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Alaris ® GW (Set Detection Mode disabled

1. Alarm volume level 1 7 4 Enable Micro mode On OFF OFF Maximum infusion rate 1 999 ml h 999ml h Enable ASCII mode for communications On OFF OFF Enable Odd parity for communications On OFF OFF Set Pump address for communications 1 250 1 Flow Sensor Connection Mode AUTO On On Set up of current time and date 00 00 to 23 59 N A 01 01 00 to 31 12 99 Language selection EnGL FrAn dEut ItAL ESPA SE nEd EnGL IrDA Communications Selection On OFF On Nurse Call Activation High Enabled On OFF On Drops per ml of fluid 1 to 200 20 Enable Automatic Set Detection and Anti On OFF OFF bolus Function Silent Mode On OFF OFF User select mode options Pressure limit Enabled On OFF OFF Alarm volume Enabled On OFF OFF Timed infusions Enabled On OFF OFF Micro infusions Enabled On OFF OFF Flow sensor sensitivity level Nor Hi Nor EnGL English FrAn French dEut German ItAL Italian ESPA Spanish SE Swedish nEd Dutch If infusion sets without anti siphon valves are being used it is recommended to change the flow sensor connection mode setting to On With On selected the Alaris GW Volumetric Pump will not operate unless a flow sensor is connected When using dedicated CareFusion Infusion sets refer to Compatible Dedicated Infusion Sets section ensure that the set detection mode is On Refer to Automatic Set D
2. 2 Ss Oncology Sets MFX273 950E Oncology set with five SmartSite Valve Y ports EI SA MFX273 952E Amber Oncology set with five SmartSite Valve Y ports ape 1 For the following infusion sets carefully read the Directions For Use supplied with the Infusion set prior to use for information on the use of the flow sensor with the infusion sets e MFX273 950E e MFX273 952E 1000DF00440 Issue 4 26 38 Associated Products The Alaris Gateway Workstation Alaris GW Volumetric Pumps Associated Products Product SKU 80203UNSOy xx Supply Voltage 115 230VAC 50 60Hz Electrical Rating 460VA Maximum Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115 230V 50 60Hz 60VA The Alaris DS Docking Station Product SKU 80283UNS00 xx Supply Voltage 230VAC 50 or 60Hz Electrical Rating 500VA nominal Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 20VA max 230V 50 60Hz y Connectivity option 1 2 or 3 xx Configuration 1000DF00440 Issue 4 27 38 Alaris GW Volumetric Pumps Maintenance 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 rou
3. It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products These documents are referenced on www carefusion com Copies can be obtained by contacting your local CareFusion representative Conventions used in this manual BOLD Used for Display names software commands controls and indicators referenced in this manual for example Battery Indicator PURGE ON OFF button Single quotes Used to indicate cross references made to another section of this manual Italics Used to refer to other documents or manuals and also used for emphasis Important Information Wherever this symbol is shown an Important note is found These notes highlight an aspect of use that is important for the user to be aware of when operating the pump Quick Start Guide Half fill the drip chamber Press to switch pump on Load the infusion set and open in line clamp Prime FILL set Press once Whilst FILL is displayed press again and hold to clear all visible air from the line Enter rate using Press once to confirm and scroll to VTBI Enter VTBI using Y or switch off VTBI by scrolling until GFF is displayed Press to confirm and scroll to VI O it ON SR Ne 9 If necessary press E to clear VI 10 Connect Infusion set to the patient access device 11 Press CD to start infusion 1
4. Refer to Clearing Air In Line section Release clamp and restart Reload set with pump at least 30cm from the Y site 1000DF00440 Issue 4 21 38 Warnings Warnings alert the user but may not stop the infusion and are indicated by an audible alarm a message on the display or both 1 Check the display for a warning message Press to silence the alarm 2 Rectify the cause of the warning or proceed with caution Alaris GW Volumetric Pumps Warnings Display Cause Action bol Bolus is being administered Release button to return to infusion once correct kt bolus has been administered End Finished pre set volume to be infused Pump will infuse at the keep vein open rate until the button is pressed Refer to KVO Rate section of this DFU D r r The pump is priming the Infusion set Ensure all air has been primed out of the infusion set before starting the infusion ra O or o ra Low Battery At least 30 mins before bAt alarm Connect pump to an AC power source Hal d The pump is on hold Press to return to infusion or press to return A to set up DL GL The pump has been left unattended for 2mins Attend to pump meee and infusion has not started L E GE Automatic set check Allow test to complete before operating the pump further 1000DF00440 Issue 4 22 38 Alaris GW Volumetric Pumps Flow Sensor Operation Flow
5. decreases in rate dependant units e g 10ml e 99 9ml h is 6mins therefore 0 06 is displayed Setting to Micro Mode Press gt button until 0 0 is displayed Select On or OFF using the keys to turn micro mode on or off Press gt button to return to Hold or set up mode an audible sounder will confirm the status Make sure that the MICRO indicator is lit if set to on SNA 1000DF00440 Issue 4 19 38 Alaris GW Volumetric Pumps Configurable Options Sheet Configurable Options Sheet 1 The default settings are configurable as displayed in brackets in the table below Each of the configurable options has a code which must only be altered by qualified service personnel with reference to the technical service manual TSM for this product Technical Service Manual reference 1000SM00006 and Addendum 1000SM00014 Description Range Default Setting Enable VTBI time infusions On OFF OFF Maximum priming volume OFF 1 to 40 ml 40ml Clear infusion parameters to zero on On OFF OFF power up Maximum VTBI in MICRO Mode 0 1 to 999 ml 999ml Bolus rate 1 to 999ml h 400ml h Maximum bolus volume OFF 1 to 99ml 5ml Keep vein open rate OFF 1 0 to 5 0 ml h 5 0ml h Air in line alarm volume single bubble 50 100 250 500uL 100ul Enable secondary infusion capability On OFF OFF Default occlusion pressure on power up Lo 250mmHg Nor 350mmHg HI SOOmmHg HI
6. Excessive increase or decrease of fluid flow detected by flow sensor Flow sensor attached to secondary Infusion set FLOW SENSOR CONNECTION ERROR Flow sensor connected disconnected during an infusion Flow sensor is not connected and the primary VTBI is OFF Too much fluid in drip chamber Ensure that the infusion set tubing is properly loaded in the pumping channel following the flow direction label Ensure that ample fluid is in the fluid container Check for blockage occlusion in infusion set After the tubing is properly inserted close the pump door and resume infusion Ensure flow sensor is attached to the primary infusion set Restart the infusion with the flow sensor connected disconnected as required Connect flow sensor or set a VTBI and re start the infusion Ensure fluid in the drip chamber is not above the fill line l o D DOWNSTREAM OCCLUSION A blockage has occurred downstream Remove pressure in the infusion set to prevent a post occlusion bolus to the patient Remove the cause of the blockage Restart the infusion Ur RR D LI rr In Incorrect infusion SET set incorrectly loaded or set worn Excessive amount of air in line Infusion started with upstream tubing clamped 273 003 set loaded with upper Y site too close to pump Remove the infusion set and load the correct or new set see Compatible Dedicated Infusion Sets Clear air from set
7. 1 0ml h is lt 45min High Pressure Maximum time to alarm at 1 0ml h is lt 30min Low Pressure Maximum time to alarm at 25ml h is lt 5 30min High Pressure Maximum time to alarm at 25ml h is lt 2 10min Low Pressure Maximum time to alarm at 999ml h is lt 3 secs High Pressure Maximum time to alarm at 999ml h is lt 2 secs Low Pressure System Accuracy Rate Accuracy 5 at 25 ml h under nominal conditions tested to IEC60601 2 24 95 confidence interval 80 population 1 For all conditions the rate accuracy should be adjusted accordingly Bolus Volume Accuracy 10 5ml under nominal conditions tested to IEC60601 2 24 Under all conditions the bolus volume accuracy should be de rated as for rate accuracy Occlusion Pressure Accuracy 150 mmHg under nominal conditions 250 mmHg under all conditions Air in Line Accuracy 20 or 0 025ml under nominal conditions 1000DF00440 Issue 4 31 38 Alaris GW Volumetric Pumps Specifications DISCLAIMER This pump has been tested and approved by CareFusion for use only with CareFusion dedicated infusion sets In the event the user is considering using infusion sets not approved for use with the Alaris GW Volumetric Pump the user should consult an authorized CareFusion representative for compatibility and or calibration information prior to use In no event however does CareFusion make any representations or warranties con
8. 1000DF00440 Issue 4 16 38 Alaris GW Volumetric Pumps Basic Features Changing the Infusion Set Press ED to put the pump ON HOLD Close in line clamp and ensure the IV access to the patient is isolated Disconnect the Infusion set from the patient Open pump door and remove Infusion set from the pump and discard the set and fluid container according to hospital protocol Place new Infusion set into pump see Loading the Infusion Set Squeeze the drip chamber approximately half full or up to fill line if the drip chamber is marked with fluid Prime the set manually Restart infusion see Getting Started gt NO fr mb When changing the Infusion set or the fluid container use aseptic technique according to hospital protocol It is recommended that Infusion sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the Infusion set prior to use The set change interval is 24 hours Changing the Fluid Container 1 Press to put the pump ON HOLD 2 Remove bag spike on Infusion set from empty used container Discard empty used container according to hospital protocol 3 Insert spike into new container 4 Squeeze the drip chamber approximately half full or up to fill line if the drip chamber is marked with fluid 5 Restart infusion see Getting Started 1 When changing the Infusion set or the fluid container use aseptic technique
9. NOTE During use of Needle Free Valve port fluid may be observed between the housing and blue piston This fluid does not enter the fluid path and requires no action NOTE For product questions or needle free valve educational materials contact your CareFusion representative Consult facility protocols Consult other organisations that publish guidelines useful in developing facility protocols 1000DF00440 Issue 4 17 38 Alaris GW Volumetric Pumps Basic Features Clearing Air In Line e dei ee Sp NA S 9 Press button to silence the air in line alarm and put the pump on hold Close the in line clamp Open the door to view the air bubble NOTE Air in line alarms can be activated by both single bubbles and bubbles accumulated over time Disconnect the Infusion set from the patient and ensure the IV access to the patient is isolated Close the door Open the in line clamp Press the button once and FILL will be displayed Press and hold the button while FILL is still displayed until there is no visible air in the IV line according to hospital protocol Close the in line clamp 10 Attach the Infusion set to the patient 11 Open the in line clamp and restore the IV access to the patient 12 Press the button to resume the infusion 1 Use aseptic technique according to hospital protocol 1 Infusion sets without an in line anti siphon valve must be clamped before disconnecting from the patient and
10. Nos Enter VTBI using the Y keys Press button once to confirm the VTBI Enter TIME using the Y keys Press gt button to confirm the TIME Press to clear VI if required Press button to start infusing 1000DF00440 Issue 4 14 38 Alaris GW Volumetric Pumps Secondary Piggyback Infusions Secondary Piggyback Infusions Secondary or piggyback Infusion mode is only available if configured refer to Configurable Options section of this DFU Secondary Infusion mode is used to administer an intermittent fluid drug solution e g 4 hourly antibiotic infusion using A primary infusion set with an in line check valve before the Y Injection site e g 273 003 or 273 303E A secondary infusion set e g 72213 or 72213N 1 Primary fluid container must hang lower approximately 20cm lower than the secondary fluid container to allow the secondary infusion to run Primary infusion will restart on completion of the secondary infusion 1 Set the primary infusion but do not start refer to Starting the Infusion section of this DFU If pump is running press button to put pump on hold 2 Prime Secondary Infusion set following the instructions supplied 3 Close the in line clamp on the secondary set 4 Connect secondary Infusion set into upper Y injection site of the primary Infusion set 5 Lower primary fluid container using extension hook supplied with the secondary Infusion set 6 Press B button and SEC w
11. be located on a hanger directly above the pump with which they are being used This minimises the potential for confusion of Infusion sets when multiple volumetric pumps are used Alaris DS Docking Station and Alaris Gateway Workstation 1000DF00440 Issue 4 11 38 Alaris GW Volumetric Pumps Getting Started Loading an Infusion Set u Ensure the appropriate Infusion set for the fluid drug to be infused has been selected Follow the instructions supplied with the individual Infusion set Use of non specified Infusion sets may impair the operation of the pump and the accuracy of the infusion For Alaris GW Volumetric Pump Infusion sets refer to Infusion Sets section of the DFU Position the IV fluid container to avoid spillage onto the pump Ensure that the tubing is inserted completely into the pumping channel avoiding any slack When using 273 003 273 003V 273 303E and 273 303EV Infusion sets ensure a separation of at least 50cm is maintained between the pump and the upper Back Check Valve 1 Close the in line clamp on the Infusion set Press the door latch to open the tubing cover door 2 Release the flow stop mechanism by pushing the lever arm up and to the right 3 Avoiding any slack insert the infusion set from left to right into the slot provided following the flow direction label Make sure that the infusion set is pressed firmly past the constriction points and into the slot
12. does not get wet Dry flow sensor before use To aid cleaning of flow sensors which have been heavily soiled contaminated or if the handle operation is not free moving then the flow sensor may be immersed and soaked in clean soapy water see UU The inside of the spring mechanism can be cleaned by activating it whilst submerged in the water After cleaning the flow sensor should be allowed to dry fully prior to use 1 The plug of the flow sensor must not be immersed in water as damage will occur 1000DF00440 Issue 4 29 38 Alaris GW Volumetric Pumps Specifications Specifications Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 Electro Magnetic Compatibility EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 Electrical Safety IEC EN 60601 1 Typical earth leakage current 40pA Potential Equalisation Conductor The function of the Potential Equalisation Connector Conductor is to provide a direct connection between the Pump and the potential equalisation busbar of the electrical installation To use the Potential Equalisation Connector connect the Potential Equalisation Connector on the Pump to the potential equalisation busbar of the electrical installation Dielectric Strength Proof strength test 1 7kV dc live and neutral to earth for 10s Performance strength test 500V dc live and neutral to earth Proof Strength Test The proof strength
13. is recommended that only qualified service personnel replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual Any use of battery packs that are not manufactured by CareFusion in the Alaris Volumetric 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 Volumetric 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 Disposal Information on Disposal for Users of Waste Electrical amp 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 Ifyou 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 consi
14. pump will alarm and display HI Dr ES To compensate for the variability in Infusion set tubing the pump performs a relative baseline pressure measurement The pump takes a reference pressure from the IV line when the infusion commences and alarms at a preset limit above the baseline pressure The pressure alarm limits are 250 350 and 500 mmHg above the baseline pressure corresponding to the low normal or high pressure limits To avoid excessively large pressures the pump is capped at 1000 mmHg Upstream Occlusion Pressure To detect upstream occlusions resulting from for example closed clamps or occluded drip chamber filters the pump continuously monitors the upstream IV tubing pressure Upon detection of an occlusion the pump will alarm and display Air H CL The pump uses the ultrasonic transducers of the air sensor to monitor for upstream occlusions and is therefore unable to differentiate an upstream occlusion from an air bubble Pump Based Free Flow Protection The pump is equipped with a flow stop mechanism that is designed to occlude the IV tubing when the pump door is open and the tubing remains properly loaded in the pump Raising the flow stop mechanism lever arm and pushing it to the right activates this mechanism Once activated the user inserts the IV tubing into the tubing guide channel When the pump door is closed the bevel integrated into the door releases the lever arm such that it will automatically occlude the tubin
15. the prime FILL procedure will not be necessary to remove the air in line as the air can be removed by gravity 1000DF00440 Issue 4 18 38 Alaris GW Volumetric Pumps User Selectable Options User Selectable Options 1 To set the user options the pump must be on Hoi d or in set up mode and the relevant user selectable options are enabled See also Configurable Options section in this DFU Press gt button and hold for 2 seconds to enter User Selectable Options Note Number of button presses are dependent upon the User Select Mode Options which have been enabled The following instructions are based upon all options being enabled Setting the Occlusion Pressure Level 1 WhenPrES is displayed 2 Select HI nor or Lo using the keys to set the occlusion pressure level to High Normal or Low 3 Press button to return to Hat or set up mode or next option Setting the Alarm Volume 1 Press button until tonE is displayed 2 Select an alarm volume between 1 Low and 7 High using the keys 3 Press button to return to Hoi d or set up mode or next option Setting a VTBI Time Infusion Press button until L oc is displayed Select On or OFF using the keys to turn the VTBI time infusion setting on or off 1 2 3 Press button to return to Hoi or set up mode or next option 4 Make sure that the TIME indicator is lit if set to on Note TheTIME increases
16. this pump in specific clinical settings e g neonatal 1000DF00440 Issue 4 13 38 Alaris GW Volumetric Pumps Starting the Infusion Starting the Infusion Check The pump is switched on The Infusion set has been primed refer to Priming the Infusion Set section of this DFU The in line clamp is open The flow sensor is connected refer to Flow Sensor Operation section of this DFU o indicates a drop is detected by the flow sensor during infusion Standard Mode SD MEDINA Enter infusion rate using the keys Press button once to confirm the infusion rate Enter VTBI using the W keys or switch VTBI off by pressing the Y button until OFF is displayed Press button to confirm the VTBI Press to clear VI if required Press button to start infusing Standard Mode with VTBI Time Infusion on Sr E BO Wor Enter VTBI using the Y W keys Press gt button once to confirm the VTBI Enter TIME using the W keys Press button to confirm the TIME Press to clear VI if required Press 9 button to start infusing Micro Mode Do Kc Enter infusion rate using the W keys Press button once to confirm the infusion rate Enter VTBI using the keys or switch VTBI off by pressing the button until OFF is displayed Press button to confirm the VTBI Press to clear VI if required Press i button to start infusing Micro Mode with VTBI Time Infusion on DE Bow
17. whether CareFusion has been advised as to the possibility of such use Intended Purpose The Alaris GW Volumetric Pump is intended for use by medical staff for the purpose of controlling infusion rate and volume Conditions for Use The Alaris GW Volumetric Pump should only be operated by medical staff competent in the use of automated volumetric pumps and in the management of infusion therapy Medical staff should determine the suitability of the device in their care area for its intended purpose Indications The Alaris GW Volumetric Pump is indicated for the infusion of fluids medications parenteral nutrition blood and blood products through clinically acceptable routes of administration such as intravenous IV intra arterial IA subcutaneous epidural or irrigation of fluid spaces The Alaris GW Volumetric Pump is indicated for use on adults and paediatrics Contraindications The Alaris GW Volumetric Pump is contraindicated for enteral therapies 1000DF00440 Issue 4 2 38 Alaris GW Volumetric Pumps About This Manual About This Manual The user must be thoroughly familiar with the 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 The complete range of settings and values are detailed in the specifications section
18. with the recommended accessories Use of any accessory transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity 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 qualified service personnel e This pump is a CISPR 11 Group 1 Class B 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 e For further information on electromagnetic compatibility please consult Technical Service Manual 1000SM00006 Hazards de An explosi
19. 000DF00440 Issue 4 3 38 Alaris GW Volumetric Pumps Features of the Alaris GW Volumetric Pump Features of the Alaris GW Volumetric Pump Display Indicators Flow Stop Mechanism When activated the mechanism will stop fluid flow en e Air Sensor VW EE Lo E Bevel z Ea L Releases the flow stop mechanism lever arm when the door is closed Door Latch Tubing Guide Press outer latch to Guide to assist in the loading open the pump door of the Infusion set Release Lever For Rotating cam Rotating Cam To lock onto the rectangular bars Mains Fuses Mains Inlet Potential Equalisation PE connector Infra Red Communications port IrDA Main Display Displays the infusion rate VTBI VI and time remaining for VTBI Time infusions Display will flash when pump is operating on battery Keypad Flow Direction Label Pressure Sensor RS232 Nurse call Connector Flow Sensor Interface Folded Pole Clamp 1000DF00440 Issue 4 4 38 Alaris GW Volumetric Pumps Controls and Indicators Controls and Indicators Controls Symbol Description S ON OFF button Press once to switch the pump ON Press and hold down for approximately 3 seconds to switch the pump OFF RUN HOLD button Press to start the infusion or to put the infusion on hold CLEAR SILENCE button P
20. Alaris GW Volumetric Pump Directions For Use with Set Detection Mode disabled Alaris GW Volumetric Pumps Contents Page sn SN 2 begannen aos Pi ada 3 Quick Start Guide cion A A A A aa 3 Features of the Alaris GW Volumetric Bump 4 Controls and indicators sed Eggs EES a SEN O VA A E Mon A eeu ove A aoe 5 Sy MbOl DENIA 6 Operating Precautions iria cc E dation wetted dE ENEE dE 7 Getting Started ais 10 Starting the INFUSION ciencias d KREE d EE a e e oa 14 Secondary Piggyback IMTUSO Seere traia tada aaa 15 BASIC FSA iaa ata 16 User Selectable Options s cerdos pei Ri bin 19 Configurable Options Sheet siserrs rire dd aaa naaa 20 Ada aaa dsd aa 21 WARIO Srita AA A 22 Flow Sensor Operation 23 Compatible Dedicated Infusion Setz 24 Associated Products vvesidiciio air ds as e andas 27 Maldten CR gtt EE EEN a e 28 Cleaning and Storage Vivar door iio ion ZE 29 Specifications poccninn e didas 30 IrDA RS232 and Nurse Call Specification 0ooooocooccocorononrncnnr rr rr rr 33 Trumpet and Flow Rate Cupves 18 SEENEN NEEN EE NENNEN NEE KENNEN a 34 Technical Description 4 s ia ada a aa ET EE NEE AN 35 Products and Spare Partidas rd 36 SEMI CONTACTS EENEG 37 1000DF00440 Issue 4 1 38 Alaris GW Volumetric Pumps Introduction Introduction The Alaris GW Volumetric Pump herein after referred to as Pump is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a
21. Sensor Operation 1 The flow sensor automatically monitors the infusion flow rate through the drip chamber The flow sensor will cause the pump to alarm if a significant deviation from the infusion rate occurs The flow sensor will also be able to detect empty containers For this reason use of a flow sensor is mandatory when the automatic set detection mode on the pump is disabled Flow Sensor Usage Alaris GW Volumetric Pump mode Infusion set with anti siphon valve Use flow sensor Set detection On YES OPTIONAL Set detection On NO RECOMMENDED Set detection Off YES MANDATORY Set detection Off NO MANDATORY Only CareFusion dedicated infusion sets can be used in this mode CareFusion does not recommend the use of other manufacturers Infusion Sets Model 180 Flow Sensor Pull back handles A Flow Sensor Flow sensor Interface interface Cover 1 Plug the flow sensor into the flow sensor interface located on the top rear part of the pump 2 Attach the Model 180 Flow Sensor to the drip chamber of the Infusion set by pulling back the handles Refer to the illustration above 3 Proceed with load priming and set up instructions as described in section Getting Started NOTE Ensure drip chamber is half full and upright 1 Always attach the flow sensor before you start an infusion Avoid using the flow sensor in direct sunlight Always ensure lens is
22. 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 0 30 2289 711 Fax 31 0 30 2289 713 NO CareFusion Fjordveien 3 1363 H VIK Norge Tel 47 64 00 99 00 Alaris GW Volumetric Pumps Service Contacts 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 Rzymowskiego 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 H 1000DF00440 Issue 4 37 38 Page Intentionally Left Blank Alaris Guardrails SmartSite 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 2014 CareFusion Corporation or one of its subsidiaries All rights reserved This document contains
23. according to hospital protocol It is recommended that Infusion sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the Infusion set prior to use SmartSite Needle Free System Instructions SmartSite Needle Free Valve is designed to permit safe gravity flow and automated flow injection and aspiration of fluids without the use of needles by utilising Luer lock and Luer slip connectors 1 Precautions Discard if packaging is not intact or protector caps are unattached If SmartSite Needle Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage Replace SmartSite Needle Free Valve immediately SmartSite Needle Free Valve contraindicated for blunt cannula system DO NOT leave slip Luer syringes unattended DIRECTIONS Use Aseptic Technique 1 Prior to every access swab top of SmartSite Needle Free Valve port with 70 Isopropyl alcohol 1 2 seconds and allow to dry approximately 30 seconds NOTE Dry time is dependent on temperature humidity ventilation of the area 2 Prime valve port If applicable attach syringe to SmartSite Needle Free Valve port and aspirate miniscule air bubbles 3 When used with administration sets always refer to individual set directions for use as change interval may vary according to clinical application e g infusions of blood blood products and lipid emulsions
24. ameter between 15 and 40 mm Recessed pole 1 Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole 2 Place pump around pole and tighten screw until the clamp is secured to the H Never mount the pump such that the Infusion stand becomes top heavy or unstable Ensure pole clamp is folded away and stored within recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use 1 Prior to each use check the pole clamp does not show any signs of excessive wear does not show any signs of excessively loose movement in the extended mountable position If these signs are observed the pumps should be taken out of service for examination by qualified service personnel Docking Station Workstation or Equipment Rail Installation Release lever Rectangular bar Rotating cam The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or equipment rails measuring 10mm by 25mm 1 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail Push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the rail or bar To release push the release lever and pull the pump forwards 1 It is recommended that infusion bags
25. ble The anti siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump Infusion sets with an anti siphon valve can only be primed when loaded in the pump When using infusion sets without an anti siphon valve eg 273 004 273 007 and 273 008 the infusion set can be primed without using the pump Use of a flow sensor is recommended when using an infusion set without an anti siphon valve The flow sensor will cause the pump to alarm if a significant deviation from the set infusion rate occurs Ensure the pump is switched on and in line clamp is open Load the Infusion set see Loading the Infusion Set Press button once FILL will be displayed Press and Hold button while FILL is still displayed prime the Infusion set until there is no visible air in the IV line according to hospital protocol Attach the set to the patient or other Infusion set 6 Start the infusion see Starting the Infusion E WN Ge 1 Use the prime function to fill the Infusion sets before starting an infusion Never connect the Infusion set to the patient during the priming process The prime FILL volume delivered will not be subtracted from the VTBI or added to the total volume infused Automatic Set Detection When using a compatible dedicated CareFusion infusion set refer to Compatible Dedicated Infusion Sets section it is recommended that the set detecti
26. cerning the adequacy and safe performance of any non dedicated infusion sets as it relates to the operation of the pump and the accuracy of the infusion In no event shall CareFusion be liable for any damages of any kind or nature including without limitation direct or indirect special consequential or incidental damages arising from or in connection with the use of non dedicated infusion sets Infusion sets not manufactured by CareFusion regardless of whether CareFusion has been advised as to the possibility of such use Notes vi All accuracy specifications are with a 95 confidence interval 95 population unless stated otherwise Nominal conditions are defined as Set Rate 125 ml h 25 ml h for rate accuracy Disposable Type 273 001 Needle 18 gauge x 40 mm Solution Type De ionized amp Degassed Water Temperature 23 2 C Fluid Head Height 0 3 0 1 m Back Pressure 0 10 mmHg All are as normal conditions with the following additions Tested using Distilled water 20 lipid 50 glucose 0 9 Normal Saline and 5 Alcohol solutions Set Rate 1 to 999 ml h Solution Type All fluids Temperature 15 to 38 C Fluid Head Height 0 1 0 m Whichever is the greater of the air in line limit set For all conditions the rate accuracy should be adjusted by the following percentages 10 over the infusion rate range 1 to 999 ml h Nominal 0 68 0 36 over 24 hours of continuous use Nom
27. clean Always replace the flow sensor interface cover when the flow sensor is disconnected 1000DF00440 Issue 4 23 38 Alaris GW Volumetric Pumps Compatible Dedicated Infusion Sets Compatible Dedicated Infusion Sets The pump uses standard single use disposable Infusion sets with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion CareFusion recommends the use of infusion sets with anti siphon valves whenever possible The anti siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump New sets are continuously being developed for our customers Please contact your local CareFusion representative for availability It is recommended that Infusion sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the Infusion set prior to use Please note these drawings are not to scale Standard Sets 273 001 Infusion set with 15um filter in drip chamber anti siphon valve 220 cm y d D 273 002 Infusion set with 15um filter in drip chamber 1 Y site and anti siphon valve 220 cm lt a D iL A 273 003 Infusion set with 15um filt
28. deration 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 1000DF00440 Issue 4 28 38 Alaris GW Volumetric Pumps Cleaning and Storage Cleaning and Storage Cleaning the pump 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 Do not use the following disinfectant types Disinfectants which are known to be corrosive to metals must not be used these include NaDcc such as Presept e Hypochlorites such as Chlorasol e Aldehydes such as Cidex e Cationic Surfactants such as Benzalkonium Chloride lodine such as Betadine will cause surface discoloration e Concentrated Isopropyl alcohol based cleaners will degrade plastic parts Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v The following products were tested and are acceptable for use on the Pump if used in accordance with the specified manufacturer s guidelines Warm soapy water Tristel Fuse sachets Mild detergent in water e g Young s Hospec Tristel Trio wipes system e 70 Isopropyl Alcohol in water Tuffie 5 wipe Chlo
29. ed to remain safe when unreasonable 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 Accessories Do not use any non recommended accessory with the pump The pump is tested and compliant with the relevant EMC claims only
30. er in drip chamber 2 Y sites back check valve and anti siphon valve 220 cm g A e 273 004 Infusion set with 15um filter in drip chamber roller clamp and Luer back check valve 210 cm Suitable for gravity infusion A F 7 CH b 273 005 Infusion set with roller clamp 225 cm Suitable for gravity infusion j z ob m 273 303E Infusion set with 15um filter in drip chamber two anti siphon valves and two SmartSite Valve Y Port 290 cm p F a K sse N deet E 273 304 Infusion set with 15um filter in drip chamber 275 cm Suitable for gravity infusion J m Blood Sets 273 007 Blood set with 1 upper Y site in line drip chamber with 200um filter and Luer back check valve 285 cm Suitable for gravity infusion lt p RR a 273 008 Blood set with 1 upper and 1 lower Y site back check valve in line drip chamber with 200um filter and Luer back check valve 285 cm Suitable for gravity infusion Bi geg A 273 080 Blood set with 2 spikes 1 upper and 1 lower Y site with anti siphon valve and in line drip chamber with 200um filter 225 cm HT Ne 1000DF00440 Issue 4 24 38 Alaris GW Volumetric Pumps Compatible Dedicated Infusion Sets Filter Sets 273 009 1 2um filter set with a
31. etection section for more details Align all Alaris GW Volumetric Pumps in your hospital to the same set detection mode ie all On or all OFF to avoid potential confusion amongst users as to the mode in which the pump is operating under Serial Number Software Version Configured by Date Approved by Date 1000DF00440 Issue 4 20 38 Alarms Alaris GW Volumetric Pumps Alarms Alarms stop the infusion and are indicated by a combination of an audible alarm and a message on the display 1 Check the display for an alarm message and review table below for cause and action Press to silence the alarm Exceptions are Err and DIE 2 When the cause of the alarm has been rectified press the button to resume the infusion Display Cause Action OCI AIR IN LINE See Clearing Air In Line II GGG UPSTREAM OCCLUSION Remove the occlusion air and restart the infusion by pressing the button Ef a CEC Peo ILLA U LAL INTERNAL BATTERY DEPLETED To silence the alarm connect the pump to AC power Restart operation on AC power to charge the internal battery door DOOR OPEN Close the door and restart the infusion Door was opened during an infusion Err SYSTEM FAULT Switch pump off Remove pump from service and have the pump inspected by qualified service personnel Crew Eo FLOW ERROR Clamp the tubing to stop fluid flow rou E vo No drops have been detected during an infusion empty container
32. euvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 0 2 267 38 99 Fax 32 0 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 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 ita PELEA BE 500 3 ESA DARE A BE 24 JE AB 200122 FRIZ 86 21 58368018 IER 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 01 30 02 81 41 Fax 33 01 30 02 81 31 Fl CareFusion PO Box 121 Ayritie 8B 01511 Vantaa Tel 358 207871 090 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 Magyarorszag Tel 36 1 488 0232 Tel 36 1 488 0233 Fax 36 1 201 5987 IT CareFusion
33. fectant detergent solution 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 It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products These documents are referenced on www carefusion com Copies can be obtained by contacting your local CareFusion representative Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure The infusion time on battery is rate dependant see Specifications section of the DFU From the battery low alarm it will take about 24 hours to fully recharge when reconnected to the AC power supply whether the pump is in use or not The battery is automatically charged during AC operation and whenever the pump is connected to the AC power supply and the AC power indicator is illuminated 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
34. fusing 282 Loc Gn Loc OFF If Panel Lock is enabled then L oc displays for all non operational button presses Panel Lock prevents button operation with the exception of Scrolling between infusion parameters using the button Muting the alarm using the button Pausing resuming the infusion using the button Optimising the Pumps Performance Pump performance may be optimised by moving a new section of the infusion set in the pumping mechanism every 24 hours To insert a new section of tubing Press to place the infusion on HOLD 2 Ensure the in line clamp is closed 3 Open the pump door release the flow stop mechanism and move the Infusion set approximately 15cm along See Loading the Infusion Set 4 Close the door press to restart the infusion Hold Mode Press ED to pause the infusion Press again to resume the infusion A call back alarm will activate if the pump is left on Hold for more than 2 minutes KVO Keep Vein Open Rate At the end of infusion the pump will continue to infuse at a very low rate refer to Specifications section of this DFU KVO is used to keep the patients vein open in order to prevent blood clots and catheter occlusions 1 If the KVO rate is greater than the set infusion parameters then the pump will continue to infuse at the set infusion rate If the KVO rate has been configured to OFF the pump will stop infusing and generate an alarm
35. g when the door is re opened Refer to Features of the Alaris GW Volumetric Pump The tubing can be removed from the tubing guide channel by repeating the activation of the lever arm Once the lever arm is re activated and the door is opened the flow stop mechanism no longer occludes flow in the tubing Anti Bolus Function The anti bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm Detection of a downstream occlusion is indicated by a Mi PrES alarm The pump returns the Infusion set line pressure to neutral within 15 seconds by pumping backwards briefly and measuring the Infusion set line pressure through the in line pressure detection system This feature can prevent the fluid bolus to the patient that can occur upon the release of an occlusion which may be caused by a downstream clamp Note The anti bolus function is disabled if the automatic set detection feature is to be switched off refer to Configurable Options section of this DFU 1000DF00440 Issue 4 35 38 Products and Spare Parts Alaris Infusion System Alaris GW Volumetric Pumps Products and Spare Parts Range of products in the Alaris Infusion System product family are Part Number Description 8002MEDO1 Alaris GH Syringe Pump with Plus Software 8003MEDO1 Alaris CC Syringe Pump with Plus Software 80043UNO1 Alaris TIVA Syringe Pump 80053UNO1 Ala
36. ically performs system integrity checks and will alarm and display Err should any of these tests fail Refer to Power On Off section of this DFU Air in Line Two ultrasonic transducers continuously check for the presence of air in the Infusion set throughout the infusion This air in line feature operates in two modes Single Bubble Detection The pump will alarm and display Ar OD CL whenever a single air bubble greater than the air in line volume alarm limit is detected The alarm limit can be configured to 50 100 250 or 500 uL See also Configurable Options section of this DFU Air in Line Accumulation This accumulation feature monitors the volume of air that passes through the Infusion set by accumulating the volume of individual bubbles over a 15 minute window This feature is particularly useful with infusions for patients that are highly sensitive to air i e infants paediatrics or when infusing products that create significant volumes of small air bubbles 1 Although an individual bubble may not exceed the pre programmed threshold the additive volume of bubbles in a 15 minute volume may be sufficient to initiate an air in line alarm indicated by an Air OCCL message Downstream Occlusion Pressure The pump includes a pressure sensor to monitor the downstream Infusion pressure When the IV pressure exceeds the alarm pressure limit as a result of for example kinked IV tubing or blocked cannula the
37. if an infusion set is incorrectly loaded or removed from the pump It is recommended that Infusion sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the Infusion set prior to use Use of non specified Infusion sets may impair the operation of the pump and the accuracy of the infusion When combining several apparatus and or instruments with Infusion sets and other tubing for example via a 3 way tap or multiple Infusion the performance of the pump may be affected and should be monitored closely Uncontrolled flow may result if the Infusion set is not properly isolated from the patient i e closing a tap in the set or activating an in line clamp roller clamp The Infusion set may be fitted with an in line clamp which can be used to occlude tubing in case it is required to stop fluid flow The Alaris GW Volumetric Pump is a positive pressure pump which should use Infusion sets fitted with Luer lock fittings or equivalent locking connectors e To infuse from a burette close the roller clamp above the burette and open the clamp on the vent on top of the burette Discard Infusion set if the packaging is not intact or the protector cap is detached Ensure sets are not kinked as this may occlude the tubing CareFusion recommends the use of the IVAC Model 180 Flow Sensor when using sets without anti siphon valves or the mandatory use of the IVAC Model 180 Flow Sen
38. ill be displayed Rate Volume Or VTBI TIME 7 Enter required rate using the Y keys Enter VTBI using the Y keys 8 Press button to scroll to VTBI Press button to scroll to TIME 9 Enter VTBI using the Y keys Enter TIME using Y keys 10 Open the in line clamp on the secondary set 11 Press button to scroll further or press button to start the secondary infusion 12 Ensure the SEC Secondary indicator is lit Note The infusion rate will automatically revert to the primary infusion rate when the secondary infusion is complete On completion of the primary infusion the pump will continue at Keep Vein Open rate KVO rate 1 During primary secondary infusion of 2 drugs into a single lumen line it is essential to ensure drug fluid compatibility by consulting a drug compatibility chart or local pharmacist prior to infusion The secondary set connects to the upper Y connection on the primary Infusion set To set the Secondary Infusion the pump must be on Hold or not running Secondary infusion rates above 270ml h may cause simultaneous flow from secondary and primary fluid sources Typical Secondary Infusions Secondary Fluid Container Extension Hook Usually a smaller container e g 50ml 100ml 200ml or 250ml Normally included with the secondary Infusion set Primary Infusion set must hang lower to allow the secondary infusion to run and primary infusion to restart on com
39. inal 3 5 1 08 15 C Nominal 0 9 0 62 38 C 1000DF00440 Issue 4 32 38 Alaris GW Volumetric Pumps IrDA RS232 and Nurse Call Specification IrDA RS232 and Nurse Call Specification RS232 IrDA Feature The RS232 IrDA feature is a standard feature on Alaris GW Volumetric Pump It allows the pump to be monitored remotely via a suitable central monitoring or computer system It also enables the internal event log of the pump to be downloaded for technical support purposes 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 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 fo
40. inated the pump displays the rate or infusion time 1000DF00440 Issue 4 5 38 Alaris GW Volumetric Pumps Symbol Definitions Labelling Symbols Symbol Definitions Symbol Description Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nursecall Connector 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 Connector for Flow Sensor Not for Municipal Waste Fuse rating Authorised representative in the European Community Infusion indicator Displays fluid drops detected by the flow sensor when infusing at a normal rate fe Gov Infusion indicator Displays fluid drops detected by the flow sensor when infusing in MICRO mode 1000DF00440 Issue 4 6 38 Alaris GW Volumetric Pumps Operating Precautions Operating Precautions Infusion Sets To ensure correct and accurate operation only use CareFusion single use infusion sets described in the Compatible Dedicated Infusion Sets section of this Directions for Use Use an infusion set with an anti siphon valve whenever possible The anti siphon valve prevents free flow from occurring
41. ir vent for semi rigid containers should take place after the spiking of the container and priming of the drip chamber Steps for the Collapsable bags Steps for Semi rigid containers Follow steps 1 to 3 as shown for the semi rigid containers however gt do not open vent as in step 4 but EA prime the set as per step 5 Ensure DEn Fill drip chamber to fill line Open the air vent to allow pressure equalisation ready for infusion the bag outlet is fully pierced before filling the drip chamber 1 Close the roller clamp Prime the set by opening closing the roller clamp 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 Medical professionals with additional necessary appropriate measures Consult Technical Service Manual appropriately trained q
42. n any Alaris GW Volumetric Pump that has been so modified or altered CareFusion s product warranty shall not apply in the event the Alaris GW Volumetric Pump has suffered damage or premature wear or malfunctions or otherwise operates incorrectly as a result of unauthorised modification or alteration of the Alaris GW Volumetric Pump 1000DF00440 Issue 4 9 38 Alaris GW Volumetric Pumps Getting Started Getting Started H Before operating the pump read this Directions For Use DFU manual carefully Initial Set Up 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 GW Volumetric Pump User Support CD Directions For Use AC Power Cable as requested Protective Packaging Model 180 Flow Sensor Pump model dependent if not supplied then the flow sensor can be ordered separately 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 EOE is lit H The pump will automatically operate from its internal battery if the pump is switched on without being connected to the power supply Should the pump fail to perform correctly replace in its original protective packaging where possible and contact qualified service personnel for investigation 4 Facilities intending to use non dedicated infusi
43. nti siphon valve with 15um filter in drip chamber 230 cm q ls eea Burette Sets 273 103 Burette set with 1 Y site and anti siphon valve 220 cm Opaque Sets 273 011 Opaque PVC infusion set with anti siphon valve and pump segment with 15um filter in drip chamber 235 cm D o D d P Low Sorbing Sets 273 053 Low Sorbing PVC infusion set with anti siphon valve and pump segment with 1 Sum filter in drip chamber 260 cm P S ech Qi 1 D 1 e Secondary Sets 72213 0006 Secondary Piggyback set with 18G needle and hanger approx 84 cm 3 Ge 72213N 0006 Secondary Piggyback set and extension hook approx 76 cm 7 O O 1000DF00440 Issue 4 25 38 Alaris GW Volumetric Pumps Compatible Dedicated Infusion Sets Filter Extension Sets C20128 C20350 20128E 0006 20350E 0006 Extension set with 1 2um filter and one Y site Rotating male Luer lock approx 51 cm e E SS a Extension set with 0 2um filter and one Y site Rotating male Luer lock approx 51 cm Low Sorbing Polyethylene Lined E Extension set with 1 2um filter and one SmartSite Valve Y port Rotating male Luer lock approx 51 cm Ss ARA EH ii m Extension set with 0 2um filter and one SmartSite Valve Y port Rotating male Luer lock approx 51 cm Low Sorbing Polyethylene Lined
44. on 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 A fire hazard may exist if the pump is used in the presence of high oxygen concentrations A Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel Electrostatic discharge ESD precautions are required when connecting RS232 Nurse Call Touching the pins GA of the connectors may result in ESD protection failure It is recommended that all actions must be taken by appropriately qualified service 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 qualified service REZ personnel 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 Warning Alaris GW Volumetric Pumps should not be modified or altered in any way except where explicitly directed or authorised by CareFusion Any use of Alaris GW Volumetric Pumps which have been altered or modified otherwise than in strict application of directions provided by CareFusion is at your sole risk and CareFusion does not provide any warranty for or endorsement o
45. on mode is enabled on the Alaris GW Volumetric Pump This mode can be enabled in Technician Mode on the pump refer to the Technical Service Manual addendum 1000SM00014 for more details Align all Alaris GW Volumetric Pumps within a particular hospital or clinical environment to the same automatic set detection mode ie All On or all OFF This will help to avoid potential confusion amongst users as to the mode in which the pump is operating under and hence to ensure that the appropriate recommendations for flow sensor usage are followed When the automatic set detection is set to On the pump automatically tests that a compatible CareFusion Infusion set has been loaded correctly refer to Compatible Dedicated Infusion Sets section The test will occur at the start of the first infusion after the pump is switched on or after the door has been opened the pump will run in reverse for 10 seconds and then forward for 10 seconds the test takes a maximum of 20 seconds to complete During this operation the clinician may observe a blood return that will be more evident if using a small catheter If the pump fails to detect a correct CareFusion Infusion set or detects a possible set misload then the pump will alarm and display bAd SEE refer to Alarms and Warnings section of this DFU Please contact your local CareFusion representative if further information or support is required regarding the Automatic Set Detection operation or the application of
46. on sets with the Set Detection Mode disabled are advised to assess performance of the pump and infusion set combination prior to clinical use If adequate performance is not achieved then the Alaris GW branded dedicated infusion sets should be used or the pump should be recalibrated by following the volumetric calibration procedure described in the Technical Service Manual Addendum 1000SM00014 u Factory set calibration values in the Alaris GW Volumetric Pump are intended specifically to support the use of Alaris GW branded dedicated infusion sets Compatibility of factory calibration settings with Alaris GW branded dedicated infusion sets is controlled by CareFusion CareFusion reserves the right to make changes to the Alaris GW Volumetric Pump without notice which may affect its performance with non dedicated infusion sets If adequate performance is not achieved then Alaris GW branded dedicated infusion sets should be used or the Alaris GW Volumetric pump should be re calibrated It is recommended that the performance of any non dedicated infusion set is re evaluated periodically as the set manufacturer may change specifications significant to the performance of the Alaris GW Volumetric Pump without notice 1000DF00440 Issue 4 10 38 Pole Clamp Installation Alaris GW Volumetric Pumps Getting Started A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I V poles of a di
47. on 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 and the degree of inter vascular integration the clinical effect cannot be determined from the trumpet curves alone The start up curves represent continuous flow versus operating time for two hours 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 IEC60601 2 24 standard The trumpet and flow rate curves are representative of the typical performance of the Alaris GW Volumetric Pump when used in combination with a typical dedicated infusion set The user is responsible for assessing the performance of the Alaris GW Volumetric Pump when used in combination with a non dedicated infusion set Start up Graph at 1 0ml h Initial Period Start up Graph at 25 0ml h Initial Period 273 001 Infusion Set 273 001 Inf
48. pletion of the secondary In line Clamp ll Primary Fluid Container e g roller clamp Primary Infusion set Secondary Infusion Set e g 273 003 with an upper Y injection site e g 72213 Usually shorter In line Clamp e g Roberts clamp tubing to reach the Y site on the primary Infusion set Check Valve Prevents secondary infusions from flowing back up the primary Infusion set instead of to the patient Upper Y Injection Site on Primary Infusion Set If using a flow sensor it must be on the primary Infusion set 1000DF00440 Issue 4 15 38 Alaris GW Volumetric Pumps Basic Features Basic Features Rate Titration 1 Enter the new infusion rate using the Y keys 2 Press button to confirm the infusion rate Note The rate can be increased or decreased without interrupting the infusion 1 If the new rate selected is not confirmed the pump will revert to the current rate and no change in the infusion rate will occur Bolus Infusions To administer a bolus infusion 1 Press D button once and bol will be displayed 2 Press and Hold button while bal is still displayed release button after administering the desired bolus volume Note Bolus volume given will be added to the total volume infused VI and subtracted from the volume to be infused VTBI Panel Lock The Panel Lock feature minimises the risk of unintentional changes to the infusion settings whilst in
49. 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 ual A One Business Centre ZA Vers La Pi ce n 10 CH 1180 Rolle CareFusion UK 305 Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS UK 1000DF00440 Issue 4 carefusion com
50. r Clean Virkon Disinfectant Clinell Sporicidal wipes Virusolve Ready To Use e Hibiscrub Virusolve Wipes TriGene Advance 1 Before cleaning always switch off and disconnect from the AC power supply Do not 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 Storing the pump 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 1 See the Technical Service Manual for further information regarding the charging of the RTC Battery BT1 Cleaning and storing the Infusion set The Infusion set is a disposable single use item and should be discarded after use according to hospital protocol Cleaning the Flow Sensor Before the transfer of the flow sensor to a new Infusion set and periodically during use clean the flow sensor by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Ensure the connector
51. r 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 Nurse Call Feature The nurse call interface is for connection to a suitable monitoring device in order to provide remote indication of the pump entering an alarm condition RS232 Nurse Call Connection Data Typical Connection Data Nurse call Relay Normally Closed NC C Transmit Data TXD Output Received Data RXD Input Power Input DSR Ground GND Not used Power Input CTS Nurse call Relay Normally open NC O Nurse call Relay Common NC COM EE NS GND DSR RXD TXD NCC 9 8 76 NC NCO CTS COM 1000DF00440 Issue 4 33 38 Alaris GW Volumetric Pumps Trumpet and Flow Rate Curves Trumpet and Flow Rate Curves In this pump as with all infusion systems the action of the pumping mechanism and variations cause short term fluctuations in rate accuracy The following curves show typical performance of the system in two ways 1 the accuracy of fluid delivery over various time periods is measured trumpet curves and 2 the delay in onset of fluid flow when infusion commences start up curves 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 observati
52. range of rates To achieve the nominal performance stated in this DFU CareFusion strongly recommends use of Alaris GW branded dedicated infusion sets Facilities intending to use non dedicated infusion sets with the set detection mode disabled are advised to assess performance prior to clinical use If adequate performance is not achieved then Alaris GW branded dedicated infusion sets should be used or the Alaris GW Volumetric Pump should be re calibrated The use of a flow sensor is mandatory when the automatic set detection mode on the pump is disabled DISCLAIMER This pump has been tested and approved by CareFusion for use only with CareFusion dedicated 1 infusion sets In the event the user is considering using infusion sets not approved for use with the Alaris GW Volumetric Pump the user should consult an authorized CareFusion representative for compatibility and or calibration information prior to use In no event however does CareFusion make any representations or warranties concerning the adequacy and safe performance of any non dedicated infusion sets as it relates to the operation of the pump and the accuracy of the infusion In no event shall CareFusion be liable for any damages of any kind or nature including without limitation direct or indirect special consequential or incidental damages arising from or in connection with the use of non dedicated infusion sets Infusion sets not manufactured by CareFusion regardless of
53. ress to silence alarm for 1 minute The alarm will resound after this time Resets numeric values to zero PRIME BOLUS button Primes the Infusion set Administers bolus during the infusion 010 PRIMARY SECONDARY button Switches the pump between Primary and Secondary infusion modes If enabled ENTER button Scrolls between rate time VTBI and total volume infused VI Enters values for selected infusion configuration parameters Confirms the rate during an infusion titration DM CHEVRON keys Increases or decreases the infusion rate TIME limit and VTBI Press and hold to increase the selection speed Used to adjust user selectable options Indicators when illuminated Symbol Description OE AC POWER indicator When illuminated the pump is connected to an AC power supply RATE The pump is displaying the infusion rate in millilitres per hour ml h VTBI The pump is displaying the Volume To Be Infused VTBI in millilitres ml vi The pump is displaying the Volume Infused VI in millilitres ml TIME The pump is displaying the infusion time in hours mins MICRO The pump is operating in the MICRO Mode When not illuminated the pump is in the STANDARD Mode SEC The pump is operating in the SECONDARY Mode When not illuminated the pump is in the PRIMARY Mode ml hr Millilitres hour When ml is illuminated the pump displays the rate VTBI or VI When the hr is illum
54. ris PK Syringe Pump 8003MEDO1 G Alaris CC Guardrails Syringe Pump with Plus Software 8002MEDO1 G Alaris GH Guardrails Syringe Pump with Plus Software 9002MED01 Alaris GP Volumetric Pump with Plus Software 9002MED01 G 80203UNSOx xx Alaris GP Guardrails Volumetric Pump with Plus Software Alaris Gateway Workstation 1 For 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 1000SM00006 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 a local customer services representative to obtain login details Part Number Description 1000EL00349 Internal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European 1000DF00440 Issue 4 36 38 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 L
55. s Battery Specifications Rechargeable NiMH Nickel Metal Hydride Automatically charges when the pump is connected to AC power Battery Life 10 hours 25 ml h Battery Charging 95 charge lt 24 hours all conditions Alarm Conditions SYSTEM ERROR UPSTREAM OCCLUSION AIR IN LINE INCORRECT INFUSION SET BATTERY DEPLETED DOOR OPEN DOWNSTREAM OCCLUSION Critical Volume The maximum volume infused following a single fault condition is 1 0ml KVO Infusion Rate Up to a max of 5ml h or the infusion rate if programmed less than the set KVO rate Occlusion Pressure User Selectable Occlusion Alarm Pressure at 125ml h 250mmHg low 350mmHg normal 500mmHg high Fuse Type 2 XT 125 mA slow blowing 100 120 VAC nominal 2 XT 63 mA slow blowing 220 240 VAC nominal Air Sensor Integral Ultrasonic Sensor Air in line detector Configurable 50ul 100ul 250ul 500ul Total Time Setting Up to 99 hours and 59 mins Memory Retention The electronic memory of the pump will be retained for at least 6 months when not powered up Minimum Occlusion Alarm Pressure 100mmHg Maximum Occlusion Alarm Pressure 1000mmHg Bolus volume generated at 25 0 ml h when the minimum occlusion alarm threshold is reached 0 3ml Bolus volume generated at 25 0 ml h when the maximum occlusion alarm threshold is reached 0 6ml Maximum time for activation of occlusion alarm Maximum time to alarm at
56. s on either side of the casing 4 Re engage the flow stop mechanism by pushing the lever left and down 5 Close the tubing cover door Use the recesses in the cover door to press the door firmly to ensure the latch is correctly applied Open in line clamp on the Infusion set 6 Observe fluid chamber and check for no fluid flow 1000DF00440 Issue 4 12 38 Alaris GW Volumetric Pumps Getting Started Power On Off To power up the pump 1 Press the button once and release 2 Check Ahigh pitch sounder is activated for 3 seconds during this time the main speaker beeps once upon power up sequence All display segments and all indicators are lit Ifan error occurs during self test the pump will alarm 3 After this self test the pump will display last rate setting entered or zero depending on the configuration To power down the pump 1 Press and hold The pump will display OFF3 OFF2 OFF1 2 Ifthe button is released during the countdown the pump will not power down and it will return to its previous state If the pump alarms segments indicators do not light up correctly or 2 audible sounds are not heard then the pump must be powered down immediately and qualified service personnel contacted If transportation to an engineer is necessary it is recommended to use the original protective packaging Priming the Infusion Set Use an infusion set with an anti siphon valve whenever possi
57. sor whenever the pump set detection mode is disabled The flow sensor automatically monitors the infusion flow rate through the drip chamber and will cause the pump to alarm if a significant deviation from the infusion rate occurs The flow sensor will detect empty containers Mounting the Pump e The fluid height in the container must not be more than 1 metre above the patients heart Do not mount the pump in a vertical position with the AC power inlet pointing upwards as this could affect electrical safety in the event of a fluid spill over the pump Operating Pressure The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Alarm Conditions 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 1000DF00440 Issue 4 7 38 Alaris GW Volumetric Pumps Operating Precautions Using Collapsable bags Glass Bottles amp Semi Rigid containers e It is recommended that the air vent be opened on the Alaris GW Volumetric Pump set if using glass bottles or semi rigid containers to reduce the partial vacuum formed as the fluid is infused from the container This action will ensure the pump can maintain volumetric accuracy whilst the container empties The action of opening the a
58. test is applied at the factory It is not recommended that the proof strength test is reapplied if the pump is tested again during service Classification Class Equipment Continuous Portable Equipment type 4 AC Power Supply 100 120 VAC 50 60Hz 10VA nominal 220 240 VAC 50 60Hz 10VA nominal Protection against fluid ingress IPX1 Proteted against vertically falling drops of water Dimensions 137mm w x 140mm h x 105mm d Weight approx 1 5kg excluding power cable Environmental Specifications Condition Operating Transport and Storage Temperature 15 C 38 C 20 C 50 C Humidity 20 90 10 95 Atmospheric Pressure 700hPa 1060 hPa 500hPa 1060hPa Priming the Infusion set Prime Parameter Range Priming Rate Fixed gt 999ml h Priming Volume 0 40mI Starting the Infusion Set up Infusion Parameter Micro Standard Flow Rate 1 0 99 9ml h 1 999ml h VIR 0 1 99 9ml 1 9999mI 100 999ml VI 0 0 99 9ml 0 9999mI 100 9999mI Administering a Bolus Parameter Range Bolus Rate 1 999ml h Bolus Volume 0 99mI Max Bolus Volume after release of hard occlusion lt 0 6ml Non condensing Measured in 0 1ml increments Measured in 1ml increments 1000DF00440 Issue 4 30 38 Alaris GW Volumetric Pumps Specification
59. tine maintenance procedures described below All servicing should only be performed by qualified service personnel with reference to the Technical Service Manual TSM Circuit diagrams and components parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from CareFusion 1 If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out of service for examination by qualified service personnel 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 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 mechanism for damage 3 Check Start up self test operation is correct 4 Check for activation of both the alert indicator and audio function during the Pump start up Before the transfer of the Pump to Clean the Pump by wiping over with a lint free cloth lightly dampened with warm water and a a new patient and as required standard disin
60. ualified service 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 e Align all Alaris GW Volumetric Pumps within a particular hospital or clinical environment to the same automatic set detection mode ie All On or all OFF to avoid potential confusion amongst users as to the mode in which the pump is operating under and hence to ensure that the appropriate recommendations for flow sensor usage are followed Earth Conductor e The Alaris GW Volumetric Pump is a Class device therefore must be earthed when connected to an AC power supply This pump also has an internal power source When connected to an external power source a three wire Live Neutral Earth supply must be used If the integrity ofthe external protective conductor on the AC power cable has been compromised the pump should be disconnected from the AC power source and operated utilising the internal battery 1000DF00440 Issue 4 8 38 Alaris GW Volumetric Pumps Operating Precautions 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 design
61. usion Set eS T w 35 0 E E A g oO oO ce co z 15 0 2 O w KE LL S i Time minutes Time minutes Trumpet Graph at 1 0ml h Initial Period Trumpet Graph at 25 0ml h Initial Period 273 001 Infusion Set 273 001 Infusion Set qe S v 10 Ou Sa 5 of i re 3 S m e 4 a O y ae LL LL Observation Window Minutes Observation Window Minutes Maximum Minimum A Overall Mean Error Maximum Minimum Overall Mean Error Rate Error Rate Error 42 5 Rate Error Rate Error 41 1 Trumpet Graph at 1 0ml h After 24 Hours Trumpet Graph at 25 0ml h After 24 Hours 273 001 Infusion Set 273 001 Infusion Set E aa S got z 2 i l Eos En a Ss O de 2 50 es 140 Observation Window Minutes Observation Window Minutes Maximum Minimum a Overall Mean Error Maximum e Minimum Overall Mean Error Rate Error Rate Error 44 2 Rate Error Rate Error 41 1 Note The typical flow rate and trumpet curves Infusion set 273 001 1000DF00440 Issue 4 34 38 Alaris GW Volumetric Pumps Technical Description Technical Description The following details outline the basic safety checks designed into the pump to minimise the possibility of under or over infusions Power on Self Tests The pump is single fault tolerant which means the pump will either stop and alarm or continue to infuse uninterrupted as a result of a single fault failure During the power on self test sequence the pump automat

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