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1. to 1000 mmHg 24hour logging of volume infused Event logging records operation of pump Advanced Communications and Nurse call interfaces Configurable drug protocols for simplified drug dosing About This Manual The user must be thoroughly familiar with the Alaris CC Syringe Pump described in this manual prior to use All illustrations 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 CLEAR SETUP NO retains previous data YES clears previous data 3 Load syringe 4 Confirm correct size and brand of syringe 5 Ensure extension set is attached to syringe but disconnected from patient Insert pressure disc into pressure transducer 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 INFUSION RATE Change rate if necessary using the amp DC keys 7 PURGE Press the button followed by the PURGE softkey 8 Connect extension set to the patient access device 9 Press the button to start the inf
2. 0 00 00 1000 Pressure Set Fitted Time To Alarm 5 0ml h typical 0 200 400 600 800 1000 mmHg ml 2 00 0 00 Pressure Set Fitted Bolus Volume without back off typical ml 200 400 600 800 1000 mmHg Pressure Set Fitted Bolus Volume with back off 2 00 typical 1 50 1 00 0 50 0 00 0 200 400 600 800 1000 mmHg 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 No Pressure Set Time To Alarm 1 0 ml l h hr min sec hr min sec typical No Pressure Set Time To Alarm 5 0 ml h typical 0 2 4 6 8 Occlusion Level 2 4 6 8 10 Occlusion Level No Pressure Set Bolus Volume without back off typical 0 00 0 T T T T 1 2 4 6 8 10 Occlusion Level No Pressure Set Bolus Volume with back off typical 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 enab
3. 3 The AUTO Pressure feature may be used when a stable pressure has been achieved over a short period of infusion If AUTO Pressure has been enabled the automatic pressure alarm level is calculated and set by pressing the AUTO softkey 4 Press the TREND softkey to view the pressure trend of the previous 12 hours The pressure trend can be viewed at 15 minute intervals by using the softkeys The pressure trend graph displays the pressure at a given time 5 Press the OK softkey to exit the pressure screen Pressure Level without pressure set fitted not applicable when FULLY DEDICATED 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 2 Press the amp AC keys to increase or decrease the alarm level The new level will be indicated on the display 3 Press OK to exit the screen The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application Rate Lock If Rate Lock is enabled when the infusion rate has been set and the infusion started or following a bolus infusion the rate lock prompt will appear on the main display To select the rate lock function press the YES softkey Press the NO softkey if the rate lock is not required When rate lock is enabled the following are unavailable Changing the infusion rate titration Bolus purg
4. 5ml syringes 10ml syringes 20ml syringes 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 Volume To Be Infused VTBI 0 1ml 100ml 0 1ml 1000ml v2 3 x and above or v1 9 x 1min 24h VTBI Complete Rate Stop KVO 0 1ml h to 2 5ml h set rate if lower than KVO or continue at set rate Near End Of Infusion Alarm 1min 15min to end of infusion or 1096 of syringe volume whichever is smaller End Of Infusion EOI Alarm 0 196 596 of syringe volume Maximum Pumping Pressure Limit Highest alarm level 1000mmHg nominal at L 10 Occlusion Accuracy without pressure set of full scale Pressure mmHg L 0 L 3 L 5 L 10 approx approx approx approx 50 mmHg 300 mmHg 500 mmHg 1000 mmHg Occlusion Accuracy with pressure set of full scale 25 500 100 Using most common 50ml syringes under normal conditions 9596 confidence 9596 of pumps 1000DF00329 Issue 1 Electrical Classification Class product Continuous Mode Operation Transportable System Accuracy Volumetri
5. as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 2 2 hours to ensure that the internal battery is charged verify that the OE 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 1000DF00329 Issue 1 9 36 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 1 Pullthe folded pole clamp towards you and unscrew the clamp to R d leave enough room for the size of the pole Place pump around pole and 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 c
6. disinfectant types Disinfectants which are known to be corrosive to metals must not be used which include NaDcc such as Presept Hypochlorites such as Chlorasol Aldehydes such as Cidex Cationic Surfactants such as Benzalkonium Chloride 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 Never 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 Ensure the pressure transducer is free from residues which may prevent correct operation of the disc detector Disposal Information on Disposal for Users of Waste Electric
7. 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 Plunger 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 Pullthe syringe clamp forward and down 1000DF00329 Issue 1 11 36 3 Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange Ce r u clamp k E H To ensure the syringe is loaded correctly place the barrel flange in the space Mul Ku between the syringe clamp and the syringe flange clamp This is correct if the L 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 finger grip returns to its original position 7 Ensure that the syringe type and size match those displayed on the pump then
8. 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 15 minutes Alarms indicated AC POWER FAIL NEAR END OF INFUSION VTBI DONE KVO or CONTINUE ATTENTION TITRATION NOT CONFIRMED BATTERY LOW All others 1000DF00329 Issue 1 18 36 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 3 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 ZS aw H NURSE CALL FITTED NURSE CALL INVERT RS232 SELECTED NEOI WARNING EOI POINT KVO AT EOI KVO RATE BACK OFF AUTO SAVE RATE LOCK QUIET MODE AC FAIL RATE TITRATION PRESSURE DISPLAY AUTO PRESSURE AUTO SET PRESSURE AUTO OFFSET PRESSURE DEFAULT MAX PRESSURE WEIGHT CAP RATE PURGE RATE PURGE VOLUME LIMIT PURGE SYRINGE BOLUS DEFAULT BOLUS CAP BOLUS RATE BOLUS VOL LIMIT MANUAL BOLUS CALL BACK TIME VTBI CLEAR RATE EVENT LOG DISPL
9. herein after referred to as pump is a fully featured high end variable pressure syringe pump suitable for critical care applications Intended Use The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU including general wards critical and intensive care neonatal operating rooms and accident and emergency rooms This pump is suitable for use by appropriately trained clinicians or nurses The syringe pump is suitable to deliver fluids and medications via intravenous and epidural routes Supporting fluid therapy blood transfusions and parenteral feeding The Asena brand name has been recently changed to the Alaris brand name This change in brand name has no effect on the intended use or functionality of the product Recommended disposable products for use with this product may refer to either the Asena brand name or Alaris brand name and both types are suitable for use with this infusion pump The Alaris CC Syringe Pump functions with a wide range of standard single use disposable Luer lock syringes It accepts syringe sizes from 5ml to 50ml See the Compatible Syringes section for a full list of compatible syringes Simple to set up and easy to operate Large graphics format display including pressure trending e Medical Device Interface MDI a unique mounting mechanism Rate Range from 0 1 to 1200ml h In line pressure monitoring from
10. m sme EOI POINT 1 096 1 096 KVO AT EOI Enabled Enabled KVO RATE 1 0ml h 1 0ml h BACK OFF Disabled Enabled Enabled Disabled AUTO SAVE Enabled Enabled Enabled Disabled RATE LOCK Disabled Disabled Enabled Disabled QUIET MODE Disabled Disabled Enabled Disabled AC FAIL Enabled Enabled Enabled Disabled RATE TITRATION Disabled Disabled Enabled Disabled PRESSURE DISPLAY Disabled Enabled Enabled Disabled AUTO PRESSURE Disabled Enabled Enabled Disabled AUTO SET PRESSURE Disabled Enabled Disabled AUTO OFFSET 30mmHg 15mmHg 100mmHg PRESSURE DEFAULT 300mmHg 300mmHg mmHg T00mmHg B C MAXPRESSURE t000mmHg 1000mmHg tmmHg 1000mmHg PWeIGHT 700 Lin 0 1 20 Cid cAPRATE Mexifusonrte 1200min 10myh 1200mh 20 200mm 100mn 500mn PURGE VOLUME LIMIT 201 2 0m PURGE SYRINGE Disabled Enabled Disabled BOLUS Enabled Enabled Disabled 1508 DEFAULT BOLUS som h 1om n i20mh CAP BOLUS RATE 1200mi h 0m h 1200 h y O BOLUS VOL LIMIT 5 0ml o5m o1mb 250m MANUAL BOLUS Disabled tnabed bisabed O 1 0 Enabled Max bolus rate Max bolus rate 5 0ml CALL BACK TIME 2 0mins VTBI CLEAR RATE Disabled EVENT LOG D SPLAY Enabled BATTERY ICON Enabled AUTO NIGHT MODE Enabled Disabled Units Enabled For software versions 1 9 x and 2 3 x and above ng min ug kg min
11. 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 indicative 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 0ml h or above are recommended Trumpet Curve BD Plastipak 50ml e 0 1ml h Start up Trend BD Plastipak 50ml 0 1ml h z zo e E g 5 10 20 30 0 0 02 50 0 10 20 30 40 50 60 70 80 90 100 110 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 4 5 St
12. press CONFIRM If required the make of syringe can be changed by pressing the TYPE softkey ON HOLD 3 04min 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 1000DF00329 Issue 1 12 36 Getting Started Continued 1 Connect the pump to an AC povver supply using the AC povver cable Press the button The pump will run a short self test Ensure that two beeps are activated during this test Check the display test pattern and ensure that rows are missing Check that the displayed time and date are correct Note A warning REPAIRING LOGS may be displayed if event log information was not completely stored at the previous power down This is for information only the pump will continue to power up as normal 2 CLEAR SETUP Answering NO will retain all previous rate and volume settings YES will automatically reset the
13. 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 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 4 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 otherwise suspected to have been damaged remove it from service for inspection by a qualified service e engineer When transporting or storing the pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging 1000DF00329 Issue 1 8 36 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 the label is compatible with your AC power supply 2 Items supplied are Alaris CC Syringe Pump User Support CD Directions For Use AC Power Cable
14. softkey 2 Use the amp amp keys to scroll through the list of syringes pressing MODIFY to enable disable a syringe brand and individual models within the brand w When all modifications are complete press QUIT 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 96 Y keys and press the OK softkey 2 Use the amp amp Y keys to select the language 3 VVhen the desired language has been selected press SELECT 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 amp Y keys and press the OK softkey 2 Use the amp amp Y keys to select a contrast ratio value The contrast of the display will change when scrolling through the numbers 3 VVhen the desired value has been reached press the OK softkey to return to the Configured Options menu This option is used to pre configure the type of units permitted for use on the pump Select all possible units which may be used and disable any that should not be used 1 Select ENABLE UNITS from the Configured Options menu using the amp amp Y keys and press the OK softkey 2 Use the amp amp Y keys to scroll through the list of units pressing MODIFY to enable disable a unit 3 When all mod
15. 2 555 660 Fax 34 902 555 661 FR CareFusion Parc d affaire le Val Saint Quentin 2 rue Ren Caudron 78960 Voisins le Bretonneux France Tel 33 1 30 05 34 00 Fax 33 1 30 05 34 43 Date October 2009 1000DF00329 Issue 1 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 t r 1 H 1013 Budapest Magyarorsz g Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 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 DB Houten Nederland Tel 31 30 228 97 11 Fax 31 30 225 86 58 NO CareFusion Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 35 36 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 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
16. 510 7562 Fax 27 21 5107567 1000DF00329 Issue 1 36 36 Alaris Guardrails IVAC and Asena are registered trademarks of CareFusion Corporation or one of its subsidiaries All rights reserved All other trademarks are property of their respective owners 2000 2009 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 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 CH 1180 Rolle CareFusion U K 305 Ltd RG22 4BS UK 1000DF00329 Issue 1 carefusion com
17. AY BATTERY ICON AUDIO VOLUME AUTO NIGHT MODE Select GENERAL OPTIONS from the menu using the amp XCV 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 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 EOI 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 disabled the infusion information is cleared on power up When enabled the rate can be locked to prevent unwanted changes of the set infusion rate When enabled the button beeps are muted When enabled the AC Power Failure Alarm will sound if the AC power is disconnected When enabled the rate can be changed whilst the pump is infusing Enables disables the Pressure Icon on the main display Enables disables the automatic pressure alarm level option Automatically sets the line occlusion pressure to a speci
18. Alaris CC Syringe Pump Directions For Use EN Page Jade MEET 2 n deg trc o tet al a zal dada 2 Quick Start G ldere rm 2 Features of the Alaris CC Syringe Pump sssssssssressersssesssssesenrererrssesrsseserererreereressseeee 3 Controls and Indicators nee AEE EEEE E E eee 4 Symibol Definitions i5 5 opo eer 0 ER E 5 Main Display Features yack ena acy ana 0000 ane OE ERAS FRE 0000 6 Operating PrecaUtiONS mad ead EEN EEE a A 7 Gettinq Started 255 eer Ly TR Uber EN be KEE 9 0 0000 0 0 00 14 Alarms and per rr rh rr ern n e ER en E ER REENEN E el s 18 Configured 9191100010 19 Sp cificat EE 24 EE 25 Associated Ee EE 25 Compatible Extension Sets 6c ccc ccc nen eme 26 a D a EE 29 Occlusion TE EE 31 IrDA RS232 and Nurse call Specification 3 3 32 Trumpet Curves and Start up Curves OEA NER ARA VA asas COR E 33 Products and Spare Parts eec AER re n Eed n ea VO rad ra RA VEO E ETUR VEI VO AA 34 Service Contacts s na a oyna R E u POL RUE orpU Ex d en UE RUE En EUR 35 Documient el rell EE ER 1000DF00329 Issue 1 1 36 Introduction The Alaris CC Syringe Pump
19. Enter the dosing information as prompted on the display 3 Press the OK softkey to confirm the dosing information 4 The BACK softkey may be used at any time to return to the previous screen See note below Drug Name Only available if Drugs are configured 1 Select a drug name from the list and press the OK softkey 2 If no protocol is required press the NO softkey 3 If no dosing is required press the NO softkey Pre configured drug dosing protocol available if Drugs are configured 1 Select the drug name from the list displayed using the amp amp keys Press the OK softkey to confirm the selection 2 Press the YES softkey to select PROTOCOL This will select the pre defined protocol for the selected drug 3 Enter the dosing information prompted on the display for the selected drug using the OK softkey See note below User programmed drug dosing available if Drugs are configured Select the drug name from the list displayed using the keys Press the OK softkey to confirm the selection Press the NO softkey to avoid selecting PROTOCOL Press the YES softkey to select DOSING This now enables user programmed information to be entered Enter the required dosing information as prompted on the display using the keys and the OK softkey See note below q ur hr Note Rate values will flash if either the rate ml h or dose rate are outside the permitted range and confirmation will not be possible Clea
20. F00329 Issue 1 5 36 Main Display Features Syringe type fitted Pressure Drug name Information Pump Status VOLUME db PRESSURE 1 A8 ml 15h 34m 10s Kl 593m A 300mmHg Infusion Volume Volume Infused VTBI Rate Infused Option Screen Icons Description E HO TIME REMAINING DISPLAY icon Indicates time before syringe will require replacing BATTERY icon Indicates battery charge level to highlight when the battery will require recharging 1000DF00329 Issue 1 6 36 Operating Precautions Disposable Syringes and Extension Sets This Alaris CC 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 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 Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is removed from the pump before the extension set is properly isolated from the patient Isolation may include closing a tap in the patient line or activating a flow stop clamp Secure the extension set to the pump using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump When combining several apparatus and o
21. RS232 circuitry to power down Isolation Socket Pump 1 5kV dc or ac peak Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit Nurse Call Relay Contacts Pins 1 8 9 30V dc 1A rating Typical Connection Data 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 RXD TXD NCC 5 4 9 8 7 6 NC NCO CTS COM 32 36 Trumpet Curves and Start up Curves In this pump as with all infusion systems the action of the pumping mechanism and variations 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
22. al and Electronic Equipment This 2 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 1000DF00329 Issue 1 30 36 Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml h and higher by the appropriate selection of occlusion levels Use of the dedicated pressure set is recommended Its use permits the occlusion alarm pressure mmHg to be set accurately with a small operating margin between the alarm and normal infusion pressures When using infusion pumps without a pressure set line pre
23. apeutic 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 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 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 recommended accessories Use of any accessory transducer or cable other than those specified by CareFusion may result in increased emissions or decrea
24. art up Trend BD Plastipak 50ml e 1 0ml h Trumpet Curve BD Plastipak 50ml e 1 0ml h Rate ml h gt L L Aug A o o o 95 5 Error 96 a A 0 10 20 30 40 50 60 70 80 90 100 110 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins S T d BD PI k 0 1 0 Uh 2 Maximum Error Minimum Error k Linear Mean 1 8 tart up Trend astipak 50ml 5 0m 15 100 P p E Trumpet Curve BD Plastipak 50ml e 5 0ml h 8 0 7 0 6 0 of A k ES a 5 50 TIAM s E z 40 5 5 2 g s A 00 30 53 20 10 00 45 0 10 20 30 40 50 60 70 80 90 100 110 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins E Maximum Error Minimum Error k LinearMean 0 196 1000DF00329 Issue 1 33 36 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 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 http www carefusion com alaris intl A username and password are required to access our manuals Please contact local customer services representative to obtain login d
25. ault values and can be changed On subsequent uses the bolus rate and bolus volume will remain as per previously set and can be changed as required Following CLEAR SETUP the default bolus rate is determined via the configuration and the default bolus volume is 0 1ml 1 During infusion press the button to display the Hands Free bolus selection screen 2 Press the YES softkey to go to Hands Free selection bolus screen press the HANDS ON softkey for Hands On bolus see section above 3 Use the keys to set the bolus volume dose required If necessary press the RATE softkey to adjust the bolus delivery rate 150 300 600 900 1200ml h Note Rate may be restricted by the syringe size and the CAP BOLUS RATE 4 Press the flashing BOLUS softkey once to begin the delivery of the preset bolus The display will show the bolus being delivered the bolus counting down and revert to main infusion display upon completion of the bolus 5 To terminate a bolus being delivered press STOP softkey This will stop the bolus and continue infusing at the set rate Press the button to stop the bolus delivery and place the pump on hold 6 Ifthe bolus volume reaches the set bolus volume limit the bolus will stop and the pump will revert to infuse at the set infusion rate and continue infusing If the Hands Free bolus option is active then this feature will be cancelled following any interruption in delivery e g occlusion even if the bolus delivery is inco
26. c Mean 2 nominal Derating Temperature 0 5 5 40 C High Rates 2 0 rates gt syringe volume h eg 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 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 Drug Specification A maximum of 50 drugs with a maximum of 12 characters are available with V1 9 x and below software A maximum of 100 drugs with a maximum of 17 characters are available with V2 3 x and above software Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Mean Time To Battery Empty from fully charged 5ml h and 20 C under normal conditions is 6 hours 95 lower confidence interval of 5 hours 50 minutes Charging takes 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 Fuse Type 2 xT 1 25A slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Dimensions 335 mm w x 121 mm h x 200 mm d Weight 2 7 kg excluding power cable Protection against fluid ingress IPX1 Prot
27. ccess device 9 START Press 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 in operation 10 STOP Press to halt the operation ON HOLD will be displayed The amber light will replace the green light FULLY DEDICATED Alaris CC Syringe Pump to start an infusion a pressure disc must be fitted SEMI DEDICATED Alaris CC Syringe Pump to start an infusion with Drug and Dosing set a pressure disc must be fitted 1000DF00329 Issue 1 13 36 Basic Features The C9 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 G button when the pump is not infusing Ensure that the extension set is not connected to the patient 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 N The pump will not purge if the rate lock has been enabled During PURGE the pressure limit alarms are temporarily increased to their maximum level Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes The pump should alwa
28. ce engineer Display DRIVE DISENGAGED OCCLUSION LINE OCCLUSION CHECK SYRINGE PRESSURE DISC OUT BATTERY LOW BATTERY EMPTY NEAR END OF INFUSION END OF INFUSION TITRATION NOT CONFIRMED VTBI DONE AC POWER FAIL Error Code and Message ATTENTION with 3 Beeps Alarm Indicator Colour AMBER RED Configurable option Description and Troubleshooting Guide The drive system has been disengaged during operation Check the finger grips and the position of the syringe 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 Excessive pressure measured in the extension set at the pressure sensing disc exceeding the alarm limit Identify and remove the cause of the blockage in the drive syringe patient access site or administration system before restarting the infusion 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 The pressure disc has been removed from the pressure transducer during the infusion The infusion will stop Replace the pressure disc then restart the infusion 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
29. e Switching the pump off VTBI over time infusions To disable the rate lock if selected 1 Press the button to access the options menu 2 Select the UNLOCK RATE option using the amp Y keys and press the OK softkey To enable the rate lock if not selected 1 Press the C2 button to access the options menu 2 Select RATE LOCK and press the OK softkey 1000DF00329 Issue 1 15 36 Basic Features Continued Drugs and Dosing The following options enable the pump to be set up for use with a specific drug and or dosing protocol Drugs are pre configured in a drug library see Configured Options to enable rapid selection of the drug name dosing units and default rate For increased security using a configured drug maximum and minimum safety limits are programmable for concentration and dose rates Note The dose infused display is the product of the volume infused and the confirmed concentration If dosing is confirmed while the volume infused is greater than 0 0ml or a drug was previously selected the dose could be inaccurate If the dose displayed could be inaccurate the digits will flash on screen To reset the flashing the volume needs to be cleared To access the Drugs and Dosing menu 1 Press the button to first access the options menu 2 Select DRUGS AND DOSING from the list using the keys 3 Press the OK softkey to confirm the selection Dosing Only 1 Select DOSING ONLY from the list and press OK 2
30. ected against vertically falling drops of water Alarm Conditions Drive Disengaged Occlusion Check Syringe Near End Of Infusion VTBI Done Internal Malfunction Pressure Disc Out Battery Low Battery Empty End of Infusion AC Power Fail Attention Nurse Callback Titration not confirmed Line Occlusion Environmental Specifications 5 C 40 C 20 90 700hPa 1060hPa 30 C 50 C 10 95 500hPa 1060hPa Operating Temperature Operating Relative Humidity Operating Atmospheric Pressure Transport and Storage Temperature Transport and Storage Relative Humidity Transport and Storage Atmospheric Pressure Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 24 36 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 TE Astrazeneca S 8 B Braun Perfusor J v 1 BDPefuor J me 15 4 CE Codan Perfusion J Fresenius 1 M Es TIE 1 Rapieee Po o The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the infusion line
31. ernal 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 interval of 5 hours 50 minutes 1000DF00329 Issue 1 29 36 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
32. etails 1000SP01 122 Internal Battery Pack 1000DF00329 Issue 1 34 36 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 2 9838 0255 Fax 61 2 9674 4444 BE CareFusion Leuvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA CareFusion 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CH CareFusion Switzerland 221 S rl 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 Document History CO Number 1 9684 Revision CN CareFusion Shanghai Representative Office Suite A Floor 24 Shanghai Times Square Office Building No 500 Zhangyang Road Shanghai 200122 China Tel 86 21 58368028 Fax 86 21 58368017 DE CareFusion Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 604 0 Fax 49 2401 604 121 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 90
33. fied amount above the current pressure Adjusts the automatic offset value used by auto pressure and auto set pressure Adjustable from 15 to 100mmHg Sets the default occlusion alarm level Sets the maximum pressure limit Sets the default patient weight in kg Sets the maximum value for infusion rate Sets the purge rate Sets the maximum permissible purge volume Prompt to purge syringe after confirmation Enables disables the bolus feature Sets the default bolus rate Sets the maximum value for bolus rate Sets the maximum permissible bolus volume 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 Rate will be set to zero when VTBI has been set up with stop as the end rate 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 1000DF00329 Issue 1 19 36 Alaris CC Syringe Pump Configured Options Record General Options Enter the pump specific information for your records on a copy of this page Opton pp Setting 8 Software Version 1 5 10 and 2 0 0 1574 2 3 x and above uo user nsss Teen Laera Test Tea ssanss Lesen aeoea
34. he 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 amp Si keys 3 Press the button to start infusing at the new rate Dosing Summary To review currently selected dosing information 1 Press the button to access the options menu 2 Select DOSING SUMMARY 3 Review the information and then press the QUIT softkey Set VTBI over Time This option allows a specific VTBI and delivery time to be set The rate necessary to deliver the required volume within the specified time is calculated and displayed 1 Stop the infusion Press the button to access the options menu Select the SET VTBI OVER TIME option using the amp Y keys and press the OK softkey Adjust the volume to be infused using the amp amp keys When the desired volume has been reached press the OK softkey Enter the time over which the volume is to be infused The infusion rate will automatically be calculated Press the OK softkey to enter the value BwM oi Select the rate at VTBI end from the list using the amp 207 3 keys and press the OK softkey The default is STOP 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 24H LOG option using the amp keys and press the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the to
35. ice 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 and 20 C under normal conditions is 6 hours From the battery low alarm it will take about 272 hours to 9096 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 int
36. ifications are complete press OK to return to the Configured Options menu 1000DF00329 Issue 1 22 36 Drug Protocol Record aeq aeq AOQE pue 5 X ZA 10 9 qe ie e 5 AL Jo UJhUJIXeUJ e UA saweu Bnap OOL x Aq Aq paaoiddy UOISJ9A Jequunyw eros u lun oJnssaJd awey 6nig uonenu uo 9jey soq wun paem Ieudeon dn3es Bnig duing 22 sue y 23 36 1000DF00329 Issue 1 Specifications 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 1ml h 1200ml h 50ml syringes The Volume Infused range is 0 0ml 9990ml Bolus Specifications Maximum Bolus rates can be set as part of the configuration Bolus rates are user adjustable in increments of 10ml h 10 ml h 150ml h 10 ml h 300ml h 10 ml h 600ml h 10 ml h 900ml h 30ml syringes 10 ml h 1200ml h 50ml syringes The bolus volume limit can be set as part of the configuration Minimum 0 5ml 0 1ml v2 3 x and above or v1 9 x Maximum 25 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
37. iming Volume 1 5ml D Ebbe P G30302M Polyethylene Lined Syringe Extension Set with occlusion sensing disc and clamp 200 cm Priming Volume 1 6ml G40720 Polyethylene Lined Syringe Extension Set with clamp 200 cm Priming Volume 1 5ml 04105010509 Polyethylene Syringe Extension Set 100 cm Priming Volume 1ml 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 1000DF00329 Issue 1 27 36 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 valve and 2 clamps 178 cm Priming Volume 1 5ml cE S t3 30842E PVC Syringe Extension Set with back check valve SmartSite Needle Free Valve Port and clamp 30 cm Priming Volume 1 4ml R PVC Y Syringe Extension Set with anti siphon valve back check valve and 2 clamps 183 cm Primi
38. is exhausted Reconnect to the AC power supply to continue operation and charge the internal battery The internal battery is exhausted Connect the pump to the AC power supply The pump is nearing the end of the infusion This value can be configured 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 The infusion rate has been changed 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 The pre set Volume To Be Infused is complete 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 The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer Three beeps will sound if the pump has been left ON
39. is secured using the infusion set hook see Loading a Syringe section ETYCO Healthcare KENDALL MONOJECT s 4 Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation 1000DF00329 Issue 1 25 36 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 CareFusion 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 connectors Kink resistant DEHP free PVC yellow striped tubing Bore 1mm Length 200cm Priming volume 1 6ml Eh L em PIII 7 r ih 5 G30402M Standard PVC Syringe Extension Set with occlusion sensing disc 200 cm Priming Volume 1 5ml G302EP Extension set with pressure sensing disc Luer lock connectors Kink resistant DEHP free PVC yellow striped tubing Bore 0 9mm Length 200cm Priming volume 1 5ml For a
40. l 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 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 1000DF00329 Issue 1 7 36 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 unreasonable levels of interference are encountered Therapeutic Radiation Equipment Do not use the pump in the vicinity of any Ther
41. led The back off will reduce the line pressure by removing the volume stored in the occluded line and deduct this volume from the volume infused Back off will terminate if the pressure reaches the level recorded by the pump when the infusion was last started or a maximum back off volume has been withdrawn from the infusion line It will also terminate if the volume infused reaches 0 0ml or a VTBI reaches the value at which it was set 1000DF00329 Issue 1 31 36 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 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 remo
42. mplete If the volume to be infused VTBI is reached during a bolus the VTBI complete alarm will sound Press c to silence the alarm or CANCEL to acknowledge the alarm See VTBI section for more details on VTBI operation Manual Bolus The Manual Bolus is delivered by moving the plunger drive mechanism forward while the pump is infusing This method of delivering a bolus is not recommended as best clinical practice The syringe must be confirmed and the plunger mechanism has to move from an engaged position to disengage and then re engage position A minimum travel of 1mm leadscrew pitch must be detected to register 1000DF00329 Issue 1 14 36 Basic Features Continued Auto Set Pressure If enabled If the Auto Set Pressure Option is enabled then the pump AUTOMATICALLY adjusts the pressure occlusion limit After 15 minutes of infusion the pump AUTOMATICALLY adjusts the occlusion pressure limit to X mmHg the AUTO OFFSET value 15 100mmHg above the average infusion pressure since the start of the infusion Pressure Level with pressure set fitted 1 To check and adjust the pressure level press the button The display will change to show a 20 minute pressure trend graph displaying the pressure alarm level and the current pressure level LINE PRESSURE ADJUST eee SS 2 Press the amp amp keys to increase or decrease the pressure alarm level The new level will be indicated on the display
43. nc Default Conc Min Conc Note use of a protocol in which the Max Bolus is set OFF will prevent bolus delivery 1000DF00329 Issue 1 21 36 ml h DOSE UNITS MAX DOSERATE DEFAULT DOSE RATE MIN DOSERATE CONC UNITS oO MIN CONC DEFAULT CONC MA CONC ei MAX BOLUS BOLUS RATE PRESSURE ALARM 904 Configured Options Continued Clock Set 1 Select CLOCK SET from the Configured Options menu using the amp SC keys and press the OK softkey 2 Use the amp amp keys to adjust the date displayed pressing 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 4706 V keys and press the OK softkey 2 Usethe 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
44. ng Volume 1 8ml e Ax 5 EF PVC Syringe Extension Set with anti siphon valve and clamp 156 cm Priming Volume 0 6ml 04102215162 PVC Syringe Extension Set with rotating luer 150 cm Priming Volume 2 9ml EHE 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 1000DF00329 Issue 1 28 36 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 plunger for damage 3 Check Start up self test operation is correct Before the transfer of the pump toa 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 serv
45. onnecting 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 Workstation or the equipment rail measuring 10 by 25 mm 1 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail 2 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 3 Torelease push the release lever and pull the pump forwards Alaris DS Docking Station Asena IDS Docking Station and Alaris Gateway Workstation 1000DF00329 Issue 1 10 36 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 incorrect syringe could adversely affect the accuracy of the infusion rate and may also affect pump performance When drawing fluid into the syringe
46. r drugs and or dosing available if a drug is selected 1 Select CLEAR DRUGS AND DOSING or CLEAR DRUG NAME displayed if a name only is selected using the ASC keys Press the OK softkey to confirm the selection Volume to be Infused VTBI This option allows a specific volume to be infused to be set Rate at the end of this VTBI can also be set selecting from stop KVO or continuous infusion at the set rate 1 Press the VTBI softkey to select the volume to be infused option 2 Enter the volume to be infused using the keys and press the OK softkey 3 Select the rate at the end of the VTBI using the amp amp Y keys to scroll through the on screen choices The default is stop 4 Press the OK softkey to enter the rate and exit the VTBI menu 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 1000DF00329 Issue 1 16 36 Basic Features Continued Rate Titration If Rate Titration is enabled the rate can be adjusted while infusing 1 Select the new rate using the 470 32 keys The message 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 t
47. r 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 1 0m Mounting the Pump The pump must be mounted within 1 0m above or below the patient s heart The most accurate pressure 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 supplies buildings used for domestic purposes However it may be used in domestic establishments under the supervision of Medica
48. rate and volume settings to zero 3 LOAD SYRINGE Load the syringe according to the procedure in this manual 4 Insert the pressure disc into the pressure transducer PRESSURE TRANSDUCER Detects if an infusion line with a pressure disc is fitted The pressure transducer will measure positive infusion line pressures Warning To remove or insert pressure disc from or into pressure transducer assembly insert finger into the recess in the pressure disc and pull forward or push back with care DO NOT PULL THE EXTENSION SET TO REMOVE OR TO INSERT THE PRESSURE DISC 5 CONFIRM SYRINGE Check that the syringe type and size being used matches the display If required the make of syringe can be changed by pressing the TYPE button Press CONFIRM when the correct type and size are shown 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 INFUSION RATE Check the rate shown if old patient data has been retained and change the rate if necessary using the ASC keys 7 PURGE if required Press the 29 button and then press and hold the PURGE softkey until fluid flows and the purging of the syringe extension line is complete Release the softkey The volume used during purging will be displayed Purge extension set massaging pressure disc to prevent ballooning and ensuring all air removal 8 CONNECT TO PATIENT Connect the extension set to the patient a
49. sed pump immunity ThispumpisaCISPR 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 In 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 An explosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise care to locate the pump away from any such hazardous sources Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or
50. ssures are estimated from pumping force For this reason the occlusion alarm needs to be set with an operating margin of at least one level between the alarm and normal infusion levels The ability to set a small operating margin permits short time to alarm and small potential bolus volumes to be achieved Bolus volumes can be minimised as described in the Alarms and Warnings Occlusion or by enabling the back off general option Occlusion level on Alaris GH Syringe Pump or other pumps with occlusion Pressure levels L2 approx 200 mmHg 300 Auto pressure setting on Alaris CC Syringe Pump e g 55 mmHg T1 T2 Alarm Alaris GH Syringe Pump L1 100 Auto Setting Alaris CC Syringe Pump 0 7 Alarm Alaris CC Syringe Pump Typical running i pressure 25 mmHg time 1 ime Occlusion a T2 With Pressure Set fitted G30402M Standard disposable extension set 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 G30402M extension set with occlusion sensing disc Pressure Set Fitted Time To Alarm 1 0ml h 2 00 02 typical 2 00 02 1 30 02 1 00 01 hr min sec 0 30 01 0 200 400 600 800 mmHg Without Pressure Set fitted G40020B Standard disposable extension set 1 30 02 1 00 01 hr min sec 0 30 01
51. t 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 Vlisadded OPTION button Press to access optional features see Basic Features PRESSURE button Use this button to display the pumping pressure trend display and alarm level CHEVRON keys Double or single for faster slower increase or decrease of values shown 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 1000DF00329 Issue 1 4 36 Labelling Symbols Symbol Definitions MAX 30V 1A e 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 vvater Alternating Current Device complies vvith the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Date of Manufacture Manufacturer Not for Municipal VVaste mportant information Fuse Rating Authorised representative in the European Community 1000D
52. tal 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 amp keys and press the OK softkey 3 Scroll through the log using the amp ACV keys Press the QUIT softkey to exit the log Drug Name To display selected drug name 1 Press the button to access the options menu 2 Select DRUG NAME 3 Press the OK softkey to confirm the drug name or press the QUIT softkey to exit the option 1000DF00329 Issue 1 17 36 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 accompanied 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 servi
53. te 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 Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit 1000DF00329 Issue 1 RS232 Nurse call Connection Data Nurse call Specification Connector D Type 9 Pin TXD RXD EIA RS232 C Standard TXD Output Voltage Range Minimum 5V mark 5V space Typical 7V mark 7V space with 3kO load to ground RXD Input Voltage Range 30V 30V max RXD Input Thresholds Low 0 6V minimum High 3 0V maximum RXD Input Resistance 3kQ minimum Enable Active Low 7V to 12V Active High 7V to 12V powers up the isolated RS232 circuitry Inactive Floating open circuit allows isolated
54. ug 24h mg kg min mg 24h g 24h U h U kg 24h ng kg min ug h ug kg 24h mg h mg kg 24h U min U kg h kU 24h ug min ug kg h mg min mg kg h g h U kg min U 24h mmol h Syringes Enabled Hospital Name Serial No Software Version Approved by Configured by Date Date 1000DF00329 Issue 1 20 36 MN Configured Options Continued Drug library Select the DRUG LIBRARY option from the Configured Options menu and press the OK softkey To enter a new drug in the library press the NEW softkey To enter the name of the new drug use the amp amp keys to scroll through the alphabet To select a letter press the NEXT softkey On completion press the OK softkey Follow the flow chart using the S keys to select values Use OK to enter selected values and move on to the next stage The BACK softkey may be used at any time to return to the previous screen of the drug library set up procedure 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 The availability of drug dose units is dependent on the software version of the pump Review the drug set up data on the display then press the OK softkey to confirm To delete a drug from the drug library select the drug using the R 796 Y keys Press MODIFY then select YES twice to delete the drug from the list Note to set a FIXED PROTOCOL set the Max Doserate Default Doserate Min Doserate Max Co
55. usion 1000DF00329 Issue 1 2 36 Features of the Alaris CC Syringe Pump Pressure ON OFF transducer Release lever for High visibility RUN Display Rotating Cam Alarm Indicator PURGE BOLUS MUTE PRESSURE OPTION Extension set HOLD Shelf for chevron Syringe Clamp Positive Plunger hook keys and softkeys Grippers Rating Plate see Symbol Definitions for Pressure an explanation of the symbols used transducer 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 optional 1000DF00329 Issue 1 3 36 Controls Indicators Controls and Indicators ON OFF button Press once to svvitch the pump ON Press and hold dovvn for approximately 3 seconds to svvitch the pump OFF RUN button Press to start the infusion The green LED vvill 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 vvill resound after this time Press and hold until 3 beeps are heard for 15 minutes silence PURGE BOLUS button Press to access PURGE or BOLUS soft keys Press and hold dovvn soft key to operate PURGE the extension set during set up Pump is on hold Extension set is not connected to the patien
56. vailability please contact your local CareFusion representative because new sets are continuously being developed for our customers 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 1000DF00329 Issue 1 26 36 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 Light Protected Sets G40215 Amber PE Syringe Extension Set 150 cm Priming Volume 1 2ml G40320 White PVC Syringe Extension Set 200 cm Priming Volume 3 6ml B FE G30653M Opaque White PVC Syringe Extension Set with occlusion sensing disc 200 cm Priming Volume 1 5ml I S E P Low Sorbing Sets G40615 Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml G40620 Polyethylene Syringe Extension Set 200 cm Priming Volume 2ml G30303M Polyethylene Syringe Extension Set with occlusion sensing disc 200 cm Priming Volume 1 5ml G30453M Opaque White PVC low sorbing Syringe Extension Set with occlusion sensing disc 200 cm Pr
57. ys be infusing and always attached to the patient Drugs given by an IV bolus could achieve immediate and high drug concentration levels Bolus can be used at the start of an infusion or during an infusion The bolus feature can be configured to a BOLUS Disabled b BOLUS Enabled i Hands On only ii Hands On and Hands Free BOLUS Disabled If configured to Disabled pressing the button will have no effect and the pump will continue to infuse at the set rate During BOLUS the pressure limit alarm is temporarily increased to the maximum level t A Hands On bolus and Hands Free bolus cannot be administered if the RATE LOCK is active BOLUS Enabled Hands On In Hands on Bolus press and hold the flashing BOLUS soft key to deliver the required bolus The bolus rate can be adjusted The bolus volume is limited in the configuration 1 During infusion press the button once to display the bolus screen 2 Use the ANY keys to adjust the bolus rate if required 3 Todeliver the bolus press and hold the BOLUS softkey During the bolus the volume being infused is displayed When the desired bolus volume has been delivered or the bolus volume limit is reached release the softkey The bolus volume is added to the total volume infused BOLUS Enabled Hands On and Hands Free The Hands Free Bolus is delivered with a single press of the flashing BOLUS soft key On intial use the bolus rate and bolus volume are at def

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