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Chapter 11

INSTRUCTIONS FOR USE ACCESSORY

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
               and demand button

       -   Metal clip 

               alternatively for fixation at the bed  
               sheet

       -   Cable strap 

               for wrapping the cable of the demand
               button

Fixation of the demand button:

       at the wrist:                                  or at the bed sheet:     

Usage of the cable strap:   

Содержание Infusomat Space P

Страница 1: ...s Instructions for Use Valid for software 687N GB It is recommended that all pumps at your care unit are equipped with the same software version or in parallel use with Software M 38911866N_Infusomat...

Страница 2: ...algesia PCA 26 3 5 Barcoding 27 3 6 Piggyback Function 28 3 7 Ramp and Taper Mode 30 3 8 Programm Mode 33 3 9 Intermittent Mode 35 3 10 Dose Over Time 37 Chapter 4 Autoprogramming 39 Chapter 5 Options...

Страница 3: ...ment Before changing the battery always disconnect the pump from the patient and switch off the device To remove the battery cover push the button below the battery compartment with a pointed pen and...

Страница 4: ...eClamp against the vertical pole and lock the screw tightly Unscrew to release For vertical position push lever down and rotate either way until lever clicks into notch Push lever for rotation Caution...

Страница 5: ...5 SYMBOLS ON PRODUCT SYMBOLS ON PRODUCT...

Страница 6: ...ow the device should be used based on its features and specifications For more details please read the Instructions for Use Operation The initial training of the Infusomat Space P is to be performed b...

Страница 7: ...ing must be carried out if life saving medication is performed The air detector cannot detect air diffusing in the following components three way stopcocks infusion adapters and further lines placed b...

Страница 8: ...01 1 2 2007 and IEC 60601 2 24 2012 are maintained If the equipment is operated in the vicinity of other equipment which may cause high levels of interference e g HF surgical equipment nuclear spin to...

Страница 9: ...Y Safety Instructions for using Pole Clamp 1 Line pump up with the Pole Clamp guide rails 2 Slide pump fully into place onto the guide rails 3 An audible Click should heard 4 Test the pump is secure W...

Страница 10: ...NAVIGATION MENU STRUCTURE NAVIGATION All display screen shots are examples and may be different when related to an individual patient and individualized therapy o On Off button x Door open button s f...

Страница 11: ...ear end an audible tone andthe yellow LED is con stantly on To confirm a pre alarm press k This hint pops up if a user tries to edit or change a parameter by pressing l when that parameter is unable t...

Страница 12: ...Dose Drug Library Change over from continuous mode to PCA Intermediate volume Intermediate amount Intermediate time Total volume Special Functions Options Status Options Menu Occlusion Pressure Total...

Страница 13: ...nd u to open the pump door in order to continue with inserting the line 4 w Caution Close the roller clamp before inserting the IV line and do not connect to patient until properly loaded and primed C...

Страница 14: ...pull the door shut Do not open roller clamp until the pump directs you to do so when self test is completed Then select the inserted line with t and confirm it with l Open the roller clamp Caution Bef...

Страница 15: ...ed to start the infusion Time will be calculated when rate is entered When time is entered rate doserate will be calculated Running arrows on the display and the green LED indicate that the pump is in...

Страница 16: ...ymbol apparent in the Main Menu shows the established para meter for the application VTBI or time When the rate is changed the so called target parameter is principally not adjusted to the new rate bu...

Страница 17: ...fter finishing the bolus volume 3 Bolus with rate calculation Press n b Then press l and set bolus dose by using q Press k to confirm bolus dose Set time with q in which a bolus is to be delivered Cal...

Страница 18: ...connection Press x and open the pump door with u Press down the green opening lever completely until it locks in place remove the line and insert a new line Note In the unlikely event the pump door ca...

Страница 19: ...and follow the instructions as described 1 5 End of Infusion Press s f to stop the infusion The green LED goes out Close the roller clamp and interrupt the patient connection Press x Answer the questi...

Страница 20: ...is supposed to switch to standby by pressing u The pump is now in Standby While the pump is in the standby mode it s display shows the drug and the remaining time for this mode Change of remaining ti...

Страница 21: ...ighlight intermediate volume in ml or intermediate time in h min with t and open parameter with l Reset values by pressing u Both parameter total volume and time are displayed in the pump as Total wit...

Страница 22: ...before starting the infusion also if body surface area related dose rate is set by Barcode The dose rate calculation enables a calculation of the rate in ml h based on the entered dose parameters Set...

Страница 23: ...A deactivation of the dose rate calculation is only possible when the pump is stopped Press c from Main Menu and then press d Caution A change of the patient weight or height will alter the flow rate...

Страница 24: ...a drug choose therapy type with t and confirm with l Confirm the displayed drug information with l Decide if the safety limits for the drug are to be applied u or if only the drug name should be used...

Страница 25: ...s within the range of the minimum soft limit Violation of the upper soft limit Violation of the lower soft limit No soft limit is defined Only a drug name is available It is possible to select a drug...

Страница 26: ...lly in case non authorised access to the settings can be anticipated The code is entered with q and confirmed with k In this state the patient is allowed to demand boli Depending on the status of the...

Страница 27: ...PCA Chart is displayed The bar represents a time axis with the points above the axis representing the number of boli administered and the points below the axis representing the number of boli refused...

Страница 28: ...can be done manually or automatically Correspondingly if an automatic change is to be made automatically or manually is to be answered with u or d The rate and VTBI of the secondary infusion can be l...

Страница 29: ...cament 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...

Страница 30: ...teau rate is used as a continuous infusion Taper phase the pump rate is decreased linearly after the continuous phase until the KVO rate is reached or pump is stopped in a predefined time Down Time Ex...

Страница 31: ...rted now by pressing s f Starting Ramp and Taper via Special Function Menu Switch on pump with o and wait until self check is finished Insert disposable Go to Special Functions Menu and select Ramp an...

Страница 32: ...nuous phase is prolonged shortened to in fuse the new entered VTBI completely with the end of the taper phase Note The delivery of drugs can be stopped and started again in Ramp and Taper Mode at any...

Страница 33: ...n always displays this icon in the Display Note Bolus function is disabled for Program Mode Set Profile Parameters The therapy can be started directly via the drug library or via the Main Menu Special...

Страница 34: ...or Program Mode appears The screen shows the following Only the VTBI may be changed during an infusion that is running Press C to check upcoming Program Mode intervals in Main Menu It is possible to c...

Страница 35: ...evice Note The active Multi Dose Mode function always displays this icon in the Display Note Regular Bolus function is disabled for Intermittent Mode In Intemittent Bolus the bolus service settings ar...

Страница 36: ...ter parameters and k to confirm After entering all desired parameters the pump can be started by pressing s f In the upper part of the display the icon for Intermittent Mode appears In bolus phase the...

Страница 37: ...lised with a characteristical symbol in the Display If besides DOT the piggyback therapy is active a combined symbol for both therapies will be displayed Note Dose Over Time should only be performed b...

Страница 38: ...l Dose was entered in libr ary The editor is also shown if the Total Dose is edited in the Main menu The editor for Time is shown if a drug with therapy Dose over Time is selected from drug library an...

Страница 39: ...seconds Ensure pump is in the Main Menu passive mode or Standby New Order message will appear with drug name and mode Press k to accept or c key to cancel order and respond to prompt Select Care Unit...

Страница 40: ...first order sent send as Continuous is always considered as the PRIMary infusion subsequent orders will be considered PIGGYback Note Order sent as Dose over Time is always considered the PRIMary infus...

Страница 41: ...o 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 Confirm...

Страница 42: ...scroll to any value and open editor with l to change value Alternately order may be cancelled and request made for revised order to be sent Note If pump is placed in standby while order is pending ne...

Страница 43: ...influences such as the tube length tube diameter viscosi ty of the liquid and the filter used in the system set up adjustments may need to be made to the pressure level Enter pressure in Options Menu...

Страница 44: ...se between nine pressure levels 1 lowest level 9 highest level by pressing l or r and confirm entry with k 5 3 Data Lock The data lock function protects the device against unauthorized access It is re...

Страница 45: ...by the following table Activation of the function Open data lock in Options Menu with l Select between level 1 2 or 3 if activated with l and r and confirm with k Enter code with q and press k in orde...

Страница 46: ...ion of the KVO delivery is selected in the service program Open the KVO mode in the Options Menu with l Answer the Yes No question with u to enable the KVO mode 5 6 Contrast Display Light Keypad Light...

Страница 47: ...Answer Yes No question by pressing u to activate the macro mode For quick activation of macro mode Press and hold r while the pump is infusing until the font size changes 5 10 Language This function e...

Страница 48: ...son The signal tone and the staff call are turned off with C Display and LED stay in pre alarm until the operating alarm goes off Pre alarms don t lead to an interruption of the infusion Alarm type De...

Страница 49: ...sage will remain on the screen until it is confirmed by pressing k After 2 minutes if the alarm has not been confirmed by pressing k the audible tone will sound again The alarm tone the alarm message...

Страница 50: ...py Check upstream The upstream sensor triggers an alarm Check if roller clamp is closed or infusion line is kinked If a drop sensor is connected the upstream alarm is deactivated Air bubble Accumulate...

Страница 51: ...displayed in the headline the audible alarm for the pre and operating alarm is silenced for a predefined time via service tool Only the visual alarm is still displayed at the pump After the predefined...

Страница 52: ...oper 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...

Страница 53: ...ges in the delivery rate may affect the battery operating time Disposable change procedures require a high power consumption A sudden break down of the battery operating time can be possible with an a...

Страница 54: ...enance it can happen that the battery pre alarm time can no longer be maintained In this case it is necessary to perform a battery maintenance To initiate the discharge process the message Battery mai...

Страница 55: ...nge IV set specification significant to system accuracy without prior notification System accuracy is 5 typical by volume as measured using the trumpet curve test method defined in IEC 60601 2 24 at r...

Страница 56: ...ime of operation 100 continuous operation Operating conditions Relative humidity 30 90 without condensation Temperature 18 35 C 64 F 95 F Atmospheric pressure 500 1060 mbar Storage conditions Relative...

Страница 57: ...ng multiple infusion lines with patient port different flow rates may affect the rate for all infusions past the point of connection Rate increments 0 1 99 99 ml h in increments of 0 01 ml h 100 0 999...

Страница 58: ...y 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...

Страница 59: ...sed RF energy is transmitted by the Space System Refer to technical data of Battery Pack SP with Wifi IFU and or SpaceStation and SpaceCom for details RF emissions CISPR 11 Harmonic emissions IEC 6100...

Страница 60: ...s power quality should be that of a typical commercial or hospital environment Surge according IEC 61000 4 5 Gegentaktspannung 1KV Gleichtaktspannung 2KV 1KV 2KV Mains power quality should be that of...

Страница 61: ...in watts W according to the transmit ter manufacturer and d is the rec ommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surv...

Страница 62: ...the recommended separation distance for transmitters in the frequency range 0 15 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it...

Страница 63: ...m 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...

Страница 64: ...The housing of Infusomat Space the slide guide and the inner tube guiding areas may be cleaned with EPA regi stered hospital disinfectants containing 1 propanol or didecyl dimenthyl ammonium chloride...

Страница 65: ...itive electrical components and or electrical shock If fluid exposure occurs the device should be swapped out with another device in a manner that presents minimal interruption to patient care The dev...

Страница 66: ...sider the applicable hygiene and disposal regulations Inspection on Delivery Despite careful packaging the risk of damage during transport cannot be entirely prevented Upon delivery please check that...

Страница 67: ...ce P and Patient Safety Power Supply SP 8713110D 8713123D The Power Supply SP is adequate to supply power for a single pump and one SpaceControl 1 Connect plug of Power Supply SP with socket P2 on bac...

Страница 68: ...o the aperture on the PoleClamp make sure that it audibly locks in 3 To remove the short stand Press the white button at the lower end of the PoleClamp and remove the short stand Note Use only one inf...

Страница 69: ...Note A maximum of three plugs can be stacked upon each other in socket P2 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 o...

Страница 70: ...ll Note A maximum of three plugs can be stacked upon each other in socket P2 turned off Alarm Operation Alarm Operation Alarm Operation turned on 1 sec 1 sec 1 sec turned off static without Off Alarm...

Страница 71: ...tape for fixation of the demand button at the patient s arm Line fixation connection between hook and loop tape and demand button Metal clip alternatively for fixation at the bed sheet Cable strap for...

Страница 72: ...133 Drop Sensor SP 8713175 Short Stand SP 8713135 Battery Pack SP NiMH 8713180 Battery Pack SP NiMH incl Pin 8713180A Battery Pack SP LiIon incl Pin and WiFi 8713182A Interface Lead CAN SP 8713230 Int...

Страница 73: ...cock 220 cm 4063006 Intrafix Safeset w y needlefree valve Caresite 210 cm 4063004C Intrafix Safeset w y needlefree valve backcheck valve 210 cm 4063004KW Full list of Infusomat Space P Lines on reques...

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Страница 76: ...free 0318 B Braun Melsungen AG Sparte Hospital Care 34209 Melsungen Germany Tel 49 0 56 61 71 0 Fax 49 0 56 61 71 20 44 www bbraun com Manufactured by B Braun Melsungen AG 34209 Melsungen Germany Tel...

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