Перфузор браун ошибка 046

Perfusor® compact

Service Manual

Version 2.1 english

0

System Overview 1

Software 2

2 Software

Service Program 3

1. Manuals
2. Brands
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4. Medical Equipment
5. Infusomat Space P
6. Instructions for use manual

• Page 1
  Infusomat® Space P and Accessories Instructions for Use It is recommended that all pumps at your care unit are equipped with the same software version or in parallel Valid for software 687N use with Software M.

• Page 2: Table Of Contents

  CONTENTS Infusomat® Space P Overview ………………..3 Symbols on Product ……………………5 Patient Safety ……………………6 Menu Structure / Navigation………………..10 Chapter 1 Operation ………………….13 1.1 Start of Infusion…………………….13 1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time……………………….16 1.3 Bolus Application……………………17 1.4 Infusion Line Change and New Therapy Start …………..18 1.5 End of Infusion ………………………19…

• Page 3: Infusomat® Space P Overview

  INFUSOMAT® SPACE P OVERVIEW I N F U S O M AT ® S PA C E P O V E R V I E W Arrow up and -down Press to reset single values Scroll through menus, change setting of numbers from to zero and switch back to Press to 0-9, answer Yes/No questions.

• Page 4
  For vertical position 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 only in horizontal pump position 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…

• Page 6: Patient Safety

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

• Page 7
  PATIENT SAFETY • Installation in medically used rooms must comply with the appropriate regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national specifications and deviations. Caution: Operate the pump at least 25 cm from flammable anaesthetics to prevent explosion. •…
• Page 8
  PATIENT SAFETY Other components • Use only pressure-proof and compatible disposable items (min. 2 bar/ 1500 mm Hg) to avoid influencing performance data — which would result in impairing patient safety. • Where several infusion lines are connected on one single vascular access, the possibility of the lines exerting a mutual influence over each other cannot be excluded.
• Page 9
  PATIENT SAFETY • When ending PCA and starting it again the therapy data are set to default values. • Using the demand button also the patient is a permitted user. With the demand button only a PCA-bolus can be requested. This is limited to pre- defined doses by drug list and pump settings.

• Page 10: Menu Structure / Navigation

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

• Page 11
  MENU STRUCTURE / NAVIGATION Display Meaning All status information is available in the bottom line of the display. The desired information can be selected by using and will be displayed permanently thereafter (e. g. drug long name, current system pressure etc.). has been pressed while the pump is infusing.
• Page 12
  MENU STRUCTURE / NAVIGATION Start Up Main Special Options Status Menu Menu Functions Menu Menu Line Dose Rate Occlusion Intermediate Dose selection Calculation Pressure volume Intermediate Prime ? Concentration Drug Library Data Lock amount Use last Change-over Bolus Intermediate Weight therapy ? from Rate…

• Page 13: Chapter 1 Operation

  OPERATION Chapter 1 OPERATION 1.1 Start of Infusion • Ensure that the pump is properly installed. Check the equipment for completeness and damages. Do not attach the infusion bottle below the pump level. • Put the spike vertically into the infusion bottle. Fill the bottom part of the drop chamber by max.

• Page 14
  OPERATION Chapter 1 Press down the opening lever. 1. Mind flow direction while inserting the infusion line (s. pictogramm) to prevent the danger of backflow. 2. Completely insert and then gently press the infusion line into the guidance and the sensors. 3.
• Page 15
  OPERATION Chapter 1 is properly occluding the IV set and the door extension hook is not broken. If the door hook is found damaged or broken remove the pump from service. Caution: If a wrong line is selected the time until the pump goes into a pressure alarm may be prolonged.

• Page 16: Entry With Different Combinations Of Rate, Vtbi (= Volume To Be Infused) And Time

  OPERATION Chapter 1 upstream sensor calibrates on the current existing underpressure in the line and air might pass the AirStop membrane. In this case please ensure that the the drip chamber is refilled and then open the door for recalibration of the upstream sensor.

• Page 17: 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 18: Infusion Line Change And New Therapy Start

  OPERATION Chapter 1 1.4 Infusion Line Change and New Therapy Start Note: Always interrupt the patient connection before changing a line to avoid dosing errors. Never let the pump run unattended when changing the line. Check and clean the safety clamp regularly. •…

• Page 19: End Of Infusion

  OPERATION Chapter 1 Remove emergency aperture cover. Turn crank inside aperture to open the door. • Close the pump door, confirm the inserted line with and open the roller clamp. • If required, prime the pump with u. Then press to proceed.

• Page 20: Standby Mode

  SPECIAL FUNCTIONS Chapter 1 1.6 Standby Mode In the case of extended interruption, the user has the option to maintain the set values. • Press to stop the infusion. Then press for less than 3 sec. • Confirm that the pump is supposed to switch to standby by pressing u. •…

• Page 21: Chapter 2 Advanced Operations

  SPECIAL FUNCTIONS Chapter 2 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 22: Chapter 3 Special Functions

  SPECIAL FUNCTIONS Chapter 3 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 23: Drug Library

  SPECIAL FUNCTIONS Chapter 3 a Enter the concentration by entering the amount of the active ingredient and the volume. In order to do so set the values with and confirm with k. a If the patient’s weight does not need to be entered press l. to choose “weight”…

• Page 24
  SPECIAL FUNCTIONS Chapter 3 Loading a drug (including the according parameters) from the Main Menu: • Go to Special Functions Menu and press l. • Open the drug library by pressing l. • Navigate through the list with and select the care unit with l. If you have already set the care unit once on your pump this step will be skipped for the next time.
• Page 25
  SPECIAL FUNCTIONS Chapter 3 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. If this occurs while the pump is infusing the pump will continue to administrate.

• Page 26: Patient Controlled Analgesia (Pca)

  SPECIAL FUNCTIONS Chapter 3 3.4 Patient Controlled Analgesia (PCA) For PCA a drug list with at least one drug activating the profile PCA is necessary. By this the conditions for an effective and safe therapy are defined. Switch on pump with and wait until self-check is finished.

• Page 27: Barcoding

  SPECIAL FUNCTIONS Chapter 3 The A/D-ratio indicates the percentage of administered and demanded boli thus giving an idea about the effectivity of the therapy. An acoustic confirmation of demanded boli can be activated and modulated by in Data Lock 3. Is a demand button connected, the therapy symbol looks like this: In case there is no demand button connected the therapy symbol looks like this:…

• Page 28: Piggyback Function

  SPECIAL FUNCTIONS Chapter 3 Piggyback Function The piggyback-mode offers the possibility to interrupt the current (primary) infusion temporarily in order to administer a piggyback (secondary) infusion. Above the pump the piggyback-infusion line is connected with a Y-connector to the administration set. The secondary infusion is supposed to be located approx. 20 cm higher than the primary infusion.

• Page 29
  SPECIAL FUNCTIONS Chapter 3 The piggyback therapy can be repeated many times by changing the piggyback medicament or by reset of the piggyback medicament. • Go to „Set new Piggyback” in the Special Functions Menu and confirm with l. Note: The Piggyback infusion can be deleted by starting a new Piggyback and by pressing cancel and answering the question „Use last therapy“…

• Page 30: Ramp And Taper Mode

  SPECIAL FUNCTIONS Chapter 3 3.7 Ramp and Taper Mode The Ramp and Taper Mode is designed to deliver infusions with gradual ramp up and taper down rates. The pump automatically calculates the rate increase and decrease required to match the total volume, time and ramp up/ramp down time parameters. It consists of 3 phases.

• Page 31
  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. • Switch on pump with and wait until self-check is finished. •…
• Page 32
  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 33: Programm Mode

  SPECIAL FUNCTIONS Chapter 3 3.8 Program Mode Program Mode is for infusion requiring a non-standard delivery pattern. The user de- fines a series of intervals (max. 12 intervals) by certain parameters (rate, time, volume) for each cycle. The pump automatically gives each programmed period, one after the other 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…

• Page 34
  SPECIAL FUNCTIONS Chapter 3 The settings for the steps of the infusion are shown on the display. These settings, configured in the Drug List Editor, need to be confirmed with r. • To change the values, press to change and to confirm.

• Page 35: Intermittent Mode

  SPECIAL FUNCTIONS Chapter 3 The Main menu informs about the current interval. The configured parameters can be checked by Program Parameter Menu in Main. Intermittent Mode The Intermittent Mode consists of 2 phases. This phases will be repeated. • Bolus phase: the configured bolus is active •…

• Page 36
  SPECIAL FUNCTIONS Chapter 3 • Select the desired drug with and press l. The pump now offers the possible therapy profiles. • Select “Intermittent Mode” with and press l. The therapy settings for “Intermittent Mode” are shown on the display. •…

• Page 37: Dose Over Time

  SPECIAL FUNCTIONS Chapter 3 • Enter the new value and press k. The pump continues infusion. Changing the bolus after start: If the user edits the bolus the therapy progression changes. • Press • Use to select Bolus and press l. •…

• Page 38
  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 39: 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 40
  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 41
  AUTOPROGRAMMING Chapter 4 While in PIGGYback: • Message will appear on top of display indicating update is available for PRIMary. • Press key to view order. • Follow prompt, pressing to accept order or key to cancel and hold order for later.
• Page 42
  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 43: Chapter 5 Options

  OPTIONS Chapter 5 O P T I O N S 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.

• Page 44: Upstream Occlusion Pressure

  OPTIONS Chapter 5 The editor is extended by maximal 3 dashes. Confirm new pressure level with and go back to Options Menu. In the Run Menu the top line shows the current infusion pressure. The bottom line and the 3 dashes before the symbol shows the pressure alarm settings.

• Page 45
  OPTIONS Chapter 5 Level 1: A modification of values as well as a bolus application are not possible but a change of the disposable can be conducted. It is possible to navigate through all menus and status data can be checked. Starting, interrupting and switching the pump off is possible.

• Page 46: Bolus Rate

  OPTIONS Chapter 5 In order to deactivate the function, select “Off” in the data lock, press k, enter the code and press again. 5.4 Bolus Rate • Open bolus rate in Options Menu with l. • Change bolus rate with and confirm setting with k.

• Page 47: Macro Mode

  OPTIONS Chapter 5 5.9 Macro Mode The infusion rate appears larger on the display when the macro mode is activated and the pump is infusing. • Open macro mode in Options Menu with l. • Answer Yes/No question by pressing to activate the macro mode.

• Page 48: Chapter 6 Alarms

  ALARMS Chapter 6 ALARMS The Infusomat® Space P is equipped with an audible and optical alarm signal. Alarm- Audible Optical signal Staff call User confirmation type signal Red LED Yellow LED Text Device flashes device alarm Press and follow Alarm and alarm the instruction on the code…

• Page 49
  ALARMS Chapter 6 Display message Pre-alarm reason “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“ VTBI/time are reached and the pump continues the infusion at the KVO-rate.
• Page 50
  ALARMS Chapter 6 When pushing on the battery cover listen for “click”. “Standby time expired“ The set standby time has ended. Set new time or continue with previously set therapy. “No battery inserted“ It is not possible to use the pump without a battery pack.

• Page 51: Reminder Alarms

  ALARMS Chapter 6 «Flow» Drop chamber is completely filled or leak in the system. Examine the line for damage and check the drop chamber. “Data were reset” Therapy and pump settings could not be restored. Enter therapy again. «Therapy data were reset» Therapy data could not be restored.

• Page 52: Alarm Hints

  ALARMS Chapter 6 6.4 Alarm Hints If inproper entries are made the display states corresponding hints (e.g. “Bol.rate out of range”; “Download failed”; “The parameter can not be modified”). These hints disappear after a few seconds and don’t need to be confirmed.

• Page 53: Battery Operation And Maintenance

  BATTERY OPERATION AND MAINTENANCE Chapter 7 BATTERY OPERATION AND MAINTENANCE The battery has an operating lifetime of 4 hours at 100 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 54
  BATTERY OPERATION AND MAINTENANCE Chapter 7 • ambient temperature • varying load (e.g. frequent boluses). The optimal life time of a battery pack will only be reached if it’s completely dischar- ged from time to time. A maintenance mode which conducts this battery maintenance is built in.

• Page 55: Start Up Graphs And Trumpet Curves

  START UP GRAPHS AND TRUMPET CURVES Chapter 8 START UP GRAPHS AND TRUMPET CURVES Start Up Graphs 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 the disposable used.

• Page 56: 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 57
  Delivery rate < 10 ml/h: KVO-rate 1 ml/h 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. Air detector Technical sensitivity: Detection of air bubbles ≥…
• Page 58
  TECHNICAL DATA Chapter 9 Sensitivity upstream sensor 9 levels from -120 mbar to -200 mbar (pressure reduction) Occlusion alarm pressures 9 levels up to 1.2 bar Occlusion pressure Time to occlusion alarm [min] at rate Note: At a rate [bar] [1 ml/h] [25 ml/h] [100 ml/h]…
• Page 59
  TECHNICAL DATA Chapter 9 EMC (ELECTROMAGNETIC COMPATIBILITY)
• Page 60
  TECHNICAL DATA Chapter 9…
• Page 61
  TECHNICAL DATA Chapter 9…
• Page 62
  TECHNICAL DATA Chapter 9…

• Page 63: Chapter 10 Warranty / Training / Tsc** / Service / Disinfecting / Disposal

  • the Technical Safety Checks are carried out regularly. Warranty B. Braun provides 24 months warranty, as from the date of delivery, for every Infusomat® Space P (12 months for every Battery-Pack SP). This covers repair or replacement of parts damaged as a result of design/manufacturing errors or material defects.

• Page 64
  WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL Chapter 10 Technical Safety Check* / Service The Technical Safety Check is recommended to be carried out every 2 years and should be documented. Servicing work must be carried out exclusively by trained personnel.
• Page 65
  Glutaral Aldehydes Glyoxal Peroxides Hydrogen Peroxide Active chlorine Sodium Hypochlorite Acid Citric Acid 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%.
• Page 66
  Disposal The pumps as well as battery packs can be returned to B. Braun for further dis- posal. When taking care of disposing of disposables as well as infusion solutions, please consider the applicable hygiene and disposal regulations.

• Page 67: Technical Safety Chapter 11 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 Infusomat®…

• Page 68
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 Note: A maximum of three plugs can be stacked upon each other in socket P2. Drop Sensor SP (8713175) The drop sensor provides an additional safety function and is therefore particularly recommended in connection with low delivery rates (10 ml/h). The connection of the Drop Sensor SP on the pump is located at the rear of the device, in the lower left corner.
• Page 69
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 2.) Connect CAN/USB converter to computer outlet as described in the Instructions for Use manual. Caution: The Interface Lead CAN SP is only to be used by the service department; never use while patient is connected. Note: A maximum of three plugs can be stacked upon each other in socket P2.
• Page 70
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 Note: Test staff call signalling before every use. The Infusomat® Space P offers three different staff call operating modes. They are displayed in the signalling scheme. Consider the staff call of the hospital when choosing an operating mode. Choose the operating mode via the service program.
• Page 71
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 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 72: Ordering

  ORDERING Art. No. B. Braun Infusomat® Space P (100 — 240 V) ……..8713070 Recommended accessories for the B. Braun Infusomat® Space P: SpaceStation…………………..8713140 SpaceCover Standard………………8713147 SpaceCover Comfort………………8713145 PoleClamp SP ………………….8713130 Power Supply SP EU III ………………8713110D Power Supply SP EU III 3.0m …………….8713123D Power Supply SP GB III………………8713111D…

• Page 73
  Codan V86 P………………….43.4291 Hint: B. Braun does not have any influence on the quality of other lines. Changes in quality of those lines may have an influence on the technical characteristics of the pump. B. Braun therefore is not liable for deviations caused by disposables from other vendors than B.
• Page 76
  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 38911866 • Drawing No. I0687700201 Fax: +49 (0) 56 61 71-20 44 Printed on pulp bleached 100 % chlorine-free www.bbraun.com…

1. Manuals
2. Brands
3. Braun Manuals
4. Medical Equipment
5. Infusomat Space P
6. Instructions for use manual

• Page 1
  Infusomat® Space P and Accessories Instructions for Use It is recommended that all pumps at your care unit are equipped with the same software version or in parallel Valid for software 687N use with Software M.

• Page 2: Table Of Contents

  CONTENTS Infusomat® Space P Overview ………………..3 Symbols on Product ……………………5 Patient Safety ……………………6 Menu Structure / Navigation………………..10 Chapter 1 Operation ………………….13 1.1 Start of Infusion…………………….13 1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time……………………….16 1.3 Bolus Application……………………17 1.4 Infusion Line Change and New Therapy Start …………..18 1.5 End of Infusion ………………………19…

• Page 3: Infusomat® Space P Overview

  INFUSOMAT® SPACE P OVERVIEW I N F U S O M AT ® S PA C E P O V E R V I E W Arrow up and -down Press to reset single values Scroll through menus, change setting of numbers from to zero and switch back to Press to 0-9, answer Yes/No questions.

• Page 4
  For vertical position 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 only in horizontal pump position 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…

• Page 6: Patient Safety

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

• Page 7
  PATIENT SAFETY • Installation in medically used rooms must comply with the appropriate regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national specifications and deviations. Caution: Operate the pump at least 25 cm from flammable anaesthetics to prevent explosion. •…
• Page 8
  PATIENT SAFETY Other components • Use only pressure-proof and compatible disposable items (min. 2 bar/ 1500 mm Hg) to avoid influencing performance data — which would result in impairing patient safety. • Where several infusion lines are connected on one single vascular access, the possibility of the lines exerting a mutual influence over each other cannot be excluded.
• Page 9
  PATIENT SAFETY • When ending PCA and starting it again the therapy data are set to default values. • Using the demand button also the patient is a permitted user. With the demand button only a PCA-bolus can be requested. This is limited to pre- defined doses by drug list and pump settings.

• Page 10: Menu Structure / Navigation

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

• Page 11
  MENU STRUCTURE / NAVIGATION Display Meaning All status information is available in the bottom line of the display. The desired information can be selected by using and will be displayed permanently thereafter (e. g. drug long name, current system pressure etc.). has been pressed while the pump is infusing.
• Page 12
  MENU STRUCTURE / NAVIGATION Start Up Main Special Options Status Menu Menu Functions Menu Menu Line Dose Rate Occlusion Intermediate Dose selection Calculation Pressure volume Intermediate Prime ? Concentration Drug Library Data Lock amount Use last Change-over Bolus Intermediate Weight therapy ? from Rate…

• Page 13: Chapter 1 Operation

  OPERATION Chapter 1 OPERATION 1.1 Start of Infusion • Ensure that the pump is properly installed. Check the equipment for completeness and damages. Do not attach the infusion bottle below the pump level. • Put the spike vertically into the infusion bottle. Fill the bottom part of the drop chamber by max.

• Page 14
  OPERATION Chapter 1 Press down the opening lever. 1. Mind flow direction while inserting the infusion line (s. pictogramm) to prevent the danger of backflow. 2. Completely insert and then gently press the infusion line into the guidance and the sensors. 3.
• Page 15
  OPERATION Chapter 1 is properly occluding the IV set and the door extension hook is not broken. If the door hook is found damaged or broken remove the pump from service. Caution: If a wrong line is selected the time until the pump goes into a pressure alarm may be prolonged.

• Page 16: Entry With Different Combinations Of Rate, Vtbi (= Volume To Be Infused) And Time

  OPERATION Chapter 1 upstream sensor calibrates on the current existing underpressure in the line and air might pass the AirStop membrane. In this case please ensure that the the drip chamber is refilled and then open the door for recalibration of the upstream sensor.

• Page 17: 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 18: Infusion Line Change And New Therapy Start

  OPERATION Chapter 1 1.4 Infusion Line Change and New Therapy Start Note: Always interrupt the patient connection before changing a line to avoid dosing errors. Never let the pump run unattended when changing the line. Check and clean the safety clamp regularly. •…

• Page 19: End Of Infusion

  OPERATION Chapter 1 Remove emergency aperture cover. Turn crank inside aperture to open the door. • Close the pump door, confirm the inserted line with and open the roller clamp. • If required, prime the pump with u. Then press to proceed.

• Page 20: Standby Mode

  SPECIAL FUNCTIONS Chapter 1 1.6 Standby Mode In the case of extended interruption, the user has the option to maintain the set values. • Press to stop the infusion. Then press for less than 3 sec. • Confirm that the pump is supposed to switch to standby by pressing u. •…

• Page 21: Chapter 2 Advanced Operations

  SPECIAL FUNCTIONS Chapter 2 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 22: Chapter 3 Special Functions

  SPECIAL FUNCTIONS Chapter 3 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 23: Drug Library

  SPECIAL FUNCTIONS Chapter 3 a Enter the concentration by entering the amount of the active ingredient and the volume. In order to do so set the values with and confirm with k. a If the patient’s weight does not need to be entered press l. to choose “weight”…

• Page 24
  SPECIAL FUNCTIONS Chapter 3 Loading a drug (including the according parameters) from the Main Menu: • Go to Special Functions Menu and press l. • Open the drug library by pressing l. • Navigate through the list with and select the care unit with l. If you have already set the care unit once on your pump this step will be skipped for the next time.
• Page 25
  SPECIAL FUNCTIONS Chapter 3 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. If this occurs while the pump is infusing the pump will continue to administrate.

• Page 26: Patient Controlled Analgesia (Pca)

  SPECIAL FUNCTIONS Chapter 3 3.4 Patient Controlled Analgesia (PCA) For PCA a drug list with at least one drug activating the profile PCA is necessary. By this the conditions for an effective and safe therapy are defined. Switch on pump with and wait until self-check is finished.

• Page 27: Barcoding

  SPECIAL FUNCTIONS Chapter 3 The A/D-ratio indicates the percentage of administered and demanded boli thus giving an idea about the effectivity of the therapy. An acoustic confirmation of demanded boli can be activated and modulated by in Data Lock 3. Is a demand button connected, the therapy symbol looks like this: In case there is no demand button connected the therapy symbol looks like this:…

• Page 28: Piggyback Function

  SPECIAL FUNCTIONS Chapter 3 Piggyback Function The piggyback-mode offers the possibility to interrupt the current (primary) infusion temporarily in order to administer a piggyback (secondary) infusion. Above the pump the piggyback-infusion line is connected with a Y-connector to the administration set. The secondary infusion is supposed to be located approx. 20 cm higher than the primary infusion.

• Page 29
  SPECIAL FUNCTIONS Chapter 3 The piggyback therapy can be repeated many times by changing the piggyback medicament or by reset of the piggyback medicament. • Go to „Set new Piggyback” in the Special Functions Menu and confirm with l. Note: The Piggyback infusion can be deleted by starting a new Piggyback and by pressing cancel and answering the question „Use last therapy“…

• Page 30: Ramp And Taper Mode

  SPECIAL FUNCTIONS Chapter 3 3.7 Ramp and Taper Mode The Ramp and Taper Mode is designed to deliver infusions with gradual ramp up and taper down rates. The pump automatically calculates the rate increase and decrease required to match the total volume, time and ramp up/ramp down time parameters. It consists of 3 phases.

• Page 31
  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. • Switch on pump with and wait until self-check is finished. •…
• Page 32
  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 33: Programm Mode

  SPECIAL FUNCTIONS Chapter 3 3.8 Program Mode Program Mode is for infusion requiring a non-standard delivery pattern. The user de- fines a series of intervals (max. 12 intervals) by certain parameters (rate, time, volume) for each cycle. The pump automatically gives each programmed period, one after the other 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…

• Page 34
  SPECIAL FUNCTIONS Chapter 3 The settings for the steps of the infusion are shown on the display. These settings, configured in the Drug List Editor, need to be confirmed with r. • To change the values, press to change and to confirm.

• Page 35: Intermittent Mode

  SPECIAL FUNCTIONS Chapter 3 The Main menu informs about the current interval. The configured parameters can be checked by Program Parameter Menu in Main. Intermittent Mode The Intermittent Mode consists of 2 phases. This phases will be repeated. • Bolus phase: the configured bolus is active •…

• Page 36
  SPECIAL FUNCTIONS Chapter 3 • Select the desired drug with and press l. The pump now offers the possible therapy profiles. • Select “Intermittent Mode” with and press l. The therapy settings for “Intermittent Mode” are shown on the display. •…

• Page 37: Dose Over Time

  SPECIAL FUNCTIONS Chapter 3 • Enter the new value and press k. The pump continues infusion. Changing the bolus after start: If the user edits the bolus the therapy progression changes. • Press • Use to select Bolus and press l. •…

• Page 38
  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 39: 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 40
  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 41
  AUTOPROGRAMMING Chapter 4 While in PIGGYback: • Message will appear on top of display indicating update is available for PRIMary. • Press key to view order. • Follow prompt, pressing to accept order or key to cancel and hold order for later.
• Page 42
  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 43: Chapter 5 Options

  OPTIONS Chapter 5 O P T I O N S 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.

• Page 44: Upstream Occlusion Pressure

  OPTIONS Chapter 5 The editor is extended by maximal 3 dashes. Confirm new pressure level with and go back to Options Menu. In the Run Menu the top line shows the current infusion pressure. The bottom line and the 3 dashes before the symbol shows the pressure alarm settings.

• Page 45
  OPTIONS Chapter 5 Level 1: A modification of values as well as a bolus application are not possible but a change of the disposable can be conducted. It is possible to navigate through all menus and status data can be checked. Starting, interrupting and switching the pump off is possible.

• Page 46: Bolus Rate

  OPTIONS Chapter 5 In order to deactivate the function, select “Off” in the data lock, press k, enter the code and press again. 5.4 Bolus Rate • Open bolus rate in Options Menu with l. • Change bolus rate with and confirm setting with k.

• Page 47: Macro Mode

  OPTIONS Chapter 5 5.9 Macro Mode The infusion rate appears larger on the display when the macro mode is activated and the pump is infusing. • Open macro mode in Options Menu with l. • Answer Yes/No question by pressing to activate the macro mode.

• Page 48: Chapter 6 Alarms

  ALARMS Chapter 6 ALARMS The Infusomat® Space P is equipped with an audible and optical alarm signal. Alarm- Audible Optical signal Staff call User confirmation type signal Red LED Yellow LED Text Device flashes device alarm Press and follow Alarm and alarm the instruction on the code…

• Page 49
  ALARMS Chapter 6 Display message Pre-alarm reason “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“ VTBI/time are reached and the pump continues the infusion at the KVO-rate.
• Page 50
  ALARMS Chapter 6 When pushing on the battery cover listen for “click”. “Standby time expired“ The set standby time has ended. Set new time or continue with previously set therapy. “No battery inserted“ It is not possible to use the pump without a battery pack.

• Page 51: Reminder Alarms

  ALARMS Chapter 6 «Flow» Drop chamber is completely filled or leak in the system. Examine the line for damage and check the drop chamber. “Data were reset” Therapy and pump settings could not be restored. Enter therapy again. «Therapy data were reset» Therapy data could not be restored.

• Page 52: Alarm Hints

  ALARMS Chapter 6 6.4 Alarm Hints If inproper entries are made the display states corresponding hints (e.g. “Bol.rate out of range”; “Download failed”; “The parameter can not be modified”). These hints disappear after a few seconds and don’t need to be confirmed.

• Page 53: Battery Operation And Maintenance

  BATTERY OPERATION AND MAINTENANCE Chapter 7 BATTERY OPERATION AND MAINTENANCE The battery has an operating lifetime of 4 hours at 100 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 54
  BATTERY OPERATION AND MAINTENANCE Chapter 7 • ambient temperature • varying load (e.g. frequent boluses). The optimal life time of a battery pack will only be reached if it’s completely dischar- ged from time to time. A maintenance mode which conducts this battery maintenance is built in.

• Page 55: Start Up Graphs And Trumpet Curves

  START UP GRAPHS AND TRUMPET CURVES Chapter 8 START UP GRAPHS AND TRUMPET CURVES Start Up Graphs 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 the disposable used.

• Page 56: 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 57
  Delivery rate < 10 ml/h: KVO-rate 1 ml/h 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. Air detector Technical sensitivity: Detection of air bubbles ≥…
• Page 58
  TECHNICAL DATA Chapter 9 Sensitivity upstream sensor 9 levels from -120 mbar to -200 mbar (pressure reduction) Occlusion alarm pressures 9 levels up to 1.2 bar Occlusion pressure Time to occlusion alarm [min] at rate Note: At a rate [bar] [1 ml/h] [25 ml/h] [100 ml/h]…
• Page 59
  TECHNICAL DATA Chapter 9 EMC (ELECTROMAGNETIC COMPATIBILITY)
• Page 60
  TECHNICAL DATA Chapter 9…
• Page 61
  TECHNICAL DATA Chapter 9…
• Page 62
  TECHNICAL DATA Chapter 9…

• Page 63: Chapter 10 Warranty / Training / Tsc** / Service / Disinfecting / Disposal

  • the Technical Safety Checks are carried out regularly. Warranty B. Braun provides 24 months warranty, as from the date of delivery, for every Infusomat® Space P (12 months for every Battery-Pack SP). This covers repair or replacement of parts damaged as a result of design/manufacturing errors or material defects.

• Page 64
  WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL Chapter 10 Technical Safety Check* / Service The Technical Safety Check is recommended to be carried out every 2 years and should be documented. Servicing work must be carried out exclusively by trained personnel.
• Page 65
  Glutaral Aldehydes Glyoxal Peroxides Hydrogen Peroxide Active chlorine Sodium Hypochlorite Acid Citric Acid 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%.
• Page 66
  Disposal The pumps as well as battery packs can be returned to B. Braun for further dis- posal. When taking care of disposing of disposables as well as infusion solutions, please consider the applicable hygiene and disposal regulations.

• Page 67: Technical Safety Chapter 11 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 Infusomat®…

• Page 68
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 Note: A maximum of three plugs can be stacked upon each other in socket P2. Drop Sensor SP (8713175) The drop sensor provides an additional safety function and is therefore particularly recommended in connection with low delivery rates (10 ml/h). The connection of the Drop Sensor SP on the pump is located at the rear of the device, in the lower left corner.
• Page 69
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 2.) Connect CAN/USB converter to computer outlet as described in the Instructions for Use manual. Caution: The Interface Lead CAN SP is only to be used by the service department; never use while patient is connected. Note: A maximum of three plugs can be stacked upon each other in socket P2.
• Page 70
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 Note: Test staff call signalling before every use. The Infusomat® Space P offers three different staff call operating modes. They are displayed in the signalling scheme. Consider the staff call of the hospital when choosing an operating mode. Choose the operating mode via the service program.
• Page 71
  INSTRUCTIONS FOR USE ACCESSORY Chapter 11 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 72: Ordering

  ORDERING Art. No. B. Braun Infusomat® Space P (100 — 240 V) ……..8713070 Recommended accessories for the B. Braun Infusomat® Space P: SpaceStation…………………..8713140 SpaceCover Standard………………8713147 SpaceCover Comfort………………8713145 PoleClamp SP ………………….8713130 Power Supply SP EU III ………………8713110D Power Supply SP EU III 3.0m …………….8713123D Power Supply SP GB III………………8713111D…

• Page 73
  Codan V86 P………………….43.4291 Hint: B. Braun does not have any influence on the quality of other lines. Changes in quality of those lines may have an influence on the technical characteristics of the pump. B. Braun therefore is not liable for deviations caused by disposables from other vendors than B.
• Page 76
  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 38911866 • Drawing No. I0687700201 Fax: +49 (0) 56 61 71-20 44 Printed on pulp bleached 100 % chlorine-free www.bbraun.com…