B braun perfusor space инструкция

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• Page 1
  Perfusor® Space and Accessories Instructions for Use It is recommended that all pumps at your care unit are equipped with the same software version. Valid for software 688M…

• Page 2: Table Of Contents

  CONTENTS Perfusor® Space Overview………………………3 Symbols on Product ……………………….5 Patient Safety ……………………….6 Menu Structure / Navigation……………………11 Chapter 1 Operation ……………………..14 1.1 Start of Infusion …………………….14 1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time……………………….15 1.3 Bolus Application ……………………16 1.4 Syringe Change and New Therapy Start …………….17 1.5 End of Infusion……………………..18 1.6 Standby Mode ……………………..18…

• Page 3: Perfusor® Space Overview

  PERFUSOR SPACE® OVERVIEW P E R F U S O R ® S PA C E O V E R V I E W Arrow up and -down Press to reset single values Drive head with Scroll through menus, change setting of numbers from 0-9,…

• Page 4
  For vertical fixation of PoleClamp push lever down and rotate either way until lever clicks into notch. Push lever for rotation. Caution: A maximum of three B. Braun Space pumps can be stacked together when used with the PoleClamp SP.

• Page 5: Symbols On Product

  SYMBOLS ON PRODUCT S Y M B O L S O N P R O D U C T Symbol Explanation Mandatory action: see instruction for use. See accompanying documents. Type CF unit with defibrillation protection Protection class II device Symbol indicating separate collection for electrical and electronic equipment (2002/96/EC) CE mark compliant to Directive 93/42/EEC…

• Page 6: Patient Safety

  Operation • The initial training of the Perfusor® Space is to be performed by B. Braun sales personnel or other authorized persons. After each software update, the user is required to inform himself of the changes to the device and accessories by referring to the Instructions for Use.

• Page 7
  PATIENT SAFETY • Only connect to patient once the syringe has been inserted correctly and there is proper fixation of the syringe pressure plate by the claws of the drive head. Interrupt connection during syringe change to prevent incorrect dose delivery.
• Page 8
  PATIENT SAFETY Enteral Nutrition The Perfusor® Space may be used for enteral nutrition. Do not use enteral fluids for intravenous infusion as this may harm your patient. For this reason only use disposables dedicated and labeled for enteral nutrition. Other components •…
• Page 9
  TCI and properly trained in using the present device. • The use of TCI with B. Braun Space does not limit the responsibility of the anaesthetist for administration of drugs. They need to be fully aware of the available literature for any parameter set used in association with a drug and need to refer to the prescribed information for rate and dosing limits.
• Page 10
  PATIENT SAFETY • While using TCI an appropriate patient monitoring is mandatory. • Take care of using the right dilution/concentration of the drug and make sure the right dilution is selected at the pump. • Never administer Propofol or Remifentanil by a second infusion as long as you use TCI.

• Page 11: Menu Structure / Navigation

  MENU STRUCTURE / NAVIGATION MENU STRUCTURE / NAVIGATION Cutline On/Off button OK button Start/Stop button Keypad with arrow up, -down, -left, -right button Bolus button Connection button Clear button All display screen shots are examples and may be different when related to an individual patient and individualized therapy.

• Page 12
  MENU STRUCTURE / NAVIGATION Display Meaning All status information is available in the bottom line of the dislplay. The desired information can be selected by using and will be displayed permanently thereafter (e. g. drug long name, time until syringe empty, current system pressure etc.).
• Page 13
  MENU STRUCTURE / NAVIGATION Start Up Main Special Options Status Menu Menu Functions Menu Menu Syringe Dose Rate Occlusion Intermediate Dose selection Calculation Pressure volume Intermediate Prime ? Concentration Drug Library OccluGuard amount Change-over Use last Pressure Intermediate Weight therapy ? from Leap/Drop time…

• Page 14: Chapter 1 Operation

  OPERATION Chapter 1 OPERATION 1.1 Start of Infusion • Ensure correct installation of the pump device. If the pump is connected to mains, the display states information such as the battery status, the mains connection symbol and the last therapy. •…

• Page 15: Entry With Different Combinations Of Rate, Vtbi (= Volume To Be Infused) And Time

  OPERATION Chapter 1 • Press to commence infusion. Running arrows on display and green LED above display indicate pump is infusing. Note: Stop the infusion at any time by pressing . The pump can be turned off at any time by pressing for 3 sec (Exception: Data lock level 2) and as long a disposable is inserted.

• Page 16: Bolus Application

  OPERATION Chapter 1 a) Target symbol is placed in front of VTBI: • Change of VTBI => Adjustment of time. Old and new target: VTBI • Change of time => Adjustment of rate. Old and new target: VTBI b) Target symbol is placed in front of time: •…

• Page 17: Syringe Change And New Therapy Start

  OPERATION Chapter 1 1.4 Syringe Change and New Therapy Start Note: To avoid incorrect dosing, always disconnect the pump from the patient when changing the syringe. Never leave the pump device unattended during syringe change. Before inserting a new syringe check if the axial fixation is properly working. •…

• Page 18: Standby Mode

  OPERATION Chapter 1 • Open pump cover. Remove the syringe, move the syringe holder into an upright position and close the front door. • Press for 3 sec. to switch the pump off. The drive moves into parking position. Note: The settings will be permanently saved by the switched off device.

• Page 19: Chapter 2 Advanced Operations

  OPERATION Chapter 1 ADVANCED OPERATIONS 2.1 Status Request of Pump when Infusion is Running Press to switch between run display and Main Menu while the device is infusing. Navigate through the menu using to check parameters. In order to check the menu parameters in the Status-/Options Menu, select «Status»…

• Page 20: Chapter 3 Special Functions

  ADVANCED OPERATIONS Chapter 2 SPECIAL FUNCTIONS 3.1 Dosing Units and Dose Rate Calculation (Overview) The following list shows the units used in the pump: Gram family: ng, mcg, mg, g Unit family: mIU, IU, kIU, MIU Equivalents family: mEq Mole family: mmol Kilocalorie family: kcal Millitliter family:…

• Page 21: Dose Rate Calculation (Operation)

  SPECIAL FUNCTIONS Chapter 3 3.2 Dose Rate Calculation (Operation) a Select dose rate calculation with l. a Select the unit of the active ingredient with and confirm it with l. a Enter the concentration by entering the amount of the active ingredient and the volume.

• Page 22
  SPECIAL FUNCTIONS Chapter 3 On the one hand, a drug name including the according therapy data can be taken from the drug library. On the other hand, if a rate, VTBI and/or time were already defined in the Main Menu, the drug name and the adjusted values of the data set will be loaded.
• Page 23
  SPECIAL FUNCTIONS Chapter 3 • Select the desired drug with and press l. Before the initial bolus begins, the bolus menu is displayed to allow editing the bolus with q. • Check the parameter and start infusion with Hard Limits: If the set rate/dose/bolus volume and bolus rate exceed the values stored in the drug library (hard limits), the drug will be rejected, a hint will be displayed and the pump will fall back into the drug selection.

• Page 24: Patient Controlled Analgesia (Pca) (Optional)

  SPECIAL FUNCTIONS Chapter 3 The Drug Library Upload starts as soon as the pump is in Passive mode. You can cancel the upload by pressing c. Note: Please contact your local sales represantative in case you like to use Remote Drug Library update.

• Page 25
  SPECIAL FUNCTIONS Chapter 3 In this state the patient is allowed to demand boli. Depending on the status of the therapy these are either administered or denied. Changing the syringe is also possible by using the code for level 1 or level 2. Altering the settings for PCA or other therapies however is only possible with the code for level 3.

• Page 26: Target Controlled Infusion (Tci) (Optional)

  The pharmacokinetic model and its parameters are schematically depicted by the following illustration: B. Braun Space is offering two modes for TCI: • TCI by targeting the plasma concentration In this mode the user selects the desired concentration of a drug in the…

• Page 27
  TCI. A pharmacokinetic model modi- fied in such way is schematically depicted by the illustration on the next page. TCI with B. Braun Space is possible with two drugs: Propofol and Remifentanil. For Propofol the user can choose between two parameter sets. The parameter…
• Page 28
  SPECIAL FUNCTIONS Chapter 3 Drug / Parameter Propofol Remifentanil [Litre] 0,228 * Weight 4,27 5,1 — 0,0201 * (Age — 40) + 0,072 * (LBM — 55) [min 0,119 0,443 + 0,0107 * (Weight — [2,6 — 0,0162 * (Age — 40) + 77) — 0,0159 * (LBM — 59) + 0,0191 * (LBM — 55)] / [5.1 — 0,0062 * (Height — 177)
• Page 29
  Chapter 3 Important note: Before installing an additional drug list please contact your local B. Braun representative! Setting up the pump For TCI a drug list with at least one drug activating the profile TCI is necessary. The drug list in this version is pre-defined. By this the conditions for an effective and safe therapy are defined.
• Page 30
  SPECIAL FUNCTIONS Chapter 3 Important notes: • Be sure to enter the data corresponding to the respective patient. • Once the TCI is started patient data can not be altered! Editing a target and starting TCI The editor window for setting the target comes up with the default value from the drug list.
• Page 31
  SPECIAL FUNCTIONS Chapter 3 Useful information while pump is running By pressing additional information can be requested. Pressing a second time is offering a graphical overview. The line describes the course of Cp over the time and the area describes the course of Ce over the time.

• Page 32: Barcoding

  SPECIAL FUNCTIONS Chapter 3 Barcoding The barcoding functionality is included but initially not activated. Please contact your local sales representative in case you like to use barcoding. Ramp and Taper Mode The Ramp and Taper Mode is designed to deliver infusions with gradual ramp up and taper down rates.

• Page 33
  SPECIAL FUNCTIONS Chapter 3 Set Profile Parameters: The therapy can be started directly via the drug library or via the Main Menu/Special functions. Starting Ramp and Taper via Drug Library: Note: Ramp and Taper settings have been configured in the Drug List Manager before and have been uploaded into the pump.

• Page 34: Program Mode

  SPECIAL FUNCTIONS Chapter 3 Taper phase The pump linearly decreases the rate in the predefined time until it reaches the KVO rate Note: After starting infusion it is only possible to change rates, time and VTBI in the continuous phase. By editing (increasing/decreasing) the plateau rate, the therapy is recalculated.

• Page 35
  SPECIAL FUNCTIONS Chapter 3 Example: Program Mode should only be performed by an experienced user being familiar with the principles of the Program Mode function and properly trained in using the present device. Note: The active Program Mode function always displays this icon in the Display Note: Bolus function is disabled for Program Mode.

• Page 36: Intermittent Mode

  SPECIAL FUNCTIONS Chapter 3 The pump can be started now by pressing Starting Program Mode via Special Function Menu: • Switch on pump with and wait until self-check is finished. • Insert disposable. • Go to Special Functions Menu and select Program Mode. •…

• Page 37
  SPECIAL FUNCTIONS Chapter 3 Example: Intermittent Mode should only be performed by an experienced user being familiar with the principles of the Intermittent Mode and properly trained in using the present device. Note: The active Multi Dose Mode function always displays this icon in the Display Note: Regular Bolus function is disabled for Intermittent Mode.
• Page 38
  SPECIAL FUNCTIONS Chapter 3 Starting Intermittent Mode via Special Function Menu: • Switch on pump with and wait until self-check is finished. • Insert disposable. • Go to Special Functions Menu and select Intermittent Mode. • Press to enter parameters and to confirm.

• Page 39: Dose Over Time

  Note: The feature Dose Over Time always requires the usage of dosing units (i.e., mg or mg/kg patient weight). Before using Dose Over Time contact your local B. Braun representative! Starting Dose Over Time via Drug Library: Note: Dose Over Time settings have been configured in the Drug List Manager before and have been uploaded into the pump.

• Page 40
  SPECIAL FUNCTIONS Chapter 3 • Insert disposable and use the drug library according to the Instructions for Use. • Select a drug by using and press l. The pump now offers the possible therapy profiles. Select “Dose over Time” with press l.

• Page 41: Take Over Mode (Tom) (Optional)

  SPECIAL FUNCTIONS Chapter 3 3.11 Take Over Mode (TOM) Take Over Mode is a feature to support the user during syringe changes by auto- matically starting a second Perfusor® Space pump when the first has run empty. The second pump automatically takes over the infusion rate from the first pump. Activation: •…

• Page 42
  SPECIAL FUNCTIONS Chapter 3 • Navigate through the list with and select in alphabetical order (all drugs) or within a category with l. The drug selected in the second pump must be the same as the first. • Navigate through the list with and select a concentration with l.
• Page 43
  SPECIAL FUNCTIONS Chapter 3 Note: Start-up behaviour is not influenced by TOM. See Chapter Start Up Graphs and Trumpet Curves. Note: Please use a seperate patient connection for Take Over Mode infusion (e.g. smallbore extension set) or use a back check valve for lines at the same access which are not used for Take Over Mode.
• Page 44
  SPECIAL FUNCTIONS Chapter 3 Recommendation Ensure first Perfusor® Space pump is infusing Ensure first Perfusor® Space pump must be running in ‘continuous mode’ (i.e. ml/h or a dose rate; not KVO, PCA etc.) Deactivate Data Lock Data connection must be active between pumps –…
• Page 45
  SPECIAL FUNCTIONS Chapter 3 Changes in TOM system: Change Reaction Rate changed in pump No user interaction necessary, will start infusion at new rate when syringe is empty. pump is stopped pump shows “connection lost – TOM aborted” alarm. TOM may be reactivated by pump is put in standby pressing and then…

• Page 46: Chapter 4 Autoprogramming

  AUTOPROGRAMMING Chapter 4 A U TO P R O G R A M M I N G Note: All normal pump functions remain in place when orders are received via autoprogramming. The pump can accept drug orders wirelessly from the EHR system or from SpaceStation with SpaceCom.

• Page 47
  AUTOPROGRAMMING Chapter 4 Note: Order may be cancelled prior to confirming order. • Once all values are confirmed, the Main Menu is displayed. Note: Soft Limit alert will be issued if value exceeds any soft limits set in drug library, soft limit may be overridden or value re-programmed per institutional policy.
• Page 48
  AUTOPROGRAMMNG Chapter 4 • Follow prompt, pressing to accept order or key to cancel and hold order for later. New Primary Infusion: • To accept a new PRIMary order, stop infusion and clear current PRIMary infusion by pressing key and responding “yes” to clear current infusion. PIGGYback Orders: Orders received after PRIMary has been set will be for PIGGYback infusions, follow prompts on screen to stop the PRIMary to accept the PIGGYback order.
• Page 49
  AUTOPROGRAMMING Chapter 4 Note: Changing values on any incoming order may only be done after confir- ming all values. Once all values are confirmed you may scroll to any value and open editor with to change value. Alternately, order may be cancelled and request made for revised order to be sent.

• Page 50: Chapter 5 Options

  OPTIONS Chapter 5 OPTIONS The options functions may be selected and changed while the pump is infusing or stopped. To edit a menu item, select “Options” in the Main Menu and press l. Then select desired function with and follow the Instructions for Use as described. 5.1 Occlusion Pressure The higher the pressure level is set at, the higher the pressure level must rise before triggering an occlusion pressure alarm.

• Page 51
  OPTIONS Chapter 5 OccluGuard activation / deactivation from the Main Menu • Go to Options Menu and press l. • Navigate through the list with and select OccluGuard. • OccluGuard can be activated with and deactivated with d. Pressure Leap/Drop detection The pressure leap/drop software detects sudden increases and decreases in infu- sion pressure respectively which can be caused by problems in IV access, or changes in pump position in the SpaceStation.
• Page 52
  OPTIONS Chapter 5 OccluGuard Meaning Recommendation Symbol OccluGuard is active. Infusion is running stably Pending – OccluGuard has not enough data OccluGuard will automatically reactivate as soon as infusion rate OccluGuard Inactive drops below threshold levels – see above. Confirm alarm and check IV access, IV setup and syringe for cause of Occlusion has been occlusion.

• Page 53: Data Lock

  OPTIONS Chapter 5 When a change is made to the infusion system (e.g. addition or removal of a pump to a SpaceStation, a change of infusion rate, a bolus application) the OccluGuard and pressure leap/drop are temporarily set to ‘pending’ ( ) to allow the system to reach a hydrostatic balance, and so prevent false alarms.

• Page 54: Bolus Rate

  OPTIONS Chapter 5 Activation of the function: • Open data lock in Options Menu with l. • Select between level 1, 2 or 3 (if activated) with and confirm with k. • Enter code with and press in order to activate data lock. Changes to the protected values and the bolus function which are marked withy are only possible after entering the code.

• Page 55: Alarm Volume

  OPTIONS Chapter 5 5.7 Alarm Volume Chose between 9 different alarm volume levels. • Open alarm volume in Options Menu with l. • Set volume with and confirm entry with k. 5.8 Date / Time • Open date/time in Options Menu with l. •…

• Page 56: Chapter6 Alarms

  ALARMS Chapter 5 ALARMS The Perfusor® Space is equipped with a audible and optical alarm signal. Audible Alarm- Optical signal Staff call User confirmation type signal Red LED Yellow LED Text Device flashes device Press and follow Alarm alarm and the instruction on the alarm code display.

• Page 57
  ALARMS Chapter 6 Display message Pre-alarm reason “Syringe nearly empty“ Very little fluid is left in syringe. “VTBI near end“ The preselected volume is nearly infused. “Time near end“ The preselected time is almost over. “Battery nearly empty“ The battery is almost discharged. “KVO mode“…
• Page 58
  ALARMS Chapter 6 the alarm message, and the staff call (optional) are all cleared by pressing k. Corrections should be made in accordance with the alarm reason. Display message Alarm reason “Syringe empty“ There is no fluid left in the syringe. Due to varying syringe tolerances of syringes from other manufacturers, some fluid may be left inside the syringe.
• Page 59
  ALARMS Chapter 6 “Calibrate device“ Pump calibration data have changed (e.g. after an update). Recalibrate device via the service program. “Claw malfunction“ The emergency release button was pressed and the claws manually opened. Take out syringe and contact technical service department. “Plunger plate not prop.

• Page 60: Reminder Alarms

  ALARMS Chapter 6 6.3 Reminder Alarms Reminder alarms only occur in two cases: 1. A syringe is inserted, the pump doesn’t administrate, no value is being edited and the device is not operated for two minutes. An acoustic tone sounds, the yellow LED is constantly on and a staff call is activated.

• Page 61: Battery Operation And Maintenance

  BATTERY OPERATION AND MAINTENANCE Chapter 7 BATTERY OPERATION AND MAINTENANCE The battery has an operating lifetime of 8 hours at 25 ml/h when new. For optimal treatment of the battery, the device is equipped with protection against overcharge and deep depletion. The battery pack is charged by the pump during connection to mains.

• Page 62
  BATTERY OPERATION AND MAINTENANCE Chapter 7 • If a battery, which is not completely discharged, is charged several times, its capacity can be reduced. • Under normal temperature conditions a battery can be charged and discharged approx. 500 times before its lifetime decreases. •…

• Page 63: Chapter 8 Compatible Syringes

  ) to ensure specific syringe brand compatibility. The Time to Occlusion alarm has been measured at 5 ml/h. The measured data are typical values which may vary because of possible syringe tolerances. Manufacturer: B. Braun Syringe Type Omnifix Omnifix Omnifix Omnifix Omnifix B.

• Page 64
  COMPATIBLE SYRINGES Chapter 8 Manufacturer: TYCO USA Syringe Type Monoject Monoject Monoject Monoject Monoject Monoject 3 ml 6 ml 12 ml 20 ml 35 ml 50/60 ml TYCO USA Mat. No. 8881- 8881- 8881- 8881- 8881- 8881- 513934 516937 512878 520657 535762 560125…
• Page 65
  COMPATIBLE SYRINGES Chapter 8 Manufacturer: TERUMO Syringe Type 3 ml 5 ml 10 ml 20 ml 30 ml 50 ml 60 ml TERUMO EU/USA/JAP Mat. No. 3SS*03L 3SS*05L 3SS*10L 3SS*20L 1SS*30LZ1 2BS-50LG 3SS*60L 1SS*05LZ1 1SS*10LZ1 SS*20ES typ. typ. typ. typ. typ.
• Page 66
  COMPATIBLE SYRINGES Chapter 8 Manufacturer: Becton-Dickinson Syringe Type BD Precise BD Precise B-D Precise 50 ml A/P 20 ml A/P Mat. No. 300144 300141 Time to Occl. [mm:ss] 03:17 01:11 [mm:ss] 16:36 05:03 Manufacturer: Polfa Syringe Type Polfa 50 ml Mat.
• Page 67
  COMPATIBLE SYRINGES Chapter 8 Syringes not specified in IEC/EN 60601-2-24 Nutrition pumps, in contrast to infusion pumps, are not classified as Class IIa according to the infusion pump norm IEC/EN 60601-2-24. There are therefore no direct guide- lines concerning the technical characteristics (accuracy of infusion rate, alarm parameters etc) of the relevant disposables.

• Page 68: Start Up Graphs And Trumpet Curves

  START UP GRAPHS AND TRUMPET CURVES Chapter 9 START UP GRAPHS AND TRUMPET CURVES Start Up Curves Trumpet Curves The graphs show the accuracy/uniformity of flow in relation to time. They allow for the following: The delivery behaviour or delivery precision is essentially influenced by the type of (disposable syringe) used.

• Page 69: Is Depending On Chapter10 Technical Data

  Moisture protection IP 22 (fluid protected for horizontal usage) External power supply: • Rated voltage Via B. Braun SpaceStation or optional mains adaptor (rated voltage 100 … 240 V AC~, 50/60 Hz) for stand alone operation • External low voltage 11 ……

• Page 70
  Delivery rate 1 ml/h: KVO-rate = set rate (default setting 0.1 ml/h) Computer connection USB connection in combination with B. Braun interface lead CAN SP (8713230) including electrical insulation. Please pay attention to safety notices. History protocol < 3000 last history entries.
• Page 71
  TECHNICAL DATA Chapter 10 • Only use combined with approved devices/accessories by the manufacturer, otherwise this may lead to higher emission or reduced immunity. • Use only compatible combinations of equipment, accessories, working parts and disposables with luer lock connectors. Essential Performance for Infusion pumps: •…
• Page 72
  TECHNICAL DATA Chapter 10 EMC (ELECTROMAGNETIC COMPATIBILITY)
• Page 73
  TECHNICAL DATA Chapter 10…
• Page 74
  TECHNICAL DATA Chapter 10…
• Page 75
  TECHNICAL DATA Chapter 10…

• Page 76: Warranty / Tsc* / Service / Training / Cleaning / Disposal

  • the Technical Safety Checks are carried out regularly. Warranty The CE mark confirms that this B. Braun provides 24 months warranty, as from the date of delivery, for every medical product Perfusor® Space (12 months for every Battery-Pack SP). This covers repair or complies with the replacement of parts damaged as a result of design/manufacturing errors or «Council Directive…

• Page 77
  Note: Do not use Hexaquart® or other alkylamine containing disinfectants. Recommended: disinfectant for wiping available from B. Braun: Meliseptol® Foam pure, Melsitt 10% and Melsept SF 10%. Note: Keep instrument upright and do not allow any part of instrument to become saturated with or submersed in fluid during cleaning operation.
• Page 78
  Disposal The pumps as well as battery packs can be returned to B. Braun for further disposal. When taking care of disposing of disposables as well as infusion soluti- ons, please consider the applicable hygiene and disposal regulations.

• Page 79: Instructions For Use Accessory

  Comfort additionaly includes a central alarm management and alarm LEDs. PoleClamp SP (8713130) A maximum of three B. Braun Space pumps and one SpaceControl can be stacked together when used with the PoleClamp SP. For detailed instructions on secure fixation of the PoleClamp SP please refer to «Overview Perfusor® Space»…

• Page 80
  INSTRUCTIONS FOR USE ACCESSORY Chapter 12 3.) Push plug of Connection Lead SP into 12 V connector. Note: A maximum of three plugs can be stacked upon each other in socket P2. Battery-Pack SP (NiMH) (8713180) Battery-Pack SP (NiMH) incl. Pin (8713180A) For further information on the Battery-Pack SP (NiMH) see “Battery Operation”.
• Page 81
  INSTRUCTIONS FOR USE ACCESSORY Chapter 12 Connection Lead SP (12 V) (8713231) Install the Connection Lead SP (12 V) in the following way: 1.) Connect plug to socket P2 on back of pump or F3 on SpaceStation respectively. 2.) Put the connection lead into the car socket. 3.) If necessary, remove red adaptor of motor vehicle connector by slightly turning and simultanously pulling.
• Page 82
  INSTRUCTIONS FOR USE ACCESSORY Chapter 12 Caution: The user should always closely observe the local pump alarms as well. Note: A maximum of three plugs can be stacked upon each other in socket P2. Technical Data Connecting Wire white and green white and brown Alarm disconnected…
• Page 83
  INSTRUCTIONS FOR USE ACCESSORY Chapter 12 P C A — A c c e s s o r i e s • Space PCA-Kit (REF 8713554) consisting of: : — Demand button — Hook and loop tape for fixation of the demand button at the patient s arm — Line fixation connection between hook and loop tape…

• Page 84: Ordering

  ORDERING Art. No. B. Braun Perfusor® Space (100 – 240 V) ……….871 3030 Recommended accessories for the B. Braun Perfusor® Space: SpaceStation ………………..871 3140 SpaceCover Standard ………………871 3147 SpaceCover Comfort ………………871 3145 PoleClamp SP…………………871 3130 Power Supply SP EU III ……………….871 3110D Power Supply SP EU III 3.0m……………..871 3123D…

• Page 85
  ORDERING 50ml, yellow inked cylinder and aspiration needle…….87 28801 F 50ml, yellow inked cylinder, aspiration needle and 15 µm particle filter …………….872 8800 F 50ml, black, aspiration needle and particle filter……..872 8828 F Omnifix® syringes Omnifix® 50/60 ml Luer Lock……………461 7509F Omnifix®…
• Page 86
  ORDERING Type PCA, PVC tube 1,5 mm, 150 cm, Luer Lock ……..872 6019 with 0.2 µm Sterifix filter, PVC tube 1,5 mm, 200cm, Luer Lock …………………872 3001 with SafeSite valve, PVC tube 1,5 mm, 150 cm, Luer Lock………………..872 2820…
• Page 90
  Manufactured by: B. Braun Melsungen AG B. Braun Melsungen AG Sparte Hospital Care 34209 Melsungen 34209 Melsungen Germany Germany Tel +49 (0) 56 61 71-0 Tel.: +49 (0) 56 61 71-0 Fax: +49 (0) 56 61 71-20 44 38916517 • Drawing No. I0688700201 Printed on pulp bleached 100 % chlorine-free www.bbraun.com…

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6. Service manual

• Page 1
  Perfusor® Space Service Manual Version 1.3 English…
• Page 2
  This Service Manual is valid for: Designation Part No. Infusion syringe pump Perfusor® Space … . 0871 3030 This Service Manual is available under Designation Part No. the following part number: Service Manual Perfusor®…
• Page 3
  Table of Contents Important Preliminary Remarks Service Work Page 0 — 5 Technical Safety Checks Page 0 — 5 Current Versions Page 0 — 5 Revision Service Page 0 — 5 Quality Management Page 0 — 6 Checks and Repair Page 0 — 6 Notes on ESD…
• Page 4
  Table of Contents Servicing the Unit Cleaning Page 4 — 1 Servicing the Battery Page 4 — 1 Technical Safety Check (TSC) Perfusor® Space 1 Technical Safety Check (TSC) Power Supply SP 1 Procedural Instructions on the TSC Visual Inspection Page 7 — 1 Electrical Safety…
• Page 5
  You will be included in the revision service after: technical training by B. Braun Melsungen or a written order placed with the sales department of B. Braun (fee required). Perfusor® Space, 1.1 gb 0 — 5…
• Page 6
  B. Braun unit. Quality Management 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…
• Page 7
  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. Setting Off Additional notes and warnings are set off as follows:…
• Page 8
  Important Preliminary Remarks 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 Table 2 — 1 References to item numbers in figures are shown as follows (Fig.: 1 — 1 / Item In this case “Fig.: 1 — 1“…
• Page 9
  Important Preliminary Remarks List of Abbreviations Abbreviations which are not generally known, but are used in this manual, are listed below. Controller Area Network Communauté Européenne (European Communities) Calibration Step Deutsche Industrie Norm (German Industrial Standard) European Standard Electrostatic Discharge Function Microprocessor International Electrotechnical Commission…
• Page 10
  Important Preliminary Remarks Unit Test Step Verband der Elektrotechnik, Elektronik und Informationstechnik e.V. (German electrical engineering association) 0 — 10 Perfusor® Space, 1.2 gb…
• Page 11
  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) Nadja Machal Fax: +49 5661 / 75 — 47 89 e-mail: nadja.machal@bbraun.com…
• Page 12
  Contact Persons For your notes: 0 — 12 Perfusor® Space, 1.0 gb…
• Page 13
  System Overview Description The Perfusor® Space (PSP) is according to IEC/EN 60601 resp. IEC/ EN 60601-2-24 a transportable infusion syringe pump for administrating fluids in the nutritional therapy and infusion technique as well as for home care applications. The medical specialist must decide on suitability for application on the basis of the warranted properties and the technical data.
• Page 14
  System Overview Physical Construction Fig.: 1 — 2 Perfusor® Space Legend of fig. 1 — 2: ItemDesignation Perfusor® Space Connector “P2“ for SpaceStation module, external 12 V DC and accessories Drive head Connector “P3“, connection to SpaceControl module Syringe holder with piston brake Battery compartment cover Operating Unit Syringe area…
• Page 15
  System Overview The Perfusor® Space housing mainly consists of the bottom part and the upper part. 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 with two hinges.
• Page 16
  System Overview The pressure in the infusion system is measured through a strain gauge measuring in the drive head and monitored in the device electronics. The data from the strain gauge is continuously compared with the limit values which are calculated dependent on the selected syringe type and the pressure settings.
• Page 17
  System Overview Fig.: 1 — 3 Block diagram Perfusor® Space Perfusor® Space, 1.0 gb 1 — 5…
• Page 18
  System Overview Unit Software Approved Software Versions 688A030032 Basic software Position 1 2 3 4 5 6 7 8 9 10 688A030035 Digit 6 8 8 C 0 3 0 0 0 1 Improved functions 688A030040 Revision level Improved functions Hardware Languages French and Swedish added Software group…
• Page 19
  PC is switched off, a component of the software may be seriously damaged so that repairs are no longer possible. In such a case the software cannot be updated via the PC and the device must be returned to B. Braun. Service Program Approved Version…
• Page 20
  System Overview 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”…
• Page 21
  System Overview The work window of the Service Program appears on the screen. All devices recognized are listed in the left column. Fig.: 1 — 8 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.
• Page 22
  System Overview 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.
• Page 23
  System Overview Service Program Version Help Info … 1. Open the “HiBaSeD“ window via . The current version of the Service Program is shown in this window. 2. Close the window by clicking “OK”. Fig.: 1 — 11 Compatibility List Help 1.
• Page 24
  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. Perfusor® Space Designation Part No.: Power supply Euro ……0871 3110A Power supply UK.
• Page 25
  Unit Diagnosis / Calibration General WARNING WHILE TESTING THE UNIT AND TROUBLE SHOOTING THE OPERATOR/SERVICE TECHNICIAN MUST WORK WITH VOLTAGES UP TO 115 / 230 V AC. THESE VOLTAGES MAY CAUSE INJURIES WHICH ARE DANGEROUS TO LIFE AND LIMB. THE NATIONAL AND INTERNATIONAL SAFETY REGULATIONS ARE TO BE ADHERED TO.
• Page 26
  Unit Diagnosis / Calibration The unit check, calibration and trouble shooting are subdivided into numbered working steps (Unit Test Step UTS, Calibration Step CS, Trouble Shooting TS) and are based on each other. Beginning with UTS 1 the operation described here has to be executed.
• Page 27
  Unit Diagnosis / Calibration Alarms and Error Codes The alarms of the Perfusor® Space 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.
• Page 28
  Unit Diagnosis / Calibration Alarms Alarm Possible Cause Fault Clearance Battery nearly discharged (type: pre- The device was not connected to the Operate the device with battery until the alarm) mains long enough message “Battery discharged“ is displayed and the unit is switched off. Then connect the unit to the mains for at least 6 hours.
• Page 29
  Unit Diagnosis / Calibration Device Alarms of the Function Processor Error Code Definition Possible Cause Fault Clearance 1001 … 1013 Internal Error 1014 Loudspeaker not off Loudspeaker connector Check the loudspeaker connector Loudspeaker Check the loudspeaker 1015 Loudspeaker lost Loudspeaker connector Check the loudspeaker connector Loudspeaker Check the loudspeaker…
• Page 30
  Unit Diagnosis / Calibration Device Alarms of the Control Microprocessor Error Code Definition Possible Cause Fault Clearance 1100 Timebase too fast Quartz of the processor PCB Exchange processor PCB 1101 Timebase too slow Quartz of the processor PCB Exchange processor PCB 1102 Timebase fail Quartz of the processor PCB…
• Page 31
  Unit Diagnosis / Calibration Error Code Definition Possible Cause Fault Clearance 1201 different version FuP to KuP Software Update unit software Software 1202 E_ERROR_STEPMOTOR_1 Phase Drive motor, lead screw Exchange processor PCB not ok 1203 E_ERROR_STEPMOTOR_2 Current Motor drive Carry out calibration value not 0x55 Recognition of direction of rotation…
• Page 32
  Unit Diagnosis / Calibration The Most Important Error Modes The following list specifies the most important error modes and their clearance. Note The device must be checked after every repair or service (see “Device Check“ pg. 2 — Error Possible Cause Fault Clearance The battery module discharges too fast The device was not used for a longer time.
• Page 33
  Unit Diagnosis / Calibration Device Check Activity Function If yes If no The device is inserted in a SpaceStation or UTS 2 UTS 3 connected to a SpaceControl. Remove the device. UTS 4 Loosen all connections from the device. UTS 4 Remove syringe and close syringe holder.
• Page 34
  Unit Diagnosis / Calibration Activity Function If yes If no Insert 2 ml / 3 ml syringe. On the LC display “Brake: stopped by holder” UTS 22 TS 21 appears in the line. Open syringe holder and remove syringe. On the LC display “Brake: stopped by light barrier” UTS 23 TS 21 appears in the line.
• Page 35
  Unit Diagnosis / Calibration Activity Function If yes If no Insert syringe gauge for the strain gauge UTS 41 measurement, close syringe holder and select syringe type „#Lehre OPS50“. The syringe gauge must not be tipped. Therefore fix the syringe gauge so far into the syringe recess by hand that the piston brake moves back and the claws surrounds the pressure element.
• Page 36
  Unit Diagnosis / Calibration Activity Function If yes If no Confirm syringe change, release syringe gauge and UTS 48 remove gauge. WARNING WHILE CHECKING THE MOTOR POWER LIMITATION WITH THE SYRINGE GAUGE THE SYRINGE HOLDER MUST NOT BE OPENED. THE SYRINGE GAUGE IS UNDER VERY HIGH PRESSURE AND MAY CAUSE INJURIES IF THE PRESSURE IS RELIEVED SUDDENLY.
• Page 37
  Unit Diagnosis / Calibration Activity Function If yes If no Select pressure stage 6 and start infusion. When the maximum pressure of this pressure stage UTS 56 CS 1 is reached, the delivery is stopped, the red LED on the operating unit flashes and the message “Alarm / Drive blocked”…
• Page 38
  Unit Diagnosis / Calibration Calibration Activity Function If yes If no Connect unit to PC with interface cable. CS 2 Start Service Program on the PC (see “Starting the The desired device is found by the Service Program CS 3 Service Program“…
• Page 39
  Unit Diagnosis / Calibration 1. Start the Service Program (see “Starting the Service Program“ pg. 1 — 2. Select the unit to be calibrated in the left column of the window with a double mouse-click. The blue and the yellow LED blinks in opposite with the red LED.
• Page 40
  Unit Diagnosis / Calibration 5. Input your user number in the window “Worker ID” as well as the six-digit serial number of the device, if necessary. 6. Confirm the input with “OK”. Fig.: 2 — 3 Note If HiBaSeD could not clearly read the device serial number, the number must be entered according to the rating plate.
• Page 41
  Unit Diagnosis / Calibration Fig.: 2 — 6 Perfusor® Space, 1.2 gb 2 — 17…
• Page 42
  Unit Diagnosis / Calibration 8. The frame “Data selection” is now activated. Fig.: 2 — 7 If the “Modify” button was pressed in the “Calibration procedure” frame, the desired data for editing and transmission can now be selected in the “Data selection” frame.
• Page 43
  Unit Diagnosis / Calibration 9. Mark at least the “Calibration data“ field in this frame if you have not selected “New device” and confirm by clicking “OK”. The device switches on and the drive head moves to the extended end position. You are prompted to press the blue connection key on the device.
• Page 44
  Unit Diagnosis / Calibration Fig.: 2 — 9 11. In the frame “Type of calibration” you can choose between a complete or a partial calibration. Select the desired calibration mode with the mouse pointer. Note The following description is applicable to a complete and a partial calibration.
• Page 45
  Unit Diagnosis / Calibration 12. Press the “OK“ button after you have selected the calibration elements. The necessary device data is read out and stored in the PC. Fig.: 2 — 10 Fig.: 2 — 11 Fig.: 2 — 12 Fig.: 2 — 13 Perfusor®…
• Page 46
  Unit Diagnosis / Calibration Fig.: 2 — 14 13. The frame “Element selection” is now activated. If you have selected a complete calibration in the “Type of calibration” frame, the individual calibration elements are already selected and cannot be changed. Actuate the “OK” button.
• Page 47
  Unit Diagnosis / Calibration Claw Calibration 1. The frame “Claw calibration” is activated and calibration is started. 2. The claws in the drive head are closed and the query “Claw closed? Please confirm” is displayed in the frame “Claw calibration”. 3.
• Page 48
  Unit Diagnosis / Calibration 4. Insert diameter gauge 23.4 mm and close the syringe holder. 5. Press the “OK” button. Fig.: 2 — 18 6. Insert diameter gauge 15.7 mm and close the syringe holder. 7. Press the “OK” button. Fig.: 2 — 19 2 — 24 Perfusor®…
• Page 49
  Unit Diagnosis / Calibration 8. Insert diameter gauge 9.0 mm and close the syringe holder. 9. Press the “OK” button. Fig.: 2 — 20 10. Open the syringe holder and remove the diameter gauge. Press the “OK” button. Note The syringe holder must always be completely turned and the axial fastening completely opened.
• Page 50
  Unit Diagnosis / Calibration 11. Close the syringe holder and actuate the “OK” button. If calibration was not terminated successfully, an error message is displayed on the PC screen. Fig.: 2 — 22 Pressure Calibration Note The term “Power gauge” in the windows of the Service Program corresponds to the syringe gauge.
• Page 51
  Unit Diagnosis / Calibration 4. If “Insert power gauge and confirm with OK” is displayed in the frame “Pressure calibration/length/PWM”, open the syringe holder and remove the length gauge. WARNING DURING PRESSURE CALIBRATION WITH THE SYRINGE GAUGE THE SYRINGE HOLDER MUST NOT BE OPENED. THE SYRINGE GAUGE IS UNDER VERY HIGH PRESSURE AND MAY CAUSE INJURIES IF THE PRESSURE IS RELIEVED SUDDENLY.
• Page 52
  Unit Diagnosis / Calibration This report can be printed out by pressing the “Print” button. Fig.: 2 — 27 2. Actuate the “OK” button to finish the calibration process and to store the data in the device. 2 — 28 Perfusor®…
• Page 53
  Unit Diagnosis / Calibration Trouble Shooting Note The following trouble shooting cannot be carried out independently. It is based on the precise observance of the steps for the device check (see “Device Check“ pg. 2 — 9). From there reference is made to the corresponding trouble shooting steps. Activity Function If yes…
• Page 54
  Unit Diagnosis / Calibration Activity Function If yes If no Switch on unit and insert syringe. The syringe piston is fastened with the syringe UTS 19 TS 23 holder blade and the default message is displayed on the LC display. Exchange processor PCB.
• Page 55
  Disassembly / Assembly Perfusor® Space 3.1 General Remarks on Disassembly / Assembly Before disassembling the unit, the system must be checked (see “Device Check“ pg. 2 — 9) to isolate the part to be exchanged. The necessary steps to disassemble the complete unit, all its subsystems and spare parts are detailed in the following description.
• Page 56
  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. 1. Start the Service Program (see “Starting the Service Program“ pg.
• Page 57
  Disassembly / Assembly 4. Select the tab “IO”. 5. Press the “To file” button. In the window which opens now you are asked for the storage position of the file on the PC hard disk and the file name. Fig.: 3 — 2 6.
• Page 58
  Disassembly / Assembly 7. Actuate the “Display” button to display the device data on screen. With “Close” the window is closed again. Fig.: 3 — 3 8. Select the storage position in the “Save as” window and input a unique file name. 9.
• Page 59
  Disassembly / Assembly 10. Select the tab “Disposable articles”. Fig.: 3 — 5 11. Actuate the “From device” button. The data is read from the pump. The data of the disposable articles read out is displayed on screen. Perfusor® Space, 1.2 gb 3 — 5…
• Page 60
  Disassembly / Assembly Fig.: 3 — 6 12. Press the “Save as” button. In the window which opens now you are asked for the storage position of the file on the PC hard disk and the file name. 3 — 6 Perfusor®…
• Page 61
  Disassembly / Assembly 13. Select the storage position in the “Save as” window and input a unique file name. 14. Press the “Save” button. The data of the pump is saved on the PC hard disk. 15. Exit the Service Program (see “Quit the Service Program“…
• Page 62
  Disassembly / Assembly Service Parts and Screw Kit All small parts, such as cover caps, are contained in a Perfusor® Space service part kit. Designation Ord. No. Service part kit Perfusor® Space ….3477 4270 with: housing cover cap (40 pieces) cover caps for operating unit (10 pieces)
• Page 63
  Disassembly / Assembly 3.2 Battery Module Designation Ord. No. Battery compartment cover PSP , cpl….3452 0872 Battery pack SP (NIMH)……0871 3180 Disassembly Note Move the drive head to the extended end position before starting…
• Page 64
  Disassembly / Assembly 2. Lift the lock (Fig.: 3 — 9 / Item 3) on the battery pack (Fig.: 3 — 9 / Item 1) and remove the battery pack out of the device. Fig.: 3 — 9 Legend of fig. 3 — 9: ItemDesignation Battery pack Battery compartment cover…
• Page 65
  Disassembly / Assembly 3.3 Unit Foot Designation Ord. No. Unit foot (see “Service Parts and Screw Kit“ pg. 3 — Disassembly 1. Pull the unit foot (Fig.: 3 — 10 / Item 1) out of the housing. Fig.: 3 — 10 Legend of fig.
• Page 66
  Disassembly / Assembly 3.4 Operating Unit Designation Ord. No. Operating unit PSP, cpl……3452 0970 Hinge plate PSP, left ……3452 1011 Hinge plate PSP, right .
• Page 67
  Disassembly / Assembly 4. Push the right and left connector locks (Fig.: 3 — 12 / Item carefully forward. 5. Disconnect the operating unit connection cable (Fig.: 3 — 12 / Item 1) from the connector. Fig.: 3 — 12 Legend of fig.
• Page 68
  Disassembly / Assembly 6. Pull the operating unit from the left hinge plate (Fig.: 3 — 13 / Item 7. Pierce two cover caps (Fig.: 3 — 13 / Item 1) with a small screwdriver and remove cover caps. 8. Unscrew two screws and remove the left hinge plate. Fig.: 3 — 13 Legend of fig.
• Page 69
  Disassembly / Assembly Disassembly 1. Pierce six cover caps (Fig.: 3 — 14 / Item 1) with a small screwdriver and remove cover caps. 2. Unscrew six screws and remove the rear panel (Fig.: 3 — 14 / Item Note The three screws of the keyboard must not be loosened.
• Page 70
  Disassembly / Assembly 3. Push the right and left connector locks of the PCB keyboard carefully to the left. 4. Pull the LC display ribbon cable (Fig.: 3 — 16 / Item 1) out of the connector. Fig.: 3 — 15 Legend of fig.
• Page 71
  Disassembly / Assembly 3.5 Upper Part of Housing Designation Ord. No. Upper part of housing PSP ….. . 3452 0910 Screws and cover caps (see “Service Parts and Screw Kit“…
• Page 72
  Disassembly / Assembly 4. Unscrew two screws and remove the contact strip (Fig.: 3 — 18 / Item (Fig.: 3 — 18 / Item Note If necessary, the spring-mounted contact pins must be carefully inserted when the contact strip is dismounted. Fig.: 3 — 18 Legend of fig.
• Page 73
  Disassembly / Assembly 3.6 Release Button Designation Ord. No. Release button PSP with leaf spring (see “Service Parts and Screw Kit“ pg. 3 — Disassembly 1. Pull the release button (Fig.: 3 — 19 / Item 1) out of the housing bottom part.
• Page 74
  Disassembly / Assembly 3.8 Drive Designation Ord. No. Drive PSP, cpl. Silver claws ……. 3452 1046 Green claws (as from unit software “F”) .
• Page 75
  Disassembly / Assembly Fig.: 3 — 23 Legend of fig. 3 — 23: ItemDesignation Screw EJOT 22×8 WN 5451 TORX 6IP A2 Washer Fastening angle Carrier Screw EJOT 22×8 WN 5451 TORX 6IP A2 Drive head Perfusor® Space, 1.1 gb 3 — 21…
• Page 76
  Disassembly / Assembly 6. Pull the drive motor connector (Fig.: 3 — 24 / Item 2) off the processor PCB. 7. Unscrew one screw (first temporary screw) and remove the processor PCB ground cable (Fig.: 3 — 24 / Item Fig.: 3 — 24 Legend of fig.
• Page 77
  Disassembly / Assembly 8. Unscrew one screw (second temporary screw) and take the drive assembly (Fig.: 3 — 25 / Item 1) out of the housing. Note Please pay attention to the corresponding notes during assembly and installation (see “Assembly / Installation“ pg.
• Page 78
  Disassembly / Assembly Disassembly of the Drive Head 1. Pierce two cover caps (Fig.: 3 — 27 / Item 4) with a small screwdriver and remove cover caps. 2. Unscrew two screws (Fig.: 3 — 27 / Item 3. Remove claws (Fig.: 3 — 27 / Item 2) carefully out of the drive head.
• Page 79
  Disassembly / Assembly 7. Pull the claw mechanism (Fig.: 3 — 29 / Item 3) off the drive head cover (Fig.: 3 — 29 / Item 2) until the connection cable connector (Fig.: 3 — 30 / Item (Fig.: 3 — 29 / Item 1) can be easily accessed.
• Page 80
  Disassembly / Assembly 10. Unscrew one screw (Fig.: 3 — 31 / Item 2) and remove the ground wire (Fig.: 3 — 31 / Item 1) of the drive PCB (Fig.: 3 — 31 / Item 3) from the driving tube. CAUTION Pay attention to the strain gauge (Fig.: 3 — 31 / Item…
• Page 81
  Disassembly / Assembly 3.9 Syringe Holder with Piston Brake Designation Ord. No. Piston brake PSP ribbon cable….3452 0864 Syringe holder with piston brake PSP, cpl… 3452 0945 Syringe holder PSP spring .
• Page 82
  Disassembly / Assembly 3. Unscrew one screw and remove the locking clip (Fig.: 3 — 33 / Item 2) from the piston brake PCB. Fig.: 3 — 33 Legend of fig. 3 — 33: ItemDesignation Screw EJOT 20×14 WN 5452 TORX 6IP Locking clip 3 — 28 Perfusor®…
• Page 83
  Disassembly / Assembly 4. Open the right and left connector lock (Fig.: 3 — 34 / Item on the piston brake PCB carefully. Fig.: 3 — 34 Legend of fig. 3 — 34: ItemDesignation Piston brake connector lock 5. Pull the ribbon cable (Fig.: 3 — 35 / Item 1) out of the connector and remove the cable from the housing.
• Page 84
  Disassembly / Assembly 6. Remove the syringe holder spring (Fig.: 3 — 36 / Item 1) from the post in the bottom part of the housing. Note The syringe holder spring can only be removed together with the piston brake drive. Fig.: 3 — 36 Legend of fig.
• Page 85
  Disassembly / Assembly 11. Drive the piston brake motor with maximum 3 V DC. The blade is moved out of the syringe holder housing. Note If the blade moves into the syringe holder housing, then the polarity on the piston brake motor must be changed. 12.
• Page 86
  Disassembly / Assembly 14. Unscrew one screw and remove the bearing cover (Fig.: 3 — 40 / Item 15. Take the lock (Fig.: 3 — 40 / Item 3) out of the bearing housing. Fig.: 3 — 40 Legend of fig. 3 — 40: ItemDesignation Screw EJOT 20×12 WN 5452 TORX 6IP Bearing cover…
• Page 87
  Disassembly / Assembly 18. Unscrew two screws and remove guide rail (Fig.: 3 — 42 / Item 2) out of the bottom part of the housing. 19. Take piston brake motor assembly (Fig.: 3 — 42 / Item 4) out of the housing bottom part.
• Page 88
  Disassembly / Assembly 3.10 Processor PCB Designation Ord. No. Processor PCB PSP ……3452 0880 (incl.
• Page 89
  Disassembly / Assembly 3.11 Assembly / Installation Assembly or installation of the modules and subsystems is done 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.
• Page 90
  Disassembly / Assembly 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 — Carry out the following steps to transmit the data back to the device.
• Page 91
  Disassembly / Assembly Fig.: 3 — 44 4. Select the desired file with the mouse pointer and press the “Open” button. Fig.: 3 — 45 Perfusor® Space, 1.2 gb 3 — 37…
• Page 92
  Disassembly / Assembly 5. Change to the tab “IO” and actuate the “To device” button. Fig.: 3 — 46 6. Press the “OK” button when the window “Confirmation” is displayed. Fig.: 3 — 47 3 — 38 Perfusor® Space, 1.2 gb…
• Page 93
  Disassembly / Assembly 7. Enter your worker id in the window “Worker ID”. Press the “OK” button to transmit the data to the device. Fig.: 3 — 48 A message is displayed that a change of the device data may affect the patients.
• Page 94
  Disassembly / Assembly 8. Select the tab “Disposable articles”. Fig.: 3 — 50 9. Press the “Load from“ button. The window “Open” is displayed on screen. 3 — 40 Perfusor® Space, 1.2 gb…
• Page 95
  Disassembly / Assembly 10. Select the desired file with the mouse pointer and press the “Open” button. The data loaded is displayed on screen. 11. Actuate the “To device” button. Fig.: 3 — 51 Fig.: 3 — 52 Perfusor® Space, 1.2 gb 3 — 41…
• Page 96
  Disassembly / Assembly 12. Press the “OK” button when the window “Confirmation” is displayed. Fig.: 3 — 53 13. Enter your worker id in the window “Worker ID”. Press the “OK” button to transmit the data to the device. Fig.: 3 — 54 A message is displayed that a change of the device data may affect the patients.
• Page 97
  Disassembly / Assembly Loudspeaker 1. Route the loudspeaker connection cable between the drive motor and its connection wires, see Fig.: 3 — Fig.: 3 — 56 Piston Brake WARNING PAY ATTENTION TO THE PISTON BRAKE BLADE WHEN WORKING ON THE PISTON BRAKE. THE BLADE IS SHARP AND MAY CAUSE INJURIES.
• Page 98
  Disassembly / Assembly Drive Head 1. Insert the drive head PCB with the strain gauge vertically in the drive head cover. Please note that the strain gauge must not get jammed in the guide. Note The three strain gauge tongues are level with the PCB upper side. 2.
• Page 99
  Disassembly / Assembly Note Check the position of the emergency release tappet before mounting the drive head housing. Fig.: 3 — 60 5. Push the drive head housing on to the driving tube until the switch flag of the membrane tappet is positioned just before the claw mechanism.
• Page 100
  Disassembly / Assembly Note Pay attention to the syringe wing sensor when inserting the side part of the housing and make sure that the sensor can be operated correctly. 1. Route the ribbon cable through the slide nut before pushing in the driving tube and then through the slide in front of the spindle nut when looking from the rear of the housing.
• Page 101
  Disassembly / Assembly Operating Unit Note Before fitting the rear panel check the screw lengths. The screws may only be 4.5 mm long (without head). Longer screws must be exchanged. Note Before mounting the operating unit check the plastic foam gaskets in the housing opening for the connection cable to the operating unit.
• Page 102
  Disassembly / Assembly Check List for Checks after Repair Visual Inspection Electrical Safety Functional Inspection according to IEC/EN 60601-1 or VDE 0750 and VDE 0751 Cleanliness The patient and housing leakage current of Locking with second unit Completeness the Perfusor® Space is caused exclusively by Operating unit magnets the operating voltage supply (Power Supply Battery compartment cover…
• Page 103
  Disassembly / Assembly Visual Inspection Electrical Safety Functional Inspection according to IEC/EN 60601-1 or VDE 0750 and VDE 0751 Pressure cut off according to TSC Syringe type: «#Lehre OPS50“ Delivery rate: 200 ml/h WARNING REMOVE SYRINGE GAUGE ONLY WHEN RELEASED. DANGER OF INJURY! Strain gauge pressure measurement Pressure stage 1 _______ N…
• Page 104
  Disassembly / Assembly For your notes: 3 — 50 Perfusor® Space, 1.0 gb…
• Page 105
  For disinfection by wiping, you should use for example Meliseptol® from B. Braun. Allow the unit to dry for at least one minute. When you disinfect the device by spraying, make sure not to spray in the system openings (such as interface sockets and connectors, loudspeaker opening).
• Page 106
  Servicing the Unit For your notes: 4 — 2 Perfusor® Space, 1.0 gb…
• Page 107
  Checklist for Technical Safety Check – Every 24 Months Unit: Perfusor® Space User 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.
• Page 108
  Technical Safety Check (TSC) Index d (Master — to be added to the documentation) Visual Inspection Electrical Safety Functional Inspection according to IEC/EN 60601-1 or VDE 0750 and VDE 0751 Pressure cut-off Syringe type: «#Lehre OPS50“ Delivery rate: 200 ml/h — Strain gauge pressure measurement Pressure stage 1 (9 …
• Page 109
  Checklist for Technical Safety Check – Every 24 Months Unit: Power Supply SP User Manufacturer: B. Braun Melsungen AG Observe the Service Manual and the instructions for use of the respective device. All measured values are to be documented. Make exclusive use of calibrated measuring equipment.
• Page 110
  Technical Safety Check (TSC) Index d (Master — to be added to the documentation) For your notes: M001 32 10 05 F04 / 3891 6142 (GB) 6 — 2 Perfusor® Space, 1.0 gb Sheet 2 of 2…
• Page 111
  Procedural Instructions on the TSC Visual Inspection Perfusor® Space 1. Check the Perfusor® Space and accessories for cleanliness. 2. Check the Perfusor® Space and accessories for completeness and check configuration. 3. Check the Perfusor® Space and its accessories for damage and the labels for readability.
• Page 112
  Procedural Instructions on the TSC Electrical Safety Perfusor® Space according to IEC/EN 60601-1 The patient and housing leakage current of the Perfusor® Space is caused exclusively by the operating voltage supply (Power Supply or VDE 0750 and VDE 0751 SP or SpaceStation). The Technical Safety Checks of the power supply SP (drawing No.
• Page 113
  Procedural Instructions on the TSC Functional Inspection Perfusor® Space 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.
• Page 114
  Procedural Instructions on the TSC 3. Check syringe recognition. a) Insert approved 2 ml / 3 ml syringe. The syringe size is recognized. b) Insert approved 50 ml / 3 ml syringe. The syringe size is recognized. 4. Carry out infusion and bolus with any syringe and press all buttons at least once.
• Page 115
  Procedural Instructions on the TSC Pressure Cut-Off (Strain Gauge Pressure Measurement) WARNING DURING THE STRAIN GAUGE MEASUREMENT WITH SYRINGE GAUGE THE SYRINGE HOLDER MUST NOT BE OPENED. THE SYRINGE GAUGE IS UNDER VERY HIGH PRESSURE AND MAY CAUSE INJURIES IF THE PRESSURE IS RELIEVED SUDDENLY. 1.
• Page 116
  Procedural Instructions on the TSC 3. Disassemble push-button plate for Perfusor® Space from syringe gauge, insert syringe gauge and select syringe type “#Lehre OPS50”. Note The threaded end of the syringe gauge must be introduced in the opening of the motor power test adapter. Hold on to syringe gauge –…
• Page 117
  Test Equipment and Special Tools Test equipment Designation Ord. No. For Device Check Syringe 2 ml / 3 ml Syringe 10 ml Syringe 30 ml Service connector SP ……3452 1062 HiBaSeD Service-CD .
• Page 118
  Test Equipment and Special Tools Syringe gauge PSP ……0770 5204 “#Lehre OPS 50” with push-button plate and motor power test adapter for Perfusor®…
• Page 119
  Test Equipment and Special Tools Special Tools Designation Ord. No. For Repairs TORX screwdriver kit 5 — 10, 25 TORX plus screwdriver kit 5 — 10, 25 Screwdriver 6IPx60 TORX plus ….4002 4806 Screwdriver 8IPx60 TORX plus .
• Page 120
  Test Equipment and Special Tools For your notes: 8 — 4 Perfusor® Space, 1.0 gb…
• Page 121
  Spare Parts List Item Designation Ord. No. Perfusor® Space Service part kit Perfusor® Space … . . 3477 4270 with: housing cover cap (40 pieces) cover caps for operating unit (10 pieces) cover cap for syringe holder (10 pieces) cover cap for drive head and claw (20 pieces) housing foot (20 pieces)
• Page 122
  Spare Parts List Fig.: 9 — 1 Exploded drawing Perfusor® Space 9 — 2 Perfusor® Space, 1.3 gb…
• Page 123
  Spare Parts List Battery compartment cover PSP , cpl..3452 0872 Battery pack SP (NIMH) ….0871 3180 Operating unit PSP, cpl.
• Page 124
  Spare Parts List 9 — 4 Perfusor® Space, 1.0 gb…
• Page 125
  Revision Documentation 10 — Description of Version Version 1.0 (Base Version) First edition of this Service Manual Release date: 07.01.05. Version 1.1 Description for disassembly of the drive head added. Claw mechanism and drive head PCB added as new spare parts.
• Page 126
  Revision Documentation 10 — 2 Perfusor® Space, 1.0 gb…
• Page 127
  Revision Documentation Title page and pages preceding main body Page 2 — 9 ……..Version 1.1 Page 0 — 1 .
• Page 128
  Revision Documentation Page 3 — 13 ……..Version 1.0 Page 3 — 49 .
• Page 129
  Revision Documentation Page 10 — 3 ……..Version 1.0 Page 10 — 4 .
• Page 130
  Revision Documentation 10 — 6 Perfusor® Space, 1.0 gb…
• Page 131
  Index 11 — Accessories ……..1 — 12 Housing Alarms .

Perfusor® Space

Service Manual

Version 1.3 English