0 - 12 Infusomat® Space P Service Manual Version 5.0 English 0- RX only 0 This Service Manual is valid for Designation Part No. Infusion Pump Infusomat® Space P . . . . . . . . . . . . . . . 0871 3070 Infusion Pump Infusomat® Space P (USA) . . . . . . . . . 0871 3070U Infusion Pump Infusomat® Space P (China). . . . . . 0871 3070CN This Service Manual is available under the following part number: Languages of this Manual Designation Part No. Service Manual Infusomat® Space P, English . . . . . . . 8713 9153 The Service Manual for this unit can be supplied in the following languages: Designation Part No. Service Manual Infusomat® Space P, German . . . . . . . 8713 9152 The complete Service Manual contains the following pages: 0- 2 Page 0-1 to Page 0-12 Page 1-1 to Page 1-18 Page 2-1 to Page 2-16 Page 3-1 to Page 3-58 Page 4-1 to Page 4-4 Page 5-1 to Page 5-4 Page 6-1 to Page 6-10 Page 7-1 to Page 7-2 Page 8-1 to Page 8-6 Page 9-1 to Page 9-2 Page 10-1 to Page 10-2 Infusomat® Space P 5.0 EN 0- Table of Contents 0 Important Preliminary Remarks Service Work Technical Safety Checks Current Versions Product availability Quality Management Checks and Repair Notes on ESD Spare Parts and Test Equipment Safety data sheets Setting Off Special PDF functions List of Abbreviations Page Page Page Page Page Page Page Page Page Page Page Page 0-5 0-5 0-5 0-5 0-6 0-6 0-6 0-7 0-7 0-7 0-8 0-9 Contact Persons Technical Training Entry for Technical Training Ordering of Spare Parts and Test Equipment Service Hotline Returns Safety Officer (§ 30 MPG) Page Page Page Page Page 0 - 11 0 - 11 0 - 11 0 - 11 0 - 11 Page 0 - 11 System Overview Description Page 1-1 System Overview Page 1-1 Physical Construction Page 1-2 Function Page 1-4 Unit Software Page 1-9 Service Program Page 1 - 10 Technical Data Page 1 - 16 Options Page 1 - 16 Accessories Page 1 - 16 Functional test acc. to §5, Section 1, MPBetreibV (German Medical Devices Operator Ordinance) Page 1 - 17 Unit Diagnosis / Calibration Alarms and Error Codes CAN error states The Most Important Error Modes Calibration Page Page Page Page 2-1 2-7 2 - 10 2 - 10 Disassembly / Assembly General Slide Guide Cover for Drop Sensor Connector Emergency Release Plug Unit Foot Battery Module Housing Upper Part Housing Bottom Part Inner Frame and Housing Front Panel Inner frame Housing Front Panel Operating Unit Processor PCB Page Page Page Page Page Page Page Page Page Page Page Page Page 3-1 3-9 3 - 10 3 - 10 3 - 11 3 - 12 3 - 19 3 - 22 3 - 23 3 - 25 3 - 29 3 - 31 3 - 37 EN Infusomat® Space P 5.0 0- 3 0 Table of Contents Installation / Assembly Pole Clamp SP Adapter Kit Checks after Repair Page Page Page 3 - 40 3 - 54 3 - 55 Servicing the Unit Cleaning and Disinfecting Servicing the Battery Page Page 4-1 4-3 Technical Safety Check (TSC) Infusomat® Space P Power Supply SP Page Page 5-1 5-4 Procedural Instructions on the TSC Visual Inspection Electrical Safety According to IEC 60601-1 or IEC 62353 Functional Inspection Infusomat® Space P Functional Inspection Power Supply SP Page 6-1 Page Page Page 6-2 6-3 6 - 10 Test equipment Special Tools Page Page 7-1 7-2 Page 8-1 Page 9-1 Page 10 - 1 Test Equipment and Special Tools Spare Parts List Revision Documentation Index 0- 4 Description of Version Infusomat® Space P 5.0 EN 0- Service Work Technical Safety Checks Important Preliminary Remarks 0 The present manual is for your information only. The possession of this manual does not authorize the performance of service work. Service tasks may only be executed by persons, who - have received appropriate training on the system from B. Braun - are included in the revision service - possess the necessary test equipment and mechanical aids, and - fulfill the personal requirements (training and knowledge). The user is obliged to perform or to have performed the Technical Safety Checks on those medical products for which these checks have been prescribed by the manufacturer and to carry them out according to the indications of the manufacturer as well as the generally approved technical standards while adhering to the periods stated (§ 6 MP BetreibV). B. Braun also recommends training on the Technical Safety Checks, or to perform at least the steps indicated in the current version of the manual, as: Current Versions - the TSC requires that the instructions in the manuals are observed - the manuals are a reference for measurements - depending on the unit type, the Service Program must be called which may lead to a dangerous unit condition in case of inappropriate operation. Furthermore, a special service connector may be necessary. This manual version corresponds to the state when the manual was written. B Braun reserves the right to make technical modifications. The state of the revision is indicated by the index number in the footer of every page. To view the current Service Manual, please visit the Service Portal at: https://extranet.bbraun.com. Approval to use the service portal will only be granted after completion of a technical training course.. Product availability EN Infusomat® Space P 5.0 Not all software versions, hardware, or spare parts are available in all regions. Please consult your local B. Braun representative for availability. 0- 5 0 Important Preliminary Remarks Responsibility of the Manufacturer Quality Management The manufacturer, person who assembles, installs or imports the device can only be held responsible for safety, reliability and performance if - mounting, enhancements, new settings, changes or repairs are carried out by duly authorized persons, - the electrical installation in the corresponding room meets the requirements of the VDE 0107, VDE 0100 part 710 or IEC 60364-7-710 and the national standards, - the device is used in accordance with the instructions for use and the Service Manual, - the Technical Safety Checks are performed at regular intervals, - a current manual which corresponds to the revision state is used when carrying out maintenance, repair and service, - the service technician takes part in the revision service, - the technician has participated in a technical training course for the specific B. Braun unit. B. Braun is certified in accordance with DIN EN ISO 9001 and ISO 13485. This certification also includes maintenance and service. The unit has the CE label. The CE label confirms that the device corresponds to the “Directive of the Council for Medical Products 93/42/EC” of June 14, 1993. Checks and Repair Training may only be performed by B. Braun. The possession of the manual does not authorize the performance of repairs. The instructions on electrostatic sensitive components (ESD standards) must be observed. After repair a device check or diagnosis is to be carried out. Notes on ESD 0- 6 Semiconductors can be destroyed by electrostatic discharge. Especially MOS components can be damaged by interference from electrostatic fields, even without discharge via contact. This type of damage is not immediately recognizable. Unit malfunctions can even occur after a longer period of operation. Infusomat® Space P 5.0 EN Important Preliminary Remarks 0 Each workstation must be equipped according to the recommendations with the necessary static protective measures, if ESD components or boards are handled. Each workstation must be equipped with a conductive table surface. The conductive surface, the soldering iron or the soldering stations must be grounded via protective resistors. Chairs must be of antistatic design. The floor or floor mats should be of electrically conductive material. Fig.: 0 - 1 Spare Parts and Test Equipment Personnel must wear conductive wristbands which are connected to a central ground potential via protective resistors, e.g. the ground contact of a wall outlet. Furthermore it is recommended that personnel wear cotton clothing and electrically conductive shoes to prevent electrostatic charge. Only use original spare parts from the manufacturer. Do not tamper with assembly groups which can only be exchanged completely. The spare parts required are listed in the repair descriptions. When assembling spare parts with a serial or batch number (see label on the packaging or number plate) the serial number of the affected medical device has to be documented. Service personnel are responsible for the calibration of their test equipment. Original test equipment can be calibrated at the works of B. Braun. Further information is available upon request. Safety data sheets You can request the material safety data sheets for the consumables described in this Service Manual free of charge from B. Braun. You can download the latest version of each document as a PDF in the service portal under https://extranet.bbraun.com. Setting Off Additional notes and warnings are set off as follows: Note Is used for additional or special notes concerning information and working steps. CAUTION Is used for working steps which may result in damage to the unit, system or to a connected device. EN Infusomat® Space P 5.0 0- 7 0 Important Preliminary Remarks ! WARNING IS USED FOR WORKING STEPS WHICH MAY RESULT IN PERSONAL INJURY. References to chapters are shown as follows (see „Setting Off“ ➨ pg. 0 - 7) References to figures and tables are shown as follows Fig.: 2 - 3 or Table 2 - 1 References to item numbers in figures are shown as follows (Fig.: 1 - 1 / Item 1) In this case “Fig.: 1 - 1“ is the figure number and “Item 1“ the item number within the figure. When the Service Manual is stored as pdf-file, these references are displayed green. Click with the mouse button on a reference to jump to the corresponding source. Menu commands are described as: Menu File. Special PDF functions In the PDF format of this manual, special functionality is integrated, which can be used with Adobe® Reader®: - Form function For completing, saving, and printing the TSC on a PC, laptop, etc. Software requirements - Adobe® Reader® Version XI or higher is installed. Form function Fig.: 0 - 2 Forms included in the manual, which are to be filled out by the reader, each show an "Edit" button at the top of the first page (Fig.: 0 - 2). The list can be completed and printed online or saved locally as a PDF: 1. Click the "Edit" button. The form is opened in a separate PDF file. 2. If you want to save the form as a PDF, you can save an empty copy of the form locally with File > Save As and open this for editing. 3. The following form field functions are available: 0- 8 Infusomat® Space P 5.0 EN Important Preliminary Remarks 4. 0 - Entry of text and figures in the form fields with the keyboard. - Checking test steps by clicking the check boxes (click again to clear). - Deletion of non-applicable test steps by marking the entry with the mouse and selecting “Strikethrough Text” in the shortcut menu (right mouse key; only for editing in the local form copy). - Printing the completed form with File > Print and then selecting a connected printer. - Saving the completed form as a PDF with File > Save. To end the form, close the PDF file. Note After the PDF file has been closed, the entered data are only saved if you were working in the local copy. This can be opened at any time to continue editing. List of Abbreviations EN Infusomat® Space P 5.0 Abbreviations which are not generally known, but are used in this manual, are listed below. CAN Controller Area Network CE Communauté Européenne (European Communities) DIN Deutsche Industrie Norm (German Industrial Standard) EN European Standard ESD Electrostatic Discharge FuP Function Microprocessor IEC International Electrotechnical Commission ISO International Standardization Organization ISP Infusomat® Space ISPS Infusomat® Space, Silicon ISPP Infusomat® Space, PVC KuP Monitoring Microprocessor LCD Liquid Crystal Display 0- 9 0 0 - 10 Important Preliminary Remarks MOS Short for the following company name: MOS Technology, Inc. (Commodore Semiconductor Group) PCA Patient-Controlled Analgesia PSP Perfusor® Space SP Space (System) SPC SpaceCover SPCC SpaceCover comfort SPCS SpaceCover standard SPCO SpaceCom SPCT SpaceControl SPS SpaceStation TEMP Temperature TSC Technical Safety Checks VDE Verband der Elektrotechnik, Elektronik und Informationstechnik e.V. (German electrical engineering association) Infusomat® Space P 5.0 EN 0 - 12 0- Contact Persons 0 Technical Training Via local representative. Entry for Technical Training Application for a technical training course must be made via the responsible representative. Ordering of Spare Parts and Test Equipment Please contact your local B. Braun subsidary. International Technicians (Intercompany) Fax: +49 (0) 5661 / 75 - 21 54 e-mail: Spare-Parts_HC@bbraun.com Service Hotline Service Hotline Germany Fax: +49 (0) 56 61 71 - 35 26 e-Mail: Service-Hotline_HC@bbraun.com Service Hotline U.S. and Canada Phone: +1 800-627-PUMP Phone: +1 800-627-7867 Returns Return of spare parts, test equipment, and units for repairs: B. Braun Melsungen AG Schwarzenberger Weg 73-79 Wareneingang Werk C 34 212 Melsungen Germany U.S. and Canada Returns: B. Braun Medical Inc. 1601 Wallace Drive, Suite 150 Carrollton, TX 75006 USA Safety Officer (§ 30 MPG) EN Infusomat® Space P 5.0 Dr. Ludwig Schütz e-mail: ludwig.schuetz@bbraun.com 0 - 11 0 Contact Persons For your notes: 0 - 12 Infusomat® Space P 5.0 EN 1 - 18 1- Description System Overview 1 The Infusomat® Space P (ISPP) is according to IEC/EN 60601-1 or IEC/EN 60601-2-24 a portable volumetric infusion pump for infusion of small to high volumes with ultimate precision and is suitable for intravenous applications, blood transfusion and enteral nutrition. The medical specialist must decide on suitability for application on the basis of the warranted properties and the technical data. System Overview The Space system is a modular design of modern infusion technology for stationary, mobile or private use. The key modules and their connection to the peripheral devices are shown in Fig.: 1 - 1. All the pump types, Perfusor® Space, Infusomat® Space and Infusomat® Space P, as well as the other devices of the system are of modular design. Up to three pumps can be connected together using L rails on the bottom of the unit and grooves on the top. The pumps can be connected to each other and to an external power supply via a connection cable. 1 2 The SpaceControl module can be used to extend operation. One single pump can be inserted onto this module. The pump is then connected via connectors to the module. 3 4 5 Fig.: 1 - 1 Space system Legend of fig. 1 - 1: Item Designation 1 SpaceCover 2 Infusion pump Infusomat® Space 3 Infusion syringe pump Perfusor® Space 4 SpaceControl 5 SpaceStation EN Infusomat® Space P 5.0 The SpaceStation module allows the set-up of a complete pump system with up to 24 pumps. Up to four pumps can be installed in every SpaceStation. The pumps are supplied with power via the integrated power supply and the built-in connectors. The pumps are connected to the optional SpaceCom via these connectors. SpaceControl can also be integrated into the system via the connected pump and from there via the connector. Up to 6 SpaceStations can be set-up as a column with a total of 24 pumps. SpaceStation placed next to each other can be connected via special connection cables, if the maximum number of 24 pumps in maximum three columns is not exceeded. SpaceCover Standard or SpaceCover Comfort forms the top of each column. Alarms are signalled by a row of LEDs and a loudspeaker in the SpaceCover Comfort. 1- 1 1 System Overview Physical Construction The Infusomat® Space P housing mainly consists of the bottom part, the upper part, the front part and the operating device. The battery module is inserted in the rear of the housing upper part. The opening is covered by the battery compartment cover. The operating unit is attached to the front of the bottom part. The thrust bearing of the tube pump (peristaltic pump), the springmounted pressure elements for the two pressure sensors and the air inline sensor as well as the release for the safety clamp (ISPP) are located at the rear of the operating unit. The operating unit is mechanically locked in its closed position via three metal pins. A motor-driven lock bolt is used to lock the operating unit. In case of an emergency, the operating unit can be opened through an opening on the left side of the housing top. During normal operation this opening is closed with a plug. According to the line run the following subsystems are installed in the housing front panel, from right to left: - Pressure sensor (upstream, container-side) - Slide guide with 12 slides (mechanically coded, can be dismantled without tool) Coding for ISPS: top left Coding for ISPP: middle right - Air inline sensor - Pressure sensor (downstream, patient-side) - Safety clamp (ISPP). The slides are moved in the slide guide by pump connecting rods. The connecting rods are mounted on an eccentric shaft and are led outside through a seal diaphragm. The complete pump is flexibly mounted in the inner frame of the device and is moved in combination with the lock bolt. The lock bolt drive of the pump is also installed in the inner frame. The processor PCB with the external connectors “P2” and “P3” is located at the bottom of the housing bottom part. 1- 2 Infusomat® Space P 5.0 EN 1 System Overview 1 3 2 4 6 5 Fig.: 1 - 2 Infusomat® Space P Legend of fig. 1 - 2: Item Designation 1 Infusomat® Space P 2 Operating unit 3 Cover for drop sensor connector EN Infusomat® Space P 5.0 4 Connector “P2“ for SpaceStation module, external 12 V DC and accessories 5 Connector “P3“, connection to SpaceControl module 6 Battery compartment cover 1- 3 1 System Overview Function There are two power options for the Infusomat® Space P: - Via the inserted battery module - Via an external 12 V DC power supply (e.g. SpaceStation, SpaceControl, an external power supply or from an ambulance car) connected to connector “P2” The voltage supplied is converted to the internal voltages required through a voltage transforming and monitoring circuit on the processor PCB. An independent circuit in the battery module monitors the battery cells and controls their charge condition. The keyboard and the display are lighted. The Infusomat® Space P is connected to a SpaceControl by connector “P3”. The function processor controls all the functions of the Infusomat® Space P. Data is stored in a non-volatile memory which also controls the external data transfer. The monitoring processor monitors all important responses of the function processor to incoming information. If a response does not correspond with that expected by the monitoring processor, an error message is generated and the device is switched to a safe stop state. The Intrafix Primeline Classic and its contents is monitored by the sensors listed below: - Optional drop sensor - Pressure sensor upstream (container-side) Monitors the upstream pressure (negative pressure) - Air inline sensor Monitors the line contents (liquid - air) - Temperature sensor Monitors the temperature of the medium in the line (integrated in the air inline sensor) - Pressure sensor downstream (patient-side) Monitors the downstream pressure (overpressure) The pump drive motor is monitored by a speed and direction of rotation detection function. The motor of the lock bolt drive is controlled via the processor PCB. The different positions of the lock bolt during operation are monitored by a linear potentiometer. 1- 4 Infusomat® Space P 5.0 EN System Overview 1 The safety clamp squeezes the line, for example, Intrafix Primeline Classic, when the operating unit is opened or internal calibration is carried out to protect the patient and prevent an uncontrolled drug flow to the patient. Beside the position monitoring via the lock bolt, the “open/closed” state of the safety clamp is monitored by a light barrier. The safety clamp is closed and the line is squeezed automatically when the operating unit is closed. The safety clamp is opened by manual operation of the safety clamp lever and the line can be removed. To ensure patient safety the operating unit is automatically locked. For this purpose, the operating unit is manually pressed in the lock bolt with the three locking pins. The resistance of the linear potentiometer which is monitored by the controller is changed when the position of the lock bolt changes. Locking is started and can take up to 10 seconds. During locking, several calibrations are carried out automatically, for example: - occlusion test To check, for example, the function of the safety clamp - pressure calibration of the two pressure sensors. The operating unit is also unlocked automatically via the lock bolt. In case of a power failure or malfunction, the operating unit can be unlocked manually by a small emergency release crank. To do this, the lock bolt is moved manually with the crank to the open position, as described below. EN Infusomat® Space P 5.0 1- 5 1 System Overview Opening the Operating Unit Manually 1. Press the locking of the battery compartment cover using a pointed tool and remove the battery compartment cover from the housing. 2. Remove the emergency release crank out of the battery compartment cover. Fig.: 1 - 3 3. Press the emergency release crank carefully in the emergency release plug on the left side of the housing until stop. Note The hexagon socket of the emergency release plug is tapered to the inside. If the emergency release crank is not inserted until stop, the hexagon socket may be damaged. Fig.: 1 - 4 1- 6 Infusomat® Space P 5.0 EN System Overview 1 4. Turn the emergency release plug carefully with the emergency release crank through 90° to the right (clockwise in arrow direction) until stop and remove the plug out of the housing. 5. Insert the emergency release crank in the housing opening. The crank must be pushed in the hexagon socket of the lock bolt drive. CAUTION Do not turn the emergency release crank past the stop as this may damage the housing. Fig.: 1 - 5 6. Turn the emergency release crank to the right (clockwise according to arrow direction) until the operating unit is released and opens. Fig.: 1 - 6 EN Infusomat® Space P 5.0 1- 7 1 System Overview Fig.: 1 - 7 Block Diagram Infusomat® Space P 1- 8 Infusomat® Space P 5.0 EN System Overview Unit Software 1 Version History* 687B030001 - Basic software 687B030002 687B030003 687B030004 687C030001 - Dose calculation - Changed CAN log 687D030001 - Drug list data base - Changed user language 687E030002 - Improved functions - Piggyback - Softlimits 687F030006 - PCA function improvements 687G030002 - Improved functions 687H030002 - TCI 687J030003 - New therapies 687J030005 - Improved functions 687L030003 - Improved functions - Modified service connector detection 687L033001 (for China only) - Modified alerting 687M030001 - Improved functions * Not all software versions, hardware, or spare parts are available in all regions. Please consult your local B. Braun representative for availability. EN Infusomat® Space P 5.0 1- 9 1 System Overview Software Update of the Device The instructions for updating the software are supplied with the software itself. CAUTION Irreparable damage to a component of the device software may occur if the device is disconnected or the device or the PC is switched off during a software update. If this happens, it may no longer be possible to carry out the software update via the PC and the device will have to be sent to B. Braun. Service Program Approved Versions Note Please note that text and / or functions of the Service Program may change depending on the software version. The following screenshots are only examples and represent the state when the manual was printed. Version HiBaSeD for Device Software Versions 4.6.0. . . . . . . . . . . . . . . . . . . . . . . . . . . 687F030001 - 687F030006 5.0.0. . . . . . . . . . . . . . . . . . . . . . . . . . 687G030001 - 687G030001 5.0.1. . . . . . . . . . . . . . . . . . . . . . . . . . 687G030002 - 687G030002 6.0.0. . . . . . . . . . . . . . . . . . . . . . . . . . 687H030001 - 687H030001 6.1.0. . . . . . . . . . . . . . . . . . . . . . . . . . 687H030002 - 687H030002 7.4.38. . . . . . . . . . . . . . . . . . . . . . . . . . 687J030001 - 687J030006 8.0.1. . . . . . . . . . . . . . . . . . . . . . . . . . . 687L030001 - 687L070001 9.0.0. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687M030001 and higher Starting the Service Program Note Installation and further operation of the Service Program is described in its separate Instructions for Use. 1 - 10 Infusomat® Space P 5.0 EN System Overview 1 1. Start the “HiBaSeD.exe“ program (History, Barcode, Service, Drug list) on the PC. The Service Program is loaded and started and the initial window of the Service Program is displayed. 2. Read the notes carefully. 3. Mark the field “I accept all conditions” and then the field “Yes” to confirm that you have read the notes. Note Click the field “English” to switch the language of the notes over to English. Fig.: 1 - 8 4. Enter the password and confirm it by clicking the field “Start”. Fig.: 1 - 9 The Service Program checks the PC interfaces for connected devices of the Space system. Units that were found are displayed for a short moment on the screen. Fig.: 1 - 10 The work window of the Service Program appears on the screen. All devices recognized are listed in the left column. EN Infusomat® Space P 5.0 1 - 11 1 System Overview Fig.: 1 - 11 5. Activate the desired device from the list on the left in the work window with a double-click. The device data is then displayed below the device name. 1 - 12 Infusomat® Space P 5.0 EN System Overview 1 If the unit software version is not compatible with the Service Program version, a window opens prompting the operator to change the Service Program version. This window displays a compatibility list of the Service Program- and unit software versions. Fig.: 1 - 12 If the software was updated or the processor PCB was replaced you are prompted to enter the device type. You can select either the Infusomat® Space P or the Infusomat® Space S. Fig.: 1 - 13 The device type must be confirmed again. Fig.: 1 - 14 If the Service Program and the unit software are compatible, all the Service Program functions are activated. EN Infusomat® Space P 5.0 1 - 13 1 System Overview Fig.: 1 - 15 Service Program Version 1. Open the “HiBaSeD“ window via Help ➨ Info .... The current version of the Service Program is shown in this window. 2. Close the window by clicking “OK”. Fig.: 1 - 16 1 - 14 Infusomat® Space P 5.0 EN System Overview 1 Compatibility List 1. Open the “Unit - Compatibility“ window via Help ➨ Compatibility. This window displays the compatibility of the HiBaSeD-version and the unit software version. 2. Close the window by clicking “OK”. Fig.: 1 - 17 Quitting the Service Program EN Infusomat® Space P 5.0 1. Exit the Service Program via File ➨ Exit. 2. Disconnect a power supply which might be connected from the unit. 3. Switch off the unit. 4. Remove the battery module. 5. The device can be restarted after appr. 10 seconds. 1 - 15 1 System Overview Technical Data All technical data is indicated in the Instructions for Use. Options The functions of the individual options are detailed in the Instructions for Use. Infusomat® Space P Designation Part No. Power supply Euro . . . . . . . . . . . . . . . . . . . . . . 0871 3110A/B/C/D Power supply UK . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3111A/C/D Power supply USA / Japan . . . . . . . . . . . . . . . . . . 0871 3112A/C/D Power supply Australia . . . . . . . . . . . . . . . . . . . . . . 0871 3113A/D Power supply South Africa. . . . . . . . . . . . . . . . . . . . 0871 3115A/D Power supply India . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3116A Power supply China . . . . . . . . . . . . . . . . . . . . . . . . . .0871 3117A/D Power supply Denmark. . . . . . . . . . . . . . . . . . . . . . . . . 0871 3118D Power supply Brazil . . . . . . . . . . . . . . . . . . . . . . . . . .0871 3119A/D Power supply Korea . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3120A/D Power supply Euro 3.0 m . . . . . . . . . . . . . . . . . . . . . . . 0871 3123D Accessories Designation Part No. Charger SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3170 Battery charging station Connection cable staff call SP. . . . . . . . . . . . . . . . . . . . 0871 3232 Power supply cable 12 V . . . . . . . . . . . . . . . . . . . . . . . . 0871 3231 for ambulance vehicles CombiLead SP 12 V . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3133 Connection cable, pump - pump InterfaceLead SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3230 Interface cable CAN SP Drop sensor SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3175 PoleClamp SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3130 The PoleClamp is a holder for one or several Space system pumps. Short stand SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3135 1 - 16 Infusomat® Space P 5.0 EN System Overview Edit Functional test acc. to §5, Section 1, MPBetreibV (German Medical Devices Operator Ordinance)* Item This functional test is to be performed with every individual device prior to first use. OK 1. Completeness, Integrity 1.1 Instructions for Use is available. ❒ 1.2 Final Inspection Sheet is available. ❒ 1.3 1.4 1 Item OK 3. Functional Test (see Instructions for Use) 3.1 Open pump door, insert a primed line, close pump door. ❒ Not applicable. 3.2 Confirm line. ❒ No mechanical damage detected at Infusomat® Space ❒ P. 3.3 Deny priming. ❒ 3.4 Select rate 100 ml/h and start Infusomat® Space P. ❒ Green LED is shining, arrows are moving from right to left. 3.5 Give a bolus by pre selecting a volume of 3 ml – bolus ❒ will be delivered. 3.6 Close roller clamp – red LED lights up, alarm text is displayed. ❒ 3.7 Confirm alarm by pressing the OK button, open the roller clamp, and start Infusomat® Space P again. ❒ 3.8 Press Clear key - the main menu opens. ❒ 3.9 Press blue key – a screen message appears ❒ 1.5 Name plate. 1.6 Read serial number from name plate and note this be- ❒ low on this page. 1.7 Seal is fixed on device and is not damaged. ❒ ❒ 1.8 Infusomat® Space P is clean. ❒ 1.9 Battery is available and in place. ❒ 2. Switching on and Self Test 2.1 Switch on Infusomat® Space P (see Instructions for Use). ❒ 2.2 Display shows: “Self test active”. ❒ 2.3 Two signal tones are audible. ❒ 4. Finalize Test 2.4 LEDs flash alternately (yellow, red/green, blue). ❒ 4.1 2.5 Not applicable. Remove the line from Infusomat® Space P and dispose ❒ of it. Switch off Infusomat® Space P. 2.6 Is the battery charged? If not: Connect device to mains (see Instructions for Use). ❒ 4.2 Place instructions for use with the Infusomat® Space ❒ P. 2.7 Is the desired language correctly displayed? If not: Set ❒ language (see Instructions for Use). 4.3 Complete this form and file properly. ❒ 4.4 Also file the Final Inspection Sheet. ❒ Functional test performed on Infusomat® Space P with serial number by on (date). Infusomat® Space P has been handed out without any damage and in proper working order. Date Signature B. Braun Signature Hospital * Mandatory in some countries in which medical product laws apply, and strongly recommended in all other countries. EN Infusomat® Space P 5.0 1 - 17 1 System Overview For your notes: 1 - 18 Infusomat® Space P 5.0 EN 2 - 16 2- Alarms and Error Codes Unit Diagnosis / Calibration 2 The alarms of the Infusomat® Space P are classified in 5 categories. These categories are listed hereafter according to their importance. - Alarm advice In case of unacceptable inputs corresponding messages are displayed (e.g. “Caution! Rate out of range“, “The parameter cannot be changed“) and a beep sounds. - Pre-alarm Pre-alarms are triggered several minutes (depending on the service settings) before the operating alarms. - Reminder alarm A reminder alarm is triggered if the device is not operated for two minutes when input or operation was not finished. - Operating alarm In case of an operating alarm the infusion is stopped. An audible signal is released, the red LED flashes and a staff call is triggered. The message “Alarm” and the cause of the alarm appear on the display. - Device alarm The most important alarms and error codes as well as their meaning and possible fault clearance are specified in the following lists. EN Infusomat® Space P 5.0 2- 1 2 Unit Diagnosis / Calibration Alarms Alarm 1 Battery nearly discharged (type: prealarm) Possible Cause The device was not connected to the mains long enough Fault Clearance Connect device to the supply voltage via the AC adaptor plug. Start battery maintenance by pressing “OK”, if this message is displayed when the device is switched off. Note The following activity must not be carried out when a patient is connected to the unit. Operate the device with battery until the message “Battery discharged“ is displayed and the unit is switched off. Then connect the unit to the mains for at least 6 hours. The battery did not recharge due to con- Check connector P2 for corrosion and tact problems of connector P2 clean if necessary (see „Cleaning of the connector“ ➨ pg. 4 - 2). Replace if defective. 2 Battery discharged (type: operating alarm) Battery module defective or too old Replace battery module The device was not connected to the mains long enough Connect the unit to the mains for at least 6 hours The battery did not recharge due to con- Check connector P2 for corrosion and tact problems of connector P2 clean if necessary (see „Cleaning of the connector“ ➨ pg. 4 - 2). Replace if defective. 3 Battery cover open (type: operating alarm) Battery module defective Replace battery module ❒ The battery compartment cover is not correctly closed Insert the battery compartment cover correctly ❒ The magnet in the battery compart- Exchange the battery compartment cover ment cover is missing ❒ The battery compartment cover is Replace battery module not recognized by the battery module 4 Device alarm (type: device alarm) A serious internal fault was detected in the system Switch device off and on If the error persists, identify it and remedy it based on the error code lists. Table 2 - 1 Alarms 2- 2 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration 2 Error Codes of the Function Processor Error Code Definition 1 2001 ... 2013 Internal Error 2 2014 ... 2016 Loudspeaker 3 2017 KUP does not work Possible Cause Fault Clearance Loudspeaker connector Check the loudspeaker connector. Loudspeaker Check the loudspeaker. Software defective or obsolete Update software, change ISP processor PCB if necessary 4 2018 FUP-KUP OS Cycle Timeout Software defective or obsolete 5 2019 FUP Flash Memory Error Software defective or obsolete 6 2020 FUP different version KuP to FuP Software defective or obsolete 7 2021 FUP UPSTREAM TOO HIGH Upstream pressure sensor defective Replace upstream pressure sensor 8 2022 FUP UPSTREAM TOO LOW Upstream pressure sensor defective 9 2023 FUP DOWNSTREAM TOO HIGH Downstream pressure sensor defective 10 2024 FUP DOWNSTREAM TOO LOW Downstream pressure sensor defective 11 2025 FUP EA key closed too long Keyboard defective Exchange operating unit Replace downstream pressure sensor 12 2026 Internal Error 13 2027 ... 2033 FUP Airsensor FUP Temperature Sensors Air sensor defective Check ribbon cable of air sensor. Replace air sensor 14 2034 FUP CAN packet scheduler list failure CAN communication error Restart device 15 2035 Light barrier or motor defective/ Light barrier defective turn backwards Exchange processor PCB 16 2036 FUP Language Flash Memory Er- Language file faulty ror Update software 17 2037 FUP Language Version Error Language file faulty Update software 18 2038 Internal Error 19 2039 FuP collective CAN Alarm Two pumps with identical serial number in system Check and correct serial numbers. 20 2040 ... 2041 Internal error 21 2042 ... 2051 FUP Syncdata KuP 22 2052 ... 2053 Internal error 23 2060 ... 2085 TCI Error 24 2088 ... 2090 Internal error Error in synchronization with the control processor Error in relation to TCI therapy to- Restart the device, change settings gether with special settings slightly if necessary. If the error persists: Please load the history file via HiBaSeD and inform B. Braun Table 2 - 2 Error Codes of the Function Processor EN Infusomat® Space P 5.0 2- 3 2 Unit Diagnosis / Calibration Error Codes of the Control Microprocessor * Error Code Definition Possible Cause Fault Clearance 1 2100 Timebase too fast Quartz of the processor PCB Exchange processor PCB 2 2101 Timebase too slow Quartz of the processor PCB Exchange processor PCB 3 2102 Timebase failure Quartz of the processor PCB Exchange processor PCB 4 2103 Keyboard High Keyboard defective Exchange operating unit 5 2104 ON/OFF key pressed too long Keyboard defective Exchange operating unit 6 2105 No keydecode Keyboard defective Exchange operating unit 7 2106 ROM Romtest defective Software Update unit software 8 2107 ROM program defective 9 2108 FuP has not changed active reset value 10 2109 MPU_Test failed 11 2110 RAM_Test failed 12 2111* KUP active reset 13 2112 2114 Internal Error 14 2115 Drive too fast 15 2116 Drive too slow 16 2117 ... 2118 Internal Error 17 2119 LCD backlight on defective 18 2120 LCD backlight off defective 19 2121 Red LED on defective 20 2122 Red LED off defective 21 2123 Key pressed too long (without ON/OFF Keyboard defective key) 22 2124 ... 2127 Internal Error 23 2128 Drive motion incorrectly forward 24 2129 Drive motion incorrectly backward 25 2130 ... 2159 Internal Error 26 2160 ... 2162 PCA Error Error in relation to PCA therapy Restart the device, change settings slightly if necessary. If the error pertogether with special settings sists: Please load the history file via HiBaSeD and inform B. Braun 27 2170 ... 2173 DLOCK Error Error in relation to Datalock to- Restart the device, change settings gether with special settings slightly if necessary. If the error persists: Please load the history file via HiBaSeD and inform B. Braun Pump was not switched off cor- Restart device rectly Motor drive Exchange processor PCB Detection of direction of rotation LC display defective Exchange operating unit Exchange operating unit Motor drive Replace processor PCB Detection of direction of rotation Table 2 - 3 Error Codes of the Control Microprocessor (Part 1 of 3) * Note: If alarm 2111 occurs during infusion, the device history logs may not be retrievable. 2- 4 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration Error Code Definition Possible Cause 2 Fault Clearance 28 2180 ... 2184 DRUG Error DIFF Error 29 2199 ... 2200 Internal Error 30 2201 different version FuP to KuP Software Update unit software 31 2202 Stepper motor PH1A not 0 Stepper motor defective 32 2203 Stepper motor not low current Replace pump drive motor or processor PCB 33 2204 Stepper motor K_SM_CLK 34 2205 Stepper motor PH1A not 1 35 2206 Stepper motor not zero current 36 2207 Stepper motor not middle current 37 2208 Stepper motor not high current 38 2209 Stepper motor PH1A, PH1B, PH2A, PH2B not 0 39 2210 K_PKM_UB not off Lock bolt drive defective 40 2211 K_PKM_UB not on Replace lock bolt drive or processor PCB 41 2215 no V_MOT Processor PCB defective Replace processor PCB 42 2216 Overvoltage test failure 43 2217 no V_MOT 44 2218 Undervoltage test failure 45 2220 Door potentiometer defective Lock bolt drive (potentiometer) defective Replace lock bolt drive 46 2221 Locking bolt position failure Software defective or obsolete Perform calibration. Update software, change ISP processor PCB if necessary 47 2222 Temperature sensor difference Air sensor defective Replace air sensor 48 2223 Air sensor defective Compare air sensor version with disDisposable articles table for Space Line Neutrapur incompat- posable article table and import new ible with existing air sensor disposable article table, if necessary. (see „Rework when Replacing the Air Inline Sensor“ ➨ pg. 3 - 52) 49 2224 Rate compensation difference 50 2225 Rate compensation max value 51 2226 Rate compensation min value 52 2227 Received air data defective 53 2228 Temperature sensor switch defective Error in relation to dose calcula- Restart the device, change settings tion together with special set- slightly if necessary. If the error pertings sists: Please load the history file via HiBaSeD and inform B. Braun Air sensor defective Replace air sensor Rate compensation error Update unit software Air sensor defective Replace air sensor Table 2 - 3 Error Codes of the Control Microprocessor (Part 2 of 3) EN Infusomat® Space P 5.0 2- 5 2 Unit Diagnosis / Calibration Error Code Definition Possible Cause Fault Clearance 54 2230 Drive totphase is defective Software defective or obsolete Update software, change ISP processor PCB if necessary 55 2231 Temperature sensor defective Software defective or obsolete Update software, change ISP processor PCB if necessary 56 2236 ... 2255 Internal error 57 2260 ... 2389 TCI error Error in relation to TCI therapy together with special settings Restart the device, change settings slightly if necessary. If the error persists: Please load the history file via HiBaSeD and inform B. Braun 58 2290 ... 2301 Internal error 59 2320 ... 2328 RTM error Error in relation to Ramp and Tapper therapy together with special settings Restart the device, change settings slightly if necessary. If the error persists: please load the history file via HiBaSeD and inform B. Braun 60 2340 ... 2344 INTBOL error Error in relation to Interval Bolus Restart the device, change settings therapy together with special slightly if necessary. If the error persettings sists: Please load the history file via HiBaSeD and inform B. Braun 61 2360 ... 2363 PGM error Error in relation to Program Restart the device, change settings Mode therapy together with spe- slightly if necessary. If the error percial settings sists: Please load the history file via HiBaSeD and inform B. Braun 62 2380 63 2400 ... 2401 TOM error 64 2420 65 8000 ... 8049 TCI error Error in relation to TCI therapy together with special settings 66 8100 ... 8102 TOM error Error in relation to Take over Restart the device, change settings Mode together with special set- slightly if necessary. If the error pertings sists: Please load the history file via HiBaSeD and inform B. Braun 67 9000 ... 9999 Internal error Internal error Error in relation to Take over Restart the device, change settings Mode together with special set- slightly if necessary. If the error pertings sists: Please load the history file via HiBaSeD and inform B. Braun Internal error Restart the device, change settings slightly if necessary. If the error persists: Please load the history file via HiBaSeD and inform B. Braun Table 2 - 3 Error Codes of the Control Microprocessor (Part 3 of 3) 2- 6 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration CAN error states 2 Signalling of a CAN error In case of SW F, a faulty CAN bus is signalled by the blue LED at the pump flashing. The LED flashes at the following speeds: - 300 ms on, 300 ms off - 100 ms on, 100 ms off - 100 ms on, 100 ms off The process is then repeated. The blue LED flashes in the following states: Alarm Cause Fault Clearance 1 CAN lists for 2 seconds after pushing into Check that the pump is pushed in cora Station rectly 2 CAN_Lists because of duplicate address assignment Duplicate address assignment This state remains active until another device is recognised with its own slot address. 3 CAN dead because of duplicate INR Duplicate INR Eliminate the state by calibrating with HiBaSeD. The device is still ready for operation but without CAN communication. Table 2 - 4 Behaviour when an alarm occurs If continuous flashing occurs at the pump, the pump is fully operational with the exception of communication-dependent therapies. The following functions are no longer available in this state: EN Infusomat® Space P 5.0 - Signalling of the alarm states at the SpaceCover - Data communication with SpaceCom (no documentation for a PDMS) - Proposal data can no longer be received. - In case of a defective address assignment, communication with HiBaSeD is not possible until after plugging into a slot which is not defective. (In the case of duplicate serial number, HiBaSeD can contact the pumps in order to carry out calibration, see Section 6) - Future therapies, such as take-over, patient data, bar code and remote control function, will not be available either. 2- 7 2 Unit Diagnosis / Calibration Locating/eliminating communication problems If communication problems arise during operation of the pump in the SpaceStation, the blue LED on the pump will flash. If all pumps flash blue, this means that they are no longer communicating via CAN and are therefore not communicating with the SpaceCover either. 1. Disconnect the SpaceStation briefly from the mains supply and then reconnect. Check whether this action remedies the fault. 2. Check the display on the pumps. The display must be active on all the pumps (not dark), show the power-on symbol and be set to the same language. (If English appears instead of the set language, this means that the default data are loaded, which is an indication of a possible pump fault.) 3. Use the HiBaSeD with the CAN Box to check whether all pumps are signaling their presence. Move the pumps one after the other in the SpaceStation, including any interconnected SpaceStation modules. Check whether this causes communication to fail. 4. Remove all pumps with communication problems from the SpaceStation. If a pump flashes when it is removed from the SpaceStation, it needs to be calibrated; a serial number assigned twice will also cause the blue LED to flash. 5. Visually check connectors P2 (pump) and F2A - F2D (SpaceStation), and, where relevant, F3 - F5 (if several SpaceStation modules are used) on the affected pumps and slots on the SpaceStation. Clean if corroded or dirty (see „Cleaning of the connector“ ➨ pg. 4 - 2). Replace if any defect is visible (for example, bent contacts, if connectors F2A - F2D do not properly engage with the device). 6. Perform function check. If the communication fault persists: a) Perform test with one pump in the SpaceStation in the affected slots. If only one slot is affected by the fault, the SpaceStation is probably defective. b) Perform the same test with another pump in the SpaceStation. If the fault occurs again, the SpaceStation is probably defective, otherwise the first pump is defective. 2- 8 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration 2 c) If the fault does not occur with the first two pumps, test the other pumps affected by the communication problem on the same slot until you have found the defective pump. Eliminating the CAN-Dead state 1. Connect the HiBaSeD in order to eliminate the CAN-Dead state. 2. Carry out calibration. 3. Take particular care to enter the serial number correctly. Entering the states in the history In order to provide diagnostic information to service technicians, the various CAN states are entered in the history. They can then recognise, for example, whether there was a duplicate INR in the system or whether address assignment function of a Station is defective. The following history entry has to be evaluated for this purpose: History Entry Value Meaning Measure CAN Error Code 1 Duplicate serial number in the system Calibrate the device using HiBaSeD and check the serial number in the process. CAN Error Code 2 Duplicate address assigned in the sys- Check the SpaceStation tem Address assignment defective Table 2 - 5 EN Infusomat® Space P 5.0 2- 9 2 Unit Diagnosis / Calibration The Most Important Error Modes Error/Fault The following list specifies the most important error modes and their clearance. Possible Cause Fault Clearance 1 The battery module discharges too fast The device has not been used for some time. The battery module has not been discharged and charged regularly. 2 Sudden loss in capacity despite fully charged battery module Loss of contact between battery module ❒ Retrofit battery fastening (see „Retand battery contact strip rofitting of the battery fastening“ ➨ pg. 3 - 16) ❒ For unit software version J0300003, contact service hotline and perform a software update, when appropriate 3 Message "Battery does not exist" Loss of contact between battery module ❒ Retrofit battery fastening (see „Retrofitting of the battery fastening“ ➨ and battery contact strip pg. 3 - 16) 4 Noises while opening or closing the oper- Defective toothed wheels in lock bolt ating unit drive ❒ Replace lock bolt drive 5 Device alarm 2027 Air sensor defective ❒ Exchange air sensor 6 Device alarms 2021 ... 2022 Upstream pressure sensor defective ❒ Replace upstream pressure sensor 7 Device alarms 2023 ... 2024 Downstream pressure sensor defective ❒ Replace downstream pressure sensor 8 Device alarm 2111 Loss of contact between battery module ❒ Retrofit battery fastening (see „Retand battery contact strip rofitting of the battery fastening“ ➨ pg. 3 - 16) 9 Device alarm 2119 Manufacturing tolerance of LC display too large ❒ Discharge and charge battery module several times. ❒ Replace battery module ❒ Replace LC display Table 2 - 6 Calibration Starting Calibration Note Calibration must be carried out with power supply connected, since the calibration can be interrupted suddenly if the unit is battery operated and the battery becomes discharged so that the device is switched off. Note Please note that text and / or functions of the Service Program may change depending on the software version. The following 2 - 10 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration 2 screenshots are only examples and represent the state when the manual was printed. 1. Start the Service Program (see „Starting the Service Program“ ➨ pg. 1 - 10). 2. Select the tab "Calibration". 3. Press the "New device" or "Modify" command button in the "Calibration procedure" group box (depending on the desired calibration scope). The device is switched on. Fig.: 2 - 1 Note "New device" initiates a complete calibration. With “Modify”, you can select the desired calibration steps yourself. EN Infusomat® Space P 5.0 2 - 11 2 Unit Diagnosis / Calibration 4. If requested by the device, enter the date and time. 5. Select a language from the list in the device and confirm your selection by using the "OK" key on the device. The "Worker ID" window opens. Note Fig.: 2 - 2 If you have not been allocated a user number (Worker ID), enter "0001". 6. Enter your user number in the window “Worker ID” as well as the six-digit serial number of the device, if necessary. 7. Confirm the entry with “OK“. The “Data selection” group box is now activated. Fig.: 2 - 3 Note If HiBaSeD could not clearly read the device serial number, the number on the rating plate must be entered. Fig.: 2 - 4 2 - 12 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration 8. 2 If HiBaSeD could not clearly read the device type, you are prompted to select a type. Select the device type by clicking the flag with the mouse. Note The device type can be specified via the article number. This article number is indicated on the rating plate. 9. Click the “OK“ button. You are prompted to confirm your selection again. Fig.: 2 - 5 10. Click the “OK“ button. Fig.: 2 - 6 EN Infusomat® Space P 5.0 2 - 13 2 Unit Diagnosis / Calibration Fig.: 2 - 7 11. Start calibration with the “OK“ button. You are prompted to press the blue connection key on the device. 12. Press the blue connection key. All device data are read out and stored in the PC. The “Lock bolt calibration” group box is now activated. The lock bolt is moved into the open position. Fig.: 2 - 8 2 - 14 Infusomat® Space P 5.0 EN Unit Diagnosis / Calibration 2 13. Check the position of the lock bolt in the device. The lock bolt lugs must not be visible in the three openings. It must be possible to tilt the operating unit almost as far as the closed position (gap between upper edge of the operating unit and upper edge of the housing top is about 5 mm). Fig.: 2 - 9 14. Check the gap and confirm the lock bolt position by pressing the “Yes” button. The lock bolt automatically closes. 15. Check the position of the lock bolt in the device. The lock bolt lugs are visible in the three openings. It must not be possible to tilt the operating unit as far as the closed position (gap between upper edge of the operating unit and upper edge of the housing top is about 10 mm). Fig.: 2 - 10 16. Check the gap and confirm the lock bolt position by pressing the “Yes” button. The lock bolt is moved into the open position. 17. After calibration you are prompted to switch the device off. Disconnect all connectors from the device. 18. Switch the device off (without connection to the power supply) and press the “OK” button. Fig.: 2 - 11 EN Infusomat® Space P 5.0 2 - 15 2 Unit Diagnosis / Calibration 19. At the end of calibration the result with all the values is displayed in the “Calibration process completed successfully” group box and the data are stored in the unit. This report can be printed out by pressing the “Print” button. Fig.: 2 - 12 20. Calibration is terminated with “OK”. Fig.: 2 - 13 2 - 16 Infusomat® Space P 5.0 EN 3 - 58 3- 3.1 General Disassembly / Assembly 3 Remarks on Disassembly / Assembly Before each disassembly and assembly of a unit subsystem check the connectors, plug contacts and connections for corrosion and tight fit. The necessary steps to disassemble the complete unit, all its subsystems and spare parts are detailed in the following description. Steps that are not necessary can be skipped. Before disassembling the unit make sure that no tubes/lines are inserted in the unit and that the operating unit is in the open position. CAUTION Always remove the battery module before opening the device in order to avoid a short-circuit. Note Plastic thread-forming screws are used in this device. These are special screws for plastic housings. Pay attention to the corresponding notes when you fit the screws. EN Infusomat® Space P 5.0 3- 1 3 Disassembly / Assembly Preparations for Exchanging the Processor PCB If the processor PCB is to be replaced, a back-up of the pump settings is to be carried out, if this is still possible. Note Please note that text and / or functions of the Service Program may change depending on the software version. The following screenshots are only examples and represent the state when the manual was printed. 1. Start the Service Program (see „Starting the Service Program“ ➨ pg. 1 - 10). Fig.: 3 - 1 2. Select the tab “Modification data”. 3. Press the „From device“ button. The data are read from the device and shown on the display. 3- 2 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 Fig.: 3 - 2 4. Select the tab “IO“ and actuate the “To device“ button. In the window that now opens you are asked for the storage position of the file on the PC hard disk and the file name. Note The suggested storage position should not be changed. EN Infusomat® Space P 5.0 3- 3 3 Disassembly / Assembly 5. Enter a unique file name. 6. Press the "Save" command button. The data of the pump are stored on the hard disk of the PC. Fig.: 3 - 3 7. Activate the "Print" command button in order to send the data of the device to a printer as required. Fig.: 3 - 4 3- 4 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 8. Select the tab “Disposable article”. 9. Press the “From device“ button. The data are read from the device. Fig.: 3 - 5 The data of the disposable articles are displayed on screen. EN Infusomat® Space P 5.0 3- 5 3 Disassembly / Assembly Fig.: 3 - 6 10. Press the “Save as“ button. In the window that now opens you are asked for the storage position of the file on the PC hard disk and the file name. 11. In the “Save file as” window, select the storage position and enter a unique file name. Note The suggested storage position should not be changed. 12. Press the "Save" command button. The data of the pump are stored on the hard disk of the PC. 13. Exit the Service Program (see „Quitting the Service Program“ ➨ pg. 1 - 15). Fig.: 3 - 7 3- 6 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 Note Once the new processor PCB has been installed, the saved data must be transferred back to the device (see „Processor PCB“ ➨ pg. 3 - 41). Service Parts and Screw Kit All small parts, such as cover caps, are contained in an Infusomat® Space P service part kit. Some of the service parts can also be ordered separately in service packs. Designation Order No. Service part kit Infusomat® Space . . . . . . . . . . . . . . . . 3452 1593 contains: Housing cover cap (100 pieces) Plug D=4mm for front flap hinge (5 pieces) Cap for housing upper part (access to pressure adjustment) (2 pieces) Housing foot SP (10 pieces) Snap-in hook SP with leaf spring (2 pieces) Emergency release plug ISP incl. O-ring (2 pieces) Emergency release crank ISP (1 piece) Bracket locking (20 pieces) Seal washer PA 2.2x4x0.3 (200 pieces) Safety clamp seal, housing bottom part (10 pieces) Injection intermediate piece (air inline sensor test) (2 pieces) Cover cap kit for housing SP (50 pieces) . . . . . . . . . . . 3477 4386 Emergency release plug ISP (10 pieces) . . . . . . . . . . . 3477 3101 Connector P2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4355 Connector P3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4359 Gasket P2 and P3 SP (10 pieces each) . . . . . . . . . . . . . 3477 4357 Connector seal P2 SP (5 pieces) . . . . . . . . . . . . . . . . . . 3477 3102 Repair kit Power Supply P2 small . . . . . . . . . . . . . . . . .3477 4311 contains: Cable repair kit (10 pieces) Spacer sleeve 6.2x10x50 (12 pieces) Shrink tubing small/black (44 pieces) Shrink tubing small/white (12 pieces) Shrink tubing large/white (12 pieces) EN Infusomat® Space P 5.0 3- 7 3 Disassembly / Assembly Designation Order No. Grease for Infusomat® Space P Polylub GLY 501. . . . . 3452 1570 Housing foot SP (20 pieces) . . . . . . . . . . . . . . . . . . . . . 3477 3106 Space sticker set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 0969 contains: Temperature sticker Space Sticker “Slide guide missing” Sticker “Insert slide clamp” Sticker “Insert tube correctly” Sticker Space P “Insert tube” Sticker “Emergency unlock short instructions” Sticker “Correct syringe position” Instruction plate Space Station All screws used in the device are included in an Infusomat® Space P screw kit. Designation Order No. Screw kit Infusomat® Space . . . . . . . . . . . . . . . . . . . . . 3452 1585 contains: Screw DELTA PT 22x8 WN 5451 TORX plus 6IP (5 pieces) Screw DELTA PT 25x7 WN 5451 TORX plus 8IP (5 pieces) Screw DELTA PT 30x8 WN 5452 TORX plus 10IP (10 pieces) Screw DELTA PT 30x12 WN 5452 A2 TORX plus 10IP (10 pieces) Countersunk screw DELTA PT 20x9 WN 5454 TORX plus 6IP (5 pieces) Fillister head screw M3x6 TORX Fillister head screw M3x10 Countersunk screw M3x5 TORX Countersunk screw M3x12 A2 TORX Hexagon nut M3 A2 Toothed locked washer M3 A2 Distance sleeve 3- 8 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.2 Slide Guide Designation 3 Order No. Slide guide ISPP, compl. . . . . . . . . . . . . . . . . . . . . . . . . 3452 1500 Disassembly 1. Remove slide guide (Fig.: 3 - 8 / Item 2) together with the 12 pump slides carefully out of the housing front panel. Note The slide guide can be prised out with a pointed object through a notch (Fig.: 3 - 8 / Item 1) in the housing front panel on the right lower side next to the slide guide. 2 1 Fig.: 3 - 8 Legend of fig. 3 - 8: Item Designation 1 Notch 2 Slide Guide EN Infusomat® Space P 5.0 3- 9 3 3.3 Disassembly / Assembly Cover for Drop Sensor Connector Designation Order No. Cover, drop sensor connector . . . . . . . . . . . . . . . . . . . . 3452 1577 1 Disassembly 1. Carefully remove the cover (Fig.: 3 - 9 / Item 1) for the drop sensor connector from the rear to the front and out of the housing. Note Be careful not to damage the lugs in the housing bottom and upper part. Fig.: 3 - 9 Legend of fig. 3 - 9: Item Designation 1 Cover for drop sensor connector 3.4 Emergency Release Plug Designation Order No. Emergency release plug ISP incl. O-ring (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Disassembly 1. Turn the emergency release plug (Fig.: 3 - 10 / Item 1) using a spanner, e.g. the emergency release crank in the battery compartment cover, through 90° to the right and pull the plug out of the housing. Note 1 The spanner must be pressed carefully until stop in the opening of the emergency release plug. The hexagon socket of the emergency release plug tapers to the inside to guarantee a certain bond when the plug is removed. Fig.: 3 - 10 Legend of fig. 3 - 10: Item Designation 1 Emergency Release Plug 3 - 10 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.5 Unit Foot Designation 3 Order No. Unit foot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 3106 (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Disassembly 1. Pull the unit foot (Fig.: 3 - 11 / Item 1) out of the housing. 1 Fig.: 3 - 11 Legend of fig. 3 - 11: Item Designation 1 Unit foot EN Infusomat® Space P 5.0 3 - 11 3 3.6 Disassembly / Assembly Battery Module Designation 1 Order No. Battery compartment cover ISP, cpl. . . . . . . . . . . . . . . 3452 1321 (incl. emergency release crank) Battery module SP (NIMH), without fixing pin . . . . . . 3452 0856 Battery module SP (NIMH), with fixing pin* . . . . 3452 0856A Battery module SP (Li-ion) with WLAN and fixing pin . . . . . . . . . . . . . . . . . . . 8713182A Note 2 Users are informed as follows: If a Infusomat® Space P pump running from battery only and showing full battery charge stops while the operating unit is closing and triggers an alarm, the user must remove the pump from use and return it to the Medical Engineering Department for replacement of the battery. In this case the battery must be replaced regardless of its age or any further tests. Disassembly 1. Press the lock (Fig.: 3 - 12 / Item 2) on the battery compartment cover (Fig.: 3 - 12 / Item 1) with a pointed tool and remove the battery compartment cover. Fig.: 3 - 12 Legend of fig. 3 - 12: Item Designation 1 Battery compartment cover 2 Lock for battery compartment cover * The new battery module, Article number 34520856A, is not downwards compatible. Please only use for devices with a new battery contact strip. Further information is available on request. 3 - 12 Infusomat® Space P 5.0 EN Disassembly / Assembly 2. 1 3 3 Lift the lock (Fig.: 3 - 13 / Item 3) on the battery module (Fig.: 3 - 13 / Item 1) and remove the battery module from the device. 2 Fig.: 3 - 13 Legend of fig. 3 - 13: Item Designation 1 Battery module 2 Battery compartment cover 3 Battery module lock EN Infusomat® Space P 5.0 3 - 13 3 Disassembly / Assembly Conversion, Retrofitting kits, and Spare Part Battery Contact Strip Designation Order No. Retrofitting kit battery fastening . . . . . . . . . . . . . . . . . 3452 1365 sufficient for 10 devices free delivery Spare part battery contact strip . . . . . . . . . . . . . . . . . . 3452 1362 consisting of: Battery contact strip with fixing hole and connecting PCB Conversion kit Infusomat® Space . . . . . . . . . . . . . . . . 3452 1361 solely for helicopter use consisting of: Battery contact strip with fixing hole and connecting PCB Housing upper part Battery module with fixing pin Battery compartment cover Note Although our infusion pumps meet all the requirements for protection against vibrations in accordance with EN 13718-1:2002, our market observation has revealed sporadic wear of the battery contacts on older Space infusion pumps. This applies only to devices up to Serial Number 83672 in the original state whose housing has not been replaced yet. 3 - 14 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 The following hardware versions of the battery module and of the battery contact strip exist: Old Version New Version Battery contact strip, without fixing hole Battery contact strip with fixing hole Battery module without fixing pin Battery module with fixing pin Top housing section, right, without fastening ribs Top housing section, right, with fastening ribs Top housing section, left, without fastening ribs Top housing section, left, with fastening ribs EN Infusomat® Space P 5.0 3 - 15 3 Disassembly / Assembly The following combinations are not compatible: - Battery module with fixing pin and battery contact strip without fixing hole - Top housing section with fastening ribs and additional bonding segments - Bonding segments in connection with a battery with fixing pin and a battery contact strip with fixing hole Retrofitting of the battery fastening Note The service technician bears the responsibility for correct execution of the repair work. A special retrofitting kit has been developed for an improved battery fixation. It contains a number of bonding segments that are bonded into the battery compartment of the Space infusion pumps. Immediate retrofitting is not necessary if the pump does not show any wear of the battery contacting. However we recommend that the retrofitting kit is fitted during the regular check every two years (TSC). 2 1 1. Remove the battery compartment cover (Fig.: 3 - 14 / Item 1) and remove the battery module (Fig.: 3 - 14 / Item 2). Fig.: 3 - 14 Legend of fig. 3 - 14: Item Designation 1 Battery compartment cover 2 Battery module 3 - 16 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 2. In order to retrofit the top housing section, clean the bonding areas (Fig.: 3 - 15 / Item 1) with isopropanol and let them air. 3. Position the bonding segments in the battery compartment using a scalpel. 4. Bond in the segments (5x) in the positions shown. 5. After bonding, press on the segments in order to avoid bubbling. Fig.: 3 - 15 Legend of fig. 3 - 15: Item Designation 1 Bonding areas 1 2 2 3 3 Fig.: 3 - 16 Legend of fig. 3 - 16: Item Designation 1 Position of top segment 2 Position of side wall segments 3 Position of bottom segments EN Infusomat® Space P 5.0 3 - 17 3 Disassembly / Assembly 6. If the retrofitting kit is used, replace the battery slide on the battery module (nominal dimension after replacement: 2.15 mm ±0.15 mm). 7. Clean the bonding areas with isopropanol and let them air. 8. Position the removal aid (Fig.: 3 - 17 / Item 1) over the fixation (Fig.: 3 - 17 / Item 2) and move it. 1 2 9. Press the removal aid onto the battery bottom in order to avoid bubbling during bonding. Fig.: 3 - 17 Legend of fig. 3 - 17: Item Designation 1 Removal aid 2 Fixation 10. After retrofitting, reinsert the battery module and place on the battery compartment cover. 11. Carry out a function test (in battery operation). - 3 - 18 Set the max. pump rate (duration of pump operation approx. 1 min). During pump operation simulate a vibratory load on the pump (shaking). Infusomat® Space P 5.0 EN Disassembly / Assembly 3.7 Housing Upper Part Designation 3 Order No. Housing upper part ISP . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1313 Screws and cover caps (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Note Please pay attention to the corresponding notes during assembly and installation (see „Housing Upper Part“ ➨ pg. 3 - 46). Disassembly 1. Pierce 6 cover caps (Fig.: 3 - 18 / Item 1) with a small screwdriver and prise out the cover caps. 2. Unscrew 6 screws (Fig.: 3 - 18 / Item 2). 1 2 Note The other 4 cover caps on the housing bottom side must not be removed during this disassembly state. Fig.: 3 - 18 Legend of fig. 3 - 18: Item Designation 1 Cover cap 2 Screw DELTA PT 30x12 WN 5452 A2 TORX plus 10IP EN Infusomat® Space P 5.0 3 - 19 3 Disassembly / Assembly 1 3. Loosen the snap-on mechanism of the housing upper part (Fig.: 3 - 19 / Item 1) carefully. To do so, a screwdriver can be inserted in the two openings between the housing front panel and the housing top. Note It is also possible to remove the housing upper part by gripping into the battery compartment and tilting the upper part forward. 4. Remove the housing upper part vertically to the top. Note Fig.: 3 - 19 Legend of fig. 3 - 19: Item Designation 1 Pay attention to the length of the connection cable to the battery compartment and to the connectors P2 and P3 when dismounting the housing. Do not pull the connectors together with the upper part out of the bottom part. Pay special attention to the loudspeaker and the length of the connection cable to the battery compartment. Snap-on openings 3 - 20 Infusomat® Space P 5.0 EN Disassembly / Assembly 5. 1 3 Unscrew two screws and remove the contact strip (Fig.: 3 20 / Item 3) to the battery compartment together with the connection cable out of the housing upper part (Fig.: 3 - 20 / Item 1). Note If necessary, the spring-mounted contact pins must be carefully pressed in when the contact strip is removed. 3 2 Fig.: 3 - 20 Legend of fig. 3 - 20: Item Designation 1 Housing upper part 2 Screw DELTA PT 25x7 WN 5451 TORX plus 8IP 3 Contact strip EN Infusomat® Space P 5.0 3 - 21 3 3.8 Disassembly / Assembly Housing Bottom Part Designation Order No. Loudspeaker SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 0937 Housing bottom part ISP . . . . . . . . . . . . . . . . . . . . . . . 3452 1305 1 Rating plate ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . On request Snap-in hook SP with leaf spring (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Screws and cover caps (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Note Please pay attention to the corresponding notes during assembly and installation (see „Housing Bottom Part“ ➨ pg. 3 - 45). 2 Disassembly 1. Remove the drop sensor connector (not depicted) from the housing bottom part (Fig.: 3 - 21 / Item 3). Note The drop sensor connector is integrated in the processor PCB. 3 4 6 2. Pierce four cover caps (Fig.: 3 - 21 / Item 5) with a small screwdriver and pry the cover caps out. 3. Unscrew three screws (Fig.: 3 - 21 / Item 6) and one screw (Fig.: 3 - 21 / Item 4). 4. Take off the housing bottom part. 5 Fig.: 3 - 21 5. Pull the loudspeaker connector off (Fig.: 3 - 21 / Item 2) the processor PCB and remove the loudspeaker. 6. Pull the snap-in hook (Fig.: 3 - 21 / Item 1) out of the housing bottom part. Legend of fig. 3 - 21: Item Designation 1 Snap-in hook 2 Loudspeaker 3 Housing bottom part 4 Screw DELTA PT 30x12 WN 5452 A2 TORX plus 10IP 5 Cover cap 6 Screw DELTA PT 30x8 WN 5452 A2 TORX plus 10IP 3 - 22 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.9 Inner Frame and Housing Front Panel Designation 3 Order No. Screws (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Note Please pay attention to the corresponding notes during assembly and installation (see „Inner Frame and Housing Front Panel“ ➨ pg. 3 - 44). Disassembly Note When dismounting the inner frame and the housing front panel please pay attention to the length of the connection cables to the processor PCB. 1 2 3 7 4 5 1. Fold the locking of the ribbon cable connector (Fig.: 3 - 22 / Item 4) to the air inline sensor up and pull the ribbon cable off the connector. 2. Pull the safety clamp connector (Fig.: 3 - 22 / Item 5) off the processor PCB. 3. Pull the pump drive connector (Fig.: 3 - 22 / Item 6) off the processor PCB. 6 Fig.: 3 - 22 Legend of fig. 3 - 22: Item Designation 1 Connector for ribbon cable, operating unit 2 Lock bolt drive connector 3 Pressure sensor connector, downstream 4 Air inline sensor connector 5 Safety clamp connector 6 Pump drive connector 7 Pressure sensor connector, upstream EN Infusomat® Space P 5.0 3 - 23 3 Disassembly / Assembly 4. Loosen four screws (Fig.: 3 - 23 / Item 2)and lift the inner frame together with the housing front panel from the bottom inner frame(Fig.: 3 - 23 / Item 6). 5. Unscrew one screw (Fig.: 3 - 23 / Item 5) and remove the PCB of the direction of rotation sensor for the pump drive from the pump frame. 1 2 3 4 Note The PCB of the direction of rotation sensor is connected to the processor PCB via the ribbon cable. 6. Pull the lock bolt drive connector (Fig.: 3 - 22 / Item 2) off the processor PCB. 7. Pull the pressure sensor connector, upstream (Fig.: 3 - 22 / Item 7) off the processor PCB. 2 8. Pull the pressure sensor connector, downstream (Fig.: 3 - 22 / Item 3) off the processor PCB. 6 5 Fig.: 3 - 23 Legend of fig. 3 - 23: Item Designation 1 Housing front panel, cpl. 2 Fillister head screw M3x6 TORX 3 Inner frame, cpl. 4 PCB of direction of rotation sensor 5 Screw DELTA PT 25x7 WN 5451 TORX plus 8IP 6 Bottom inner frame Disassembly 1. Carefully remove the inner frame (Fig.: 3 - 23 / Item 3) from the housing front (Fig.: 3 - 23 / Item 1) panel. Note The membrane in the housing front panel must not be used again. Always use a new membrane for assembly. 3 - 24 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.10 Inner frame Designation 3 Order No. Lock bolt drive ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1429 Linear poti ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1056 Pressure adjustment unit ISPS . . . . . . . . . . . . . . . . . . . 3452 1445 (spring holder, pressure springs, adjusting screw adjusting nut, bracket, bracket locking) Pump frame ISP, without motor . . . . . . . . . . . . . . . . . 3452 1402 Pump drive motor ISP . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1410 Lock bolt ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1496 Inner frame ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1437 Bracket locking and screws (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Note Please pay attention to the corresponding notes during assembly and installation (see „Inner Frame“ ➨ pg. 3 - 42). Disassembly 1. Carefully press two bracket lockings (Fig.: 3 - 24 / Item 10) at the front and rear out of the inner frame (Fig.: 3 - 24 / Item 3). * 2. Push the bracket (Fig.: 3 - 24 / Item 6) forward against spring tension, unhook from the inner frame and remove it together with the pressure adjustment unit (Fig.: 3 - 24 / Item 7). 3. Press the pump frame guide (6 mm straight pin) (Fig.: 3 - 24 / Item 8) in longitudinal direction out of the linear bearings of the pump frame and the inner frame holders and remove the pump frame from the inner frame. * EN Infusomat® Space P 5.0 Do not reuse the bracket lockings 3 - 25 3 Disassembly / Assembly 2 1 3 10 4 5 6 9 8 7 Fig.: 3 - 24 Legend of fig. 3 - 24: Item Designation 1 Lock bolt 6 Bracket 2 Countersunk screw M3x5 TORX 7 Pressure adjustment unit 3 Inner frame 8 Pump frame 4 Lock bolt drive 9 Guide (6 mm straight pin) 5 Linear potentiometer with cable loom 10 Bracket locking 3 - 26 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 4. Unscrew one screw (Fig.: 3 - 25 / Item 1), turn the pump drive motor (Fig.: 3 - 25 / Item 2) clockwise out of the holder and remove it from the pump frame. 5. Move the lock bolt drive by hand in the middle position. 6. Unscrew two screws (Fig.: 3 - 24 / Item 2) and pull the lock bolt drive (Fig.: 3 - 24 / Item 4) off the lock bolt tappet (Fig.: 3 - 24 / Item 1). Note The lock bolt drive is slightly engaged when installed. When dismantling the drive make sure that the toothed wheels do not rub along the metal edges of the inner frame as the toothed wheels can easily be damaged. The toothed wheels are very easily damaged. 2 1 Fig.: 3 - 25 Legend of fig. 3 - 25: Item Designation 1 Screw DELTA PT 30x8 WN 5452 TORX plus 10IP 2 Pump drive motor EN Infusomat® Space P 5.0 7. Lift the claw on the right side and push it to the left until the guide rivet is exactly positioned in the mounting hole of the lock bolt. 8. Lift the lock bolt over the guide rivet of the inner frame. 3 - 27 3 Disassembly / Assembly ! WARNING Injuries through hot soldering iron tip and development of dangerous vapours! RISK OF INJURY AND POISONING! - 1 Have soldering work carried out only by trained and authorised persons and in suitable premises. 9. Unsolder the two connection leads (Fig.: 3 - 26 / Item 2) at the pump drive motor (Fig.: 3 - 26 / Item 3). 10. Pull the linear potentiometer carefully out of the lock bolt drive. Note The linear potentiometer is held in the lock bolt drive by two top snap-in pins. 3 2 Fig.: 3 - 26 Legend of fig. 3 - 26: Item Designation 1 Locking opening for snap-in pins 2 Connection leads to the pump drive motor 3 Pump drive motor 3 - 28 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.11 Housing Front Panel Designation 3 Order No. Membrane ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1356 Pressure sensor ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1372 Air inline sensor ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1380 Ribbon tape air inline sensor ISP (10 pieces) . . . . . . . . 3477 4356 Safety clamp ISPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1526 Front frame ISPS, cpl. . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1518 Screws (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Instructions on Replacing the Air Inline Sensor Two versions of the air inline sensor exist. If the old version of the air inline sensor is replaced with the new version, a new disposable article table must be imported. 1. Before installing the new air inline sensor, check its serial number (Fig.: 3 - 27 / Item 1). New versions of the air inline sensor bear the serial number 248223 and higher. 1 Note 2 Do not confuse the serial number of the new air inline sensor with the serial number of the spare part (Fig.: 3 - 27 / Item 2). 2. Fig.: 3 - 27 Legend of fig. 3 - 27: 1 Serial number of the air inline sensor 2 Serial number of the spare part EN Infusomat® Space P 5.0 After completing installation, compare the version of the air inline sensor with the stored disposable article table and import the new table, if necessary. (see „Rework when Replacing the Air Inline Sensor“ ➨ pg. 3 - 52) 3 - 29 3 Disassembly / Assembly Disassembly 1 2 4 3 1. Press the membrane out of the housing front panel. 2. Unscrew two screws and remove the pressure sensor, upstream from the housing front panel. 3. Unscrew two screws and remove the pressure sensor, downstream from the housing front panel. 4. Unlock two lugs of the air inline sensor carefully and remove the air inline sensor from the housing front panel. 5. Open the safety clamp with the operating lever and engage. 6. Unscrew two screws and remove the safety clamp from the housing front panel. Note The safety clamp must not be disassembled further. 8 7 6 5 Fig.: 3 - 28 Legend of fig. 3 - 28: Item Designation 1 Safety clamp 2 Screw DELTA PT 22x8 WN 5451 TORX plus 6IP 3 Pressure sensor, downstream 4 Screw DELTA PT 25x7 WN 5451 TORX plus 8IP 5 Pressure sensor, upstream 6 Front frame 7 Membrane 8 Air inline sensor 3 - 30 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.12 Operating Unit Designation 3 Order No. Operating unit ISPS, cpl. . . . . . . . . . . . . . . . . . . . . . . . . 3452 1534 LC display SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 0988 Metal front sheet, Outsert ISPP . . . . . . . . . . . . . . . . . . 3452 1542 Axle ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1461 (incl. hinge covers and hinge spring) Screws (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) Note Please pay attention to the corresponding notes during assembly and installation (see „Operating Unit“ ➨ pg. 3 - 41). Assembly / Disassembly 1 1. Push the right and left connector lock (Fig.: 3 - 29 / Item 2) on the processor PCB carefully to the rear. 2. Disconnect the operating unit connection cable (Fig.: 3 - 29 / Item 1) from the processor PCB. 2 Fig.: 3 - 29 Legend of fig. 3 - 29: Item Designation 1 Operating unit connection cable 2 Connector lock EN Infusomat® Space P 5.0 3 - 31 3 Disassembly / Assembly 1 3. Unscrew 6 screws (Fig.: 3 - 30 / Item 1) and remove the seal washers (Fig.: 3 - 30 / Item 2) from the operating unit rear panel (metal front sheet, Outsert) (Fig.: 3 - 30 / Item 3). 2 Note The screws of the keyboard must not be loosened. A uniform pressure point of all keys is only guaranteed when a special tool is used for assembly. 4. Remove the operating unit (Fig.: 3 - 30 / Item 5)from the rear panel (metal front sheet, Outsert). Note Please pay attention to the ground connection(Fig.: 3 - 30 / Item 4) on the keyboard PCB during disassembly. 3 5 4 Fig.: 3 - 30 Legend of fig. 3 - 30: Item Designation 1 Countersunk screw EJOT 20x9 WN 5454 TORX plus 6IP (tighten finger tight) 2 Seal washer PA 2.2x0.3 3 Operating unit rear panel (metal front sheet, Outsert) 4 Ground connection 5 Operating unit with LC display 3 - 32 Infusomat® Space P 5.0 EN Disassembly / Assembly 1 3 5. Open the connector lock (Fig.: 3 - 31 / Item 2) on the keyboard PCB. 6. Pull the LC display ribbon cable (Fig.: 3 - 31 / Item 1) out of the connector. 7. Lift the LC display (Fig.: 3 - 32 / Item 1) out of the operating unit front panel (Fig.: 3 - 32 / Item 4) . 2 Fig.: 3 - 31 Legend of fig. 3 - 31: Item Designation 1 Ribbon cable 2 LC display connection cable lock 1 Note The keyboard screws (Fig.: 3 - 32 / Item 3) must not be loosened. A special procedure is required to install the keyboard, so that a uniform pressure point is guaranteed for all keys. 2 4 3 Fig.: 3 - 32 Legend of fig. 3 - 32: Item Designation 1 LC display 2 Axle mounting plug 3 Keyboard screws 4 Front side, operating unit with keyboard EN Infusomat® Space P 5.0 3 - 33 3 Disassembly / Assembly 2 3 8. Pull the left (Fig.: 3 - 33 / Item 1) and right hinge cover (Fig.: 3 - 33 / Item 4) off the axle (Fig.: 3 - 33 / Item 6). 4 9. Press the axle out of the operating unit rear panel (Fig.: 3 33 / Item 7), the bottom inner frame (Fig.: 3 - 33 / Item 5), from the hinge cover, spring (Fig.: 3 - 33 / Item 2), the hinge cover, cable (Fig.: 3 - 33 / Item 3) and the hinge spring (Fig.: 3 - 33 / Item 8). 1 5 8 7 6 Fig.: 3 - 33 Legend of fig. 3 - 33: Item Designation 1 Hinge cover, left 2 Hinge cover, spring 3 Hinge cover, cable 4 Hinge cover, right 5 Bottom inner frame 6 Axle 7 Operating unit rear panel 8 Hinge spring 3 - 34 Infusomat® Space P 5.0 EN 3 Disassembly / Assembly Repairing Metal Front Sheet, Outsert ISPP Designation Order No. Front flap sealing strip. . . . . . . . . . . . . . . . . . . . . . . . . . On request 1. 1 Loosen the six screws. The screws can be reused, but use new sealing disks. Note The keyboard screws (Fig.: 3 - 32 / Item 3) must not be loosened. A special procedure is required to install the keyboard, so that a uniform pressure point is guaranteed for all keys. Fig.: 3 - 34 Legend of fig. 3 - 34: Item Designation 1 2. Open the rear wall of the operating unit carefully (silicone seal). Pay attention to the chassis earth of the keyboard circuit board. 3. Ensure that the flexible strip is not damaged. 4. If the silicone seal is damaged, remove the loose residues. 5. Bend the earthing wire upward. 6. Fold up the bonded protection at the sealing strip for the front hood at both ends approx. 1 cm. 7. First bond the sealing strip in the corners. 8. Always roll and bond the bonded protection only approx. 5 cm. Screw Fig.: 3 - 35 EN Infusomat® Space P 5.0 3 - 35 3 Disassembly / Assembly 9. Press the sealing strip (Fig.: 3 - 36 / Item 1) down to the bottom using a spatula and bond it. 10. After bonding smoothen the sealing strip with the spatula. 1 Fig.: 3 - 36 Legend of fig. 3 - 36: Item Designation 1 Sealing strip 11. Bend the earthing wire (Fig.: 3 - 37 / Item 1) over the sealing strip. 1 Fig.: 3 - 37 Legend of fig. 3 - 37: Item Designation 1 Earthing wire 3 - 36 Infusomat® Space P 5.0 EN Disassembly / Assembly 3.13 Processor PCB Designation Order No. Processor PCB ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1348 (incl. connectors) 2 1 3 Connector P2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4355 3 Connector P3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4359 4 Connector seal P2 and P3 SP (inside) . . . . . . . . . . . . . . 3477 4357 5 Bottom inner frame ISP . . . . . . . . . . . . . . . . . . . . . . . . 3452 1453 EMC plate ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1440 Rating plate ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . On request 10 Screws (see „Service Parts and Screw Kit“ ➨ pg. 3 - 7) 1 Note Please pay attention to the corresponding notes during assembly and installation (see „Processor PCB“ ➨ pg. 3 - 41). 6 Disassembly 8 7 Fig.: 3 - 38 1. Loosen two hexagon nuts (Fig.: 3 - 38 / Item 1) and remove the nuts with the toothed locked washers (Fig.: 3 - 38 / Item 2), the distance sleeve (Fig.: 3 - 38 / Item 10) and the countersunk screw. 2. Remove the processor PCB (Fig.: 3 - 38 / Item 5) from the bottom inner frame. 3. Loosen one hexagon nut and remove the nut together with the EMC shield (Fig.: 3 - 38 / Item 8) and the screw (Fig.: 3 38 / Item 7) from the bottom inner frame (Fig.: 3 - 38 / Item 6) . Legend of fig. 3 - 38: Item Designation 1 Hexagon nut M3 2 Toothed locked washer M3 3 Connector P2 4 Connector P3 5 Processor PCB 6 Bottom inner frame 7 Fillister head screw M3x10 8 EMC plate 9 Countersunk screw M3x12 A2 TORX (not depicted) 10 Distance sleeve EN Infusomat® Space P 5.0 3 - 37 3 Disassembly / Assembly Mounting Connector Seal P2 (self-adhesive) Designation Order No. Connector seal P2 SP 3477 3102 1. Clean the adapter (Fig.: 3 - 39 / Item 1) of the connector seal P2 all round with isopropanol and let it air. 1 Fig.: 3 - 39 Legend of fig. 3 - 39: Item Designation 1 Adapter 1 2. Preposition the connector seal P2 (Fig.: 3 - 40 / Item 1) (incl. inner cut-out). Fig.: 3 - 40 Legend of fig. 3 - 40: Item Designation 1 Connector seal P2 3 - 38 Infusomat® Space P 5.0 EN Disassembly / Assembly 3. 3 Slide the connector seal P2 (Fig.: 3 - 41 / Item 1) onto the connector enclosure using a scalpel. 1 Fig.: 3 - 41 Legend of fig. 3 - 41: Item Designation 1 Connector seal P2 In order to avoid bubbling press the connector seal P2 (Fig.: 3 - 42 / Item 1) on completely. 1 Fig.: 3 - 42 Legend of fig. 3 - 42: Item Designation 1 Connector seal P2 EN Infusomat® Space P 5.0 3 - 39 3 Disassembly / Assembly 3.14 Installation / Assembly Assembly or installation of the modules and subsystems is performed in reverse order of disassembly. Special steps to be observed are described hereafter in detail. Only new cover caps are to be used. Special Screws Special screws for plastic housings are used in this unit. These are special screws for plastic housings. The screws are not self-cutting but produce a thread in the plastic of the housing through deformation when fitted in for the first time. If the beginning of the thread is not engaged when the screw is fitted, a new thread is produced. The old thread is destroyed. As a result, the strength of the screw connection is longer guaranteed. Screw in the special screws for plastic housings as follows: 1. Position the special screw on the thread. 2. Rotate screw anti-clockwise (loosen) until a faint click can be heard. This click is produced when the screw thread drops into the existing thread. 3. Screw in screw and tighten carefully. Zero Force Insertion Connector Note Make sure that the ribbon cable is centered between the plug guides when the zero force insertion connector is locked. Check the lock and the ribbon cable for correct fit before any further installation. 3 - 40 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 Processor PCB 1. The adjusting lug of the bottom inner frame must be positioned in the processor PCB boring. When the processor PCB is replaced all data of the pump except for the calibration data was probably saved on a PC(see „Preparations for Exchanging the Processor PCB“ ➨ pg. 3 - 2). Carry out the following steps to transmit the data back to the device (see „Rework when Replacing the Processor PCB“ ➨ pg. 3 - 46). Fig.: 3 - 43 Operating Unit EN Infusomat® Space P 5.0 1. Insert the hinge spring with its long side in the hinge cover opening, spring, and with its angled side in the rear panel bore hole of the operating unit. 2. Please pay attention to the ground connection on the keyboard PCB when mounting the rear panel of the operating unit. 3. The grooves of the hinge covers are pointing to the operating unit rear panel. 4. Push the operating unit connection cable into the processor PCB connector. 5. Lock the connector. 6. The ribbon cable cover of the operating unit must be laid between the bottom inner frame and the operating unit and over the connector. 7. Check the seal washers for correct position and completeness once again after assembly. 3 - 41 3 Disassembly / Assembly Inner Frame 1 1 * 2 8 3 4 7 6 5 Fig.: 3 - 44 Legend of fig. 3 - 44: Item Designation * 1 Lock bolt, plastic guides 5 Inner frame, spring holder with pressure spring 2 Bracket locking 6 Pump frame, bearing of the 6 mm straight pin 3 Pump drive, movement areas 7 Pump drive, toothed wheels 4 Lock bolt drive, toothed wheels 8 Lock bolt, guides and supporting area Do not reuse the bracket lockings 3 - 42 Infusomat® Space P 5.0 EN 3 Disassembly / Assembly 1. Make sure that the following components are sufficiently lubricated when installing the inner frame. If the grease film is not sufficient (stiff or jerky movements) grease these areas slightly with Polylub GLY 501. Note If chemical substances such as lubricating grease are used the safety data sheets are to be observed (see „Safety Data Sheets“ ➨ pg. 9 - 1). EN Infusomat® Space P 5.0 - Plastic guides (Fig.: 3 - 44 / Item 1) of the lock bolt - Spring bearings and dovetail of the spring holder (Fig.: 3 - 44 / Item 5) - Guide (6 mm straight pin) of the pump frame at the bearings (Fig.: 3 - 44 / Item 6) - Toothed wheels (Fig.: 3 - 44 / Item 7) of the pump drive - Movement areas (Fig.: 3 - 44 / Item 3) of the pump frame - Toothed wheels (Fig.: 3 - 44 / Item 4) of the lock bolt drive - Guides (Fig.: 3 - 44 / Item 8) and supporting area of the lock bolt 2. Pay attention to the operating pin of the linear potentiometer when installing the lock bolt drive. The pin must engage in the fork for the potentiometer when the spindle tappet is clipped in. 3. Check all toothed wheels for damage after installation of the lock bolt drive. 4. The spring holder of the pressure adjustment unit must run smoothly with its dovetail guide in the guide of the pump frame. Check smooth running without springs inserted before final assembly. 3 - 43 3 Disassembly / Assembly Inner Frame and Housing Front Panel 1. Move the lock bolt by hand to the left until stop (open position) before mounting the housing front panel. 2. Close the safety clamp with a slide clamp after installation. 3. Push the membrane carefully over the pump drive pusher. 4. Route the cable of the lock bolt drive in the cable guide on the lock bolt drive and between the two cable guide pins of the front frame. Note Always use a new membrane for assembly. Use Meliseptol® to facilitate installation of the membrane over the pushers. 5. Engage the front frame lugs (arrow, Fig.: 3 - 45) exactly in the inner frame openings. Note When mounting the inner frame and the housing front panel, make sure that the operating unit is opened. Fig.: 3 - 45 3 - 44 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 6. During installation of the complete housing front panel on the bottom inner frame the positioning hemispheres (arrow, Fig.: 3 - 46) of the inner frame must be adjusted in the slots of the bottom inner frame. 7. The housing front panel is pushed on to the bottom inner frame until stop and aligned in parallel (arrow, Fig.: 3 - 47). Fig.: 3 - 46 Fig.: 3 - 47 Snap-in Hook 1. The snap-in hook must be inserted before mounting the housing bottom part. Housing Bottom Part 1. Check the correct position of the seal relative to the safety clamp before mounting the housing bottom part. 2. Make sure that the hinge spring with the housing bottom part is pressed in the spring holder of the housing front panel. Note Please pay attention to the various screw lengths when you mount the bottom part. EN Infusomat® Space P 5.0 3 - 45 3 Disassembly / Assembly Housing Upper Part 1. If you have carried out any activities on the pressure adjustment unit, or dismounted or replaced the pressure adjustment unit, remove the rectangular cover cap from the housing top and keep it in a safe place until calibration, before mounting the housing upper part. Note Take care that no cables are squeezed, and check that the connector seals at the back are correctly placed in the housing, the snapin hook spring is located outside the housing wall and that the loudspeaker is correctly placed when the housing is fitted. The two wires must point downwards, so that the loudspeaker wires are placed in the insulation to the coil in the cut-out of the housing bottom part. 2. Check beforehand the position of the cable cover at the top and bottom of the housing upper part and the bottom part. 3. Lower the upper part of the housing vertically and carefully on to the lower part. 4. Engage the snap-in hooks between housing top and front frame. Rework when Replacing the Processor PCB When the processor PCB is replaced all data of the pump except for the calibration data was probably saved on a PC(see „Preparations for Exchanging the Processor PCB“ ➨ pg. 3 - 2). Carry out the following steps to transmit the data back to the device. Note When data previously saved is transferred back to the device, calibration data is not transferred. Therefore, a complete new calibration of the unit is required. Note Please note that text and / or functions of the Service Program may change depending on the software version. The following screenshots are only examples and represent the state when the manual was printed. 3 - 46 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 1. Start the Service Program (see „Starting the Service Program“ ➨ pg. 1 - 10). 2. Select the tab “Modification data”. 3. Press the “From file“ button. The window “Open” is displayed on screen. Fig.: 3 - 48 EN Infusomat® Space P 5.0 3 - 47 3 Disassembly / Assembly 4. Select the desired file with the mouse pointer and press the “Open” button. 5. On tab “IO”, press the “To device“ button. Fig.: 3 - 49 Fig.: 3 - 50 3 - 48 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 6. Press the “OK“ button when the window “Confirmation“ is displayed. 7. Enter your user number in the window “Worker ID” as well as the six-digit serial number of the device, if necessary. 8. Confirm the entry with “OK“. 9. A message is displayed that a change of the device data may affect the patients. Confirm by pressing the “OK“ button. Fig.: 3 - 51 Fig.: 3 - 52 10. The data are transferred to the device. Fig.: 3 - 53 11. Select the tab “Disposable article”. EN Infusomat® Space P 5.0 3 - 49 3 Disassembly / Assembly Fig.: 3 - 54 12. Press the “Load from“ button. The window “Open” is displayed on screen. 13. Select the desired file with the mouse pointer and press the “Open” button. The loaded data are displayed on screen. Fig.: 3 - 55 3 - 50 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 Fig.: 3 - 56 14. Press the “To device“ button. The data is saved in the Infusomat® Space P. 15. Exit the Service Program (see „Quitting the Service Program“ ➨ pg. 1 - 15). EN Infusomat® Space P 5.0 3 - 51 3 Disassembly / Assembly Rework when Replacing the Air Inline Sensor Device alarm 2223 may occur sporadically if the Space Line Neutrapur is used with the new version of the air inline sensor. To avoid this, it may be necessary to import a new table after comparing the air inline sensor version with the disposable articles table. Old version 1. Check version of the stored disposable article table against menu Line selection (Fig.: 3 - 57).* If “Space Line Neutrap” (no fullstop after Neutrap) is displayed, a new disposable article table already exists. No other actions are necessary. New version Fig.: 3 - 57 Line selection Space Line Neutrapur 2. Check the air inline sensor version.† (see „Instructions on Replacing the Air Inline Sensor“ ➨ pg. 3 - 29) CAUTION The new disposable article table must not be imported for old air inline sensors versions (up to air inline sensor serial number 248222). Importing the new disposable article table:‡ 3. Install an identical HiBaSeD version on the PC. During installation, accept the target directory offered .../HiBaSeD_8.0.1_1. Fig.: 3 - 58 4. Rename the resulting link to “HiBaSeD 8.0.1_1_neue Schlauchdaten”. Fig.: 3 - 59 5. Delete all subdirectories under the following directory C:\B.Braun Space\HiBaSeD_8.0.1_1\dat\Infusomat. Fig.: 3 - 60 * In the case ofInfusomat® Space P serial numbers 229867 and higher, a new disposable article table for SW L has already been imported at the factory. † In the case ofInfusomat® Space P serial numbers 229867 and higher, a new version of the air inline sensor has already been installed in the factory. ‡ Procedure based on HiBaSeD Version 8.0.1 for software version L 3 - 52 Infusomat® Space P 5.0 EN Disassembly / Assembly 3 6. Unpack the zip file with the new tube data (available on request) into the following directory C:\B.Braun Space\HiBaSeD_8.0.1_1\dat\Infusomat. Alternatively: Copy the unpacked folders “default” and “Disposables” to that same directory. 7. Start “HiBaSeD 8.0.1_1_neue Schlauchdaten” by doubleclicking on the link. 8. Ontab “Service” > “Calibration“, press button “Modify”. 9. Only choose “Disposable article” from the data selection. Fig.: 3 - 61 Fig.: 3 - 62 10. Start calibration with “OK”. The new tube data are imported. Fig.: 3 - 63 11. In menu Line selection check whether the new disposable article table exists in the device. Fig.: 3 - 64 EN Infusomat® Space P 5.0 3 - 53 3 Disassembly / Assembly 3.15 Pole Clamp SP Adapter Kit Designation 9 1 8 2 3 4 7 6 Retrofit kit Pole Clamp* . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4390 contains: Grid right reworked (10 pieces) Grid left reworked (10 pieces) VDO compression spring (40 pieces) Straight pin 2x10 A2 (20 pieces) Service kit Pole Clamp SP spindle with handle† . . . . . 3477 4383 contains: Spindle (10 pieces) Handle of spindle (10 pieces) Rivet plate (10 pieces) 5 Note Fig.: 3 - 65 Observe the industrial safety regulations. Legend of fig. 3 - 65: Item Designation Note 1 Oval head screw 2 Washer (steel) 3 Washer (white) 4 Sleeve 5 Guide frame 6 Flange adapter 7 Rotary profile 8 Blocking cap (PU with 1 piece, in Service Kit Pole Clamp SP) 9 Grid (PU with 5 pieces, in service kit Pole Clamp SP) Version 1 Order No. The service technician bears the responsibility for correct execution of the repair work. Note After successful installation carry out a function test. Version 2 Version 3 Fig.: 3 - 66 Pole Clamp versions * † 3 - 54 For Pole Clamp versions 1 and 2 For Pole Clamp versions 1 to 3 (serial number 3000 and higher) Infusomat® Space P 5.0 EN Disassembly / Assembly 3.16 Checks after Repair EN Infusomat® Space P 5.0 3 Procedure 1. When the activities described in chapter 3.2 to 3.8 have been performed, a visual inspection and self test are necessary. 2. Depending on the work carried out, the specific steps of the check list for checks after repair must be performed(see „Checkliste für Prüfung nach Reparatur“ ➨ pg. 3 - 56). 3. Check the flow accuracy according to the TSC if activities of chapter 3.10 were carried out (see „Technical Safety Check (TSC)“ ➨ pg. 5 - 1). 4. The technical safety checks should be performed to ascertain that the device functions safely (see „Technical Safety Check (TSC)“ ➨ pg. 5 - 1). 3 - 55 3 Disassembly / Assembly Check List for Checks after Repair Unit: Infusomat® Space P Article No. Unit No. Manufacturer: B. Braun Melsungen AG Visual Inspection Electrical Safety Functional Inspection According to IEC 60601-1 or IEC 62353 ❒ Cleanliness, completeness, damage and fault affecting safety, damage to and readability of the labels. Special: ❒ Connectors "P2" and "P3" ❒ Safety clamp ❒ Pressure sensor membrane, downstream ❒ Pressure sensor membrane, upstream ❒ Pump membrane ❒ Pump slide (All 12 slides are engaged) ❒ Coding of the pump slide guide ❒ Pump connecting rod ❒ Air inline sensor (free of grease or ultrasound gel, free of cracks) ❒ Drop sensor (lens) The patient and housing leakage current of ❒ Locking with second unit the Infusomat® Space P is caused exclusive- ❒ Battery compartment cover ly by the operating voltage supply (Power Switch on unit with power supply: Supply SP or SpaceStation). ❒ Self-test The Technical Safety Checks of the power ❒ Indicator lamps (LEDs) supply SP (drawing No. M001321005F04) or ❒ Audible alarm of the SpaceStation (drawing No. ❒ Visual alarm M690000046F04) serve to check whether ❒ Status display ❒ Lighting both limit values are met. Operation ❒ Opening and closing mechanism of the operating unit ❒ The clamp lever of the safety clamp is released when the operating unit is closed down. The line is pinched. ❒ Buttons on the operating unit ❒ Infusion ❒ Staff call ❒ Trigger bolus at the device ❒ Trigger bolus by pressing the PCA button ❒ The operating lever of the safety clamp can be pressed down evenly against the spring tension and engages. The yellow caution sign flashes. (Part 1 of 3) 3 - 56 Infusomat® Space P 5.0 EN Disassembly / Assembly Visual Inspection Electrical Safety 3 Functional Inspection According to IEC 60601-1 or IEC 62353 Pressure switch-off, electronic: (see TSC for limit values) Delivery rate: 250 ml/h Testing without drop sensor Intrafix Primeline Classic ❒ Upstream ❒ Alarm ❒ Downstream ❒ Pressure stage 1 ❒ Pressure stage 5 ❒ Pressure stage 9 Pressure limitation, mechanical (see TSC for limit values) ❒ Pmax ❒ Pmin Safety clamp (see TSC for limit values) ❒ Pmin Flow accuracy (see TSC for limit values) Room temperature 20 … 25°C, delivery rate: 250 ml/h, measuring quantity: 25 ml ❒ Deviation within tolerance Drop sensor (optional) Delivery rate: 250 ml/h ❒ Drop sensor alarm passage ❒ Drop sensor alarm closure (Part 2 of 3) EN Infusomat® Space P 5.0 3 - 57 3 Disassembly / Assembly Visual Inspection Functional Inspection Electrical Safety According to IEC 60601-1 or IEC 62353 Air inline sensor (see TSC for limit values) Intrafix Primeline Classic ❒ ❒ ❒ ❒ Water value Difference of temperature sensors Air alarm Air value Switch on unit without power supply ❒ Self-test ❒ Magnetic function of the battery compartment cover ❒ Charging level of the battery module Remove battery module ❒ Alarm for at least 3 minutes. (Part 3 of 3) Date: 3 - 58 Name: Signature: Infusomat® Space P 5.0 EN 4-4 4- Cleaning and Disinfecting Servicing the Unit 4 Notes ! WARNING Liquid may penetrate live parts of the unit. DANGER OF ELECTRIC SHOCK. - Before disinfecting the pump, always disconnect the pump from Infusomat® Space P the patient, switch off the device and disconnect from power and other devices (e.g. staff call). - To reduce the likelihood of moisture ingress into the electrical connectors, the P2 connector of a power supply or connection cable may be used to cover the connections during cleaning operations. Ensure that any connectors used to cover are not connected to a wall outlet or other voltage source. - Do not touch any parts of the wiring or the tube pump with sharp objects. - We recommend using the cleaning and disinfecting agents Meliseptol® Wipes sensitive or Meliseptol® Foam pure from B. Braun for cleaning and disinfecting. - In the case of severe soiling that cannot be removed by the above method, please contact the hospital's technical department. - The current internal hygiene measures of the hospital apply. Housing Clean and disinfect all surfaces of the Infusomat® Space P. Start by cleaning the display with a dampened nonwoven cloth. Clean using a damp and NOT a soaking cloth. Dispose of the cloth after use. We recommend: Meliseptol® Wipes sensitive or Meliseptol® Foam pure. You can use Meliseptol® Foam pure to clean the flex cable of the Infusomat® Space P. Apply with a cotton swab.. Fig.: 4 - 1 Make sure that no liquid is allowed to enter the contacts or ventilation slots. Allow the device to dry after cleaning/disinfecting (for at least 1 minute). When they are dry, insert the cleaned/disinfected Space infusion pumps back into the holder or SpaceStation (see cleaning plan for SpaceStation) and protect from dirt until they are next used. EN Infusomat® Space P 5.0 4- 1 4 Servicing the Unit Internal tube routing areas The slide guide and the internal tube guides can be cleaned with disinfectants containing 1-propanol or didecyl dimenthyl ammonium chloride. The slide guide can be prised out with a pointed object (ballpoint pen) through a notch in the housing front panel on the right lower side (Fig.: 4 - 2). The cover can then be cleaned by immersing it, the pump slide can be cleaned with a soft cloth. Fig.: 4 - 2 When you reinsert the slide guide, make sure it is not damaged and audibly snaps into place. Cleaning of the connector Corroded or soiled connector contacts can result in connection problems and fault messages output during operation. After it has been identified by a visual or function check, clean the offending connector as follows. Cleaning agents and materials: * Connector corroded Connector cleaned Fig.: 4 - 3 Example: connector on SpaceStation - Contact cleaner: Kontakt WL, order no. 20.710.6.13.12.01 or DeoxIT® D5 Spray, part no. D5S-6 † - Contact spray: Kontakt 60 plus, order no. 20.739.6.09.12.01 or DeoxIT® D100 Spray, part no. D100S-2 † - Cleaning brush: Kontakt Chemie, ref. no. 30206 (3 each) or Connector Cleaning Brush, part no. AB-25 (25 each) † - Swabs: Chemtronics Chamois Tips CC50 (50 each) or DeoxIT® Precision Foam Swabs, part no. SWPX-25 (25 each)† * † 4- 2 Not all products are available in all regions. Caig Laboratories, Inc. (www.caig.com) Infusomat® Space P 5.0 EN Servicing the Unit 4 Procedure: Fig.: 4 - 4 Example: connector on SpaceStation Servicing the Battery 1. Set the pump down with the rear facing upward; fix it in position, if necessary. 2. Fill the connector with contact cleaner. Depending on the extent of soiling, allow to work. 3. Loosen any incrustations with a cleaning brush. 4. Moisten swabs with contact cleaner and clean the contacts with them. 5. Rinse connector with contact cleaner, dry off with compressed air. 6. Perform a visual check, repeat cleaning, if necessary. 7. Spray cleaned contacts with contact spray; allow to evaporate for several minutes. 8. Check that the connectors function correctly (connection problems remedied?). The instructions for use contain a detailed description on how to service the battery. If a battery module is not discharged completely for more than 28 days, a servicing program for the battery module can be started on the unit. EN Infusomat® Space P 5.0 4- 3 4 Servicing the Unit For your notes: 4- 4 Infusomat® Space P 5.0 EN 5-4 Edit 5- Technical Safety Check (TSC) Infusomat® Space P Index d (Master – to be added to the documentation) Checklist for Technical Safety Check – Every 24 Months User Unit: Infusion Pump Infusomat® Space P Manufacturer: B. Braun Melsungen AG Observe the Service Manual and the instructions for use. All measured values are to be documented. Accessories used should be included in testing. Make exclusive use of calibrated measuring equipment. Article No. Visual Inspection Year of Procurement Unit No. Stock No. Electrical Safety Functional Inspection According to IEC 60601-1 or IEC 62353 ❒ Infusomat® Space P: Cleanliness, completeness, damage and defects affecting safety, damage and readability of the labels. Particularly: ❒ Connectors „P2“ and „P3“ ❒ Safety clamp ❒ Pressure sensor, downstream (membrane) ❒ Pressure sensor, upstream (membrane) ❒ Pump membrane ❒ Pump slide ❒ Coding of pump slide guide ❒ Pump connecting rod ❒ Air inline sensor (free from grease or ultrasonic gel, free from cracks) ❒ Drop sensor (lens) ❒ Accessories: Cleanliness, completeness, damage and faults affecting safety, damage and readability of the label. ❒ Check the unit and the accessories for compatibility M687 70 01 05 F04 / 38919036 EN Infusomat® Space P 5.0 The patient and housing leakage current of ❒ Locking with second unit the Infusomat® Space P is caused exclusive- ❒ Battery compartment cover ly by the operating voltage supply (Power Supply SP or SpaceStation). Determine age of battery ❒ If older than 8 years: recommend reThe Technical Safety Checks of the power placement of battery or perform batsupply SP (drawing No. M001321005F04) or tery check (see ➨ “Procedural of the SpaceStation (drawing No. Instructions on the TSC“) M690000046F04) serve to check whether both limit values are met. Switch on unit with power supply: ❒ Self-test ❒ Indicator lamps (LEDs) ❒ Audible alarm ❒ Visual alarm ❒ Status display ❒ Lighting Operation ❒ Opening and closing mechanism of the operating unit ❒ Clamping lever of the safety clamp is released when the operating unit is closed. The tube is squeezed. ❒ Buttons on the operating unit ❒ Infusion ❒ Staff call Sheet 1 of 3 5- 1 5- Technical Safety Check (TSC) Index d (Master – to be added to the documentation) Visual Inspection Electrical Safety Functional Inspection According to IEC 60601-1 or IEC 62353 Operation (continued) ❒ Trigger bolus at the device ❒ Trigger bolus by pressing the PCA button ❒ The operating lever of the safety clamp can be pressed down uniformly against spring tension and engages. The yellow caution sign flashes. Pressure cut-off, electronic: Delivery rate: 250 ml/h Test without drop sensor ❒ Upstream ❒ Alarm ❒ Downstream ❒ Pressure stage 1 (0,1 … 0,6 bar) ❒ Pressure stage 5 (0,4 … 1,0 bar ❒ Pressure stage 9 (0,8 … 1,4 bar) ____ bar ____ bar ____ bar Pressure limitation, mechanical: ❒ Pmax (< 4 bar) ____ bar ❒ Pmin (> 1,8 bar) ____ bar Safety clamp ❒ Pmin (> 1 bar) ____ bar Delivery accuracy Ambient temperature 20 … 25°C, Delivery rate: 250 ml/h, Measured volume: 25 ml ❒ Divergence (± 5 %) ____ % Drop sensor (optional) Delivery rate: 250 ml/h ❒ Drop sensor alarm, flow ❒ Drop sensor alarm, occlusion M687 70 01 05 F04 / 38919036 5- 2 Sheet 2 of 3 Infusomat® Space P 5.0 EN 5- Technical Safety Check (TSC) Index d (Master – to be added to the documentation) Visual Inspection Functional Inspection Electrical Safety According to IEC 60601-1 or IEC 62353 Air inline sensor ❒ Water value (> 600 mV) ____ mV ❒ Difference of temperature sensors (< 3 °C) ____ °C ❒ Air alarm ❒ Air value (< 100 mV) ____ mV Switch on unit without power supply ❒ Self-test ❒ Magnetic function of the battery compartment cover Remove battery module ❒ Alarm for min. 3 minutes Mech. Aids and Measuring Equip. Used ❒ Disposables Type: _______________________ Part No.: __________________ ❒ Manometer Ident. No.: ____________________ Calibrated until ________________ ❒ Scales Ident. No.: ____________________ Calibrated until ________________ ❒ ❒ ❒ ❒ ❒ Graduated cylinder Stop watch Service connector SP __________________________ __________________________ Accessories Used ❒ ❒ ❒ ❒ ❒ ❒ ❒ ❒ Staff call line Power Supply SP Battery module Space PCA Kit (PCA button) Intrafix Primeline Classic Drop sensor __________________________ __________________________ Test result: Defects found which could endanger patients, users or third parties: Yes No Inspection performed by: Unit handed over on: Measures to be taken: None Repair Replacement of battery recommended __________________________________________ To: Special features / documentation: ___________________________________________________________________________ Date / Signature: ___________________________________________________________________________ Next deadline: M687 70 01 05 F04 / 38919036 EN Infusomat® Space P 5.0 Sheet 3 of 3 5- 3 1.0 Edit 5- Technical Safety Check (TSC) Power Supply SP Index f (Master – to be added to the documentation) Checklist for Technical Safety Check – Every 24 Months User Unit: Power Supply SP Manufacturer: B. Braun Melsungen AG Observe the Service Manual and the instructions for use. All measured values are to be documented. Accessories used should be included in testing. Make exclusive use of calibrated measuring equipment. Article No. Visual Inspection Year of Procurement Unit No. Stock No. Electrical Safety Functional Inspection According to IEC 60601-1 or IEC 62353 ❒ Power Supply SP: Cleanliness, completeness, damage and faults affecting safety, damage and readability of the label ❒ Connecting line: Cleanliness, damage and faults affecting safety ❒ Measure mains voltage ______ V~ ❒ Equivalent leakage current ≤ 7 μA ______ μA Measurement is to be carried out with service adapter SP between primary and secondary circuit. Note: This measurement ensures that the admissible limit values regarding the patient and housing leakage current of the Perfusor® Space or the Infusomat® Space are met. ❒ Connector locking ❒ After connecting the power supply the respective unit displays that it is operated in mains operation Check of power supply with ord. nos. 3310 2694 and 3310 2708 ❒ Check lock of primary adapter with power supply. The adapter must engage on both sides. Mech. Aids and Measuring Equip. Used ❒ Perfusor® Space Serial No. ____________________ ❒ Infusomat® Space Serial No. ____________________ ❒ Safety tester Ident. No.: ____________________ Calibrated until ________________ ❒ ___________________________ Test result: Defects found which could endanger patients, users or third parties: Yes No Inspection performed by: Unit handed over on: Measures to be taken: None Dispose of Power Supply SP __________________________________________ To: Special features / documentation: ___________________________________________________________________________ Date / Signature: ___________________________________________________________________________ Next deadline: M001 32 10 05 F04 / 38916142 5- 4 Sheet 1 of 1 Infusomat® Space P 5.0 EN 6 - 10 6- Procedural Instructions on the TSC Visual Inspection 6 Infusomat® Space P 1. Check the Infusomat® Space P and accessories for cleanness. 2. Check the Infusomat® Space P and accessories for completeness and check configuration. 3. Check the Infusomat® Space P and its accessories for damage and the labels for readability. Pay special attention to the following parts: a) Safety clamp b) Pressure sensor membrane, downstream (not damaged) c) Pressure sensor membrane, upstream (not damaged) d) Pressure webs for pressure sensors (smooth running, movable without jamming) e) Pump membrane (not damaged) f) Coding of pump slide guide present g) Pump connecting rod (12 pieces, not damaged) h) Pump slide (12 pieces, smooth running and engaged) i) Air inline sensor (free of oil and ultrasound gel), free of cracks) j) Pressure webs for air inline sensor (smooth running, movable without jamming) k) Drop sensor (lens) l) Screw covers m) Connectors "P2" and "P3" n) Completeness and correct position of the insulating washers on the operating unit back panel o) Completeness and readability of both pictograms on the inside of the operating unit EN Infusomat® Space P 5.0 6- 1 6 Procedural Instructions on the TSC Power Supply SP 1. Power supply SP incl. Check that the connecting line is clean. 2. Power supply SP incl. Check the connecting line for damage and the labels for readability. Electrical Safety According to IEC 60601-1 or IEC 62353 Infusomat® Space P The patient and housing leakage current of the Infusomat® Space P is caused exclusively by the operating voltage supply (Power Supply SP or SpaceStation). Observance of both limits is checked with the technical safety checks of the power supply SP (drawing No. M001 32 10 05 F04) and the SpaceStation (drawing No. M690 00 00 46 F04). Power Supply - Equivalent Leakage Current Note The values to be measured are indicated in the TSC (see „Technical Safety Check (TSC)“ ➨ pg. 5 - 4). 1 3 2 4 The equivalent leakage current is to be measured between primary and secondary circuit using the service adapter SP. Designation Order No. Service adapter SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0770 5174 Check 1. Select leakage current on the testing equipment. 5 Fig.: 6 - 1 Legend of fig. 6 - 1: Item Designation 1 Mains connection 2 Primary of the power supply 3 Secondary of the power supply 4 Service adapter SP with probe 5 Leakage current measuring device 6- 2 2. Bridge pin 6, 7 12 and 13 with service adapter SP at the connector to the unit. 3. Measure value. 4. Measure value with reverse polarity of the mains connection. 5. Document the largest value. Infusomat® Space P 5.0 EN Procedural Instructions on the TSC Functional Inspection Infusomat® Space P 6 Mechanical Inspection 1. Fit the unit to be tested on top of another Space device and check the proper functioning of the lock. 2. Fit the unit to be tested under another Space device and check the proper functioning of the lock. 3. Check the battery compartment cover lock for proper operation. Functional Check 1. Determine age of battery Open battery compartment cover and remove battery. Read batch number on the battery nameplate and determine age of the battery: a) Please see Fig.: 6 - 2 for NiMH batteries. b) Please see Fig.: 6 - 3 for Li-ion batteries. Example: Manufactured in week 42/2008 Example: Manufactured in week 41/2011 D 2003 E 2004 F 2005 G 2006 H 2007 I 2008 ... N 2013 Second two digits: Year of manufacture Two digits: Calendar week First two digits: Calendar week Letter: Year of manufacture according to table left Fig.: 6 - 2 NiMH batteries Fig.: 6 - 3 Li-ion batteries Note If the battery is more than 8 years old, recommend changing the battery or conducting a battery check. EN Infusomat® Space P 5.0 6- 3 6 Procedural Instructions on the TSC 2. Battery check Perform the battery service to discharge the battery until the battery pre-alarm is issued (no bar displayed for battery discharge level (Fig.: 6 - 4), but it must not flash). Open and close the operating unit 5x. Fig.: 6 - 4 Replace the battery if the battery alarm sounds while you open or close the operating unit. 3. Switch on the device with the power supply connected and check the following points: - Self-test Display on the LC display - Indicator lamps LEDs (yellow, green, blue)* light up for a short moment LED changes from green to red† - Audible alarm A low and then a high sound - Visual alarm Red LED lights up for a short moment - Self-test Display on the LC display - Status display Battery capacity, mains operation - Lighting LC display lighting, keyboard lighting 4. Operation a) Open operating unit. Yellow warning light beside the safety clamp flashes. b) Insert Intrafix Primeline Classic. The clamp lever of the safety clamp is released when the operating unit is closed down. The Intrafix Primeline Classic is pinched. c) * † 6- 4 Close operating unit. As of software version J: yellow, red, blue As of software version J: from red to green Infusomat® Space P 5.0 EN Procedural Instructions on the TSC 6 d) Staff call - Plug service connector Space onto connector “P2”.* - Lock roller clamp of Intrafix Primeline Classic. The red LED on the Space service connector lights up after an alarm is issued. e) Carry out infusion with intermediate bolus and press all buttons at least once. Infusion and bolus are performed and all buttons trigger the desired function. f) Trigger the bolus administration with the PCA button. For this purpose, select a PCA drug from the database, place the PCA button on P2 and trigger the bolus. Ensure that the green LED at the PCA button lights up. The bolus is transported. g) Open operating unit. h) Operating lever of the safety clamp can be pressed down easily against spring tension, engages and the caution sign flashes yellow. * As of software version L07, the service connector is only detected if it is plugged in before the pump is ready to start, for example, before inserting a disposable article EN Infusomat® Space P 5.0 6- 5 6 Procedural Instructions on the TSC Test Setup 1 2 Perform test setup with the subassemblies listed below, please see also Fig.: 6 - 5: 3 Note The filling level in the container must be approx. 50 cm above the middle of the unit opening for the Intrafix Primeline Classic. 2 8 7 Intrafix Primeline Classic (new, unused, can be used for the complete TSC incl. functional check) (1 piece) appr. 50 cm 1 6 Infusion bag or bottle, min. 100 ml (1 piece) 5 4 Fig.: 6 - 5 Three-way valve (2 pieces for measurement with electronic pressure gauge) 1 Electronic pressure gauge accuracy class 1 10 ml syringe (air buffer for measurement with electronic pressure gauge) (syringe drawn up to 10 ml and piston fixed mechanically) (1 piece) 2 10 ml syringe (piston fixed) 1 ml syringe for air bubble injection (1 piece) 3 Infusion bottle Electronic pressure gauge with peak value recognition (1 piece) 4 Intrafix Primeline Classic Graduated cylinder 25 ml, ±0.4 ml (1 piece) 5 Distance between liquid level and middle Intrafix Primeline Classic 6 Three-way valve 1 7 Three-way valve 2 8 Graduated cylinder Legend of fig. 6 - 5: Item Designation 6- 6 Infusomat® Space P 5.0 EN Procedural Instructions on the TSC 6 Pressure Cut-Off, Electronic The Space service connector must not be connected to the device. The optional drop sensor must not be connected. 1. Insert the Intrafix Primeline Classic of the test setup (Fig.: 6 5) in the device. 2. Enter a delivery rate according to the TSC and a volume of 250 ml. 3. Select pressure stage according to the TSC. 4. Vent test setup, position of the three-way cocks please see Fig.: 6 - 6, start infusion and deliver first of all in to an open system (without pressure gauge). Upstream 2 5. Push roller clamp of the Intrafix Primeline Classic up to approx. 30 cm before the pump and close the roller clamp or pinch the Intrafix Primeline Classic between the container and 30 cm before the pump. An alarm is output. 6. Open roller clamp. 1 Fig.: 6 - 6 Downstream 2 Fig.: 6 - 7 1 7. Switch over three-way valve, please see Fig.: 6 - 7, and deliver towards the pressure gauge. Read off maximum value on the pressure gauge upon an alarm and before an automatic pressure reduction and compare with the specifications in the TSC. 8. Check all pressure stages listed in the TSC and document values. Pressure Limitation, Mechanical The optional drop sensor must not be connected. Pmax and Pmin EN Infusomat® Space P 5.0 1. Plug service connector Space on connector “P2” so that the electronic pressure cut-off is deactivated. 2. Input a delivery rate according to the TSC, start infusion and deliver first of all in to an open system (without pressure gauge), position of the three-way cocks please see Fig.: 6 - 6. 3. Switch over three-way valve, please see Fig.: 6 - 7, and deliver towards the pressure gauge. Read off the corresponding value on the pressure gauge and compare with the specifications of the TSC for Pmax und Pmin. 6- 7 6 Procedural Instructions on the TSC Note If the pressure values are not reached, the mechanical pressure limit can be adjusted at the spring set of the peristaltic pump, see (Fig.: 3 - 24 / Item 7). 4. Document values. Do not reduce pressure. Safety Clamp 1. Stop infusion mechanically from the pressure limitation check and unlock operating unit but do not open by hand. Read off value on the pressure gauge after min. 10 seconds and compare with the specifications in the TSC. 2. Document value. 3. Pull out the Space service connector. Flow Accuracy Requirements: - Test setup according to Fig.: 6 - 5 - Ambient temperature according to the TSC 1. Insert the Intrafix Primeline Classic of the test setup (Fig.: 6 5) in the device. 2. Close three-way cock 1 to the syringe, please see Fig.: 6 - 8. 3. Vent test setup. Bottom part of drop chamber must be 2/3 filled. 4. Insert cannula in empty graduated cylinder. 2 Fig.: 6 - 8 1 5. Set delivery rate according to the TSC. 6. Simultaneously start infusion and stop watch. 7. Stop the stop watch when the measured volume defined in the TSC is reached. 8. Evaluate deviation in percent according to Table 6 - 2 and document. Flow Accuracy (alternative measuring method) Checking of the flow accuracy by weight measurement. Avoid errors due to evaporation! Measuring equipment: - 6- 8 Scales Measuring duration at precision 0.1 g: 12 min Measuring duration at precision 0.01 g: 6 - 12 min Infusomat® Space P 5.0 EN Procedural Instructions on the TSC 6 Delivery rate determination: 1. Set a delivery rate of 200 ml/h and let device fill up ≥60 s. 2. Hang the outlet cannula over the container and at the same time start the stop watch and the Infusomat® Space P. 3. After the time has expired stop the stop watch and the Infusomat® Space P. 4. Determine the delivery rate immediately. - Delivery volume to be expected: at 12 min: 40 g ± 2 g (± 5%) at 6 min: 20 g ± 1 g (± 5%) Drop Sensor (Option) Measuring Time Deviation % 1. Connect the optional drop sensor to the device. 2. Start infusion according to the specifications of the TSC. 3. Squeeze the drop chamber bottom part to generate a jet. The drop sensor triggers an alarm immediately. 4. Pull the drop sensor from the drop chamber. Only then start the device. Alarm by the drop sensor within 5 seconds. 6 min 36.0 sec -10 6 min 18.0 sec -5 6 min 14.4 sec -4 6 min 10.8 sec -3 6 min 7.2 sec -2 Air Inline Sensor 6 min 3.6 sec -1 1. Plug Space service connector onto connector “P2”. 6 min 0.0 sec 0 2. 5 min 56.4 sec 1 Insert an Intrafix Primeline Classic filled with water in the device and close operating unit. 5 min 52.8 sec 2 3. 5 min 49.2 sec 3 5 min 45.6 sec 4 In the Line change menu, press the “>“ button on the device . The value of the air inline sensor is displayed on the LC display. 5 min 42.0 sec 5 4. 5 min 24.0 sec 10 Read off value after approximately 10 seconds and compare with the specifications of the TSC. Table 6 - 2 Note If the water or air value is not reached immediately, these values must be read again after 120 seconds. EN Infusomat® Space P 5.0 5. Document values. 6. Read off the values of the temperature sensors on the LC display and compare the difference with the specifications of the TSC. 7. Enter a delivery rate of 250 ml/h and a volume of 250 ml. 8. Start infusion. 6- 9 6 Procedural Instructions on the TSC 9. Generate an air bubble of approx. 0.4 ml (approx. 56 mm length of line with air) in the supply line to the pump. An alarm is triggered when the air bubble is detected. 10. Insert an air-filled Intrafix Primeline Classic into the device and close the operating unit, or disconnect the line at the container and “empty“, so that there is no longer any water in the line. 11. In the Line change menu, press the “>“ button on the device. The value of the air inline sensor is displayed on the LC display. 12. Read off value after approximately 10 seconds and compare with the specifications of the TSC. 13. To exit the Service Info mode press the “>“ button once more. Note If the water or air value is not reached immediately, these values must be read again after 120 seconds. Battery Check 1. Switch device off. 2. Disconnect the power supply. 3. Switch on unit. Self-test is carried out. 4. Open battery compartment cover during operation. An alarm is output. Functional Inspection Power Supply SP Mechanical Inspection 1. Connect the power supply to a Space system device and check the lock for proper function. Functional Check 1. The connected device operates correctly after being switched on. 6 - 10 Infusomat® Space P 5.0 EN 7-2 7- Test Equipment and Special Tools Test equipment Designation 7 Order No. For Calibration Space service connector . . . . . . . . . . . . . . . . . . . . . . . . 3452 1062 HiBaSeD Service-CD. . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3301 HiBaSeD Service-CD (US version) . . . . . . . . . . . . . On request Intrafix Primeline Classic (new, not used) Infusion bag or bottle, min. 100 ml Three-way valve (2 pieces) 10 ml syringe (air buffer for measurement with electronic pressure gauge) (syringe drawn up to 10 ml and piston fixed mechanically) 1 ml syringe for air bubble injection Electronic pressure gauge with peak value recognition (accuracy class 1) Pressure cell (alternative of electronic pressure gauge) For Repairs HiBaSeD Service-CD. . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3301 HiBaSeD Service-CD (US version) . . . . . . . . . . . . . On request For the TSC Measuring instrument for electrical safety Service adapter SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0770 5174 for measuring the electrical safety Intrafix Primeline Classic (new, not used) Infusion bag or bottle, min. 100 ml Three-way valve (2 pieces) 10 ml syringe (air buffer for measurement with electronic pressure gauge) (syringe drawn up to 10 ml and piston fixed mechanically) 1 ml syringe for air bubble injection Electronic pressure gauge with peak value recognition (accuracy class 1) Pressure cell (alternative of electronic pressure gauge) Graduated cylinder 25 ml, +/- 0.4 ml Stop watch EN Infusomat® Space P 5.0 7- 1 7 Test Equipment and Special Tools Special Tools Designation Order No. Screwdriver 6IPx60 TORX plus . . . . . . . . . . . . . . . . . . . 4002 4806 Screwdriver 8IPx60 TORX plus . . . . . . . . . . . . . . . . . . . 4002 4814 Screwdriver 10IPx80 TORX plus . . . . . . . . . . . . . . . . . . 4002 4822 Screwdriver T10x80 TORX . . . . . . . . . . . . . . . . . . . . . . . 4002 4903 Screwdriver T25x100 TORX . . . . . . . . . . . . . . . . . . . . . . 4002 4911 7- 2 Infusomat® Space P 5.0 EN 8-6 8- Spare Parts List Item Designation 8 Ord. No. Service part kit Infusomat® Space . . . . . . . . . . . 3452 1593 contains: Housing cover cap (100 pieces) Plug D=4mm for front flap hinge (5 pieces) Cap for housing upper part (access to pressure adjustment) (2 pieces) Housing foot SP (10 pieces) Snap-in hook SP with leaf spring (2 pieces) Emergency release plug ISP incl. O-ring (2 pieces) Emergency release crank ISP (1 piece) Bracket locking (20 pieces) Seal washer PA 2.2x4x0.3 (200 pieces) Safety clamp seal, housing bottom part (10 pieces) Injection intermediate piece (air inline sensor test) (2 pieces) Cover cap kit for housing SP (50 pieces) . . . . . . 3477 4386 Emergency release plug ISP (10 pieces) . . . . . . . 3477 3101 Connector P2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4355 Connector P3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4359 Gasket P2 and P3 SP (10 pieces each) . . . . . . . . 3477 4357 Connector seal P2 SP (5 pieces) . . . . . . . . . . . . . 3477 3102 Repair kit Power Supply P2 small . . . . . . . . . . . . .3477 4311 contains: Cable repair kit (10 pieces) Spacer sleeve 6.2x10x50 (12 pieces) Shrink tubing small/black (44 pieces) Shrink tubing small/white (12 pieces) Shrink tubing large/white (12 pieces) Grease for Infusomat® Space P Polylub GLY 501 3452 1570 Housing foot SP (20 pieces) . . . . . . . . . . . . . . . . 3477 3106 Space sticker set . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 0969 contains: Temperature sticker Space Sticker “Slide guide missing” Sticker “Insert slide clamp” Sticker “Insert tube correctly” Sticker Space P “Insert tube” Sticker “Emergency unlock short instructions” Sticker “Correct syringe position” Instruction plate Space Station EN Infusomat® Space P 5.0 8- 1 8 Spare Parts List Item Designation Ord. No. Screw kit Infusomat® Space . . . . . . . . . . . . . . . . 3452 1585 contains: Screw DELTA PT 22x8 WN 5451 TORX plus 6IP (5 pieces) Screw DELTA PT 25x7 WN 5451 TORX plus 8IP (5 pieces) Screw DELTA PT 30x8 WN 5452 TORX plus 10IP (10 pieces) Screw DELTA PT 30x12 WN 5452 A2 TORX plus 10IP (10 pieces) Countersunk screw DELTA PT 20x9 WN 5454 TORX plus 6IP (5 pieces) Fillister head screw M3x6 TORX Fillister head screw M3x10 Countersunk screw M3x5 TORX Countersunk screw M3x12 A2 TORX Hexagon nut M3 A2 Toothed locked washer M3 A2 Distance sleeve Retrofitting kit battery fastening. . . . . . . . . . . . . 3452 1365 sufficient for 10 devices free delivery Spare part battery contact strip. . . . . . . . . . . . . . 3452 1362 consisting of: Battery contact strip with fixing hole and connecting PCB Conversion kit Infusomat® Space . . . . . . . . . . . . 3452 1361 solely for helicopter use consisting of: Battery contact strip with fixing hole and connecting PCB Housing upper part Battery module with fixing pin Battery compartment cover Rating plate ISP. . . . . . . . . . . . . . . . . . . . . . . . . . . On request Front flap sealing strip . . . . . . . . . . . . . . . . . . . . . On request 8- 2 Infusomat® Space P 5.0 EN Spare Parts List Item Designation 8 Ord. No. Retrofit kit Pole Clamp . . . . . . . . . . . . . . . . . . . . . 3477 4390 contains: Grid right reworked (10 pieces) Grid left reworked (10 pieces) VDO compression spring (40 pieces) Straight pin 2x10 A2 (20 pieces) Service kit Pole Clamp SP spindle with handle. . 3477 4383 contains: Spindle (10 pieces) Handle of spindle (10 pieces) Rivet plate (10 pieces) EN Infusomat® Space P 5.0 8- 3 0-6 8 Spare Parts List 8- Spare Parts List 3 4, 5 6 14 17 20 11 21 15 18 16 10 1 12, 13 24 9 23 27 28 26 19 22 30 29 25 7 8 2 Fig.: 8 - 1 Exploded drawing Infusomat® Space P 8- 4 Infusomat® Space P 5.0 EN Spare Parts List EN Infusomat® Space P 5.0 8 1 Slide guide ISPP, compl. . . . . . . . . . . . . . . . . . . . 3452 1500 2 Cover, drop sensor connector . . . . . . . . . . . . . . . 3452 1577 3 Battery compartment cover ISP, cpl. . . . . . . . . . 3452 1321 (incl. emergency release crank) 4 Battery module SP (NIMH), without fixing pin . 3452 0856 Battery module SP (NIMH), with fixing pin3452 0856A 5 Battery module SP (Li-ion) with WLAN and fixing pin . . . . . . . . . . . . . . 8713182A 6 Housing upper part ISP. . . . . . . . . . . . . . . . . . . . . 3452 1313 7 Loudspeaker SP . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 0937 8 Housing bottom part ISP . . . . . . . . . . . . . . . . . . . 3452 1305 9 Lock bolt drive ISP . . . . . . . . . . . . . . . . . . . . . . . . 3452 1429 10 Linear poti ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1056 11 Pressure adjustment unit ISPS . . . . . . . . . . . . . . 3452 1445 (spring holder, pressure springs, adjusting screw adjusting nut, bracket, bracket locking) 12 Pump frame ISP, without motor . . . . . . . . . . . . . 3452 1402 13 Pump drive motor ISP . . . . . . . . . . . . . . . . . . . . . 3452 1410 14 Lock bolt ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1496 15 Inner frame ISP . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1437 16 Membrane ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1356 17 Pressure sensor ISP . . . . . . . . . . . . . . . . . . . . . . . 3452 1372 18 Air inline sensor ISP . . . . . . . . . . . . . . . . . . . . . . . 3452 1380 19 Ribbon tape air inline sensor ISP (10 pieces) . . . 3477 4356 20 Safety clamp ISPP . . . . . . . . . . . . . . . . . . . . . . . . 3452 1526 21 Front frame ISPS, cpl. . . . . . . . . . . . . . . . . . . . . . 3452 1518 22 Operating unit ISPS, cpl.. . . . . . . . . . . . . . . . . . . . 3452 1534 23 LC display SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 0988 24 Metal front sheet, Outsert ISPP . . . . . . . . . . . . . 3452 1542 25 Axle ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1461 (incl. hinge covers and hinge spring) 26 Processor PCB ISP . . . . . . . . . . . . . . . . . . . . . . . . 3452 1348 (incl. connectors) 27 Connector P2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4355 28 Connector P3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 4359 29 Bottom inner frame ISP . . . . . . . . . . . . . . . . . . . . 3452 1453 30 EMC plate ISP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452 1440 8- 5 8 Spare Parts List For your notes: 8- 6 Infusomat® Space P 5.0 EN 9-2 9- Description of Version Revision Documentation 9 Version 1.0 (Base Version) - First version of this Service Manual. - Release date: 03.04.2007 Version 2.0 - Modified TSC of the Infusomat® Space P - Text corrections - Changed spare part number battery module SP - Worded warnings to conform with ANSI - Addition to Chapter 3.6 Battery Module: Retrofitting of the battery fixation - Addition to Chapter 3.14 Processor PCB: Exchanging the connector seal P2 - New Chapter 3.16 Pole Clamp SP Adapter Kit - Release date: 15.05.2010 Version 3.0 - Text corrections - Release date: 08.02.2011 Version 4.0 - Checklist for functional test prior to first use - Revised error code lists - New air inline sensor - Revised instructions for cleaning and disinfection - Changed TSC of the unit - Revised procedural instructions on the TSC - Version-specific Pole Clamp spare parts - Changed general spare parts Version 5.0 - EN Infusomat® Space P 5.0 Screenshot corrections 9- 1 9 Revision Documentation For your notes: 9- 2 Infusomat® Space P 5.0 EN 10 - 2 10 - Index 10 A H Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 16 Housing bottom part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 22 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 45 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1, 3 - 40 Housing front panel . . . . . . . . . . . . . . . . . . . . . . . . 3 - 23, 3 - 29 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 44 B Battery module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 12 Housing upper part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 19 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 46 Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 3 Block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 8 I Inner frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 23, 3 - 25 C Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 42 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 10 Checks after repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 55 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1 Commissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 17 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 44 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 40 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1 Compatibility List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 15 L Contact Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 11 Linear potentiometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 28 Cover for drop sensor connector . . . . . . . . . . . . . . . . . . . . . 3 - 10 List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 9 Current versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5 Loudspeaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 22 D O Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1 Operating unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 31 Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 41 Drop sensor connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 10 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 41 Open manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 6 E Emergency Release Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 10 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 16 Error codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1 P Error modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 10 Physical construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2 Ersatzteilliste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 1 Pressure cut-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7 Pressure limitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7 F Flow accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 8 Processor PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 37 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 41 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4 Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 2 Functional test §5, Section 1, MPBetreibV . . . . . . . . . . . . . . . . . . . . . . 1 - 17 R Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 6 EN Infusomat® Space P 5.0 10 - 1 10 Index S Safety data sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 7 Service Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 10 Quit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 15 Starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 10 Service Program Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 14 Servicing the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1 Sicherheitstechnische Kontrolle Infusomat® Space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Slide Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 9 Special tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 STK Infusomat® Space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1 T Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 16 Technical Safety Check Power Supply SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4 Technical Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 TSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5 Power Supply SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4 Procedural instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 U Unit foot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 11 Unit Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 9 Update software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 10 Z Zero force insertion connector . . . . . . . . . . . . . . . . . . . . . . . 3 - 40 10 - 2 Infusomat® Space P 5.0 EN Manufactured by: Distributed in U.S. and Canada by: B. Braun Melsungen AG 34209 Melsungen Germany B. Braun Medical Inc. 824 Twelfth Avenue Bethlehem, PA 18018 USA B. Braun Melsungen AG | Carl-Braun-Straße 1 | 34209 Melsungen | Germany Tel +49 (0) 5661 71-0 | Fax +49 (0) 5661 71-4567 | www.bbraun.de Mat. No. 8713 9153, Doc. No. M687_000061, Version 5.0