. The display test with the Fresenius Kabi message is performed. This is followed by an audible alarm to check the audible alarm generator. If a Powerpack is inserted in the device, the battery symbol is displayed. The CompoGuard is ready for operation. Fresenius Kabi CompoGuard TM 4/04.07 2-3 Chapter 2: Initial Start-Up 2.1.1 Start-up Report for the CompoGuard Manufacturer: Date: Machine: Technician: Software version: DECT ID (option): Serial number: No. 1 OK Model CompoGuard Complete CompoGuard Data CompoGuard Seal CompoGuard Basic 2 Scope of delivery Operating Instructions AC adapter Gooseneck Autosense scanner Hand sealer with cable Donationmaster NT/Net DECT Fixedpart Network converter Y-piece Network cable Transport case Transport case with charging function Powerpack Multicharger for Powerpack 3 General external checks 4 Connect the AC adapter 5 Turn the device on. An internal system check is performed. 2-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up I herewith confirm proper performance of any maintenance work as specified above, and the data to be true and correct. Technician's signature: Customer's signature: .............................................., Date: ................. .............................................., Date: ................. ............................................................................. ............................................................................. Fresenius Kabi CompoGuard TM 4/04.07 2-5 Chapter 2: Initial Start-Up 2.2 Initial Start-Up Donationmaster NT/Net 2.2.1 System Requirements Processor Intel-compatible CPU with a clock pulse frequency of at least 350 MHz Memory min. 128 MB main memory Hard disk min. 10 MB unused memory location CD-ROM Drive is only required for installation of Donationmaster NT/Net. Ports One unused serial interface for operating the CompoGuard network (cable-dependent via RS-485 or via DECT) Network connection The network connection is required for bidirectional data exchange with the blood bank information system. This requires a network card which must be configured according to the network topology used in the blood bank. Operating systems – – – – Microsoft Windows 95 b / 98, second edition Microsoft Windows NT 4.0, SP5; Microsoft Windows 2000, SP1 Microsoft Windows XP The following list shows you how to install the Donationmaster NT/Net software on your PC. Note Donationmaster NT/Net and the CompoGuard mixer may be installed and started up initially only by authorized Fresenius Kabi service personnel or by service technicians approved by Fresenius Kabi. Requirements – PC complying with the minimum requirements specified. – DECT fixed part for radio transmission network Including power cable and data cable – Interface converter RS 485 Necessary for cable network only; including power cable and data cable. – Y-piece Necessary for cable network only; one each per CompoGuard. – Network cable Necessary for cable network only. – Software license for the CompoGuard models Seal and Basic, to enable the collection of data at the system 2-6 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up Installation Note If you are running Windows NT or Windows 2000, you might require administrator access rights on your PC to be able to install new software packages. Before installing CompoGuard, ensure that you have the necessary user rights. – Insert the Donationmaster NT/Net installation CD in the CD-ROM drive of your PC. Select the CD drive in the Explorer. – Start the installation program SETUP.EXE. – An installation window opens. – Double-click the installation button. – Confirm the suggested directory C:\Donationmaster or select another one. – Donationmaster NT/Net is now being installed on your PC. – After having completed the installation, restart your PC. Checking the installation After completed installation, the following directories must be available: C:\Donationmaster\ – Directory initially suggested by the installation program or the directory you have selected. C:\Donationmaster\BCL – Directory where barcode check lists can be filed by a blood bank information system. C:\Donationmaster\DB – Database directory of Donationmaster NT/Net. C:\Donationmaster\Orders – Directory where orders can be filed by a blood bank information system. C:\Donationmaster\Results – Directory where Donationmaster NT/Net feeds donation results back to a blood bank information system. C:\Donationmaster\System – Program directory of Donationmaster NT/Net. Fresenius Kabi CompoGuard TM 4/04.07 2-7 Chapter 2: Initial Start-Up 2.2.2 Donationmaster NT/Net Start Options Windows Start menu Select the command Start / Programs / Donationmaster / Donationmaster from the Windows Start menu. Icon on the desktop Open the CompoGuard program directory in the Explorer, e.g. C:\Donationmaster\System. Pressing the right mouse button, click the file DM.EXE. From the opening context-sensitive menu, select the command Send To / Desktop. A program icon appears on your desktop. Autostart From the Windows Start menu, select the command Settings / Task Bar and Start Menu.... The Properties of Task Bar and Start Menu dialog opens. Select the Extended tab. Click the Add button. A Windows Wizard window opens, where you can enter C:\Donationmaster\System\DM.EXE or click the Search... button to find CompoGuard in the file system of your PC. Now click the Next > button. In the list window, click the Autostart folder, where you wish to file the link to CompoGuard, and click the Next > button. Assign a name to the link in the Autostart folder; the system suggests DM. To complete creation of the link, click the Complete button. Exit the Properties of Task Bar and Start Menu dialog by clicking OK. Donationmaster NT/Net will now be started automatically upon each system start of your PC. 2-8 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up 2.3 CompoGuard Network Installation (Radio) The following list describes integration of a new CompoGuard mixer in the radio network. Note Proceed as follows to operate the CompoGuard in the network: – Switch the first CompoGuard on. – Wait until the system check is completed. – Switch on the next CompoGuard and proceed as described above. After you have switched on the last CompoGuard, you can start the Donationmaster NT/Net software. 2.3.1 Operating Steps on the CompoGuard Mixer Condition The Donationmaster NT/Net program is already installed on your PC, but has not yet been started. Connect the fixed part to an unused serial interface of your computer. Connecting the CompoGuard Connect the barcode scanner to the CompoGuard. Connect the AC adapter to the CompoGuard and to a receptacle outlet. Press the On/Standby key. – The CompoGuard is switched on. – A system check is carried out – The Open clamp message is displayed. Press the Enter key for approx. two seconds. – The setting level Settings is opened. Using the key, select the Common Setup menu. Press the Enter key. – The Common Settings menu is displayed. Using the key or the key, select the Operation mode option. Press the Enter key. Using the Fresenius Kabi CompoGuard TM 4/04.07 key, select the Network option. 2-9 Chapter 2: Initial Start-Up Press the Enter key. – The selection is accepted. Using the key or the key, select the Communication option. Press the Enter key. Using the key, select the Radio (DECT) option. Press the Enter key. – The selection is accepted. Using the key or the key, select the DECT FP Address option. Press the Enter key. – The edit screen DECT FP Address is displayed. Note Should the CompoGuard mixer have already been run in a radio network, a DECT address of the old fixed part (FP) will be displayed. Scan the barcode on the adhesive label of the fixed part using the barcode scanner of the CompoGuard mixer. – The barcode is shown on the display of the CompoGuard mixer in the New FP Address line. Press the Enter key. – The Common Settings menu is displayed. Press the Stop key. – Configuration of the CompoGuard mixer is completed; the settings have been saved. – The setting level is exited. – The CompoGuard is in the basic setting mode. – The Device updating... message is displayed. 2-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up 2.4 Installation of the CompoGuard Cable Network The following list describes the integration of a new CompoGuard mixer in the cable network. Note Proceed as follows to operate the CompoGuard in the network: – Switch the first CompoGuard on. – Wait until the system check is completed. – Switch on the next CompoGuard and proceed as described above. – After you have switched on the last CompoGuard, you can start the Donationmaster NT/Net software. 2.4.1 Operating Steps on the CompoGuard Mixer Condition The CompoGuard program is already installed on your PC, but has not yet been started. Installing the cable network Connect the RS 232 cable to an unused serial interface of your computer. Connect the RS 232 cable to the converter. Connect the RS 485 cable to the converter. Connect the RS 485 cable to the connector for the cable-dependent network on the CompoGuard. Connect the AC adapter of the converter to the external power supply. Connecting the CompoGuard Connect the barcode scanner to the CompoGuard. Connect the AC adapter to the CompoGuard and to a receptacle outlet. Press the On/Standby key. – The CompoGuard is switched on. – A system check is carried out – The Open clamp message is displayed. Press the Enter key for approx. two seconds. – The setting level Settings is opened. Using the key, select the Common Setup menu. Press the Enter key. – The Common Settings menu is displayed. Using the Fresenius Kabi CompoGuard TM 4/04.07 key or the key, select the Operation mode option. 2-11 Chapter 2: Initial Start-Up Press the Enter key. Using the key, select the Network option. Press the Enter key. – The selection is accepted. Using the key or the key, select the Communication option. Press the Enter key. Using the key, select the Cable (RS 485) option. Press the Enter key. – The selection is accepted. Press the Stop key. – Configuration of the CompoGuard mixer is completed; the settings have been saved. – The setting level is exited. – The CompoGuard is in the basic setting mode. – The Device updating... message is displayed. 2-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up 2.5 Operating Steps on the Donationmaster NT/Net Starting the program Start Donationmaster NT/Net using the Start menu. Log in using the Log in at Donationmaster NT menu with supervisor access rights. Name: Master Password Master Confirm with the OK button. Donationmaster NT/Net is case-sensitive. Passwords must be entered exactly as printed here. The access level 3, intended for configuration of the system, is assigned to the Master. Configuring the CompoGuard In the Setup menu, click the CompoGuard management command; the CompoGuard dialog opens. – Click an unused entry in the No column of the list box. – Enter a name for the CompoGuard mixer in the Name edit field, e.g. CG1 Fresenius Kabi CompoGuard TM 4/04.07 2-13 Chapter 2: Initial Start-Up – Enter the ten-digit serial number specified on the type label of the CompoGuard mixer in the edit field Ser.no. CompoGuard, e.g. 002CGA0001. – The CompoGuard mixer is provided with another label specifying a six- or seven-digit DECT ID number. Enter this number in the DECT ID edit field, e.g. 635384. – The first column active of the CompoGuard list consists of check boxes. Checking a check box defines the corresponding CompoGuard mixer with which Donationmaster NT/Net should communicate. Repeat the five steps described above for each CompoGuard mixer you wish to configure. – Click the Close button to close the dialog. – Confirm any changes made with Yes. – Confirm with the OK button. – This completes configuration of the new CompoGuard mixer. 2-14 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 2: Initial Start-Up 2.5.1 Additional Settings To complete installation, user-specific configurations must still be made. These settings must be made together with authorized Fresenius Kabi service technicians during the initial start-up of your CompoGuard. Programs menu – Command Donationprograms Use the common CompoGuardsettings dialog to adjust the settings. Use the Donation program:‘xxx‘ dialog to create new programs, if necessary. Setup menu – Select network mode Selects the manual program selection. – User management Creates new users and their access rights. – CompoGuard management Activates configured CompoGuard mixers with which CompoGuard is to communicate. – Configuration Makes settings in the parameter window Communication for communication with the CompoGuard mixers and the blood bank. Network menu – Start CompoGuard network Donationmaster NT/Net starts data exchange with all configured CompoGuard mixers. When all steps are executed, Donationmaster NT/Net is ready for use. Fresenius Kabi CompoGuard TM 4/04.07 2-15 Chapter 2: Initial Start-Up 2-16 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes 3 Service Program / Alarm Codes 3.1 Service Program 3.1.1 Installing the Cable Network – Connect the RS 232 cable to the RS 232 / COM 1 port of the PC. – Connect the RS 232 cable to the converter. – Connect the RS 485 cable to the converter. – Connect the RS 485 cable to the connector for the cable-dependent network on the CompoGuard. – Connect the AC adapter of the converter to the external power supply. – Connect the AC adapter to the CompoGuard and to the external power supply. – Press the On/Standby key for two seconds to switch the CompoGuard on. The system check is performed. – Press the Enter key for approx. two seconds. The setting level is opened. – Select Common Setup in the setting level. – Select the Communication menu. – Select the Wire (RS485) menu item. – Press the Stop key. RS232 / COM1 RS232 / converter PC CompoGuard converter RS485 / converter AC adapter converter Fresenius Kabi CompoGuard AC adapter CompoGuard TM 4/04.07 3-1 Chapter 3: Service Program / Alarm Codes 3.1.2 HyperTerminal Program Open the HyperTerminal program using the Start / Programs / Accessories / Communication menu. The Connection Description dialog opens. In the Name field, enter CompoGuard as the name of the connection. Confirm with the OK button. The Connect To dialog opens. In the Connect using drop-down list box, select the PC port, e.g. COM1. Confirm with the OK button. The COM1 Properties dialog opens. Configure the port settings: – Bits per second: 115200 – Data bits: 8 – Parity: None – Stop bits: 1 – Flow control: None Confirm with the OK button. 3-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes Open the File drop-down menu in the menu bar of the HyperTerminal program. Select the Properties command. The CompoGuard Properties dialog opens. Select the Settings tab. Click the ASCII Setup... button. The ASCII Setup dialog opens. Check the Echo typed characters locally checkbox. Confirm with the OK button. Fresenius Kabi CompoGuard TM 4/04.07 3-3 Chapter 3: Service Program / Alarm Codes The CompoGuard Properties dialog opens. Confirm with the OK button. Open the Transfer drop-down menu in the menu bar of the HyperTerminal program. Select the Send Text File... command. The Send Text File dialog opens. Select the path and name of the file to be sent from the File name drop-down list box: e.g. C:\Service.txt Click the Open button to confirm. The software is automatically installed in the CompoGuard. 3-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes 3.1.3 Service Program – Install the cable network (see Chapter 3.1.1, page 3-1). – Start the HyperTerminal program. – Enter any commands using the keyboard of the PC. – Commands and parameters must be separated by a blank character. – Confirm entries by pressing the Enter key. – Save the calibration values using the cal save command. – Exit the service program using the Exit command. – The parameters described in angle brackets <> must contain numeric values. Example: FRONT <percent>: Front 30 Note Calibration values are specific to each device and can, therefore, be different in the various CompoGuard mixers. Verification commands Command Parameter Description CLOSE – Closes the safety clamp. WIDE – Opens the safety clamp to its maximum. OPEN – Opens the safety clamp while donation is in progress. DISPLAY CLAMP Shows the voltage at the sensor of the safety clamp on the display. SWING Shows the voltage at the sensor of the swing unit on the display. NO Deactivates display of the values. Test 0 – Switches off endurance test. Test 1 – 5 hours endurance test of swing unit and safety clamp. Test 2 – 2 hours endurance test of swing unit and safety clamp. Fresenius Kabi CompoGuard TM 4/04.07 3-5 Chapter 3: Service Program / Alarm Codes Command Parameter Description GET SWING Uploads the calibration values of the swing unit. CLAMP Uploads the calibration values of the safety clamp. WEIGHT Uploads the calibration values of the weighing unit. SPEED Uploads the calibration values of the swing speed. UPGRADE Software upgrade status (high-end/low-end version of the device). SEAL Uploads the status of the sealing generator. Display with integrated sealing function: INSTALLED Display without integrated sealing function: NOT INSTALLED. SER Uploads the serial number of the device. DEVICE Uploads the device state. Device state: OK Device virgin: NO. ACCBC Uploads the status of the access barcode. Access Barcode: NO. PPID Uploads the ID number of the DECT module (PP = portable part). Reading DECT modules ID: XXXXXX. BL Uploads the brightness of the display backlighting in [%]. Backlighting brightness: XX %. LOUD Uploads the volume of the alarm tone generator. Speaker: SILENT Speaker: LOUD CD Uploads the calibration values (motor voltage) of the safety clamp. CODE Requests required upgrade code for high-end version upgrade of device (dependent on serial number!). WFT Weight Filter Treshold Filter parameter for detection of a change in weight after donation start. Filter threshold value Current default value: 3.000 mg WFE Weight Filter Error Time Filter parameter for detection of a change in weight after donation start. If a constant weight is detected, the weight will be tared. If no constant weight is detected after a defined period of time, the large display starts to flash. Time after which switch-over to extended averaging takes place. Current default value: 5.000 ms 3-6 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes Command Parameter Description GET WFF Weight Filter Flow Limit Filter parameter for detection of a change in weight after donation start. Maximum flow taken into consideration during filtering. Current default value: 200 ml/min. MBB Minimum background lighting, for brightness control 0–100%. BSS Step size, for brightness control 0 – 100%. BDT Background dimming time start: 0 – 120s BDI Background dimming interval. CCT Idle mode, automatic clamp closing time. SSCMIN Sealing start current min 1.000 – 12.000 mA SSCMAX Sealing start current max 5.000 – 18.000 mA SECMAX Sealing end current max (percentage of measured starting current) 20 – 100 % ERR Requests all available system error log entries. ASV Requests accumulator battery service log entries. Calibration commands Command Parameter Description FRONT <percent> If the large inline tray fails to be in a horizontal position after completed self-calibration of the swing unit, its position can be corrected towards the front by <percent> steps. <percent> has a value range from 0 .. 100. BACK <percent> If the large inline tray fails to be in a horizontal position after completed self-calibration of the swing unit, its position can be corrected towards the back by <percent> steps. <percent> has a value range from 0 .. 100. CYCLE <cycles> Defined number of swing cycles. Fresenius Kabi CompoGuard TM 4/04.07 3-7 Chapter 3: Service Program / Alarm Codes Command Parameter Description CAL CLAMP Calibrates the safety clamp. Calibration instructions are displayed in the HyperTerminal program. Note: The new calibration values must be saved with the CAL SAVE command. SWING Calibrates the swing motor. During calibration, the swing unit is moving repeatedly, thus being calibrated automatically. Note: The new calibration values must be saved with the CAL SAVE command. SPEED Calibrates the speed of the mixing movement. During calibration of the swing speed, the swing unit completes several cycles, thus being calibrated automatically. Note: The new calibration values must be saved with the CAL SAVE command. WEIGHT Calibrates the weight measurement. Calibration instructions are displayed via the HyperTerminal program. Note: The new calibration values must be saved with the CAL SAVE command. SAVE Saves the calibration values. The calibration values of the Front and Back commands are saved as well. 3-8 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes Configuration commands Command Parameter Description Set DEVICE OK Resets the flag for a defective device in the EEPROM. DEVICE DEFECT Sets 'Device Defect' flag in EEPROM (check device behavior in this state for simulation purposes) DEVICE VIRGIN Resets 'Not virgin flag' in NOVRAM (check behavior of device in this state for simulation purposes) DEVICE UNVIRGIN Sets 'Not virgin flag' in NOVRAM (check behavior of device in this state for simulation purposes) SER <10 chars> Sets the serial number of the device (10 characters). SEAL YES Installs the sealing generator. SEAL NO Uninstalls the sealing generator. UPGRADE NO Sets device to low-end. ACCBC YES Activates the access barcode after the system check. ACCBC NO Deactivates the access barcode after the system check. BL <percent> Sets the brightness of the display backlighting in [%]. LOUD YES Sets the volume of the alarm tone generator to loud. LOUD NO Sets the volume of the alarm tone generator to silent. EE VIRGIN Sets EEPROM to original status. EE UNVIRGIN Sets EEPROM to non-original status. CDO <voltage> Sets clamp driver voltage for opening the clamp [mV] NOTE: The setting becomes effective immediately, but has to be saved with CAL SAVE! CDHO <voltage> Sets clamp driver voltage for holding open the clamp [mV] NOTE: The setting becomes effective immediately, but has to be saved with CAL SAVE! CDW <voltage> Sets clamp driver voltage for wide opening of the clamp [mV] NOTE: The setting becomes effective immediately, but has to be saved with CAL SAVE! CDHW <voltage> Sets clamp driver voltage for holding the clamp wide open [mV] NOTE: The setting becomes effective immediately, but has to be saved with CAL SAVE! CDHW <4 chars> Sets the motor withstand voltage value of the safety clamp opened to its maximum (holding clamp open wide) WFT Weight Filter Treshold WFE Weight Filter Error Time WFF Weight Filter Flow Limit MBB Minimum background lighting, for brightness control 0–100% SET Fresenius Kabi CompoGuard TM 4/04.07 3-9 Chapter 3: Service Program / Alarm Codes Command CLEAR PROT TEST Parameter Description BSS Step size, for brightness control 0 – 100% BDT Background dimming time start: 0 – 120s BDI Background dimming interval. CCT Idle mode, automatic clamp closing time. SSCMAX Sealing start current max 5.000 – 18.000 mA SECMAX Sealing end current max (percentage of measured starting current) 20 – 100 % ERR Requests all available system error log entries. ASV Requests accumulator battery service log entries. CLEAR Clears all donation results saved in the CompoGuard. RESTORE Restores the previously uploaded 100 donation results to the CompoGuard, so that they can again be uploaded to the Donationmaster NT/Net. 1 2 0 EXIT 3-10 – Exits the service program. The CompoGuard is in the standby mode. Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes 3.2 Alarm Codes Each alarm is filed to the alarm memory. Alarms are displayed in various ways: – In plaintext on the display of the CompoGuard – In hexadecimal format on the display of the CompoGuard – In decimal format in the Donation results dialog of Donationmaster NT/Net 3.2.1 Operation Alarms Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Display message CompoGuard 0b 11 Device defective! 0c 12 No tube 0d 13 No battery! 0e 14 No Sealer! 0f 15 Upgrade Device! 10 16 No flow (flow alarm) 11 17 Weight jump! 12 18 Weight drop! 13 19 Swing blocked! 14 20 Date/time error 15 21 Volume reached 16 22 Time reached 17 23 Seal error! 18 24 Too much donation data 19 25 Accu discharge: 1a 26 Change battery ! 1b 27 Program not found! 1c 28 Wrong Barcode! 1d 29 Donation aborted! 1e 30 Pause exceeded! Fresenius Kabi CompoGuard TM 4/04.07 3-11 Chapter 3: Service Program / Alarm Codes Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Display message CompoGuard 1f 31 Battery symbol flashing 20 32 Tare is not possible! 21 33 Clamp function incorrect! 3.2.2 System Alarms – Whenever a system alarm is emitted, the display shows the System alarm message as well as the alarm code of the error. Up to three successive alarm codes may be displayed. – Record the alarm code and turn the device off by pressing the On/Standby key. Eliminate the possible cause using the alarm code table. Configuration alarms Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Alarm description 22 34 Device state 23 35 Common CompoGuard settings (Novram) 24 36 Donation program (display) 25 37 Action list 26 38 Order file 27 39 Language 28 40 Function barcode panel 29 41 Reference donation program 2a 42 Barcode check list 2b 43 Donation results 3-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 3: Service Program / Alarm Codes Battery alarms Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Alarm description 2c 44 Excess battery temperature Disconnect the charging unit and let the battery cool down 2d 45 Excess battery current Check the charging current; battery error 2e 46 Time exceeded in case of trickle charge Calibration alarms Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Alarm description 2F 47 Calibration System alarms 1 Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Alarm description 45 69 ROM error (program code memory) 46 70 RAM error 47 71 Time error of serial interface IN/OUT 48 72 Time error of analog-to-digital converter 49 73 System check error 4a 74 ADC does not respond 4b 75 Error during self test Fresenius Kabi CompoGuard TM 4/04.07 3-13 Chapter 3: Service Program / Alarm Codes System alarms 2 Alarm code (Hexadecimal) CompoGuard Alarm code (Decimal) Donationmaster NT /Net Alarm description 30 48 Novram check in system check failed 31 49 Touch panel error 32 50 Charging current 33 51 Voltage supply 34 52 Watchdog / clamp fails to open 35 53 Watchdog / clamp fails to open 36 54 Watchdog / generator monitoring 37 55 Watchdog / generator monitoring 38 56 Watchdog / charge monitoring 39 57 Real time clock 3A 58 Analog-to-digital converter 3B 59 Analog-to-digital converter 3C 60 Clamp fails to close 3D 61 Buffer battery of NOVRAM (donation programs, common settings, barcode check lists, etc.) too weak – replace. 3E 62 Time error of swing, swing sluggish 3F 63 Swing speed 40 64 Excess motor current 41 65 Output buffer full (e.g. donation results) 42 66 Check the set parameters in the EEPROM 43 67 LCD display controller 44 68 EEPROM defective 3-14 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4 Setup / Repair 4.1 Opening the Device – Remove the large inline tray, the gooseneck, the CompoGuard AC adapter, and the powerpack. – Remove the six screws (A) from the bottom tray of the housing. Pull off the connector X3/P.C.B. LP 1087. – Place the upper tray aside to the left of the bottom tray. + A X3 4.2 Assembling the Device – Connect the plug. – When assembling the device, ensure proper cable routing. – Attach the upper tray of the housing. Note Ensure that the two short Phillips screws are in the central holes when assembling the device. – Insert the six screws (A) and tighten them. – Mount the large inline tray, the gooseneck, the CompoGuard AC adapter, and the powerpack. Fresenius Kabi CompoGuard TM 4/04.07 4-1 Chapter 4: Setup / Repair 4.3 Safety Clamp 4.3.1 Removal/Installation Removal – Open the device (see Chapter 4.1, page 4-1). – Pull off the connector X12 / P.C.B. LP 1085 of the safety clamp. – Remove the four EJOT Phillips screws (A). – Carefully take out the safety clamp. – Exchange the flat packing (part no. M63 637 1) if it is defective; remove the flat packing, clean the adhesive surface with isopropyl alcohol, and glue on the new packing using Loctite 406 adhesive. A X12 A Installation – Insert the safety clamp, ensuring proper cable routing. – Tighten the four EJOT Phillips screws. – Connect the connector X12 / P.C.B. OP 1085. – Assemble the device (see Chapter 4.2, page 4-1). 4-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.3.2 Exchanging the Tension Spring – Open the device (see Chapter 4.1, page 4-1). – Remove the tension spring (3) from the spring bracket (4). – Remove the round litz wire (2) from the guide of the spring lever (1). – Install in reverse order. 4 1 4.3.3 2 3 Test Test equipment Syringe 4.55 mm PVC tubing (part no. M60 025 1) Test tubing (part no. M60 299 1) Pressure gauge Occluded tubing – Press the On/Standby key for 2 seconds to switch the CompoGuard on. The system check is performed. The Open clamp message is displayed. If necessary, set the operating mode to Manual in the Common Setup setting level. – Press the Tube key (the yellow LED is flashing). The safety clamp opens. The Insert bag system message will be displayed. – Insert 4.55 mm PVC tubing (part no. M60 025 1). Press the Tube key. The safety clamp closes. – Connect the input to the pressure gauge and the syringe using a Y-piece; immerse the output in a vessel filled with water. Apply a pressure of 750 mmHg to the tubing. The clamp has to close tightly, no air bubbles may rise. – Repeat test with test tubing (part no. M63 299 1). Fresenius Kabi CompoGuard TM 4/04.07 4-3 Chapter 4: Setup / Repair 4.3.4 Calibrating the Safety Clamp Test equipment 3.8 mm test pin (part no. M63 885 1) 4.55 mm PVC tubing (part no. M60 025 1) Test tubing (part no. M60 299 1) Extension cable (part no. M63 849 1) Description The safety clamp sensor is a Hall sensor and must be positioned inside an annular magnet. The magnetic flow through the sensor is output as a sinusoidal wave in relation to the function angle. Adjust the mechanical position of the safety clamp using the annular magnet. Four positions of the tube clamp are illustrated in the drawing. Actual voltage readings in the diagram may deviate from the specified voltage values. closed No tube is located in the closed safety clamp. The highest voltage value is indicated here. closed with tube A tube is inserted and the safety clamp is closed. open The safety clamp is open just like during a blood donation. wide The safety clamp is opened to a maximum. Umin The minimum voltage value is required for setting the safety clamp. Voltage values Uclosed < 4500[mV] 250>(Uopen-Umin)<150 400>(Uwide-Uopen)<1000 4-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Calibration – Call up the service program . Note There must not be inserted anything in the safety clamp. – In the service program, enter the cal clamp command and press the ENTER key. The following message will be displayed: Calibrating clamp closed and open wide... Clamp calibration: Insert OPEN measure into clamp and press ENTER – Insert the 3.8 mm test pin in the safety clamp and press the ENTER key. The following message will be displayed: Calibrating open clamp... Clamp calibration: Insert TUBE measure into clamp and press ENTER – Insert 4.55 mm tube (part no. M60 025 1) in the safety clamp and press the ENTER key. After completed calibration of the safety clamp, the following message will be displayed: Calibrating clamp with tube... measure into clamp and press ENTER OK SERVICE\> – Enter the cal save command and press the ENTER key. The setting is saved. Note If an error message appears during clamp calibration or if uncontrolled closing of the clamp occurs after the calibration, the annular magnet has to be readjusted and the clamp has to be calibrated. – Repeatedly close and open the clamp after the calibration using the commands close, open,close, wide. The corresponding position has to be retained for at least 5 sec. and the clamp must not change its position on its own. – Check the settings (see Chapter 4.3.3, page 4-3). Fresenius Kabi CompoGuard TM 4/04.07 4-5 Chapter 4: Setup / Repair Setting of annular magnet Note The annular magnet has to be readjusted only if the clamp has been improperly calibrated. – Open the device (see Chapter 4.1, page 4-1). – Call up the service program (see Chapter 3.1.3, page 3-5). – Enter the display clamp command and press the Enter key. The signal of the particular position of the safety clamp selected is shown on the CompoGuard display in [mV]. – Enter the wide command and press the Enter key. The safety clamp opens to an end position. – Insert the 3.8 mm test pin in the clamp. – Enter the close command and press the Enter key The test pin has to be held by the clamp. – Loosen the two Allen screws, size 2.5, of the annular magnet. – Check the position of the sensor in the annular magnet. The sensor must be located as close as possible to the annular magnet without touching it. The annular magnet holder must have been slided on completely. – Slowly turn the annular magnet clockwise until the minimum voltage is shown on the display. Umin:______mV – Keep turning the annular magnet until the voltage displayed exceeds the minimum voltage by 150 250 mV. Tighten the Allen screws to secure the annular magnet in this position. Uopen:_________mV – Slowly open the clamp by hand using the large toothed wheel. The voltage must drop by 150 mV 250 mV, then rise again (see hysteresis curve of the Hall sensor). Readjust the annular magnet if this is not the case. – Enter the wide command and press the Enter key. The safety clamp opens to an end position. Uwide:______mV – The difference between the voltage values Uwide and Uopen may be min 400 mV and max 1.000 mV. 400>(Uwide -Uopen)<1000 4-6 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Note Depending on the magnets, it may occur that the voltage differences of (Uopen-Umin) and (Uwide-Uopen) cannot be maintained. If this is the case, the maximum value of (Uopen-Umin) of 250 may also be exceeded. The voltage difference of (Uwide -Uopen)<1000 has to be maintained. – Replace the annular magnet if adjustment of the difference is not possible. – Calibrate the safety clamp. – Assemble the device (see Chapter 4.2, page 4-1). – Enter the get clamp command and press the Enter key. Verify the clamp values. Voltage Clamp Closed: ____ mV Voltage Clamp Open: _____ mV Voltage Clamp Open Wide: _____ mV Voltage Clamp closed with tube: _____ mV Voltage Clamp closed without tube at last start up: _____ mV Fresenius Kabi CompoGuard TM 4/04.07 4-7 Chapter 4: Setup / Repair 4.4 Swing Unit 4.4.1 Removal/Installation Removal – Open the device (see Chapter 4.1, page 4-1). – Pull off the connector X11 / P.C.B. LP 1085 of the swing unit. – Remove the two Allen screws, size 5, (A). – Take out the swing unit. A 4-8 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Installation – Insert the swing unit and force it against the swing unit holder, ensuring proper cable routing. – Insert the Allen screws and spring washers and tighten slightly. – Align swing unit parallel to the anti-torsion device using the spacer plate. – Tighten the two Allen screws, size 5, with 10 Nm. – The distance between the swing unit and the anti-torsion device has to be 0.85 mm ± 0.15 mm at all of the three contact points. – Lay the connection cable and connect the connector X11 / P.C.B. LP 1085. – Attach the upper tray of the housing, but do not screw it yet. Fit the large inline tray and check the distance between the large inline tray and the housing for being parallel and uniform. Desired value: 4 mm ± 2 mm. Repeat setting of the swing unit if the large inline tray fails to be positioned centrally. – Place a 1kg weight near the rear edge of the base of the horizontal inline tray. The inline tray remains in place and does not tilt. The tray will tilt with 2 kg. – Assemble the device (see Chapter 4.2, page 4-1). Fresenius Kabi CompoGuard TM 4/04.07 4-9 Chapter 4: Setup / Repair 4.4.2 Calibrating the Swing Unit Description The swing sensor is a Hall sensor and must be positioned inside an annular magnet. The magnetic flow through the sensor is output as a sinusoidal wave in relation to the function angle of the magnet. Adjust the mechanical position of the swing using the magnet. Basic setting – Open the device (see Chapter 4.1, page 4-1). – Call up the service program (see Chapter 3.1.3, page 3-5). – Enter the display swing command and press the Enter key. The signal of the swing sensor is shown on the CompoGuard display in [mV]. – Unscrew the Allen screws, size 2, of the annular magnet. – Check the position of the sensor in the annular magnet. – Position the swing straight, so that the side edge of the weighing pan receptacle is parallel to the upper edge of the holding plate. The sensor must be located as close as possible to the annular magnet without touching it. The annular magnet holder must have been slided on completely. Note Turn the annular magnet only slowly. – Slowly turn the annular magnet in a clockwise direction, while maintaining the position in relation to the magnet edge, until the maximum value of the swing sensor is shown. Record the maximum value. – Slowly turn the annular magnet anticlockwise, while maintaining the position in relation to the magnet edge, until the minimum value of the swing sensor is shown. Record the minimum value. – Calculate the mean swing value: (maximum value + minimum value)/2 = mean swing value – Turn magnet forward until the calculated mean swing value of ± 50mV is displayed, while ensuring the position in relation to the magnet edge. – Tighten the two Allen screws, size 2.5. – Move the swing backwards; the value must be increasing. – Calibrate swing 4-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Calibration – Fit the large inline tray. Note The cal swing command resets the swing and speed calibration (cal speed values). After you have completed the swing calibration (cal swing), always perform the swing and speed calibration (cal speed). – Enter the cal swing command and press the ENTER key. The following message will be displayed: cal swing Calibrating swing... OK SERVICE\> – Enter the cal speed command and press the ENTER key. The following message will be displayed: cal speed Calibrating swing speed... OK SERVICE\> Fine adjustment – If the position of the large inline tray is not horizontal, correct it using the front n or back ncommand (n is a percentage of the angle). The value range is between 0 and 100; changes in the value by 10 are equal to changes in the angle by 1.5 degrees. Note This command is always based on the theoretical horizontal position of the inline tray which has been calculated during the self-calibration of the swing unit. As a consequence, the position of the inline tray will not be changed even if the same command is executed repeatedly. Front 0 positions the large inline tray to the horizontal position calculated during the self-calibration of the swing unit (mean swing value). – After having positioned the inline tray, enter the cal save command and press the ENTER key. The setting is saved. Fresenius Kabi CompoGuard TM 4/04.07 4-11 Chapter 4: Setup / Repair 4.5 Weighing Sensor 4.5.1 Removal/Installation Removal – Open the device (see Chapter 4.1, page 4-1). – Unscrew the connections X10 / P.C.B. LP 1085. – Unscrew the connection X3 / P.C.B. LP 1087. – Remove the swing unit (see Chapter 4.4.1, page 4-8). – Unscrew the six Allen screws, size 4, of the base plate. – Remove the insulating foil of the connection board LP 1086. – Remove the base plate and screw out the hex head screws, size 10, of the weighing beam. – Carefully pull the weighing sensor out of the anti-torsion device . Note Do not touch the silicone of the weighing sensor! Installation – Push the weighing sensor into the anti-torsion device. – Insert backing strips as spacers. Bender bar 0.4 mm (part no. M63 820 1); 0.6 mm (part no. M63 638 1). – Slightly tighten the locking screws. Using a feeler gauge, set the distances of the weighing sensor from the base plate and the anti-torsion device. Target values: Distance of weighing sensor to anti-torsion device, to the left, the right, the top 0.07 mm Distance of weighing sensor to base plate 0.6 mm – Securely tighten and seal the screws of the weighing beam. – Check the distance values between the weighing sensor and the anti-torsion device and between the weighing sensor and the base plate; if necessary, unscrew the screws and repeat the two previous steps. The weighing sensor must be positioned in the anti-torsion device without contact. – Lay the connecting cables 4-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair . Note The cables must be laid without any mechanical tension and without kinks! – Install the base plate including insulating foil of the P.C.B. LP 1086 in the bottom tray of the housing. – Install the swing unit (see Chapter 4.4.1, page 4-8). – Assemble the device (see Chapter 4.2, page 4-1). – Calibrate the weighing sensor (see Chapter 4.5.3, page 4-15). – Calibrate the swing unit (see Chapter 4.4.2, page 4-10) Fresenius Kabi CompoGuard TM 4/04.07 4-13 Chapter 4: Setup / Repair 4.5.2 Test Test equipment 10-gram weight (part no. M63 886 1) 500-gram weight (part no. M63 925 1) 1000-gram weight (part no. M63 669 1) Test – Turn on the CompoGuard with inline trays; a system check is performed. – After a swing of the inline tray, place a 10 g weight on the tray. – After a brief beep, the display shows zero. – 10 g weight is then removed. – 500 g weight is positioned centrally on the inline tray. Desired value: 490 g ±2 g – Position the 1000 g weight centrally on the inline tray. Desired value: 990 g ±5 g – Remove the 1000 g weight. – Press the Tube key. The inline tray swings back. – 1000 g weight is positioned on the inline tray. Desired value: 990 g ±5 g – 1000 g weight is removed. 4-14 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.5.3 Calibrating the Weighing Sensor Test equipment 1000-gram weight (part no. M63 669 1) Description The weighing sensor consists of a Wheatstone bridge with strain gauge (load cell). Zero calibration – Fit the large inline tray. – Enter the cal weight command and press the ENTER key. After completed calibration of the zero point, the following message will be displayed: cal weight Weight calibration: Empty bowl and press ENTER Calibrating weight with empty bowl... Reference calibration – When the following message is displayed, place the 1.000g weight in the middle of the large inline tray: Weight calibration: Place 1000 g on bowl and press Enter – Press the ENTER key. After completed calibration, the following message will be displayed: Calibrating weight with 1000 g on bowl... OK SERVICE\> – After having completed the calibration, enter the cal save command and press the ENTER key. The setting is saved. – Check the setting (see Chapter 4.5.2, page 4-14). Fresenius Kabi CompoGuard TM 4/04.07 4-15 Chapter 4: Setup / Repair 4.6 RF Generator 4.6.1 Removal/Installation Removal – Open the device (see Chapter 4.1, page 4-1). – Pull off the connector X8 / P.C.B. LP 1087. – Solder off the coaxial cable from the hand sealer connector. – Remove the two Phillips locking screws of the RF generator. – Take out the RF generator. Installation – Apply thermal compound to the base plate of the RF generator. – Install the RF generator and lock it using the two Phillips locking screws. – Connect the connector X8 / P.C.B. LP 1087 to the battery board. Note Do not shorten the coaxial cable! – Solder the coaxial cable to the hand sealer connector. – Check the cable routing. – Assemble the device (see Chapter 4.2, page 4-1). – Perform the sealing seam test (see Chapter 4.11, page 4-27). 4-16 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.7 DECT Module Removal – Open the device (see Chapter 4.1, page 4-1). – Remove the hot-melt adhesive or the double-faced tape between the DECT module and the upper tray of the housing. – Remove the P.C.B. LP 1089 and pull off the connector X3 / P.C.B. LP 1089. Installation – Connect the connector X3 / LP1089. – Insert the P.C.B. LP 1089 into the lateral pocket of the upper tray. – Insert the P.C.B. LP 1089 into the lateral pocket of the upper tray and press it on. – Align the two antennas at an angle of 90 degrees to each other. – Check the cable routing. – Assemble the device (see Chapter 4.2, page 4-1). – Start the service program (see Chapter 3.1.3, page 3-5). – Enter the get ppid command. Upload the DECT ID number of the new P.C.B. LP 1089 and compare it with the supplied DECT ID label. Note The DECT ID number of the P.C.B. LP 1089 must be changed in Donationmaster NT/Net in the CompoGuard Management dialog of the particular CompoGuard concerned. – Establish the radio network connection between the CompoGuard and Donationmaster NT/Net and check the system for proper functioning. – Attach the new DECT ID label to the rear of the device. Fresenius Kabi CompoGuard TM 4/04.07 4-17 Chapter 4: Setup / Repair 4.8 Display 4.8.1 Removal/Installation Removal – Open the device (see Chapter 4.1, page 4-1). – Disconnect all plug connectors on P.C.B LP1085. – Remove the Phillips screws from P.C.B. LP1085. – Remove the printed circuit board. – Pull off the connector X14 / P.C.B. LP1085. – Remove the display from the spacers. Installation – Make sure that the display is clean and dust-free. – Place the new display on the spacers and press in place. – Connect the connector X14 / P.C.B. LP1085. – Install the printed circuit board in the housing and secure with 4 Phillips screws. – Connect all plug connectors on P.C.B LP1085. – Assemble the device (see Chapter 4.2, page 4-1). 4-18 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.8.2 Test – Press the On/Standby key for 2 seconds to switch the CompoGuard on. – The System Check is performed. – The following messages are displayed: 1 3 2 4 5 1 Software version 2 Serial number 3 Software Mode: High indicates that data management is possible Software Mode: Standard indicates that data management is not possible 4 UID: Indicates the date and the time when the last transmitted donation program was saved in Donationmaster NT/Net. YYMMDDHHMMSS In our example: 020514152941, i.e. 14.05.02 at 15:29:41 5 Set language – The LEDs of the donation-relevant keys are lit for approx. 2 seconds. – The safety clamp is opened and closed again. – A mixing movement is made. – The display test with the Fresenius Kabi message is performed. – This is followed by an audible alarm to check the audible alarm generator. – If a Powerpack is inserted in the device, the battery symbol is displayed. Fresenius Kabi CompoGuard TM 4/04.07 4-19 Chapter 4: Setup / Repair 4.9 Simulating a Donation Process Description This test is intended to serve as a functional check of the Optenna, the donation display and the alarms. Test equipment Dual-bag system with clamp (part no. M63 924 1) Test – Press the On/Standby key for 2 seconds to switch the CompoGuard on. The system check is performed. Message displayed: Open clamp 4-20 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Note If the Device updating... message is displayed, set the operating mode to "Manual" in the Common Setup setting level. – Press the Tube key (the yellow LED is flashing). The safety clamp opens. Message displayed: Insert bag system – Place the empty bag on the large inline tray and insert the tubing in the safety clamp. – Suspend the full bag. – Press the Tube key (the yellow LED is flashing) once again. The safety clamp is closed. Message displayed: start the donation process – Press the Start key (the yellow LED is flashing) to start the donation process. The safety clamp is set to the donation-open position. The weight is tared. While donation is in progress, the CompoGuard makes mixing movements and checks the inflow. – Close the tube clamp of the dual-bag system. After some time, the two red LEDs are flashing, thus indicating a preliminary flow alarm on the donation display of the gooseneck. The tube clamp of the dual-bag system remains closed. The flow alarm is emitted, and the Optenna is flashing. Message displayed: No flow – Open the tube clamp of the dual-bag system. The alarm is reset. – Shortly before the target volume is reached, the flow alarm is activated on the gooseneck. – After the target volume has been reached, the clamp closes. The Optenna on the gooseneck is flashing, and an alarm is emitted. Message displayed: Volume reached – Retract the Optenna completely. The LED turns dark, and the audible alarm is emitted at a higher frequency. Move the Optenna between the markings. Check the LED for proper functioning with various Optenna positions. – Press the Stop key. The mixing movement stops. Message displayed: Open clamp – Press the Tube key. Message displayed: Remove System – Remove the bag systems. Message displayed: Insert bag system Fresenius Kabi CompoGuard TM 4/04.07 4-21 Chapter 4: Setup / Repair 4.10 Hand Sealer Introduction The hand sealer is designed for radio-frequency sealing of PVC blood bag lines having a maximum outer diameter of 4.6 mm. The hand sealer may only be connected to an RF generator of the Composealer devices (Mobilea, Universal, Duet). The hand sealer is provided with a spark detector which will trigger an audible signal if there is a spark or moisture between the electrodes. 4.10.1 Spark Detector Introduction The spark detector detects the development of sparks, while sealing is in progress. If the lines are moist or leaky, an alarm is emitted. If the line is leaky on one side only, a crackling noise may be heard or smoke may develop without an alarm being triggered. This is caused by the hot PVC line heating the moisture. Generally, the sealing quality is satisfactory. Test equipment Spark board (part no. M64 245 1) Check Place the conducting side of the spark board into the sealing head and actuate the hand sealer. The alarm will be sounded. 4.10.2 Cleaning the Hand Sealer Disconnect the hand sealer from the exchangeable cable. Hold the hand sealer with the jaws facing forward exposing the sealing cavity. Clean the sealing cavity and its environment with a cotton applicator dampened with alcohol. Dry the cleaned surfaces using another cotton applicator. Put the device in operation only when the surfaces are clean and dry. If unable to clean satisfactorily, disassemble the hand sealer for thorough cleaning. 4-22 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.10.3 Disassembling the Hand Sealer Disconnect the exchangeable cable from the hand sealer. Using your right hand, hold the hand sealer in a horizontal position. Firmly close the movable sealing head by pushing with your middle finger (1), while exerting a counter-pressure on the immovable part with your thumb (2). Compress (3) and abruptly release (4) the lever. 1 3 4 2 This will disengage the lever. Put down the hand sealer. The lever must be in the position shown in the illustration. Fresenius Kabi CompoGuard TM 4/04.07 4-23 Chapter 4: Setup / Repair 2 Push the sealing head upwards with your thumb (1), while exerting a counter-pressure on the immovable part with your index finger (2), slightly tilt and remove the sealing head by pulling it to the front (3). 3 2 1 Remove the leaf spring (1) by pulling it to the front. Remove the lever. 1 4.10.4 Reassembling the Hand Sealer Before reassembling the hand sealer, lubricate the following movable parts using Vaseline: – Leaf spring near the bolt – Sealing head inside the guiding range – Bar in the lever – Hand sealer housing at all sliding parts Put down the hand sealer. The lever must be in the position shown in the illustration. 4-24 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Fully insert the leaf spring into the hand sealer (1). 1 Place the sealing head onto the hand sealer (1). Close the lever (2). The lever will click into place. 1 2 For checking purposes, actuate the hand sealer 2 to 3 times. The sealing head must close and open smoothly. Connect the exchangeable cable to the hand sealer and the CompoGuard. The hand sealer is again ready for operation. 4.10.5 Adjusting the Hand Sealer Note After replacing the lever, the hand sealer must be readjusted. Disconnect the hand sealer from the Powerpack. Press the lever of the hand sealer to the maximum. Use an Allen wrench to adjust the screw (A) so that the electrodes are just touching each other. Fresenius Kabi CompoGuard TM 4/04.07 4-25 Chapter 4: Setup / Repair Screw out the screw (A) by three full revolutions in anticlockwise direction and secure it with Loctite 638 (part no. M60 702 1). 4-26 Exchangeable cable A defective exchangeable cable must be replaced by a new one. Hand sealer Contamination of the hand sealer may seriously impair the sealing quality. If the sealer electrodes are contaminated by fluid, sparks may occur and lead to poor-quality seals. Sparking will be indicated by an alarm (spark alarm). If the hand sealer is soiled, it must be cleaned immediately. Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.11 Sealing Test 4.11.1 Sealing Test 1 Test equipment Vise with a clamping jaw width of 50 mm (Bernstein Spannfix 9-205) Caliper Scissors Spring balance 4.55 mm PVC tubing (part no. M60 025 1) Sealing test Seal a line section, 4.2 mm in diameter, and one 4.55 mm in diameter, into 5 segments of 80 mm each. Visual check Before the sealing tests are performed, the sealing electrodes must be free from any contamination. The line to be sealed must be clean and dry. Both the line and the CompoGuard should have room temperature. The sealing seam must be symmetrical at its upper and bottom sides as well as to the left and right. Sealing seam No sharp edges Tube To avoid micro-leaks, the transition from the line to the sealing seam must be free from any sharp edges and/or leaky points. Tensile load Allow the sealing seam to cool down for 2 min. Pull the two segments of the line apart smoothly and uniformly, using the spring balance. The tensile loading capacity of the sealing seam should be between 2 and 5 kg. Spring balance Fresenius Kabi CompoGuard TM 4/04.07 4-27 Chapter 4: Setup / Repair Pressure test Clamp the section symmetrical between the clamping jaws of the vise. The line must project for 15 mm at both ends of the jaws. With the vise fully tightened, no fluid must leak at the sealing seam. Sealing seam size Cut off the upper and bottom sides of the sealing seam. Measure the sealing seam using the caliper. Desired value: 0.2 – 0.5 mm Electrodes 4-28 If the sealed junction fails to be symmetrical in shape, then: – Check the electrode alignment. – Check the alignment of the removable sealing head. – Check the alignment of the cold electrode mounted in the removable sealing head. Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair 4.11.2 Sealing Test 2 Test equipment Test tubing (part no. M60 299 1) Sealing test Perform ten seals with a distance of 20 mm. Wait 10 seconds after every second seal. The test must not reveal any defective seal. Visual check Before the sealing tests are performed, the sealing electrodes must be free from any contamination. The line to be sealed must be clean and dry. Both the line and the CompoGuard should have room temperature. The sealing seam must be symmetrical at its upper and bottom sides as well as to the left and right. Sealing seam Tube No sharp edges To avoid micro-leaks, the transition from the line to the sealing seam must be free from any sharp edges and/or leaky points. Fresenius Kabi CompoGuard TM 4/04.07 4-29 Chapter 4: Setup / Repair 4.12 Autosense Scanner Barcode Test Window – Select Barcode Test Window on the CompoGuard – Scan the test barcode: Test barcode Display message Type of bar code MCOMPOGUARD Code 39 NA12345678A Codabar Kcode128 Code 128 l25112233 2/5 Interleaved Autosense function The scanner is provided with an autosense function. When a bar code scan is expected and a label is held in front of the scanner or the scanner is held over a label, the scanner is automatically activated. It is not necessary to press a key, and scanning is possible even if the autosense scanner is fitted in the holder. This particularly makes scanning the bar codes on the tubes easier. The autosense scanner must be connected to the bar code scanner connector on the CompoGuard. Note The Autosense scanner may only be connected or disconnected with the CompoGuard switched off. Secure the connector with the screws in order to avoid malfunctions. The scanner is switched on by the CompoGuard for bar code scanning. 4-30 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Bar code scanner initialization The scanner has been programmed by default for immediate use with the CompoGuard. If the scanner fails to function properly, it can be re-initialized by means of the bar code initialization plan. Autosense operation:The scanner is activated automatically when being approached to a bar code. Continuous flashing:The scanner flashes intermittently, as long as the bar code scan is active. Note The initialization process must be started within 10s after opening the bar code test window. – The applicable column of the initialization plan can be determined by means of the serial number of the scanner. – Select Barcode Test Window on the CompoGuard. – Scan the following bar codes of the bar code initialization plan one after the other. Wait at least one second after each scanning process before scanning the next bar code. After each scanning process, a sequence of tones can be heard indicating internal acknowledgement. Bar code initialization plan Applicable to all bar code scanners 1 2 3 4 Fresenius Kabi CompoGuard TM 4/04.07 4-31 Chapter 4: Setup / Repair Applicable to all bar code scanners 5 6 7 8 9 10 11 12 13 14 15 From here, continue initialization corresponding to the serial number and the intended function. 4-32 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 4: Setup / Repair Up to serial number 251120 Autosense operation 16 Up to serial number 251120 Continuously flashing light Serial number 251121 or higher Initialization completed 17 Initialization completed 18 19 Initialization completed – Check by scanning the test bar code Fresenius Kabi CompoGuard TM 4/04.07 4-33 Chapter 4: Setup / Repair 4-34 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 5: Functional Description 5 Functional Description Fresenius Kabi CompoGuard TM 4/04.07 5-1 Chapter 5: Functional Description 5.1 5-2 Block Diagram Fresenius Kabi CompoGuard TM 4/04.07 Chapter 5: Functional Description 5.2 Position and Wiring Diagram Fresenius Kabi CompoGuard TM 4/04.07 5-3 Chapter 5: Functional Description 5.3 P.C.B. LP 1085 Control Board 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation 1 2 3 4 5 1 2 3 4 5 6 6 Steuerplatine 1/1 M63 506 1 BP ERSATZ FORMAT A3 ERSATZ 7 8 F F E E D D C C B B A BLATT Technical Documentation 1 5-4 2 3 4 5 6 Fresenius Kabi Steuerplatine 1/1 M63 506 1 BP ERSATZ ERSATZ CompoGuard FORMAT A3 TM 4/04.07 Chapter 5: Functional Description The following components are located on P.C.B. LP 1085 – Power distribution The power distribution includes the main power switch, the step-down regulator for VCC and the sub switch for PW_DIGI. – Main power switch On/Standby key with LED – Weight measurement Weighing sensor and sensor amplifier – User interface Liquid crystal display (LCD) Keypad – Gooseneck interface terminal There are two identical interfaces for the gooseneck terminal. The interfaces are supplied by a separate linear voltage regulator. The selection is done by REED switches that give their signals to the microcontroller. – Wireless data transfer / DECT interface The wireless interface is made up by a DECT module in its standard application. Its power supply is a separate linear regulator. Since it is run at 3.3 V, all signals are fed through level shifters. For further information please refer to the appropriate data sheets. – RS232 scanner interface – Blood flow control – Safety clamp motor – Tube sensor TBD Tube sensing is done by the position sensor of the safety clamp. – Swing unit for donation bags – MPU Fresenius Kabi CompoGuard TM 4/04.07 5-5 Chapter 5: Functional Description 5.4 P.C.B. LP 1086 Connection Board 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation 1 2 3 4 5 1 2 3 4 5 6 6 Connection Board 1/1 M63 602 1 BP ERSATZ FORMAT A3 ERSATZ 7 8 F F E E D D C C B B A BLATT Technical Documentation 1 5-6 2 3 4 5 6 Fresenius Kabi Connection Board 1/1 M63 602 1 BP ERSATZ ERSATZ CompoGuard FORMAT A3 TM 4/04.07 Chapter 5: Functional Description The following components are located on P.C.B. LP 1086 – Line input The line input is the circuit that receives the power from the AC adapter and feeds it to the various modules. – Charging unit and charge monitoring Fresenius Kabi CompoGuard TM 4/04.07 5-7 Chapter 5: Functional Description 5.5 P.C.B. LP 1087 Accumulator Contact Board 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation Accu PCB 1/1 M63 605 1 1 2 3 4 5 6 ERSATZ BP ERSATZ FORMAT A3 The following components are located on P.C.B. LP 1087 – Accumulator voltage The system is designed for use of a 10-cell NiCd accumulator. The accumulator must be equipped with a NTC temperature sensor connected to the negative terminal. The accumulator is connected to the accumulator board by slide contacts. 5-8 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 5: Functional Description 5.6 P.C.B. LP 1088 Gooseneck 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation Remote Control Unit M63 608 1 1 2 3 4 5 6 ERSATZ 1/1 BP ERSATZ FORMAT A3 The following components are located on P.C.B. LP 1088 – Remote control unit / gooseneck The remote control unit comprises the following three subunits: – Input shift register with LED driver – Output shift register with keypad-connector – Timer IC5; the timer restores the chip selection and provides the signal for saving the keypad information into the output register. Fresenius Kabi CompoGuard TM 4/04.07 5-9 Chapter 5: Functional Description 5.7 P.C.B. LP 1089 DECT Module 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation DECT-Module 1/1 M63 611 1 1 2 3 4 5 6 ERSATZ BP ERSATZ FORMAT A3 Description The radio interface is made up by a DECT module in its standard application. Its power supply is a separate linear regulator. Since it is run at 3.3 V, all signals are fed through level shifters. For further information please refer to the appropriate data sheets. 5-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 5: Functional Description 5.8 P.C.B. LP 1300 Sensor 1 2 3 4 5 6 7 8 F F E E D D C C B B A BLATT Technical Documentation 1 2 3 4 5 6 Sensor-PCB 1/1 M63 654 1 BP ERSATZ ERSATZ FORMAT A3 Description Clamp position sensor / scale position sensor / ambient temperature sensor The position sensors are integrated compensated Hall sensors, detecting the position of a rotary permanent ferrite magnet. The sensors are controlled by the microcontroller to save current. For further information please refer to the appropriate data sheet. The ambient temperature is measured by a NTC located on the P.C.B. All sensor signals mentioned here are tied to the internal analog to digital converter of the microcontroller. Fresenius Kabi CompoGuard TM 4/04.07 5-11 Chapter 5: Functional Description 5.9 Hand Sealer Description When the handle of the hand sealer is pushed down, a switch is closed and a coil is connected to the ground, activating the timer board and controlling the generator for one second. The high-frequency signal makes light up the neon lamp. 5-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 6: CompoGuard Maintenance Checklist 6 CompoGuard Maintenance Checklist We recommend to perform the maintenance procedures for the CompoGuard once a year. Note Maintenance, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him. Manufacturer: Date: Machine: Technician: Software version: DECT ID number (optional): Serial number: Location: Model: E-Code: Description 1 Maintenance measures on the open device 1.1 Device inside 1.2 Function – Clean the device inside E.g. compressed air – – Cable routing Laid properly, without kinks or tension – Function/contamination – Clean and grease the swing unit – Powerpack board – Battery contacts 1.3 Meas. value Repaired No. Checked Save all settings from the CompoGuard before performing maintenance procedures (see Chapter 8.2.1, page 8-4). Swing unit – Smooth running Fresenius Kabi CompoGuard TM 4/04.07 6-1 Description Function 2 Maintenance measures on the closed device 2.1 Device outside – Thoroughly clean the device E.g. with Frekanol – – Housing Damage / cracks – – Check the labels for completeness If necessary, replace the labels. – – Keypad External damage Distinct action point of keys LED function – 3 AC adapter / battery / display messages 3.1 AC adapter and battery 3.2 Meas. value – Cable / strain relief Damage / wear and tear – – Connect the AC adapter The power-on symbol is displayed. – – Connect the battery The battery symbol is displayed. – – Disconnect the AC adapter The power-on symbol is off. The device changes to the powerpack mode. – – Connect the AC adapter The power-on symbol is displayed. – – The system check is performed. – Repaired No. Checked Chapter 6: CompoGuard Maintenance Checklist Display messages – Turn the CompoGuard power on – The LEDs of the keys are lit. – The safety clamp opens and closes. – The large inline tray makes mixing movements. – The audible alarm is emitted. – Display test (Fresenius HemoCare logo) 4 Weighing function 4.1 – Place the 500-g weight centrally on the inline tray Remove the weight 6-2 Desired value: 500 g ± 2 g Fresenius Kabi ______g CompoGuard TM 4/04.07 Description 5 Safety clamp 5.1 Functional check 5.2 Function Meas. value – Press the Tube key The large inline tray swings back. The safety clamp opens. – – Press the Tube key The large inline tray moves to the central position. The safety clamp closes. – – Insert a line and start the donation process The safety clamp opens – – Disconnect the power plug (device without battery) The safety clamp closes – – Reconnect the power plug and turn the device on The donation process is continued after the system check – Occlusion at 750 mmHg – Occluded tubing – Insert the 4.55 x 0.6 mm tubing system and close the safety clamp 6 Option – Transport case with / without charging function 6.1 With or without charging function – Housing, hinges 6.2 Repaired No. Checked Chapter 6: CompoGuard Maintenance Checklist Damage / cracks / smoothness With charging function – – Turn power on to the transport case via the AC adapter and connect the CompoGuard to the charging cable. Fresenius Kabi CompoGuard – TM 4/04.07 The Power on symbol is displayed. The charging state of the battery is displayed. – 6-3 Description 7 Option – Integrated sealing function: CompoGuard Complete / CompoGuard Seal 7.1 Check the sealing function 7.2 Function Meas. value – Remove the powerpack and select a program with a sealing action. Make a seal. Display message: No battery! – – Insert the power pack. Make a seal test Check the seal. – – Make a seal with spark board. Display message: Seal error! – – Sealing indicator Turns dark after each sealing process. – – Make a seal with spark board (part no. M64 245 1). The sealing indicator is lit and an alarm is emitted. – – Exchangeable cable Tight seat / wear and tear / damaged plugs – – Make a seal test Check the sealing seam – Hand sealer 8 Option – Autosense scanner 8.1 Test the scanner Scan in a barcode. – Barcode Test Window on the CompoGuard. 6-4 Repaired No. Checked Chapter 6: CompoGuard Maintenance Checklist – Fresenius Kabi CompoGuard TM 4/04.07 Description 9 Option – Gooseneck 9.1 Check the keys. 9.2 Function Meas. value – Insert the gooseneck in the lefthand holder. Key function – – Insert the gooseneck in the righthand holder. Key function – Simulate a blood donation process with a dual-bag system and check the Optenna, the donation display and the preliminary flow alarm for proper functioning. – Check displays and alarms. – Simulate a blood donation process. 10 Option – DECT radio module / RS485 cable network 10.1 Check the communication with Donationmaster NT/Net. – Establish the network connection for radio and/or cable transmission. 11 Repaired No. Checked Chapter 6: CompoGuard Maintenance Checklist Communication is shown in the Network monitor dialog in Donationmaster NT/Net. – Saving data Read in the previously saved device data at the CompoGuard Saving data (see Chapter 8.2.1, page 8-4) 12 AC adapter Check before start-up In Germany according to DIN VDE 0751-1, edition 10/2001. In other countries, observe the local regulations! 12.1 Visual inspection Labelling – Must be present and clearly legible. Mechanical condition – Must permit further safe use. Damage or contaminations affecting safety. – Not acceptable Power connection/ connector – Must not be damaged. Fresenius Kabi CompoGuard TM 4/04.07 6-5 Description Function Meas. value 12.2 Device leakage current measurement Device leakage current for safety class ll devices. ______mA With a measurement value of 0.9 mA (90% of the alarm limit) or higher, consult the previous measurement values for assessment. If necessary, shorten check test interval. Measured in accordance with Appendix C. Figure C.4 12.3 12.4 Checked No. Repaired Chapter 6: CompoGuard Maintenance Checklist Desired value: 1.0 mA Functional test – Clamp function see no. 5.2 Safety assessment The device has been released for further use. yes no Corrective action must be taken to restore the safe function of any device which is not in proper or safe service and/or operating condition, or the operator is to be informed of the risk which the use of this device may present. I herewith confirm proper performance of any maintenance work as specified above, and the data to be true and correct. Technician's signature: Customer's signature: ................................................., Date: ......................... ................................................., Date: ......................... ............................................................................. ............................................................................. 6-6 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog 7 Spare Parts Catalog Fresenius Kabi CompoGuard TM 4/04.07 7-1 Chapter 7: Spare Parts Catalog 7.1 CompoGuard Bottom Tray 1 2 3 4 5 6 4 7-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description 1 M65 838 1 Bottom tray of housing 2 M63 622 1 Speaker 3 M63 569 1 Discharge resistor 4 M63 625 1 Swing unit 5 M63 542 1 RF generator 6 M63 803 1 Insulating foil for connection board w/o ill. M63 833 1 Annular magnet (incl. annular magnet holder) w/o ill. M63 623 1 Weighing beam with connector w/o ill. 641 950 1 Screwlock (Loctite no. 243 medium-tight, 50ml) w/o ill. 640 673 1 Housing foot w/o ill. M63 855 1 Motor support (incl. springs, rivets and internal programming cable) Fresenius Kabi CompoGuard TM 4/04.07 7-3 Chapter 7: Spare Parts Catalog 7.2 CompoGuard Upper Tray 1 2 5‚ 3 6 7 4 8 9 10 11 7-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description 1 M63 628 1 DECT module (adapter board LP1089, double-faced tape, sponge rubber, connecting cable) 1 M63 858 1 DECT module USA (adapter board LP1089, double-faced tape, sponge rubber, connecting cable) 2 M63 665 1 LC display with connector strip 3 M63 851 1 Upper tray with keypad, plexiglass disk and gooseneck contacts 4 M66 542 1 Keypad 5 M63 626 1 Safety clamp 6 M63 590 1 Tension spring 7 M63 618 1 Tension coupling piece 8 M63 619 1 Rope 9 M63 637 1 Flat packing 10 M63 661 1 Large inline tray 11 M65 798 1 Filter holder (order 2 pcs. per inline tray) w/o ill. 671 595 1 Adhesive (Loctite no. 406) Fresenius Kabi CompoGuard TM 4/04.07 7-5 Chapter 7: Spare Parts Catalog 7.3 Gooseneck (Optional) 1 2 4 3 5 7-6 6 7 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description 1 902 838 1 Gooseneck with scanner holder 1 902 905 1 Gooseneck without scanner holder 2 M63 540 1 Optenna 3 M63 834 1 Holder for barcode scanner 4 M63 538 1 Donation display foil 5 M63 609 1 P.C.B. LP 1088, gooseneck board 6 M66 543 1 Keypad 7 M65 219 1 Upper part of gooseneck Fresenius Kabi CompoGuard TM 4/04.07 7-7 Chapter 7: Spare Parts Catalog 7.4 7-8 CompoGuard Hand Sealer (Optional) Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description M63 837 1 Hand sealer with cable 1 M60 086 1 Cold electrode 2 M60 081 1 Hot electrode, complete 3 M60 070 1 Electrode carrier 4 M60 073 1 Disk, transparent 5 M61 649 1 Label 6 M60 261 1 LP Hand sealer board 7 M63 582 1 Cover 8 M65 772 1 Coaxial cable 9 M63 944 1 Soldering eye 10 M61 879 1 Reducing sleeve 11 M60 034 1 BNC bushing 12 552 550 1 Countersunk screw 13 M60 087 1 Contact sheet, separate 13 M60 095 1 Contact sheet, complete, incl. Hot electrode Contact sheet M 2x5 fillister head screw Silicone tubing 14 M60 103 1 Coil 15 M60 075 1 Leaf spring 16 M60 084 1 Spring holder 17 M60 078 1 Setting screw 18 M63 583 1 Lever 19 M60 076 1 Switching pin 20 M60 090 1 O-ring 21 M60 083 1 Housing 22 M61 688 1 Exchangeable cable w/o ill. M60 702 1 Adhesive (Loctite no. 638) Fresenius Kabi CompoGuard TM 4/04.07 7-9 Chapter 7: Spare Parts Catalog 7.5 Printed Circuit Boards 1 2 4 3 2 5 6 7-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description 1 M63 507 1 P.C.B. LP 1085 Control board without display 1 M65 412 1 P.C.B. LP 1085 Control board with display 2 M63 655 1 P.C.B. LP 1300 sensor board / weighing sensor, safety clamp 3 M63 612 1 LP 1089 DECT adapter board 4 M63 606 1 LP 1087 accumulator contact board 5 M63 603 1 LP 1086 connection board 6 M63 609 1 P.C.B. LP 1088 gooseneck board Fresenius Kabi CompoGuard TM 4/04.07 7-11 Chapter 7: Spare Parts Catalog 7.6 Accessories – Options 1 4 8 7-12 3 2 5 6 7 9 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description 1 902 832 1 Barcode scanner 2 902 834 1 DECT fixed part for radio transmission network 3 902 833 1 RS 485 network converter 4 902 836 1 Quadruple charging unit for battery pack 5 902 950 1 Battery pack 6 M63 522 1 Handle for battery pack up to manufacturing date 3/04 (see manufacturing date on the battery) M65 166 1 Handle for battery pack for manufacturing date 4/04 or later (see manufacturing date on the battery) 7 M66 075 1 24-W / 12-V / 2-A AC adapter (Europe) w/o ill. M63 852 1 24-W / 12-V / 2-A AC adapter (USA) w/o ill. M66 077 1 24-W / 12-V / 2-A AC adapter (GB) 8 902 837 1 Transport case for CompoGuard 8 902 827 1 Transport case for CompoGuard with charging function 9 902 838 1 Gooseneck with scanner holder 9 902 905 1 Gooseneck without scanner holder w/o ill. 661 242 1 Cable protection w/o ill. 902 826 1 CompoGuard Basic Basic unit w/o ill. 902 830 1 CompoGuard Complete Basic unit + DECT option + sealing option + battery + gooseneck w/o ill. 902 829 1 CompoGuard Data Basic unit + DECT option + gooseneck w/o ill. 902 828 1 CompoGuard Seal Basic unit + sealing option + battery + gooseneck w/o ill. 902 839 1 Software license for CompoGuard w/o ill. 902 931 1 Donationmaster NT/Net software (German) with user manual w/o ill. M63 670 1 Y-piece for cable network w/o ill. M63 667 1 Network cable, 5 m w/o ill. M65 932 1 Programming adapter between Flashmaster and RS-232 in the CompoGuard battery compartment Fresenius Kabi CompoGuard TM 4/04.07 7-13 Chapter 7: Spare Parts Catalog 7.7 7-14 Test Equipment Fresenius Kabi CompoGuard TM 4/04.07 Chapter 7: Spare Parts Catalog Pos. Part number Description w/o ill. M63 886 1 10 g calibration weight w/o ill. M63 925 1 500 g calibration weight (Mettler Toledo) w/o ill. M63 669 1 1000 g calibration weight w/o ill. M63 924 1 Dual-bag system w/o ill. M64 245 1 Spark board w/o ill. 902 833 1 RS485 network converter w/o ill. M63 849 1 Extension cable for safety clamp w/o ill. M63 827 1 Adapter cable for software update w/o ill. M63 820 1 0.4 mm backing strip w/o ill. M63 638 1 0.6 mm backing strip w/o ill. M63 883 1 Flashmaster configured with latest CompoGuard software w/o ill. M63 885 1 Test pin 3.8 mm Fresenius Kabi CompoGuard TM 4/04.07 7-15 Chapter 7: Spare Parts Catalog 7-16 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update 8 Software Update Compatibility CompoGuard – Donationmaster NT/Net CompoGuard Donationmaster NT/Net V 1.06 v 1.0.8.x v 1.1.2.x V 1.12 v 1.1.2.x v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.0.1 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.0.2 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.0.4 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.0.5 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.1.2 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.2.1.4 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.3.0.5 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.3.0.6 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x V 1.3.0.7 v 1.2.0.2 v 1.2.1.3 v 1.3.0.x Fresenius Kabi CompoGuard TM 4/04.07 8-1 Chapter 8: Software Update 8.1 Software Update of Donationmaster NT/Net Saving directories – If an older Donationmaster NT/Net version is installed on your computer, first create a backup of your data before installing the new version. Installation Note If you are running Windows NT or Windows 2000, you might require administrator access rights on your PC to be able to install new software packages. Before installing Donationmaster NT/Net, ensure that you have the necessary user rights. – Close all other programs before starting the installation. – Insert the Donationmaster NT/Net installation CD into the CD-ROM drive of the computer. Select the CD drive in the Explorer. – Start the installation program SETUP.EXE. – An information window opens prompting to close all other programs. – Click the Next button to confirm. – In the User Information window, enter the name and the company in the appropriate text boxes. – Click the Next button to confirm. – Click the I agree ... selection field to confirm the license agreement. If, by clicking the I do not agree... select box, you do not acknowledge the license agreement, you can stop installation by clicking the Cancel button. – Click the Next button. – In the Serial Number window, enter the serial number into the text field using the xxxx-xxxx-xxxx-xxxx format. The serial number is indicated on the CD cover. – Click the Next button to confirm. An information window opens, summarizing the changes compared to the previous version V1.1.2.0. – Click the Next button. The Select Install Type selection window opens, providing three installation options. Complete (English) If you select this option, the complete English Donationmaster NT/Net version will be installed. Complete (German) If you select this option, the complete German Donationmaster NT/Net version will be installed. Update software If you select this option, the software will be updated to version 1.2.1.3. Settings and databases are imported automatically. An update can be made only from version 1.1.2.0 and higher versions. – Select the installation type. Click the Next button to confirm. – The Installation Folder window opens. – Confirm the directory to which Donationmaster NT/Net is installed or select a different directory. 8-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update Note If you are making an update, select the directory containing the already installed Donationmaster NT/Net version! – Click the Next button to confirm. The Shortcut Folder window opens. – Click Next to confirm the program group that is proposed to contain the program; or by making the appropriate entry in the Shortcut Folder box, create a new program group and click Next to confirm; or select an existing program group and click Next to confirm. Donationmaster NT/Net is installed on the computer. – The Setup window opens. After successfully completed installation, the Installation completed message is displayed. – Click OK. – An information window opens, indicating that, if a runtime error occurs, database drivers are missing or fail to be detected properly. In this case, the mdac_typ2.5exe installation routine must be started. This routine resides in the installation folder of Donationmaster NT/Net. – Click the Next button to confirm. – Installation has been completed successfully, and the Donationmaster NT/Net program can be started. Converting the database After Donationmaster NT/Net has been updated to the new version, the database must be converted. To achieve this, the appropriate window appears when Donationmaster NT/Net is started for the first time. – Click Yes to convert the database. Fresenius Kabi CompoGuard TM 4/04.07 8-3 Chapter 8: Software Update 8.2 Software Update of CompoGuard 8.2.1 Saving Data Preparation – Turn the CompoGuard power on. – To be able to check the settings after the update, record the CompoGuard settings while the system check is in progress. Software version: Serial number: Mode: UID number: Language: Saving the settings/data from the CompoGuard – Install the cable network . – Start Donationmaster NT/Net. – From the Setup drop-down menu, select the Configuration command. – In the Communication option group, set the CompoGuardnetwork channel to Cable. – Close the dialog box. Note Do not establish any network connection in the Setup menu! From the Network drop-down menu, select the Single network commands command. The Manual CompoGuard commands dialog box opens. From the Command dialog box, select the Receive settings/data/language from CompoGuard (Service) command. From the CompoGuard: dialog box, select Enter CompoGuard settings manually. Confirm by clicking the Go button. 8-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update The CompoGuard Address dialog box opens. In the Ser. No. CompoGuard dialog box, enter the serial number XXXCGAXXXX of the CompoGuard. Confirm with the OK button. The Select the path please! dialog box opens. Select the path and directory to which you wish to save the data. Confirm with the OK button. The data is saved to the directory selected. The -Donationmaster- dialog box opens. Confirm with the OK button. – Disconnect the CompoGuard from the PC. – The new CompoGuard software VX.X.X.X can now be installed. Fresenius Kabi CompoGuard TM 4/04.07 8-5 Chapter 8: Software Update 8.2.2 Software Update with Flash-Master – Perform a data backup Up to E-code 160 – Remove all power supplies (PSU and battery). – Open the machine. – Connect the adapter cable (part no. M63 287 1) to X1 / P.C.B. LP 1085. – Connect the target cable 1 (Cable1) to the programmed flash MASTER. – Connect the target cable 1 (Cable1) to the adapter cable. E-code 160 and higher – Remove all power supplies (PSU and battery). – Connect the adapter cable (part no. M65 932 1) to the SUB-D socket in the battery compartment and to the programmed Flash-Master. 8-6 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update Applicable to all E-codes Note The software is updated using the Flash-Master. A PC is not necessary. – Press the START button on the flash MASTER. – The STATE display on the flash MASTER indicates the current state. E: Erase P and "running 0": Program V (U) and "running 0": Verify – If the seven-segment display shows UP, the software has been updated successfully. – Disconnect the adapter cable from X1 / P.C.B. LP 1085. – Assemble the device . – Connect the AC adapter and the battery. – Turn the CompoGuard power on. – Check the new version number for being displayed correctly. Message displayed: SW-Ver.: VX.XX Setting the saved data on the CompoGuard – Install the cable network. – Start Donationmaster NT/Net. Note Do not establish any network connection in the Setup menu! From the Network drop-down menu, select the Single network commands command. The Manual CompoGuard commands dialog box opens. From the Command drop-down list box, select the Restore settings on CompoGuard (Service) command. From the CompoGuard dialog box, select Enter CompoGuard settings manually. Confirm by clicking the Go button. Fresenius Kabi CompoGuard TM 4/04.07 8-7 Chapter 8: Software Update In the CompoGuard Address dialog, enter the serial number XXXCGAXXXX of the CompoGuard. Confirm with the OK button. The Open dialog box opens. Select the path and directory where the data you have saved before are residing. Select Scripts.mdb. Click the Open button to confirm. The data is transferred to the CompoGuard. The -Donationmaster- dialog box opens. Confirm with the OK button. – Disconnect the CompoGuard from the PC. – Perform the final inspection and testing. 8-8 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update 8.2.3 Software Update with FlashPro4 LP 1085 X7 X4 X9 X8 X11 AC adaptor X12 X2 JP4 Command E.P.V USB HOST JP5 POWER PG-FP4 X1 STATUS (FlashPro4) X10 X13 X6 Enter X3 X5 DEVICE PARALLEL HOST Enter X1 SERIAL HOST Next cable1 adapter cable – Perform a data backup Up to E-code 160 – Remove all power supplies (PSU and battery). – Open the machine. – Connect the adapter cable (part no. M63 287 1) to X1 / P.C.B. LP 1085. – Connect the target cable 1 (Cable1) to the programmed flash MASTER. – Connect the target cable 1 (Cable1) to the adapter cable. E-code 160 and higher – Remove all power supplies (PSU and battery). – Connect the adapter cable (part no. M65 932 1) to the SUB-D socket in the battery compartment and to the programmed FlashPro4. Fresenius Kabi CompoGuard TM 4/04.07 8-9 Chapter 8: Software Update Applicable to all E-codes Note The software is updated using the FlashPro4. A PC is not necessary. – Press the Enter on the FlashPro4. – The seven-segment display shows Command E.P.V. erase programming verify.... – Press the Enter key. – The seven-segment display shows the various update steps. Wait until the message Command E.P.V. is displayed. – The software has been updated successfully. – Disconnect the adapter cable from X1 / P.C.B. LP 1085. – Assemble the device . – Connect the AC adapter and the battery. – Turn the CompoGuard power on. With software 1.2.x.x and 1.3.x.x, System error will be displayed when the device is turned on for the first time. – Turn the CompoGuard off and on again. – Check the new version number for being displayed correctly. Message displayed: SW-Ver.: VX.XX Setting the saved data on the CompoGuard – Install the cable network. – Start Donationmaster NT/Net. Note Do not establish any network connection in the Setup menu! From the Network drop-down menu, select the Single network commands command. The Manual CompoGuard commands dialog box opens. From the Command drop-down list box, select the Restore settings on CompoGuard (Service) command. From the CompoGuard dialog box, select Enter CompoGuard settings manually. Confirm by clicking the Go button. 8-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update In the CompoGuard Address dialog, enter the serial number XXXCGAXXXX of the CompoGuard. Confirm with the OK button. The Open dialog box opens. Select the path and directory where the data you have saved before are residing. Select Scripts.mdb. Click the Open button to confirm. The data is transferred to the CompoGuard. The -Donationmaster- dialog box opens. Confirm with the OK button. – Disconnect the CompoGuard from the PC. – Perform the final inspection and testing. Fresenius Kabi CompoGuard TM 4/04.07 8-11 Chapter 8: Software Update 8.2.4 Final Inspection and Testing Caution The following tests must be carried out after a software update, in accordance with the maintenance report. Machine: Model: Software version old: Software version new: Serial number: DECT ID: UID number: Mode: Language: Maintenance report number Description OK 3 AC adapter / battery / display messages 4 Weighing function 5 Safety clamp 7 Option – Integrated sealing function: CompoGuard Complete / CompoGuard Seal 9 Option – Gooseneck 10 Option – DECT radio module / RS485 cable network I herewith confirm proper performance of any maintenance work as specified above, and the data to be true and correct. Technician's signature: Customer’s signature: .............................................., Date: ................. .............................................., Date: ................. ............................................................................. ............................................................................. 8-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update 8.3 Programming the Flash-Master Condition Programming device Flash-Master with latest CompoGuard software (part no. M63 883 1) Flash-Master scope of delivery PC software is supplied with the programming unit. This software must be installed on a PC as described in the instructions. Also supplied with the programming unit are an AC adapter, a PC -> programming unit interface cable via COM1 or COM2 and two target cables. Use the target cable 1 (cable 1) for updating the CompoGuard. Programming – Make the settings of the flash MASTER using the flash MASTER software. – Connect the flash MASTER to the serial interface (e.g. COM1) of the PC (see figure). – Connect the flash MASTER to the AC adapter and connect the AC adapter to the external power supply. – Insert the floppy disk of the flash MASTER software into the appropriate drive (e.g. A). – Open the flash MASTER with flashMASTER.exe using the directory in the Windows Explorer. The Trying to connect COM1 with 38400 Baud dialog box opens. The connection to the flash MASTER is being established. Fresenius Kabi CompoGuard TM 4/04.07 8-13 Chapter 8: Software Update The main window is displayed. Once the connection to the flash MASTER has been established, the yellow folder appears in the main window of the flash MASTER. Open the Device drop-down menu in the menu bar. Select the Setup... command. Should an error message be displayed, confirm it with the OK button. The Eigenschaften von Device Setup (Device setup properties) dialog box opens. Select the V850/SF1,DS1.0 microcontroller of the CompoGuard from the Device dialog box. Settings of the option group Supply – Vdd (mV) 5000 On Target unchecked – Fosc (Hz) 16000000 – Prescaler 1 8-14 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 8: Software Update Select the Advanced tab. Check all checkboxes in the Autoprocedure option group. Enter 80 in the Multiply Factor input field in the Misc dialog box. Confirm with the OK button. New values are applied automatically. Open the Programmer drop-down menu in the menu bar. Select the Memory selection... command. The Programmer Memory dialog box opens. Activate the Use external Flash option in the Memory Selection dialog box. Confirm with the OK button. Note: The code file must be transferred to the flash MASTER only once. It will then reside in the flash MASTER memory. Fresenius Kabi CompoGuard TM 4/04.07 8-15 Chapter 8: Software Update Open the File drop-down menu in the menu bar. Select the Download... command. The Select a File to download dialog box opens. Insert the supplied floppy disk containing the CompoGuard device software VX.XX. Select the path and name of the file for software version VX.XX from the Dateiname (File name) drop-down list box: e.g.: A:\bds26_v1_12.rec Click the Öffnen (Open) button to confirm. The seven-segment display of the flash MASTER shows Lo (load). The Downloading Motorola S-Record File (via COM1) dialog box opens. After completed data transfer, the sevensegment display shows rd (ready). The flash MASTER is programmed and the settings are completed. Disconnect the flash MASTER from the PC. 8-16 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix 9 Appendix 9.1 Concept of the Data Interface Between Donationmaster NT/Net and the Blood Bank Information System 9.1.1 Introduction This document describes the concept used for implementing the bidirectional data exchange between Donationmaster NT/Net and a blood bank information system (BIS). The particular editing and processing steps of Donationmaster NT/Net and the BIS will not be explained in detail in this document. 9.1.2 Physical Connection The physical connection between the PC where Donationmaster NT/Net is executed and the BIS is established with customary network components. The network components selected and their configuration must comply with the network topology used to implement the BIS. The network components required must be provided by the customer. 9.1.3 Logical Connection A file interface, described in detail in the following chapter, is used for bidirectional data exchange between Donationmaster NT/Net and the BIS. Fresenius Kabi CompoGuard TM 4/04.07 9-1 Chapter 9: Appendix 9.1.4 Exceptions Non-processed orders After completion of the donation process, there may still be orders in the order list which have not yet been processed completely. These orders can be deleted using Donationmaster NT/Net. If necessary, they can be exported beforehand. Network interruption between Donationmaster NT/Net and the BIS Donationmaster NT/Net requires a network connection to the BIS only for receiving order file data from or returning donation results to the BIS. Donationmaster NT/Net will function properly even if there is no connection to a BIS. Network interruption between Donationmaster NT/Net and the CompoGuard If problems occur during the donation process with the CompoGuard network communication being activated, the CompoGuard devices may still be operated. The following restrictions are applicable for each CompoGuard: – It is possible to process a maximum of 100 donations. – In the Order file operation mode a maximum of 100 orders are stored in the CompoGuard devices. Only these orders can be processed on the CompoGuard devices. If network communication with Donationmaster NT/Net is restored, regular work can be resumed without any restriction after data calibration of the CompoGuard devices. 9-2 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix 9.2 Description of the Interface Files 9.2.1 Order File General notes The order file is the interface for transferring order data from the BIS to Donationmaster NT/Net. The BIS provides Donationmaster NT/Net with the order file in ASCII format. Directory and file names of the order file are defined under the Setup / Configuration in Donationmaster NT/Net. Note The semicolon ´;´ is exclusively used as delimiter and may not be used within file names, bar code names, and bar codes. The order data records are filed in CSV format using the semicolon ´;´ (ASCII code 0x3B) as field separator. Each order data record must be filed in a single text line. The line end is defined by a carriage return linefeed sequence (<CR><LF>, ASCII code 0x0D 0x0A). The order file provided by the BIS may contain more than 100 entries. A concerted erasion of an order in network-active CompoGuard mixers can be accomplished when completing the corresponding order entry by „ ;100 “. Transfer direction BIS Donationmaster NT/Net. Format <DonationNumber>;<DonationScriptNumber><CR><LF> Field descriptions DonationNumber Donation or donor number Type STRING Length: max. 32 characters DonationScriptNumber Number of the donation program to be executed Type INTEGER Value range: 1.. 50 Example 12345;1 12346;2 Fresenius Kabi CompoGuard TM 4/04.07 9-3 Chapter 9: Appendix 9.2.2 Order Error File General notes If errors are occurring, Donationmaster NT/Net creates an order error file used as acknowledgement by the BIS. The order error file has the file name WrongOrders.txt and is filed in the same directory as the order file. This directory can be set in Donationmaster NT/Net under Setup / Configuration. Note The semicolon ´;´ is exclusively used as delimiter and may not be used within file names, bar code names, and bar codes. The order error data records are filed in CSV format using a semicolon ´;´ (ASCII code 0x3B) as field separator. Each order error data record is filed in a single text line. The line end is defined by a carriage return linefeed sequence (<CR><LF>, ASCII code 0x0D 0x0A). Transfer direction Donationmaster NT/Net BIS. Format <DonationNumber>;<DonationScriptNumber>;<ErrorText><CR><LF> Field descriptions DonationNumber Donation or donor number Type STRING Length: max. 32 characters DonationScriptNumber Number of the donation program to be executed Type INTEGER Value range: 1.. 50 Error text Plaintext description of the error having caused rejection of the data record. 9-4 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix Error text Description Invalid number of script No valid program number has been assigned to the donation number. More than 1 valid scriptnumber The database contains several data records for the assigned donation program. Donation already exists The donation number specified in the data record has already been assigned. Wrong CRC The CRC specified in the data record is invalid. Fresenius Kabi CompoGuard TM 4/04.07 9-5 Chapter 9: Appendix 9.2.3 Donation Results General notes Export the donation results in ASCII format. File name and path of the export file are defined under Setup / Configuration in Donationmaster NT/Net. Note The semicolon ´;´ is exclusively used as delimiter and may not be used within file names, bar code names, and bar codes. The data records are filed in CSV format using a semicolon ´;´ (ASCII code 0x3B) as field separator. File each donation result data record in a single text line. Use a carriage return linefeed sequence (<CR><LF>, ASCII code 0x0D 0x0A) as end-of-line character. CompoGuard With software version Donationmaster NT/Net version v1.2.0.1 or higher, a constant number of 61 data fields per donation data set is displayed. The fields are each separated by a semicolon „;“. If no data are stored for one field, the field remains empty. The corresponding field length is zero. Positions 1-24: – Comply with the order of the screen display. from position 25 to 60 – up to 30 seal and bar code definitions Position 61 – CRC result Example: – Printout as ASCII file 3;3 Program Scan;20030509122349;20030513081951;20030521072416;20030522081916; 002CGA0277/V1.2.0.1;0;255;480;481;0;335;40;0;100;0;106;568;0;0;0;4;ABR,;BAG0,K7755234; LOT,K7755234;OPE,M0034;TUB,K7755234;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CRC,0x0F9A; – decoded ASCII file: 9-6 Pos. Description Display donation result 1. No. donation program 3 2. Name Donationprogram 3 Program Scan 3. Date/time program 20030509122349 4. Date/time action list 20030513081951 5. Date/time com. CG s. 20030521072416 6. Date/time donation 20030522081916 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix 7. Ser.-No. CompoGuard 002CGA0277/V1.2.0.1 8. Premature donation end 0 9. Alarm 255 10. Target volume 11. Volume [ml] 481 12. Max. time [min:sec] 0 13. Duration [min:sec] 335 14. Limit Flow [ml/min] 40 15. No. flow alarms 0 16. Limit weight jump [g] 100 17. No. jump alarms 0 18. Mean flow [ml / min] 106 19. Weight 568 20. Bar code checks OK 0 21. No. interrupts 0 22. Sum pause 23. Operation mode 4 24. Interrupt barcode ABR, 25. BAG0, BAG0,K7755234 26. DNO, LOT,K7755234 [ml] [g] [min:sec] 480 0 27. OPE,M0034 28. TUB,K7755234 ... Maximum of 30 scan and sealing actions 61. CRC CRC,0x0F9A Transfer direction Donationmaster NT/Net BIS. Format <DonationScriptNumber;<DonationScriptName>;<UIDDonationScript>; <UIDActionList>;<UIDGeneralDeviceConfig>;<UIDOfDonationStart>; <SerialNumberDU>;<DonationState>;<AlarmCodeAtDonationEnd>; Fresenius Kabi CompoGuard TM 4/04.07 9-7 Chapter 9: Appendix <TargetVolume>;<ReachedVolume>;<MaxDonationTime>; <DurationOfDonation>;<FlowLimit>;<NumberFlowAlarms>; <JumpWeightLimit>;<NumberJumpAlarms>;<MeanFlow>; <TotalWeight>;<BarcodeChecksOK>;<NumberOfInterrupts>; <PausedTime>;<OperationMode>;<InterruptBarcode>; [<Action1>;] [<Action2>;] ... [<Action30>];CRC,<CRC> Field descriptions DonationScriptNumber Number of the donation program Type INTEGER Value range: 1.. 50 DonationScriptName Name of the donation program Type STRING Length: max. 20 characters. UIDDonationScript Up to Date Identifier (UID) of the donation program executed Type STRING Format: YYYYMMDDHHMMSS UIDActionList Up to Date Identifier (UID) of the action list of the donation program executed Type STRING Format: YYYYMMDDHHMMSS UIDGeneralDeviceConfig Up to Date Identifier (UID) of the common mixer settings Type STRING Format: YYYYMMDDHHMMSS UIDOfDonationStart Date / time of donation program execution Type STRING Format: YYYYMMDDHHMMSS SerialNumberDU Serial number of the CompoGuard mixer Type STRING Length: maximum of 10 characters Depending on the CompoGuard software used, the currently used software version may be displayed in addition to the serial number. DonationState 9-8 State of the donation when terminated Type INTEGER Value range 0.. 3 0 donation completed 1 donation prematurely terminated by user 2 donation prematurely terminated on Donationmaster NT/Net 3 donation prematurely terminated by power failure Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix AlarmCodeAtDonationEnd Code of the alarm still present at donation end Type INTEGER Info field exclusively intended for service technicians trained by Fresenius TargetVolume Preset target volume in [ml] Type INTEGER Value range: 100.. 650 Depending on the CompoGuard software used and the activation of corresponding functions, the displayed target volume preset by the donation program may change to the value of the volume changed during the donation. If the target volume has been changed during donation against the preset target volume, a „c“ (changed) will be attached to the value of the volume. ReachedVolume The donation volume reached at donation end in [ml] Type INTEGER MaxDonationTime Maximum donation time in [min] Type INTEGER Value range: 8.. 14 DurationOfDonation Donation time in [sec] Type INTEGER FlowLimit Flow limit in [ml / min] Type INTEGER Value range: 0.. 100 NumberFlowAlarms Number of flow alarms having occurred during donation Type INTEGER JumpWeightLimit Alarm limit of weight jump in [g] Type INTEGER Value range: 0 = weight jump detector deactivated 100.. 200 = weight jump detector activated NumberJumpAlarms Number of weight jump alarms having occurred during donation Type INTEGER MeanFlow Mean supply flow during donation in [ml / min] Type INTEGER TotalWeight Total donation weight in [g] Type INTEGER Value range: 0.. 999 BarcodeChecksOK Indicates whether invalid barcodes have been scanned during donation BarcodeChecks = 0 At least one invalid barcode has been scanned. Fresenius Kabi CompoGuard TM 4/04.07 9-9 Chapter 9: Appendix BarcodeChecks = 1 All scanned barcodes were okay. Type INTEGER Value range: 0.. 1 NumberOfInterrupts Number of interruptions during donation Type INTEGER PausedTime Total time of all pauses during donation in [sec] Type INTEGER OperationMode Operating mode of the CompoGuard mixer during the execution time of the donation program Type INTEGER 0 = Order file 1 = intelligent donation number 2 = Function barcode panel 3 = manual program selection (network mode) 4 = manual program selection (without network mode) InterruptBarcode The output format is as follows: <Abbreviation>,<Data> If an interrupt barcode has not been defined in the donation program, a blank string is output. Type STRING <Abbreviation>: Maximum of 4 characters in length <Data>: Maximum of 32 characters in length Action1...Action30 Variable range of donation results. The list may contain no more than 30 actions, depending on the configuration of the donation program executed. The output format is as follows: <Abbreviation>,<Data> Type STRING <Abbreviation>: Maximum of 4 characters in length <Data>: Maximum of 32 characters in length CRC 16-bit checksum according to CCITT via the preceding data block in hexadecimal spelling, start polynom 0x11021. The output format is as follows: CRC,<Value> <Value>: hexadecimal notation Type INTEGER Value range: 0x0000.. 0xFFFF 9-10 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix PROGESA With software version Donationmaster NT/Net version v1.2.1.1 or higher, a constant number of 41 data fields per donation data set is displayed. The fields are each separated by a semicolon „;“. If no data are stored for one field, the field remains empty. The corresponding field length is zero. Positions 1-4: – fixed from position 5 to 40 – up to 30 seal and bar code definitions Position 41 – CRC result Example: – Printout as ASCII file 20030801120226;002CGA0024;205;171;K9876543;;;;NA33456789B;NA33456789A;ND33456789A; ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CRC,0xFBCA; – decoded ASCII file: Pos. Description Display donation result 1. Date/time com. CG s. 20030801120226 2. Ser.-No. CompoGuard 002CGA0282 3. Volume 205 4. Duration 5. K9876543 6. -- 7. --, 8. --, 9. NA33456789B OPE,NA33456789A 10. NA33456789A LOT,NA33456789B 11. ND33456789A TUB,ND33456789A ... Maximum of 30 scan and sealing actions 41. CRC [ml] [min:sec] 171 BAG0,K9876543 CRC,0x4499 Transfer direction Donationmaster NT/Net Fresenius Kabi CompoGuard TM BIS. 4/04.07 9-11 Chapter 9: Appendix Format <UIDGeneralDeviceConfig>;<SerialNumberDU>;<ReachedVolume>;<DurationOfDonation>; [<Action1>;] [<Action2>;] ... [<Action30>];CRC,<CRC> Field descriptions UIDGeneralDeviceConfig Up to Date Identifier (UID) of the common mixer settings Type STRING Format: YYYYMMDDHHMMSS SerialNumberDU Serial number of the CompoGuard mixer Type STRING Length: maximum of 10 characters Depending on the CompoGuard software used, the currently used software version may be displayed in addition to the serial number. ReachedVolume The donation volume reached at donation end in [ml] Type INTEGER DurationOfDonation Donation time in [sec] Type INTEGER Action1...Action30 Variable range of donation results. The list may contain no more than 30 actions, depending on the configuration of the donation program executed. The output format is as follows: <Abbreviation>,<Data> Type STRING <Abbreviation>: Maximum of 4 characters in length <Data>: Maximum of 32 characters in length CRC 16-bit checksum according to CCITT via the preceding data block in hexadecimal spelling, start polynom 0x11021. The output format is as follows: CRC,<Value> <Value>: hexadecimal notation Type INTEGER Value range: 0x0000.. 0xFFFF 9-12 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix 9.2.4 Barcode Check Lists General notes Up to five barcode check lists with no more than 70 entries each can be managed in Donationmaster NT/ Net. The barcode check list files must be saved in ASCII format. Use a carriage return linefeed sequence (<CR><LF>, ASCII code 0x0D 0x0A) as end-of-line character. Transfer direction BIS Donationmaster NT/Net. Format [Barcode] Barcode1 = 01234567890123456789 ... Barcode70 = 98765432109876543210 Field descriptions [Barcode] Constant entry in the first line of each barcode check list Type STRING Barcode1 … Barcode70 Barcodes Type STRING Length: maximum of 32 characters Fresenius Kabi CompoGuard TM 4/04.07 9-13 Chapter 9: Appendix 9.3 Donationmaster NT/Net Requirements to be Met by the BIS 9.3.1 Introduction Donationmaster NT/Net can be connected to a blood bank information system. This connection is intended for the transfer of orders from the BIS to Donationmaster NT/Net. An order is combined of the donation number and the number of the program to be executed by a CompoGuard. This connection is, in addition, used to transfer the donation results to the BIS. The connection between Donationmaster NT/Net and the BIS is established via a file interface. It must be ensured that both Donationmaster NT/Net and the BIS have access to these jointly used interface files. 9.3.2 System Requirements The PC where Donationmaster NT/Net is installed, must be equipped with a network interface unless this has been already integrated by the manufacturer. This interface must be configured such that Donationmaster NT/Net and the BIS have access to the same transfer files. Possible configurations are as follows: – Enabling a directory structure for the BIS on the Donationmaster NT/Net PC. – Enabling a directory structure for Donationmaster NT/Net on the computer system of the BIS. – Joint use of a directory structure by Donationmaster NT/Net and the BIS on a server. 9.3.3 What does the Customer Have to Do? The customer must configure his BIS for bidirectional data exchange with Donationmaster NT/Net. This includes: – Setup of a directory structure with the appropriate access rights for Donationmaster NT/Net and BIS (reading / writing / deleting / creating of files). – Installation and configuration of the appropriate network software on the PC where Donationmaster NT/Net is executed. – Implementation of the interface for transferring the order file data to Donationmaster NT/Net. – Optional implementation of the interface for receiving acknowledgements of errors occurring while Donationmaster NT/Net is processing the order file data. – Optional implementation of the interface for receiving orders not processed in Donationmaster NT/Net. – Optional implementation of the interface for providing the barcode check lists to Donationmaster NT/ Net. – Implementation of the interface for receiving the donation results from Donationmaster NT/Net. 9.3.4 Issues to be Noted Do not open any other applications while executing Donationmaster NT/Net. 9-14 Fresenius Kabi CompoGuard TM 4/04.07 Chapter 9: Appendix If required, Fresenius Transfusions GmbH is ready to support you in connecting Donationmaster NT/Net to the BIS. You may also consult an external IT or software expert with specific BIS knowledge for carrying out the tasks required. Fresenius Kabi CompoGuard TM 4/04.07 9-15 Chapter 9: Appendix 9-16 Fresenius Kabi CompoGuard TM 4/04.07