Directions for Use
Contents
1. Starting the Pump NORMAL Mode When a drug is selected the pump enters TIVA Mode see Starting the Pump TIVA Mode 1 Connect the pump to an AC power supply using the AC power cable Press the button 2 NEW DRUG To reset the drug information press the YES softkey If you want to use the previous drug information press the NO softkey continue in TIVA mode as above 3 Select the NO DRUG option from the list displayed 5 Load the syringe according to the Loading a Syringe section 5 CONFIRM SYRINGE Check that the syringe type and size being used matches the display If required the type of syringe can be changed by pressing the TYPE softkey Press CONFIRM when the correct type and size are shown Purge extension set if necessary If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required 6 SET INFUSION RATE Set the desired infusion rate in ml h using the A2 keys 7 PURGE If required See instructions in Purge section 8 CONNECT PATIENT Connect the extension set to the patient access device 9 START Press the button to commence operation INFUSING will be displayed The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is operating 1000DF00330 Issue3 14 34 Basic Features During the pause and maintenance modes the bolus function is enabled During hold mode the bolus function is disabl2. Configurable option 1000DF00330 Issue3 18 34 Configured Options This menu comprises a list of options which are configurable by the user 1 Turn the pump OFF 2 Whilst holding down the button turn the pump ON 3 The main display will show 000 Enter the access code for Configured Options using the ASV 4 keys pressing NEXT to move through the digits A full list of access codes can be found in the Technical Service Manual When the complete code shows on screen press OK to enter The Configured Options menu will be displayed General Options 5 00 NURSE CALL FITTED NURSE CALL INVERT RS232 SELECTED NEOI WARNING EOI POINT KVO AT EOI KVO RATE BACK OFF AC FAIL PRESSURE DISPLAY PRESSURE DEFAULT WEIGHT PURGE RATE PURGE VOLUME LIMIT PURGE SYRINGE HANDS FREE BOLUS DEFAULT BOLUS VOL DEFAULT BOLUS RATE MANUAL BOLUS CALL BACK TIME EVENT LOG DISPLAY BATTERY ICON AUDIO VOLUME AUTO NIGHT MODE Select GENERAL OPTIONS from the menu using the S keys and press the OK softkey Select the option you wish to enable disable or adjust and press the MODIFY softkey When all the desired modifications have been carried out press the QUIT softkey Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required Enables Nurse Call hardware option When enabled the nurse call output is inverted Sets the pump s communications to use RS232 hardware
3. 1 To check and adjust the pressure level press the button A bar graph will be displayed showing the pressure alarm level and the current pressure level Press the R keys to increase or decrease the alarm level The new level will be indicated on the display Press OK to exit the screen wen The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application During a bolus or induction phase the pressure level is set to maximum The level remains at maximum for 10 seconds after the end of the phase Rate Titration If Rate Titration is enabled the rate can be adjusted while infusing 1 Select the new rate using the 470 keys The message lt START TO CONFIRM gt will flash on screen and pump continues to infuse at the original rate 2 Press the button to confirm the new infusion rate and start infusing at the new rate If Rate Titration is disabled the rate can only be adjusted whilst on hold 1 Press the button to put the pump on hold 2 Select the new rate using the amp DCV keys 3 Press the button to start infusing at the new rate Clear Volume This option enables the volume infused to be cleared 1 Press the VOLUME softkey to display the CLEAR VOLUME option 2 Press the YES softkey to clear the volume Press the NO softkey to retain the volume Selecting YES resets the volume infused in the 24H LOG option Clear Induction TIVA Mode
4. BATTERY icon Indicates battery charge level to highlight when the battery will require recharging mg Induction Phase Dose Displayed on protocol confirmation screen T R Duration of Induction Phase Displayed on protocol confirmation screen Duration of Hands Free Bolus Displayed in bolus set up screen nu Maintenance Phase Dose Rate Displayed on protocol confirmation screen 1000DF00330 Issue3 6 34 Operating Precautions Disposable Syringes and Extension Sets e Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the pump Failure to do so may result in unintended administration e This Alaris TIVA Syringe Pump has been calibrated for use with single use disposable syringes To ensure correct and accurate operation only use 3 piece Luer lock versions of the syringe make specified on Luer Lock y the pump or described in this manual Use of non specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion lt i Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is li removed from the pump before the extension set is properly isolated from the patient Isolation may gt include closing a tap in the patient line or activating a flow stop clamp Erg Secure the extension set to the pump using the extension set hook at the rear of the pump This provides p
5. Drug Set up Select the DRUG LIBRARY option using the keys and press the OK softkey indicated on the screen To add a DRUG NAME press NEW softkey indicated on the screen and modify as indicated Select the required drug and press the MODIFY softkey To use a drug it must be enabled SR na d To change the drug name press the EDIT softkey indicated using the S keys to toggle through the alphabet To select a letter press the NEXT softkey On completion press the OK softkey indicated on the screen 6 Select the CONCENTRATION UNITS Units using the S keys press the OK softkey to select the concentration units Select the MINIMUM CONCENTRATION of the drug selected Use the amp SC V keys to increase decrease the minimum concentration shown on the screen When the minimum concentration has been selected press the OK softkey 8 Select the DEFAULT CONCENTRATION of the drug selected use the AY keys to increase decrease the default concentration shown on the screen When the default concentration has been selected press the OK softkey 9 Select the MAXIMUM CONCENTRATION of the drug selected Use the ASV keys to increase decrease the maximum concentration shown on the screen When the maximum concentration has been selected press the OK softkey If the default concentration the minimum concentration and the maximum concentration are equal the start up sequence will bypass the concentration request 10 Select the DOS
6. but has not been confirmed and 2 minutes has expired without any operation Press the button to silence the alarm then press the CANCEL softkey to clear this message and silence the alarm Check infusion rate and confirm by pressing the button or press the button to revert to the previous rate Press the button to start infusion This alarm only occurs if rate titration is enabled AC POWER FAIL AC Power has been disconnected and the pump is operating on battery power if this occurs when the pump is infusing the message INFUSION CONTINUES will be displayed Reconnect AC power supply or press the G button to silence the alarm and continue with battery operation The alarm will automatically cancel if the AC power supply is reconnected Error Code and Message The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer ATTENTION with 3 Beeps Three beeps will sound if the pump has been left ON for more than 2 minutes referred to as CALLBACK in the log without starting the operation Press the button to silence the alarm for a further 2 minutes Alternatively press and hold down the button and wait for 3 beeps in succession this will put the warning alarm on standby for 60 minutes Alarm Indicator Colour Alarms indicated AMBER AC POWER FAIL NEAR END OF INFUSION ATTENTION TITRATION NOT CONFIRMED BATTERY LOW RED All others
7. this step is bypassed 8 INDUCTION Using the Gs keys enter the induction dose amount per kg if required for dosing of patient weight Press the OK softkey to enter The Induction feature may be disabled Refer to Drug Set Up to disable enable the Induction feature 9 TIME Enter the induction time in seconds over which the induction dose will be delivered Press the OK softkey to enter 10 MAINTENANCE Set the maintenance dose rate in the drug protocol units Press the OK softkey to enter 11 Press OK softkey to confirm the induction and maintenance rates are set up correctly Load syringe or press MODIFY to change 12 Load the syringe according to the Loading a Syringe section 13 CONFIRM SYRINGE Check that the syringe type and size being used matches the display If required the type of syringe can be changed by pressing the TYPE button Press CONFIRM when the correct type and size are shown Purge extension set if necessary If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required 14 PURGE If required See instructions in Purge section 15 CONNECT PATIENT Connect the extension set to the patient access device 16 START Press to commence operation INDUCTION will be displayed The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is operating 1000DF00330 Issue3 13 34 Getting Started Continued
8. 24H LOG option using the 4206 keys and press the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the total volume infused since the volume was last cleared See example below 07 48 08 00 4 34ml 4 34ml 08 00 09 00 2 10ml 6 44ml 09 00 10 00 2 10ml 8 54ml VOLUME CLEARED 3 Press the QUIT softkey to exit the log Event Log This option allows the event log to be reviewed It can be enabled disabled 1 Press the button to access the options menu 2 Select the EVENT LOG option using the keys and press the OK softkey 3 Scroll through the log using the 2 keys Press the QUIT softkey to exit the log Dosing Summary TIVA Mode only 1 Press the button to access the options menu 2 Select the DOSING SUMMARY option using the AS keys and press the OK softkey 3 Press the QUIT softkey to exit the menu 1000DF00330 Issue3 17 34 Alarms and Warnings Alarms are indicated by a combination of an audible alarm flashing alarm indicator and a descriptive message in the display 1 First press the Q button to silence the alarm for a maximum of 2 minutes then check the display for an alarm message Press CANCEL to cancel the alarm message 2 If the infusion has stopped rectify the cause of the alarm then press the button to resume the infusion If the pump initiates a safety processor alarm condition an audible high pitched continuous shrill accompanie
9. 5 10 15 20 25 30 35 Time mins Observation Window mins R Maximum Error Minimum Error Linear Mean 0 2 1000DF00330 Issue3 32 34 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are Alaris CC Guardrails Syringe Pump Alaris GP Guardrails Volumetric Pump 1 For Docking Stations and Workstation contact local customer services representative to obtain configurations availability and part numbers Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual The Technical Service Manual 1000SM00001 is now available in electronic format on the World Wide Web at www carefusion co uk alaris technical A username and password are required to access our manuals Please contact local customer services representative to obtain login details 1000SP01122 Internal Battery Pack 1000DF00330 Issue3 33 34 Service Contacts For service contact your local Affiliate Office or Distributor AE CareFusion PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 AU CareFusion 3 167 Prospect Highway PO Box 355 Seven Hills NSW 2147 Australia Tel 61 1800 833 372 Fax 61 1800 833 518 BE CareFusion Leuvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA CareFusion 235 Shields C
10. Perfusion 1 Fresenius 1 Nipo 1 s Rapiject The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the infusion line is secured using the infusion set hook see Loading a Syringe section x Healthcare KENDALL MONOJECT ES v Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation 1000DF00330 Issue3 23 34 Compatible Extension Sets The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health For availability please contact your local CareFusion representative because new sets are continuously being developed for our customers Standard Sets G40015 Standard PVC Syringe Extension Set 150 cm Priming Volume 2 6ml G40020B Standard PVC Syringe Extension Set 200 cm Priming Volume 1 5ml G402EP Extension set Luer lock connecto
11. finger grip returns to its original position 7 Ensure that the syringe type and size match those displayed on the pump then press CONFIRM If required the make of syringe can be changed by pressing the TYPE softkey ON HOLD 3 04min gt 3 00 mg kg h ADJUST Note If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required however ensure that the extension set is not connected to the patient during this process CareFusion recommends to limit the number of configured syringe types and sizes available for selection on the pump Secure the extension set using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position 1000DF00330 Issue3 12 34 Getting Started Continued There are no Volume To Be Infused VTBI features in the Alaris TIVA Syringe Pump during either maintenance or no drug mode Thus infusion will continue until manual intervention or end of syringe Exercise care when entering or adjusting any settings to ensure that the data and units entered are correct Starting the Pump TIVA Mode The sequence of operation in TIVA mode is INDUCTION PAUSE and MAINTENANCE The active mode of this pump is displayed
12. only 1 To clear the induction press the button 2 The CLEAR INDUCTION prompt is shown To clear the induction press the YES softkey Answering NO to the CLEAR INDUCTION prompt will leave the pump in the ON HOLD state the induction can continue by pressing the button Set by Doserate Set by ml h TIVA Mode only To set doserate or flowrate in precise increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml h An arrow to the left of the rate display shows the rate changed when the 2 keys are used to increase decrease the infusion rate To set a doserate precisely the arrow must be pointing to the doserate mg kg h the flowrate will be calculated from the doserate To precisely set a flowrate the arrow must be pointing to flowrate ml h the doserate will be calculated from the flowrate Selecting the Set By ml h Option 1 Whilst the pump is infusing press the button to access the options menu 2 Select the SET BY ml h option using the keys and press the OK softkey indicated on the screen This will select the set by flowrate option the arrow on the display will automatically select the flowrate the flowrate can be adjusted if necessary Selecting the Set By Doserate Option 1 Whilst the pump is infusing press the button to access the options menu 2 Select the SET BY DOSERATE option using the 400 keys and press the OK softkey indicated on the screen This
13. option Sets the Near End Of Infusion warning time as time left to End Of Infusion Sets the End Of Infusion point When enabled the pump will switch to running at the KVO rate when EOl is reached Sets the Keep Vein Open KVO rate at which the pump will operate if KVO at EOI is enabled When enabled the motor will reverse to relieve line pressure when an occlusion occurs When enabled the AC Power Failure Alarm will sound if the AC power is disconnected Enables disables the Pressure Icon on the main display Sets the default occlusion alarm level Sets up default patient weight for TIVA mode only Sets the purge rate Sets the maximum permissible purge volume Prompt to purge syringe after confirmation Enables disables the hands free bolus feature Sets the default hands free bolus volume for no drug mode only Sets the default bolus rate Volume infused will be increased if plunger is manually moved in and syringe remains confirmed Adjusts the time for the pump to sound the call back alarm Enables disables the event log Enables disables the Battery Icon on the main display Sets the alarm volume of the pump at high medium or low Backlight dims between hours 21 00 and 06 00 1000DF00330 Issue3 19 34 Configured Options Continued Clock Set 1 Select CLOCK SET from the Configured Options menu using the amp C keys and press the OK softkey 2 Use the 56 35 keys to adjust the date displayed pressi
14. other than for the intended purpose without specific written authorization of CareFusion Corporation or one of its subsidiaries is strictly forbidden CareFusion Switzerland 317 Sarl A One Business Centre Z A Vers La Pi ce n 10 CH 1180 Rolle CareFusion UK 305 Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS UK 1000DF00330 Issue 3 carefusion com
15. plunger for damage 3 Check Start up self test operation is correct Before the transfer of the pump to a Clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a new patient and as required standard disinfectant detergent solution If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out of service for examination by a qualified service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion For Preventative and Corrective Maintenance instructions please refer to the Technical Service Manual TSM All servicing should only be performed by a qualified service engineer with reference to the TSM Please refer to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI The International System of Units units Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure Mean Time To Battery Empty from fully charged 5ml h amp 20 C under normal conditions is 6 hours From the battery low alarm it will take about 2 2 hours
16. to 90 charge when reconnected to the AC power supply whether the pump is in use or not The battery is maintenance free sealed Nickel Metal Hydride and requires no routine servicing However to achieve optimum operation ensure that the battery is fully recharged after full discharge before storage and at regular 3 month intervals during storage Charge retention will eventually degrade Where retention is critical the internal battery should be replaced every 3 years It is recommended that only a qualified service engineer replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual The battery pack used in this Alaris Syringe Pump is manufactured by CareFusion and includes a proprietary PCB printed circuit board designed specifically for the Alaris Syringe Pump and in conjunction with Alaris Syringe Pump software controls battery use charge and temperature Any use of battery packs that are not manufactured by CareFusion in the Alaris Syringe Pump is at your sole risk and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion CareFusion s product warranty shall not apply in the event the Alaris Syringe Pump has suffered damage or premature wear or malfunctions or otherwise operates incorrectly as a result of use with a battery pack that is not manufactured by CareFusion 95 lower confidence inte
17. will select the set by doserate option the arrow on the display will automatically select the doserate the doserate can be adjusted if necessary 1000DF00330 Issue3 16 34 Basic Features Continued Repeat Operation When activating REPEAT OPERATION the protocol used for the preceeding operation will be used This includes any changes made to the concentration induction dose rate induction time and maintenance dose rate prior to confirmation This option will only appear in the options menu when the infusion has been stopped 1 Press the button to access the options menu 2 Select the REPEAT OPERATION option using the S keys 3 Press the OK softkey indicated on the screen This will revert the pump to the initial programming WEIGHT step if the drug protocol is weight dependant without powering down the pump End of Operation This option will only appear in the options menu when the infusion has been stopped 1 Press the button to access the options menu 2 Select the END OF OPERATION option using the GG 56 keys 3 Press the OK softkey indicated on the screen The pump will display the NEW DRUG prompt and will not be powered down If you wish to reset the information press the YES softkey If you wish to use the previous information press NO 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed 1 Press the button to access the options menu 2 Select the
18. 95 500hPa 1060hPa Operating Temperature Operating Relative Humidity Operating Atmospheric Pressure Transport amp Storage Temperature Transport amp Storage Relative Humidity Transport amp Storage Atmospheric Pressure Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 Protection against fluid ingress IPX1 Protected against vertically falling drops of water EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 Conversion Factor Dosing Conversion 1 0 ug 1000 ng 1 0 mg h 24 0 mg 24 h 1 0 mg min 60 0 mg h 1 0 mg 1000 ug Volume Unit Time Dose Rate Concentration 1 0 ml h 1 0 mg h 1 0 mg ml The formula is Volume Rate ug kg min x kg x 60 min h g h ml h conc in mg ml x 1000 ug mg Drug Units Available ug ml ml h ng min ng kg min ug min g kg min ug h ug kg h ug 24h ug kg 24h mg min mg kg min mg h mg kg h mg 24h mg kg 24h g h g 24h U min U kg min U h U kg h U 24h U kg 24h kU 24h mmol h 1000DF00330 Issue 3 24 34 Compatible Syringes The pump is calibrated and labelled for use with single use disposable Luer lock syringes Only use the size and type of syringe specified on the pump display The full list of permitted syringe models is dependent on the software version of the pump Sml T Astrazeneca 0018185818 8 1 BBraun Perfusor TTT l BD Perfusor bifidis L 1 1 Cod Te Codan
19. Alaris TIVA Syringe Pump Directions For Use en Page gd Le ET 2 Leer eu EE EIER 2 Quick Start Guide EE 2 Features of the Alaris TIVA Syringe Pump v 9 RR 4 094 0 eee teen yk yaaa yak TREE A 3 Controls amp IMNGICATONS e AER miy esya daa yaaa Ee 4 Kuuscht ge 5 Main Display Features aZ a n EE E RA EE EE aber E 6 Operating Precautions U ENEE dias a R Ra ARAL headed oe RDA YR Dm RA dn a d D dis 7 Getting Started Zeit SEENEN KEE ENEE ENEE RAN Yas Lana 9 Basic FOAtUICS EE 15 EIER Leier EE 18 Confiqured Optio EE 19 Klee d EE 24 Compatible a TEE 25 Associated Sasa T az ao AZ S S a Ada aad aa A s sik 25 Compatible Extension e s s ya NEE aa ay aa asa aa a wwe ala ala g ya sala ala EA OU 26 aa 28 Occlusion Pressure uyma daaa 30 IrDA RS232 and Nurse Call Specification 31 Trumpet Curves amp Start Up CurveS nee eee 222 2222 6222 226 2222 2 23 32 Prod ctsand Spare T s das e SA daaa b Sege At oe evs b eege O may 33 KELTEN 34 1000DF00330 Issue3 1 34 ntroduction The Alaris TIVA Syringe Pump herein after referred to as is a fully featured syringe pump which provides the anaesthe
20. B Houten Nederland Tel 31 0 30 2289 711 Fax 31 0 30 2289 713 NO CareFusion Solbraveien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 34 34 NZ CareFusion 14B George Bourke Drive Mt Wellington 1060 PO Box 14 518 Panmure 1741 Auckland New Zealand Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 PL CareFusion ul Rzymovvskiego 53 02 697 Warszawa Polska Tel 48 225480069 Fax 48 225480001 SE CareFusion Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 US CareFusion 10020 Pacific Mesa Blvd San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179 ZA CareFusion Unit 2 Oude Molen Business Park Oude Molen Road Ndabeni Cape Town 7405 South Africa Tel 27 0 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 Rev B Alaris Guardrails and IVAC are registered trademarks of CareFusion Corporation or one of its subsidiaries All rights reserved All other trademarks are property of their respective owners 2000 2012 CareFusion Corporation or one of its subsidiaries All rights reserved This document contains proprietary information of CareFusion Corporation or one of its subsidiaries and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any product described Reproduction disclosure or use
21. E RATE UNITS required for maintenance doses use the 8 56 keys to select the dose units required When the dose units required have been selected press the OK softkey 11 Select the INDUCTION DOSE in dose units required use the Gas keys to increase decrease the induction displayed When the induction has been selected press the OK softkey If the setting is less than 0 01 then it turns the Induction setting off It will disable the Induction Set Up in TIVA mode 12 Select the INDUCTION TIME required use the AC keys to increase decrease the time over which the induction is to take place When the time has been selected press the OK softkey 13 PAUSE AFTER INDUCTION Select ENABLED and the infusion will stop after the induction period awaiting the operator pressing the button to continue at the chosen maintenance rate Select DISABLED and the infusion will continue to give the chosen maintenance rate after induction 14 Select the MAINTENANCE RATE required use the AY keys to increase decrease the maintenance rate When the rate has been selected press the OK softkey 15 Select the BOLUS DOSE selected in dose units required Use the Gas keys to increase decrease the bolus dose When the dose has been selected press the OK softkey If the OFF softkey is pressed then it turns the Bolus setting off It will disable the Bolus feature in TIVA mode 16 Select the default BOLUS RATE required use the S keys to select fro
22. T softkey to return to the Configured Options menu Contrast This option is used to set the contrast on the pump display 1 Select CONTRAST from the Configured Options menu using the amp AC Si keys and press the OK softkey 2 Use the CSV keys to select a contrast ratio value The contrast of the display will change when scrolling through the numbers 3 When the desired value has been reached press the OK softkey to return to the Configured Options menu 1000DF00330 Issue3 20 34 Alaris TIVA Syringe Pump Configured Options Record General Options Enter the pump specific information for your records on a copy of this page ft 1 fame 1 9 x 8 Softvvare Version 1 6 2 amp 2 1 0 12 3 x and above NURSE CALL FITTED Disabled Disabled Enabled Disabled NURSE CALL INVERT Disabled Disabled Enabled Disabled RS232 SELECTED Disabled Disabled Enabled Disabled KVO AT EO KVO RATE BACK OFF AC FAL PRESSURE DISPLAY Disabled Enabled Enabled Disabled NEO WARNING WEIGHT 70 0Kg 70 0Kg 0 01Kg 250Kg PURGE RATE 200ml h 200ml h 100ml h 500ml h PURGE SYRINGE Enabled Disabled Enabled Disabled HANDS FREE BOLUS Enabled Enabled Enabled Disabled DEFAULT BOLUS VOL DEFAULT BOLUS RATE MANUAL BOLUS CALLBACKTIME EVENT LOG DISPLAY BATTERY ICON AUDIO VOLUME AUTO NIGHT MODE Syringes Enabled Hospital Name Serial No Software Version Approved by Configured by Date Date 1000DF00330 Issue3 21 34 Configured Options Continued
23. a command from the serial interface communication must take place over the serial interface a communication must take place every 15 seconds or the pump will alarm display communications failure and stop infusing This failure protects against failure of the communications including the removal of the RS232 cable The nurse call interface provides a remote backup to the internal audible alarm It should not be relied upon to replace monitoring of the internal alarm Refer to the Technical Service Manual for further information regarding the RS232 interface Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient responsibility for the control of the pump is vested in the software run on the computer control system The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Technical Service Manual and is for general information only Any connected analogue and_ digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyoneconnecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standa
24. cate the pump away from any such hazardous sources Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel When connected to an external power source a three wire Live Neutral Earth supply must be used If the integrity of the external protective conductor in the installation or its arrangement is in doubt the pump should be operated from the battery e Do not open the RS232 Nurse Call protective covering when not in use Electrostatic discharge ESD precautions are required when connecting RS232 Nurse Call Touching the pins of the dr A connectors may result in ESD protection failure It is recommended that all actions must be taken by appropriately trained personnel If this pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or m othervvise suspected to have been damaged remove it from service for inspection by a qualified service 66 engineer When transporting or storing the pump use original packaging where possible and adhere xx to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging 1000DF00330 Issue 3 g 34 Getting Started Initial Set up Before operating the pump read this Directions For Use manual carefully 1 Check that the pump is complete undamaged and that the voltage rating specified on t
25. d accessories Use of any accessory transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity This pumpis a CISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal product offering Therefore its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment However this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC EN60601 1 2 and IEC EN60601 2 24 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation n some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv or by radio frequency radiation close to or above 10v m If the pump is affected by this external interference the pump will remain in a safe mode the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel Consult Technical Service Manual for further information explosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise care to lo
26. d with a red alarm indicator and there is no error message displayed on the pump remove the pump from service for examination by a qualified service engineer Display Description and Troubleshooting Guide DRIVE DISENGAGED The drive system has been disengaged during operation Check the finger grips and the position of the syringe OCCLUSION Excessive pressure measured at the syringe plunger exceeding the alarm limit Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion CHECK SYRINGE Incorrect size of syringe has been fitted the syringe has not been positioned correctly or has been disturbed during operation Check the syringe location and the position BATTERY LOW Battery charge low with 30 minutes operation remaining Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to the AC power supply to continue operation and charge the internal battery BATTERY EMPTY The internal battery is exhausted Connect the pump to the AC power supply NEAR END OF INFUSION The pump is nearing the end of the infusion This value can be configured END OF INFUSION The pump has reached the end of the infusion A pre set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set This value can be configured TITRATION NOT CONFIRMED The infusion rate has been changed
27. e of operation under negative pressure Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0 ml h or above are recommended Start up Trend BD Plastipak 50ml e 0 1ml h Trumpet Curve BD Plastipak 50ml e 0 1ml h 0 14 20 is i Z A 2 E aa W nz g 5 01 AA A A 2 006 5 20 0 04 0 02 kal 0 00 40 0 02 rA 0 10 20 30 40 50 60 70 80 90 100 110 120 N N 48 E 25 p N Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 10 2 Start up Trend BD Plastipak 50 ml 1 0 ml h Trumpet Curve BD Plastipak 50 ml 1 0 ml h 20 20 15 18 10 14 5 12 0 S w AA 8 E 8 06 u 10 04 15 0 2 00 20 0 10 20 30 40 50 60 70 80 90 100 110 120 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error 9 Minimum Error 4 Linear Mean 1 8 15 H Trumpet Curve BD Plastipak 50 ml 5 0 ml h 100 Start up Trend BD Plastipak 50 ml 5 0 ml h 90 10 80 5 7 0 eebe S 50 ZS 2 P 40 5 me Z 30 di 20 10 10 00 15 0 10 20 30 40 50 60 70 80 90 100 110 120 0
28. ect syringe could adversely affect the accuracy of the infusion rate and may also affect pump performance When drawing fluid into the syringe draw enough to compensate for any dead space volume in the extension set and syringe at the end of infusion as this cannot be fully infused LA E Plunger P Plunger Flange Grippers Plunger Plunger Holder Syringe Barrel Barrel Flange Syringe Clamp Syringe Flange Clamp Place the pump on a stable horizontal surface or secure as described previously Prepare load and prime the single use disposable syringe and extension set using standard aseptic techniques 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right 2 Pull the syringe clamp forward and down 1000DF00330 Issue3 11 34 3 Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange uu clamp E H To ensure the syringe is loaded correctly place the barrel flange in the space 1 between the syringe clamp and the syringe flange clamp This is correct if the syringe remains in position before the syringe clamp is closed 4 Lift the syringe clamp until it locks against the syringe barrel 5 Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end 6 Release the finger grips Ensure that the plunger grippers are securing the plunger in place and the
29. ed The purge feature is available before the infusion has been started and when the syringe is changed the syringe must be reconfirmed to activate the purge feature No alarms are disabled during the operation of the purge feature The 460 button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe 1 Press the 49 button when the pump is not infusing Ensure that the extension set is not connected to the patient 2 Press and hold the PURGE softkey until fluid flows and the purging of the IV infusion set is complete The volume used during purging will be displayed but it is not added to the volume infused 3 When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display During PURGE the pressure limit alarms are temporarily increased to their maximum level eddi Bolus Infusion The hands free bolus will be cancelled following any interruption in delivery even if the bolus delivery is incomplete During BOLUS the pressure limit alarm is temporarily increased to the maximum level BOLUS Infusion The Bolus feature is enabled in Drug Set Up refer to Drug Set Up section t is not possible to deliver a bolus during an induction or if bolus is disabled To use this feature ensure that the hands free bolus option is disabled Refer to the Drug Set section 1 During the main
30. f 1 ml h and higher by the appropriate selection of occlusion levels The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G40020B standard extension set Ras Time to alarm 1 0 ml h Time to alarm 5 0 ml h typical typical 1 30 9 5 E 1 00 0 30 2 4 6 8 10 Occlusion Level Occlusion Level aog Bolus Volume without back off 200 Bolus Volume with back off typical typical E Occlusion Level Occlusion Level Tests at low alarm levels may alarm immediately the force at these levels is commonly less than the friction in the syringe with no additional fluid pressure The result is that the pressure relating to the low forces will be less than the nominal quoted occlusion pressure Bolus volume following occlusion will be minimised by the back off feature if enabled The back off will reduce the line pressure by removing the volume stored in the occluded line and deducting this volume from the volume infused 1000DF00330 Issue3 30 34 IrDA RS232 and Nurse Call Specification IrDA RS232 Nurse Call Feature The RS232 Nurse call feature is an optional feature on Alaris Syringe Pumps It allows the pump to be monitored remotely and or controlled via a suitable central monitoring or computer system When the pump is started by
31. he label is compatible with your AC power supply 2 Items supplied are Alaris TIVA Syringe Pump User Support CD Directions For Use AC Power Cable as requested 6 Protective Packaging 3 Connect the pump to the AC power supply for at least 212 hours to ensure that the internal battery is charged verify that the 2 is lit Language Selection 1 On initial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the keys 3 Press the OK softkey to confirm your selection The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply Should the pump fail to perform correctly replace in its original protective packaging where possible and contact a qualified service engineer for investigation 1000DF00330 Issue3 9 34 Getting Started continued Do not mount the pump with the AC power inlet or the syringe pointing upwards This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe Pole Clamp Installation The pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical LV poles of a diameter between 15 and 40 mm Recessed area Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole Place pump around pole and
32. in large characters on the upper left side of the display These modes are optional and can be enabled in the drug setup dialog Configuration allows the user to define drug names and typical defaults for the information entered in the start sequence below If there have been no drugs configured these steps will not appear and the pump will operate in normal mode See Starting the Pump NORMAL Mode 1 Connect the pump to an AC power supply using the AC power cable Press the button 2 NEW DRUG If you wish to reset the drug information press the YES softkey If you want to use the previous drug information press the NO softkey Go to step 4 The start up drug configuration is 3 SELECT DRUG Select a drug from the list displayed If there are no drugs programmed refer to the configured options to set up the drug protocols 4 WEIGHT if required for dosing Enter the patient weight using the S keys Press the OK softkey to enter 5 Press OK softkey to confirm the induction and maintenance rates are set up correctly Go to step 12 Load syringe or press MODIFY to change 6 WEIGHT if required for dosing Enter the patient weight using the 8 56 35 keys Press the OK softkey to enter 7 CONC Enter the drug concentration for example in mg ml between the limits set in the drug protocol Press the OK softkey to enter If the drug default concentration minimum concentration and the maximum concentration are equal
33. l Definitions for an explanation of the symbols used Release lever for Rotating Cam Rotating Cam to lock on to horizontal rectangular bars IR Communications port Carrying Potential Folded Pole RS232 Extension set Handle Equalisation Clamp Connector hook PE connector 1000DF00330 Issue3 3 34 Controls Indicators Controls amp Indicators ON OFF button Press once to switch the pump ON Press and hold down for 3 seconds to switch the pump OFF RUN button Press to start the infusion The green LED will flash during infusion HOLD button Press to put the infusion on hold The amber LED will be lit while on hold MUTE button Press to silence alarm for 2 minutes configurable The alarm will resound after this time Press and hold until 3 beeps are heard for 60 minutes silence PURGE BOLUS button Press to access PURGE or BOLUS soft keys Press and hold down soft key to operate PURGE the extension set during set up Pump is on hold Extension set is not connected to the patient Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate Pump is infusing Extension set is connected to the patient Vlis added OPTION button Press to access optional features see Basic Features PRESSURE button Use this button to display the pumping pressure and alarm level CHEVRON keys Double or single for faster slower increase or decrease of values sh
34. m 100 0ml Increments of 0 1ml default 5 0ml During BOLUS the pressure limit alarms are temporarily increased to their maximum level Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50 ml syringe is Maximum Overinfusion 0 5ml Purge Specifications The purge rate is limited to the maximum rate for the syringe and can be set as part of the configuration 100ml h 500ml h The purge volume range is 0 5ml 5ml During PURGE the pressure limit alarms are temporarily increased to their maximum level Keep Vein Open KVO Rate 0 1 ml h 2 5ml h End Of Syringe Rate Stop KVO 0 1ml h to 2 5ml h or set rate if lower than KVO Near End Of Infusion Alarm 1min 15min to end of infusion or 10 of syringe volume whichever is smaller End Of Infusion EOI Alarm 0 1 5 of syringe volume Electrical Classification Class product Continuous Mode Operation Transportable Maximum Pumping Pressure Limit Highest alarm level 1000mmhHg nominal at L 10 Occlusion Accuracy of full scale Pressure mmHg 1 0 1 3 1 5 1 10 50 mmHg 300 mmHg 500 mmHg 1000 mmHg Using most common 50ml syringes under normal conditions 95 confidence 95 of pumps Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Mean Time To Battery Empty fr
35. m 150ml h 300ml h 600ml h 900ml h or 1200mI h When the rate has been selected press the OK softkey 17 To select HANDS FREE BOLUS use the keys to choose ENABLED DISABLED Press the OK softkey to confirm selection 18 REVIEW THE DRUG SETUP DATA press the OK softkey to confirm the data displayed This will return the pump to the drug setup menu 1000DF00330 Issue3 22 34 Drug Protocol Record DUR 5 X E ZA 10 aqejleae ase SI PLILYI LL nn wnwixew e YM saweu BNP OOL x Aq UOISJD A Dar soq YOHONPUI spun ae soq jaye uon npui Snap 55 uonenu suoo UU BIR dnjas 020 01d 6nig duund abuisAs YALL oSUeIV L ya Aq paaoiddy JaquiNN elas xew 5862 21 5n q 1221450 23 34 1000DF00330 Issue 3 Infusion Specifications Maximum infusion rate can be set as part of the configuration 0 1ml h 150ml h 5ml syringes 0 1ml h 300ml h 10ml syringes 0 1ml h 600ml h 20ml syringes 0 1ml h 900ml h 30ml syringes 0 1m h 1200mI h 50ml syringes The Volume Infused range is 0 0ml 9990ml Bolus Specifications Selected maximum rates are shown below 150ml h 5ml syringes 300ml h 10ml syringes 600ml h 20ml syringes 900ml h 30ml syringes 1200ml h 50ml syringes The default bolus volume can be set as part of the configuration Minimum 0 1ml Maximu
36. ng the NEXT softkey to access the next field 3 When the correct time and date are displayed press the OK softkey to return to the Configured Options menu Hospital Name This option allows the user to programme in the name of the hospital ward or department This will appear during the power up display sequence 1 Select HOSPITAL NAME from the Configured Options menu using the S keys and press the OK softkey 2 Use the keys to adjust the character displayed pressing NEXT to access the next position 3 When the correct name is displayed press OK to return to the Configured Options menu Enable Syringes This option is used to pre configure the type and size of syringe permitted for use on the pump Select all possible syringes which may be used and disable any that should not be used 1 Select ENABLE SYRINGES from the Configured Options menu using the S keys and press the OK softkey 2 Use the 4706 keys to scroll through the list of syringes pressing MODIFY to enable disable a syringe brand and individual models within the brand 3 When all modifications are complete press OK to return to the Configured Options menu Language This option is used to set the language of messages shovvn on the pump display 1 Select LANGUAGE from the Configured Options menu using the GG 296 35 keys and press the OK softkey 2 Use the CDV keys to select the language 3 VVhen the desired language has been selected press SELEC
37. ns in individual syringes cause short term fluctuations in rate accuracy The following curves show typical performance of the system in two ways 1 the delay in onset of fluid flow when infusion commences start up curves and 2 the accuracy of fluid delivery over various time periods is measured trumpet curves The start up curves represent continuous flow versus operating time from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Tests performed per IEC EN60601 2 24 standard Trumpet curves are named for their characteristic shape They display discrete data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore the clinical effect cannot be determined from the trumpet curves alone Start up and trumpet curves may not be indicativ
38. om fully charged 5ml h amp 20 C under normal conditions is 6 hours 95 lower confidence interval of 5 hours 50 minutes Charging takes 2 2 hours from discharge to 90 charge Memory Retention The electronic memory of the pump will be retained for more than 6 months when not powered up System Accuracy Volumetric Mean 2 nominal Derating Temperature 0 5 5 40 C High Rates 2 0 rates gt syringe volume h eg gt 50ml h in a 50ml syringe Important System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in IEC EN60601 2 24 at rates of 1 0ml h 23 C and above when the pump is used with the recommended syringes Caution Infusion volume accuracy may be compromised at rates below 1 0ml h Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves See also trumpet curves section in this manual Fuse Type 2 xT 1 25A slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Dimensions 310 mm w x 121 mm h x 200 mm d Weight 2 7 kg excluding power cable Alarm Conditions Drive Disengaged Occlusion Check Syringe Battery Low Battery Empty Near End Of Infusion End of Infusion AC Power Fail Internal Malfunction Attention Nurse Callback Titration not confirmed Environmental Specifications 5 C 40 C 20 90 700hPa 1060hPa 30 C 50 C 10
39. ourt Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CH CareFusion Svvitzerland 221 Sarl Critical Care A One Business Centre Zone d activiti s Vers la Pi ce n 10 1180 Rolle Switzerland Ph 0848 244 433 Fax 0848 244 100 CN CareFusion EIS HEE ETTIK 5005 Lisi rain A EE 24 EE DIE 200122 FA R 86 2158368018 168 86 21 58368017 DE CareFusion Pascalstr 2 52499 Baesweiler Deutschland Tel 49 931 4972 837 Fax 49 931 4972 318 DK CareFusion Firskovvej 25 B 2800 Lyngby Danmark TIf 45 70 20 30 74 Fax 45 70 20 30 98 ES CareFusion Edificio Veganova Avenida de La Vega n 1 Bloque 1 Planta 1 28108 Alcobendas Madrid Espana Tel 34 902 555 660 Fax 34 902 555 661 FR CareFusion Parc d affaire le Val Saint Quentin 2 rue Ren Caudron 78960 Voisins le Bretonneux France T l 33 1 30 05 34 00 Fax 33 1 30 05 34 43 1000DF00330 Issue 3 GB CareFusion The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 HU CareFusion D brentei ter 1 H 1013 Budapest Magyarorszag Tel 36 1 488 0232 Tel 36 1 488 0233 Fax 36 1 201 5987 IT CareFusion Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 30 33 93 00 Fax 39 055 34 00 24 NL CareFusion De Molen 8 10 3994 D
40. own on display BLANK SOFTKEYS Use in conjunction with the prompts shown on the display BATTERY indicator When illuminated the pump is running on the internal battery When flashing the battery power is low with less than 30 minutes of use remaining AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged 1000DF00330 Issue3 4 34 Symbol Definitions Labelling Symbols Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nurse call Connector Optional Defibrillation proof type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Alternating Current Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Date of Manufacture Manufacturer Not for Municipal Waste Fuse Rating Important information Authorised representative in the European Community 1000DF00330 Issue3 5 34 Main Display Features Pump Syringe type fitted D Pressure Status rug name Information Y SYRINGENAME NAME DF DOSE 0 0 ae a KO AOE 56 Onn G al s mg kg h OP ost apsust Infusion Volume Volume Infused Rate Infused Option Screen Icons Description E HO TIME REMAINING DISPLAY icon Indicates time before syringe will require replacing
41. plies buildings used for domestic purposes However it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures Consult Technical Service Manual appropriately trained technical personnel or CareFusion for further information This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide Operating Pressure e This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Alarm Conditions e Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating 1000DF00330 Issue3 7 34 Operating Precautions continued Electromagnetic Compatibility and Interference This pump is protected against the effects of external interference including high energy radio frequency emissions magnetic fields and electrostatic discharge for example as generated by electrosurgical and cauterising equipment large motors portable radios cellular telephones etc and is designed to remain safe when un
42. rd IEC EN60601 1 1 Baud Rate Start Bits Data Bits Parity Stop Bits 1000DF00330 Issue 3 38 4 kBaud 1 Start Bit 8 Data Bits No Parity 1 stop bit RS232 Nurse Call Connection Data Nurse call Specification Connector TXD RXD TXD Output Voltage Range RXD Input Voltage Range RXD Input Thresholds RXD Input Resistance Enable Isolation Socket Pump Baud Rate Start Bits Data Bits Parity Stop Bits Nurse Call Relay Contacts Typical Connection Data D Type 9 Pin EIA RS232 C Standard Minimum 5V mark 5V space Typical 7V mark 7V space with 3kQ load to ground 30V 30V max Low 0 6V minimum High 3 0V maximum 3 minimum Active Low 7V to 12V Active High 7V to 12V powers up the isolated RS232 circuitry Inactive Floating open circuit allows isolated RS232 circuitry to power down 1 5kV dc or ac peak 38 4 kBaud 1 Start Bit 8 Data Bits No Parity 1 stop bit Pins 1 8 9 30V dc 1A rating 1 Nurse call Relay Normally Closed NC C 2 Transmit Data TXD Output 3 Received Data RXD Input 4 Power Input DSR 5 Ground GND 6 Not used 7 Power Input CTS 8 Nurse call Relay Normally open NC O 9 Nurse call Relay Common NC COM GND DSR Ep TXD NCC 5 4 9 7 6 NC NCO CTS COM 31 34 Trumpet Curves amp Start up Curves In this pump as with all infusion systems the action of the pumping mechanism and variatio
43. reasonable levels of interference are encountered Therapeutic Radiation Equipment Do not use the pump in the vicinity of any Therapeutic Radiation Equipment Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator may severely affect functioning of the pump Please consult manufacturer s recommendations for safe distance and other precautionary requirements For further information please contact your local CareFusion representative e Magnetic Resonance Imaging MRI The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices Therefore the pump is not considered an MRI compatible pump as such If use of the pump within an MRI environment is unavoidable then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the pump or MRI image distortion This safe distance should be established in accordance with the manufacturers recommendations regarding electromagnetic interference EMI For further information please refer to the product technical service manual TSM Alternatively contact your local CareFusion representative for further guidance e Accessories Do not use any non recommended accessory with the pump The pump is tested and compliant with the relevant EMC claims only with the recommende
44. rotection against accidental dislodging of the syringe from the pump nN O When combining several apparatus and or instruments with extension sets and other tubing for example via a 3 way tap the performance of the pump may be impacted and should be monitored closely Mounting the Pump 10m The pump must be mounted within 1 0m above or below the patient s heart The most accurate pressure CH monitoring in the extension set is achieved when the pump is positioned close to the patients heart level Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe To protect against the introduction of air the user should regularly monitor the progress of the infusion syringe extension line and patient connections and follow the priming procedure specified herein Operating Environment When using any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is advised Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications This pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that sup
45. rs Kink resistant DEHP free PVC yellovv striped tubing Bore 1mm Length 200cm Priming volume 1 6ml BBE e rx 7777777777 BRI Lp Light Protected Sets G40215 Amber PVC Syringe Extension Set 150 cm Priming Volume 1 2ml G40320 VVhite PVC Syringe Extension Set 200 cm Priming Volume 3 6ml 04105010509 Polyethylene Syringe Extension Set 100 cm Priming Volume 1ml Low Sorbing Sets G40615 Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml G40620 Polyethylene Syringe Extension Set 200 cm Priming Volume 1 6ml G40720 Polyethylene Lined Syringe Extension Set with clamp 200 cm Priming Volume 1 5ml It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00330 Issue3 26 34 Compatible Extension Sets Continued The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion For availability please contact your local CareFusion representative because new sets are continuously being developed for our customers Patient Controlled Analgesia PCA Sets 30822 PVC Syringe Extension Set with clamp 152 cm Priming Volume 0 5ml PVC Y Syringe Extension Set with back check
46. rval of 5 hours 50 minutes 1000DF00330 Issue3 28 34 Maintenance continued Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v Do not use the following disinfectant types e Disinfectants which are known to be corrosive to metals must not be used which include e NaDcc such as Presept Hypochlorites such as Chlorasol e Aldehydes such as Cidex e Cationic Surfactants such as Benzalkonium Chloride e Use of lodine such as Betadine will cause surface discoloration Concentrated Isopropyl alcohol based cleaners will degrade plastic parts The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Once every 3 months during storage carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged Before cleaning always switch OFF and disconnect from the AC power supply Ne
47. strations used in this manual show typical settings and values which may be used in setting up the functions of the pump These settings and values are for illustrative use only Where stated a minimum infusion rate refers to a nominal rate of 1 0ml h and an intermediate infusion rate refers to a nominal rate of 5 0ml h The complete range of infusion rates settings and values are shown in the Specifications section Quick Start Guide 1 Press the button to turn the pump on 2 NEW DRUG NO retains previous drug data YES clears previous drug data 3 Select drug 4 Enter patient weight 5 Confirm protocol 6 Load syringe 7 Confirm correct size and brand of syringe 8 Ensure extension set is attached to syringe but disconnected from patient If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required 9 INFUSION RATE Change rate if necessary using the amp DCV keys 10 PURGE Press the 490 button followed by the PURGE softkey 11 Connect extension set to the patient access device 12 Press the button to start the infusion 1000DF00330 Issue3 2 34 Features of the Alaris TIVA Syringe Pump ON OFF Release lever for High visibility Display MDI Alarm Indicator PURGE BOLUS MUTE PRESSURE OPTION Extension HOLD Shelf for chevron Syringe Clamp Positive Plunger set hook keys and softkeys Grippers Rating Plate see Symbo
48. tenance phase infusion press the 49 button once This displays the bolus screen 2 The bolus delivery rate can be adjusted using the RATE softkey 3 To deliver the bolus press the BOLUS softkey The pump will display the volume being delivered 4 When the desired bolus has been delivered release the BOLUS softkey The bolus volume will be added to the total volume infused To exit the bolus feature press the QUIT softkey BOLUS Infusion Hands Free During induction it is not possible to deliver a bolus This option is enabled disabled within the drug set up 1 During maintenance phase infusion press the button This will display the bolus screen 2 Use the S to set the bolus dose required If necessary press the RATE softkey to select the bolus delivery rate 3 Press the BOLUS softkey once to begin the delivery of the bolus dose The display will revert to the main display showing the bolus being delivered counting down on the review section of the screen On completion of the bolus the pump will automatically revert to the maintenance rate The pump will display BOLUS nn n nn n To exit the bolus feature press the QUIT softkey 5 To terminate a bolus being delivered either press the button and restart the infusion or press the 449 button and press the STOP softkey This will stop the bolus and continue infusing at the maintenance rate 1000DF00330 Issue3 15 34 Basic Features Continued Pressure Level
49. tighten screw until the clamp is secured to the pole Ensure the pole clamp is folded away and stored within the recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use Never mount the pump such that the IV infusion stand becomes top heavy or unstable Docking Station Workstation or Equipment Rail Installation Release lever push to release Rotating cam The rotating cam can be fitted to the rectangular bar on the Docking Station VVorkstation or the equipment rail measuring 10 by 25 mm i 2 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station VVorkstation or the equipment rail Hold the pump horizontally push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the bar To release push the release lever and pull the pump forwards Alaris DS Docking Station and Alaris Gateway Workstation 1000DF00330 Issue3 10 34 Getting Started continued Loading and Confirming a Syringe Warning To securely load and confirm a syringe carefully follow the steps below An incorrect loading of a syringe may result in misidentification of the syringe type and size If then confirmed this may lead to significant inaccuracy of the infusion rate and may also affect pump performance Only use a syringe of the type stated on the pump or in this manual Using an incorr
50. tist with a pump which has been designed to work in the way drugs are delivered in the operating theatre including dose based calculations of induction and maintenance rates The Alaris TIVA Syringe Pump is compatible with a wide range of standard single use disposable Luer lock syringes It accepts syringe sizes from 5 ml to 50 ml See the Compatible Syringes section for a full list of compatible syringes Intended Purpose The Alaris TIVA Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume Conditions of Use The Alaris TIVA Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post placement management of intravenous catheters CareFusion cannot guarantee the continued system accuracy with other manufacturer s syringes as identified in the Compatible Syringes table Manufacturers may change syringe specification significant to system accuracy without prior notification Indications The Alaris TIVA Syringe Pump is indicated for infusion of therapeutics including e analgesics e antimicrobials e blood products chemotherapy subcutaneous e nutrition Contraindications The Alaris TIVA Syringe Pumps is contraindicated for e enteral therapies e epidural About This Manual The user must be thoroughly familiar with the Alaris TIVA Syringe Pump described in this manual prior to use All illu
51. valve and 2 clamps 178 cm Priming Volume 1 5ml rf CH Ep 30842E PVC Syringe Extension Set with back check valve SmartSite Needle Free Valve Port and clamp 30 cm Priming Volume 1 4ml PVC Y Syringe Extension Set with anti siphon valve back check valve and 2 clamps 183 cm Priming Volume 1 8ml EF d EP PVC Syringe Extension Set vvith anti siphon valve and clamp 156 cm Priming Volume 0 6ml 04102215162 PVC Syringe Extension Set vvith rotating luer 150 cm Priming Volume 2 9ml BI 04100010162 PVC Syringe Extension Set 105 cm Priming Volume 7 2ml It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00330 Issue3 27 34 Maintenance Routine Maintenance Procedures To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below Interval Routine Maintenance Procedure As per Hospital Policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage Each usage 1 Inspect AC power supply plug and cable for damage 2 Inspect case keypad and
52. ver allow liquid to enter the casing and avoid excess fluid build up on the pump Do not use aggressive cleaning agents as these may damage the exterior surface of the pump Do not steam autoclave ethylene oxide sterilise or immerse this pump in any fluid Disposal nformation on Disposal for Users of VVaste Electrical 8 Electronic Equipment This X symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with household waste If you wish to discard electrical and electronic equipment please contact your CareFusion affiliate office or distributor for further information Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling Information on Disposal in Countries outside the European Union This symbol is only valid in the European Union The product should be disposed of taking environmental factors into consideration To ensure no risk or hazard remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and dispose of as outlined by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00330 Issue3 29 34 Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates o
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