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Alaris ® GP Guardrails ® Volumetric Pump - Directions

1. IR communications port Potential Equalisation PE Connector Kg P LS 1000DF00498 Issue 1 4 42 Controls and Indicators Controls Symbol ON OFF button Press once to switch the pump ON Press and hold down for approximately 3 seconds to switch the pump OFF RUN button Press to start the infusion The green LED will flash during infusion HOLD button Press to put the infusion on hold The amber LED will be lit while on hold MUTE button Press to silence alarm for approximately 2 minutes The alarm will resound after this time BOLUS button Press to access BOLUS softkey Press and hold down softkey to operate BOLUS fluid or drug delivered at an accelerated rate e Pump is infusing e Infusion set is connected to patient e Volume infused VI is added to the total volume infused displayed OPTION button Press to access optional features PRESSURE button Use this button to display the pumping pressure and adjust the alarm limit CHEVRON keys Double or single for faster slower increase decrease of values shown on display BLANK SOFTKEYS Use in conjunction with the prompts shown on the display AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged BATTERY indicator When illuminated the pump is running on the internal battery When flashing the battery power is low with
2. i 1000DF00498 Issue 1 30 42 Please note these drawings are not to scale Infusion Sets Continued The Alaris GP Guardrails Volumetric Pump uses standard single New sets are continuously being developed for our customers use disposable infusion sets The user is responsible for verifying Please contact your local CareFusion representative for the suitability of a product used if it is not recommended by availability CareFusion Alaris GP light resistant infusion sets e 15 Micron Filter e PVC tubing e Length 250cm Alaris GP burette infusion sets 60103E 2 SmartSite Needle Free Valve Port e 1 Burette 150ml Length 270cm 63441E 4SmartSite Needle Free Valve Port e 1 Burette 150ml Length 330cm Alaris GP low sorbing infusion sets 15 Micron Filter e Polyethylene lined PVC tubing e Length 260cm 63260NY e Polyethylene lined PVC tubing No Filter e Length 295cm 60033E 2 SmartSite Needle Free Valve Ports 0 2 Micron Filter e Length 265cm Check infusion set materials and drug compatibility before selecting an infusion set It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use Please note these drawings are not to scale 1000DF00498 Issue 1 31 42 In
3. 1000SP01390 Guardrails Editor v3 1 Transfer Tool Software Kit 1000DF00498 Issue 1 41 42 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 Date Revision 1 9685 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 Mad
4. 3 To release push the release lever and pull the pump forwards It is recommended that infusion bags 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 Pump can only be mounted on the horizontal section of the docking stations listed above 1000DF00498 Issue 1 11 42 The Alaris Safety Clamp ALARIS SAFETY CLAMP Safety Clamp Frame 4 SAFETY CLAMP IN OCCLUDED POSITION After infusion set is loaded into the pump opening the door activates door hooks which will pull the Safety Clamp slider out as shown Clamp is in OCCLUDED POSITION SAFETY CLAMP IN NON OCCLUDED POSITION When a new infusion set is removed from packaging the Safety Clamp will be in this position Clamp in NON OCCLUDED POSITION FLOW ENABLED This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming MANUALLY OPERATING THE SAFETY CLAMP To move the slider into the non occluded position manually push up Safety Clamp Tab and push Safety Clamp Slider completely into Frame Pushing on the Safety Clamp Slider enables full set flow to the patient Therefore it is recommended to always close the roller clamp as well However if gravity infusion is required push up Safety C
5. 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 Needle Free Valve port with 7096 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 Primevalve port If applicable attach syringe to Needle Free Valve port and aspirate minuscule 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 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 organizations that publish guidelines useful in developing facility protocols 1000DF00498 Issue 1 20 42 Secondary Piggyback Infusions Secondary or piggyback Infusion mode is only available if it has been configured The application of secondary infusions should be limited to the intermittent therapy of medications which are not sensitive to the total time required to complete an infusion Typically antibiotics may be infused u
6. z 04 L o m 02 30 H 1 oot 0 5 10 15 20 25 30 35 02 d H d d d Observation Window Minutes O 10 20 30 40 50 60 70 80 90 100 110 120 Minimum Rate Error Time minutes BR Maximum Rate Error A Overall Mean Error 0 796 Note The typical flow rate and trumpet curves are achieved using a recommended infusion set The plot range has been increased to 150 to allow visualization of the graph 1000DF00498 Issue 1 39 42 Error Flow Rate ml h Trumpet amp Flow Rate Curves Continued Trumpet Graph at 1 0ml h Initial Period 30 7 20 101 Lu P he 10 20 30 d d d 4 d 0 5 10 15 20 25 30 35 Observation Window Minutes Minimum Rate Error RB Maximum Rate Error A Overall Mean Error 0 796 Start up Graph at 25 0ml h Initial Period 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Trumpet Graph at 25 0ml h Initial Period 15 10 Error 96 15 4 t t d d 0 5 10 15 20 25 30 35 Observation Window Minutes Minimum Rate Error gm Maximum Rate Error R4A amp Overall Mean Error 0 696 Error 96 Error 96 Error 96 Trumpet Graph at 1 0ml h After 72 Hours 30 0 7 20 0 10 0 m a 00 Ak he he 10 0 20 0 30 0 4 4 n n H f i 0 5 10 15 20 25 30 35 Observation Window Minutes Minimum Rate Error
7. 1ml DOOR OPEN Infusion stopped Door was opened during an Close door or clamp infusion set using roller clamp infusion Restart infusion DOWNSTREAM OCCLUSION nfusion stopped A blockage has occurred e Check fluid path between pump and patient for downstream clamps connectors kinks or blockages Examine access site for signs of complications redness swelling pain heat UPSTREAM OCCLUSION Infusion stopped A blockage has occurred Check set above the pump upstream Possible e Check all clamps above pump container empty e Check fluid level in container e Ensure drip chamber is half filled e Ensure that the bag spike is inserted correctly e Ensure air vent on drip chamber is open on all glass and semi rigid containers NO FLOW Infusion stopped Flow sensor detects no flow Check flow sensor Check fluid level in container e Ensure all clamps above pump are open e Ensure drip chamber is half filled e Ensure that the bag spike is inserted correctly Check flow sensor is clean FLOW ERROR Infusion stopped Gross difference between Clamp infusion set using roller clamp detected drops and e Check flow sensor expected amount of drops Check fluid level in drip chamber FLOW ERROR In secondary Infusion stopped Unexpected drops e Hang secondary container above primary detected Check drops are from secondary container when infusion mode only infusing Flow sensor disconnection is recommende
8. 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 1000DF00498 Issue 1 34 42 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 Recommended cleaners are Before cleaning always switch off and disconnect from the AC power supply Do not allow liquid to enter the Brand Concentration casing and avoid excess fluid build up on the pump Hibiscrub 20 v v Virkon 1 w v Do not use aggressive cleaning agents as these Do not use the following disinfectant types may damage the exterior surface of the pump NaDcc such as PRESEPT Do not steam autoclave ethylene oxide sterilise or Hypochlorites such as CHLORASOL immerse this pump in any fluid Aldehydes such as CIDEX Please ensure the membrane covering the pumping Cationic Surfactants such as Benzalkonium Chloride mechanism is intact prior to cleaning If faulty remove lodine such as Betadine from use
9. 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 Alaris Asena Guardrails IVAC and SmartSite are registered trademarks of CareFusion Corporation or one of its subsidiaries All rights reserved All other trademarks are property of their respective owners 2008 2010 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 ul CareFusion Switzerland 317 Sarl CH 1180 Rolle CareFusion U K 305 Ltd RG22 4BS UK 1000DF00498 Issue 1 carefusion com
10. C keys are used to increase decrease the infusion rate To set a doserate precisely the arrow must be pointing to the doserate for example mg kg h the flowrate will be calculated from the doserate To precisely set a flowrate the arrow must be pointing to flowrate ml h the doserate will be calculated from the flowrate Selecting the SET BY ml h Option 1 Press the button to access the options menu 2 Select the SET BY ml h option using the amp ACV keys and press the OK softkey indicated on the screen This will select the set by flowrate option the arrow on the display will automatically select the flowrate the flowrate can be adjusted if necessary Selecting the SET BY DOSERATE Option 1 Press the button to access the options menu 2 Select the SET BY DOSERATE option using the amp X amp Y keys and press the OK softkey indicated on the screen This will select the set by doserate option the arrow on the display will automatically select the doserate the doserate can be adjusted if necessary Dosing Summary To review currently selected dosing information 1 Press the C2 button to first access the options menu 2 Select DOSING SUMMARY 3 Review the information and then press the QUIT softkey Infusion Setup To change the Infusion Setup refer to Basic Features Drugs and Dosing Selecting the INFUSION SETUP section Drug Name Only This feature adds a drug name to an existing infusion when infusing
11. Refer to Display of Units section of the DFU for AIL Limit 100ul configurable units Primary VTBI Max 9999ml The default data set does not have Guardrails limits ScndapsdnBIsIBR Disabled To set the limits use the Guardrails Editor software y Care should be taken when specifying the Guardrails limits 1000DF00498 Issue 1 10 42 Getting Started Continued Pole Clamp Installation A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I V poles of a diameter between 15 and 40 mm Recessed 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 pole 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 The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or equipment rails measuring 10mm by 25mm Rotating cam Release lever push 1 Align the rotating cam on the rear of the pump with the to release rectangular bar on the Docking Station Workstation or the equipment rail 2 Push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the rail or bar
12. and contact a qualified service engineer Concentrated Isopropyl alcohol based cleaners will degrade plastic parts 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 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 door Refer to the Technical Service Manual for information for removing the door to facilitate cleaning of the fluid path the use of a screwdriver torx is required and should only be carried out by a qualified service engineer 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 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
13. is operating solely on battery power Controls the audio volume of the pump used for alarms and warnings Controls whether the user is able to adjust the Alarm Volume setting The default downstream occlusion limit The maximum permitted downstream occlusion limit Allows the adjustment of the infusion rate while the pump is infusing without putting the pump on hold The maximum permissible infusion rate Controls whether the Rate Lock feature is available for use Controls whether or not the pump allows bolus delivery The maximum permissible bolus rate The default value for bolus rates The maximum permissible bolus volume The default patient weight The minimum patient weight for weight based drug dosing calculations before alerting the user The maximum patient weight for weight based drug dosing calculations before alerting the user The single bubble Air in line alarm setting The maximum VTBI for primary infusions Allows the use of a secondary infusion Piggyback in the same channel The maximum permissible setting for the Volume To Be Infused for secondary infusions The maximum permissible infusion rate for secondary infusions 1000DF00498 Issue 1 23 42 Drug List available via the Guardrails Editor Software The following drug parameters are only configurable via the Guardrails Editor Software PC based see Guardrails Editor help files for further details CONCENTRATION SETTINGS Con
14. less than 30 minutes of use remaining 1000DF00498 Issue 1 5 42 Symbol Definitions Labelling Symbols Symbol Attention Consult accompanying document Potential Equalisation PE Connector RS232 Nursecall Connector Defibrillation proof type CF applied part Degree of protection against electrical shock Protected against spraying water Alternating Current Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC ze 0086 Date of Manufacture Manufacturer Connector for Flow Sensor Important Information Not for Municipal Waste Authorised representative in the European Community jai m E 1000DF00498 Issue 1 6 42 Main Display Features Main Display If VTBI has not been set flow sensor must be used Infusion Status Drug Name Profile ON HOLD Name Primary or Secondary Only if secondary RATE is enabled in the data set 2 5 0 ml h 50 0 ml Softkey Identifiers VOLUME VTBI Clear Volume Infused Set VTBI Option Infusion Rate 4 Volume Infused VOLUME Main Display If VTBl is set Infusion Status Drug Name Profile Name Primary or Seconda ry Only if secondary is enabled in the data set d g 25 0 ml h nfusion Rate Dose Rate 16 7 ug kg 24h Volume to be Infused gt Volume Infused Time Remaining gt 1h 48m 00s Softkey Ide
15. rate and start infusing at the new rate VTBI 450 ml VOLUME 50 0 ml 2 1h 48m00s If Rate Titration is disabled the rate can only be adjusted whilst ON HOLD 4 1 Press the button to put the pump ON HOLD 2 Select the new rate using the amp amp keys 3 Press the button to start infusing at the new rate 1000DF00498 Issue 1 17 42 Rate Lock If Enabled Basic Features continued 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 Switching the pump off VTBI over time infusions Secondary infusions if enabled To turn rate lock off 1 Press the C button to access the options menu 2 Select UNLOCK RATE and press the OK softkey To turn rate lock on 1 Press the button to access the options menu 2 Select RATE LOCK and press the OK softkey Adjusting Existing Dosing or Protocol Infusions Set By ml h Set By Doserate To set doserate or flowrate in precise increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml h An arrow to the left of the rate display shows the rate changed when the amp
16. to set the VTBI When the desired volume has been reached press the OK softkey B Enter the time over which the volume is to be infused using the G oe keys The infusion rate will automatically be calculated Press OK softkey to enter the value or BACK to return to the VTBI D i Adjust Alarm Volume This option allows adjustment of the volume if enabled Press the button to access the options menu Select ADJUST ALARM VOLUME Select HIGH MEDIUM or LOW using the amp DC Y keys Press OK softkey to confirm or QUIT to exit screen Bw No Pump Details To review pump information 1 Press the button to access the options menu 2 Select PUMP DETAILS 3 Review the information and then press the QUIT softkey 1000DF00498 Issue 1 19 42 Basic Features continued Changing the Infusion Set Press to put the pump ON HOLD Close in line clamp and ensure the 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 Prepare the new infusion set load infusion set into pump and close the door see Loading the Infusion Set Restart infusion see Getting Started On Bw O 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 Ca
17. 98 Issue 1 33 42 Maintenance Routine Maintenance Procedures To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below Interval Routine Maintenance Procedure As per Hospital Policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage Each usage 1 Inspect AC power supply plug and cable for damage 2 Inspect case keypad and mechanism 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 service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion For Preventative and Corrective Maintenance instructions please refer to the Technical Service Manual TSM All servicing should only be performed by a qualified service engineer with reference to the TSM Please refer to Technical Service Manua
18. Alaris GP Guardrails Directions For Use Volumetric Pump EN Page e Introduction coo Res eo ERU ve eR RU Ree e RUM d ew Te B REDE ais UE MOLAR LR geg 2 e Abouttbis Manual oe boves vere tour p n les es We eee WR ER v ere eer VINE RIS aie VIR ULIS 2 e Creating a Data Set ee 3 e Features of the Alaris GP Guardrails Volumetric Pump ccc cece ccc r cree cece ccc nnn 4 e lt COntrols anid Indicators o ovo Serge REES 5 Symbol Definitions voor Ree IS RE YE eR Y SERES NEE RR ERR VU RN RE IRI d 6 e Main Display Features cece cece ccc cece nenne cence eee he he nnn 7 e Operating Precautions ccc cece cece ence cece renee eee eee nn 8 lt Getting Started ii nne 10 e The Alaris Safety Clamp ov Rr E UR SEELEN EP SEE gie 12 Loading anInfusiori Bet i eco inini nonn nEn EEN ERENNERT ANN 13 Starting thie Infusion vore repe terere pre tu Une S Vus e e dE EE UE EGRET e EE EEN ev Fa iE 14 e BasicFedt res ioosoes osos eder EPOD PLUS ERU Ee eege S UOS SEN E E PES E ie 15 Secondary Piggyback Infusions cece cece cece c cece sists eene hh hn 21 v Service Configuration Mode i cse so er e A rer e P TEE ERE e PPP EE UR P ered EE 22 e Pump Configuration available via the Guardrails Editor Software EEN 23 e Drug List available via the Guardrails Editor Software cece cece cere cece cece cece eeeeeecees 24 EE ET EE 25 WAT UU EE 26 e Promptsand Advisorie
19. C EN60601 2 24 Electro Magnetic Compatibility EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 Electrical Safety Typical earth leakage current 78pA Typical Enclosure Leakage Current Normal Condition OWA Typical Protective Earth Resistance 32mOhms The above measurements are for guidance only IEC EN60601 1 limits are defined below Earth Leakage Current Normal Condition lt 500pA Enclosure Leakage Current Normal Condition lt 100A Protective Earth Resistance lt 200mOhms Classification Continuous mode of operation Portable Equipment AC Power Supply 100 230 VAC 50 60Hz 60VA Maximum Fuse Type 2 XT 1 25 A slow blowing Dimensions 148mm w x 225mm h x 148mm d Weight approx 2 5kg excluding power cable Protection against fluid ingress IPX3 Protected against spraying water Environmental Specifications ee 440 C 20 C 50 C 20 90 15 95 Atmospheric 700hPa 1060 hPa 500hPa 1060hPa Pressure Non condensing 1000DF00498 Issue 1 BATTERY SPECIFICATIONS Rechargeable NiMH Nickel Metal Hydride Automatically charges when the pump is connected to AC power Battery Life For a 24 hour battery charge time the pump at 25ml h will have a Mean Time To Battery Empty of 6 hours Battery Charging 2 5 hours to 9596 Alarm Conditions AC POWER FAIL VTBI DONE BATTERY LOW AIR IN LINE TITRATION SET CLOCK RATE LOCK LOG FAILURE SET SE
20. HIER inside of the spring mechanism can be cleaned by activating it whilst submerged in the water After cleaning the sensor should be allowed to dry fully prior to use The plug of the flow sensor must not be immersed in water as damage will occur 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 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 1000DF00498 Issue 1 35 42 Electrical Protection Class Type CF Defibrillation proof Electrical Mechanical Safety Complies with IEC EN60601 1 and IE
21. Only Press and hold the flashing BOLUS softkey to deliver the required bolus The bolus rate can be adjusted The bolus volume is limited in the configuration via Guardrails Editor 1 During infusion press the C button once to display the bolus screen 2 Usethe Gs keys to adjust the bolus rate if required NOTE Rate may be restricted by the Bolus Rate Max which is configured in the Guardrails Editor 3 To deliver 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 displayed Ifthe volume to be infused VTBI is reached during a bolus the VTBI complete alarm will sound Press CO to silence the alarm or CANCEL to acknowledge the alarm See VTBI section for more details on VTBI operation When using infusion set 63280NY the maximum infusion rate is 150ml h TITRATE PRESS lt gt TO CONFIRM If Rate Titration is enabled via the Guardrails Editor the infusion rate or dose rate if available can be f bled h drails Editor the infi d if lable b RATE 25 0 ml h adjusted while infusing 16 7 yg kg 24h 1 Select the new rate using the AS 32 keys The message TITRATE PRESS TO CONFIRM gt will flash on screen and the pump continues to infuse at the original rate 2 Press the button to confirm the new infusion
22. RIAL NUMBER ATTENTION SET VTBI SET NOT FITTED LOCKED Advisories DOSE WOULD EXCEED DOSE UNDER DOSE NOT PERMITTED RATE NOT PERMITTED WEIGHT ABOVE LIMIT WEIGHT BELOW LIMIT CONCENTRATION NOT PERMITTED Memory Retention AIR IN LINE SINGLE BUBBLE AIR IN LINE ACCUMULATED DOOR OPEN DOWNSTREAM OCCLUSION UPSTREAM OCCLUSION NO FLOW FLOW ERROR FREE FLOW BATTERY EMPTY SAFETY CLAMP SET MISLOAD FLOW SENSOR DISCONNECTED WRONG SET DOOR CLOSE INCOMPLETE DO NOT USE LEVER OPEN The electronic memory of the pump will be retained for more than 2 years with normal use 36 42 IrDA RS232 and Nursecall Specification IrDA RS232 Nursecall Feature RS232 Nursecall Connection Data The IrDA or RS232 Nursecall optional feature is a feature on Nursecall Specification Alaris GP Guardrails Volumetric Pump that allows the pump to be connected to an external device for the purpose of data Connector D Type 9 Pin communication TXD RXD EIA RS232 C Standard Baud Rate 115k Baud The nursecall interface provides a remote backup Start Bits 1 Start Bit to the internal audible alarm It should not be relied Data Bits 8 Data Bits upon to replace monitoring of the internal alarm Pari No Pari Refer to the Technical Service Manual for further arity SE information regarding the RS232 _ interface Stop Bits 1 Stop Bit The assessment for the suitability of any software used in the clinical environment to control rec
23. any corresponding changes to the infusion rate in ml h This does not affect the accuracy of the infusion Selecting the INFUSION SETUP 1 Press the button to first access the options menu 2 Drugs and dosing set up options are available by selecting INFUSION SETUP from the list using the amp DC keys 3 Select from the list of the options ml h DOSING ONLY or DRUGS as detailed below and press the OK softkey to confirm the selection SELECT mun ml h 1 Select ml h from the list using the A SY 32 keys if necessary DOSING ONLY 2 Press OK to confirm DRUGS ABCDE 3 Enter the ml h rate as prompted on the display in the next screen FGHIJ KLMNO PQRST UVWXYZ SELECT WITH A v v SELECT ml h 1 Select DOSING ONLY from the list using the amp DC keys DOSING ONLY 2 Press OK to confirm DRUGS EC i Ts 3 Select the dosing units from the list using the C keys press OK to confirm KLMNO 4 Enter WEIGHT using the amp SC SI keys press OK to confirm i ey Z 5 Use the ADDY D keys to select the TOTAL VOLUME press OK to confirm 6 Enter DRUG AMOUNT using the CS AG keys and if units need to be changed select UNITS which will scroll through the units available Press OK to confirm selection 7 A summary of the DOSING ONLY information is displayed to CONFIRM all details shown press OK The BACK softkey may be used at any time to return to the previous screen SELECT WITH A v v 1 Only displ
24. ayed if weight based units are used 2 Total Volume Drug Volume Diluent Volume i e Total Volume of fluid in the fluid container after a drug is added SELECT M ml h 1 Select the required DRUGS alphabetical row from the list using the CS A keys DOSING ONLY 2 Press OK to confirm DRUGS ABCDE 3 Select the drug from the displayed list using the CS AG keys press OK to confirm 4 Enter WEIGHT using the CS AG keys press OK to confirm 5 Use the A amp A DCD keys to enter the TOTAL VOLUME press OK to confirm 6 Enter DRUG AMOUNT using the CS AG keys press OK to confirm selection SELECT WITH A v Y 7 A summary of the DRUG information is displayed to CONFIRM all details shown press OK The BACK softkey may be used at any time to return to the previous screen UVWXYZ 1 Only displayed if weight based units are used 2 Total Volume Drug Volume Diluent Volume i e Total Volume of fluid in the fluid container after a drug is added 1000DF00498 Issue 1 15 42 VOLUME VOLUME INFUSED This option enables the volume infused to be cleared 1 Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option 2 Press the CLEAR softkey to clear the volume infused Press the QUIT softkey to retain the volume has not been cleared then the message DOSE INFUSED HAS BEEN CLEARED will be displayed 1 When a new drug or a new concentration has been setup and the previous volume infused Sett
25. centration Units Concentrations Units Only Concentration Min Concentration Max DOSE RATE SETTINGS Weight Based Units Dose Rate Default Dose Rate Soft Max Dose Rate Units Dose Rate Soft Min Dose Rate Hard Max BOLUS SETTINGS Bolus Mode Bolus Rate Default Bolus Dose Hard Max Bolus Dose Units Display of Units The unit for concentration parameters The concentrations defined for this drug The calculated value of drug amount total volume Permits the user to attach a range of concentration limits to a drug name The concentration can then be defined on the pump by the user within the min and max limits The weakest permissible concentration for this drug The strongest permissible concentration for this drug Controls whether dose rate units are weight based or non weight based The default dose rate for infusing this drug The maximum permissible dose rate which does not generate an alert on the pump The unit for dose rate parameters The minimum permissible dose rate which does not generate an alert on the pump The maximum permissible dose rate for infusing this drug Controls bolus delivery method These settings override the pump configuration settings in the profile The default value for bolus rate for this drug The maximum permissible bolus dose for this drug The unit for bolus dose parameters Units are selected via the Data Set Editor Micrograms can be displayed as mcg or ug depending up
26. cessories About this Manual The user must be thoroughly familiar with the pump described in this manual prior to use The Alaris GP Guardrails Volumetric Pump has minor functionality differences to the Alaris GH CC Guardrails Syringe Pumps 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 1000DF00498 Issue 1 2 42 Creating a Data Set To create a data set for the Alaris GP Guardrails Volumetric Pump first the hospital will need to develop review approve upload according to the following process Refer to the Guardrails Editor help file for further details and operating precautions 1 Create care area data set Using Guardrails Editor Profile A unique set of configurations and best practice guidelines for a specific population patient type or care area Each profile consists of Pump Configuration Drug List Up to 30 profiles can be defined for each Data Set Pump Configuration Pump configuration settings and units for dosing only Drug List Drug names and concentrations for a data set with default value and maximum limits Up to 100 unique drug names drug protocol set ups 2 Review approve and export data set Using Guardrails Editor Review and Approve Entire data set report to be p
27. cklight amp Contrast This option is used to set the backlight and contrast on the pump display 1 Select BACKLIGHT amp CONTRAST from the SERVICE CONFIGURATION menu using the G amp 32 keys and press the OK softkey 2 Use the amp amp Y keys to adjust BACKLIGHT CONTRAST amp DIMMING The contrast of the display will change when scrolling through the numbers Use PARAM to scroll between each option 3 When the desired value has been reached press the OK softkey then QUIT to get back to the SERVICE menu and press to exit and power down 1000DF00498 Issue 1 22 42 Pump Configuration available via the Guardrails Editor Software The following options are only configurable via the Guardrails Editor Software PC based see Guardrails Editor help files for further details GENERAL SETTINGS AC Fail Warning Alarm Volume Alarm Volume Adjustable DOWNSTREAM OCCLUSION SETTINGS Occlusion Limit Default Occlusion Limit Max RATE SETTINGS Rate Titration Infusion Rate Max Rate Lock BOLUS SETTINGS Bolus Mode Bolus Rate Max Bolus Rate Default Bolus Volume Max PATIENT SETTINGS Weight Default Weight Soft Min Weight Soft Max AIR IN LINE SETTINGS AIL Limit VTBI SETTINGS Primary VTBI Max SECONDARY INFUSION SETTINGS Secondary Infusion Sec VTBI Max Sec Infusion Rate Max Controls whether when main power has been disconnected a warning is generated to inform the user that the pump
28. d FREE FLOW Infusion stopped Uncontrolled flow possible Clamp infusion set using roller clamp Remove pump from use BATTERY EMPTY Infusion stopped The internal battery is Connect to power supply exhausted The pump will immediately or switch pump off automatically switch off in the immediate future SAFETY CLAMP Pump on hold Safety clamp broken or Clamp infusion set using roller clamp missing Replace infusion set Investigate and correct set loading SET MISLOAD Pump on hold Set loaded incorrectly e Clamp infusion set using roller clamp e Investigate and correct set loading FLOW SENSOR Infusion stopped Flow sensor unplugged Check replace flow sensor or set VTBI during infusion DISCONNECT 1000DF00498 Issue 1 25 42 Alarms Continued Infusion Status Cause WRONG SET Pump on hold Safety clamp not detected e Clamp infusion set using roller clamp Check set and close door Replace infusion set If necessary DOOR CLOSE Pump on hold Safety clamp in non occluded e Clamp infusion set using roller clamp position with door open or Investigate and correct set loading INCOMPLETE obstructed Close door DO NOT USE Pump on hold infusion Internal error has occurred Remove pump from use stopped LEVER OPEN Infusion stopped Door lever is open Check door lever Check lever hooks Check lever is not obstructed if so free obstruction Warnings alert the user but may not stop t
29. 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 IEC EN60601 2 24 standard Start up Graph at 0 1ml h Initial Period Trumpet Graph at 0 1ml h After 24 Hours 15000 Ael A Mn l m n i lh fh 00 4 4 n n a sf CE SP ea wr d SE Time minutes Observation Window Minutes Minimum Rate Error RB Maximum Rate Error A amp Overall Mean Error 5 Trumpet Graph at 0 1ml h Initial Period Trumpet Graph at 0 1ml h After 72 Hours 150 1500 4 100 E 50 B g e be rem i a B 0 07 474 a ui 50 100 150 1500 7 T T T T T 1 g T S 3 i n 0 5 10 15 20 25 30 35 Observation Window Minutes N ss Observation Window Minutes Minimum Rate Error Minimum Rate Error Maximum Rate Error BR Maximum Rate Error A Overall Mean Error 6 A Overall Mean Error 4 096 Start up Graph at 1 0ml h Initial Period Trumpet Graph at 1 0ml h After 24 Hours 207 30 7 18 F 20 16 144 10 KM 12 L E T S 04i Ax E E 3 10 E L ost 5 A o o 719 amp oe wi a 20
30. ed section this DRUGS ABCDE is recommended for a new patient or when a new infusion is set up 8 Enter VTBI if required by selecting VTBI softkey on main display Set VTBI by using the BAGS option and or amp SY keys and press OK to confirm Refer to Setting a VTBI or Setting VTBI over Time section SELECT WITH A v Y 9 Enter or adjust the RATE if necessary using the amp SC keys 10 Press key to start the infusion INFUSING will be displayed NOTE The green run LED will flash to show that the pump is infusing If the infusion requires to be stopped immediately the following actions may be applied e by pressing the key recommended action e by closing the roller clamp by opening the door If a drug name is selected then CLEAR SETUP will alternate with the drug name If secondary infusions have been enabled in the data set then PRIMARY may also alternate 1000DF00498 Issue 1 14 42 Basic Features Drugs and Dosing The following options enable the pump to be set up for use with a specific drug name and or drug protocol Drugs are pre configured in the Guardrails Editor 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 Using the Guardrails Editor software t When adjusting an infusion using the dose rate the display may not show
31. ed to as profiles Each profile contains a specific library of drugs as well as an appropriate pump configuration A profile also contains Guardrails hard limits that cannot be overridden during infusion programming Additionally Guardrails soft limits are available and can be overridden based on clinical requirements The hospital defined data set is developed and approved through pharmacy and clinical input and then transferred into the Alaris GP Guardrails Volumetric Pump by qualified technical personnel The Alaris GP Guardrails Volumetric Pump with a data set loaded provides automatic alerts when a dosing limit bolus limit concentration limit or weight limit has been exceeded These safety alerts are provided without the need for the pump to be connected to a PC or network 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 operating rooms and accident and emergency rooms The clinician is responsible for evaluating whether the pump is appropriate for use in a specified patient care area This pump is suitable for use by appropriately trained clinicians or nurses This pump can be used for Intravenous modes supporting fluid therapy drug therapy blood transfusions and parenteral nutrition Only some parts of the Guardrails Editor software are classified as medical device ac
32. eive data from the pump lies with the user of the equipment This software should include detection of the disconnection Typical Connection Data Nurse Call Relay Contacts Pins 1 8 9 30V dc 1A rating or other failure of the RS232 cable Any connected analogue and digital components are 1 Nursecall Relay Normally Closed required to meet IEC EN60950 for data processing and 2 Transmit Data TXD Output IEC EN60601 for medical devices Anyone connecting 3 Received Data RXD Input additional devices to the signal input or output is a system configurator and responsible for meeting the 4 DTR DSR 6 requirements of the system standard IEC EN60601 1 1 5 Ground GND To connect to the RS232 port use spare part 1000SP01183 RS232 cable Ee 7 Not used 8 Nursecall Relay Normally Open 9 Nursecall Relay Common ep ew ore me 5 4 3 Baud Rate 115k Baud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 Stop Bit 1000DF00498 Issue 1 37 42 Infusion Specifications System Accuracy Rate Accuracy is 5 achieved under nominal conditions 22 Rate Accuracy is 10 achieved under low flow conditions b2 Occlusion Alarm Limits Achieved under nominal conditions 4 Level L2 Low i i lt 200 ml h gt 200 ml h Pressure 725 mmHg approx Maximum Occlusion Alarm Pressure 1250 mmHg Post Occlusion Bolus Bolus volume generated at 25 ml h when the minimum occlusion alarm thresh
33. er 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 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 interfe
34. es from battery Connect flow sensor if required See Flow Sensor Operation section Press the key The pump will run a short self test Check two beeps are activated during this test Check the displayed date and time are correct Check display shows the data set name and version number NOTE The pump starts up and displays previous settings 4 Confirm current PROFILE a Selecting CHANGE will display the profile selection screen select profile using amp 7 amp 3 keys and press OK softkey to confirm Profile screen will display again press KEEP softkey and SELECT screen will be displayed go to step 6 b Selecting KEEP go to step 5 NOTE Profile screen is only shown if more than one profile is available in the data set e No Drug Name e Drug Protocol e Primary Secondary e ml h e Dosing Only e Drug Names e Drug Name CLEAR SETUP RATE 300 mn CLEAR SETUP RATE 150 vi 1 50 mgn CLEAR SETUP 0 01nym 1 4 ml 3 5 ml 5 CLEAR SETUP Selecting KEEP will retain all previous rate and volume settings go to step 7 Selecting CLEAR will automatically reset the rate and volume settings to zero and the SELECT screen will be displayed if configured 6 Select either ml h DOSING ONLY or DRUGS A Z and press OK to confirm S E L E C T Then follow the prompts as required Refer to Basic Features Drugs and ml h Dosing section DOSING ONLY 7 Clear VOLUME infused if required Refer to Clear Volume Infus
35. escribed in this Directions For Use tis recommended that infusion sets are changed according to the instructions in the Changing the p c Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use e 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 SS the set or activating an in line clamp roller clamp i 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 GP Guardrails Volumetric Pump is a positive pressure pump which should use infusion sets fitted with Luer lock fittings or equivalent locking connectors 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 Using Collapsible bags Glass Bottles amp Semi Rigid containers tis recommended that the air vent be opened on the Alar
36. et as follows e Fit blue adaptor of infusion set into blue top set retainer Insert orange safety clamp into orange retainer Alaris Safety Clamp Orange 7 Ensure infusion set is fully inserted into tubing guide Safety Clamp retainer Orange 8 Close door and open roller clamp Ensure no drops are Air in line sensor falling in the drip chamber Tubing guide 9 Ensure all air is removed from the set Connect the infusion set to the patient access device 1 Follow steps 1 to 4 as above where necessary 2 Ensure roller clamp is closed 3 Open door and load infusion set as follows e Fit blue adaptor on infusion set into blue top set retainer e Insert orange safety clamp leaving slider extended in the occluded position into orange retainer Alaris Safety Clamp Orange in occluded position See previous page Pushing on the Safety Clamp Slider may lead to uncontrolled flow to the patient Therefore always close the roller clamp before pushing on the safety clamp slider 4 Ensure infusion set is fully inserted into tubing guide Tubing guide 5 Close door and open roller clamp Ensure no drops are falling in the drip chamber 6 Ensure all air is removed from the set Connect the infusion set to the patient access device 1000DF00498 Issue 1 13 42 Starting the Infusion 1 PRIME AND LOAD THE SET Refer to Loading an Infusion Set ls Ensure the pump is connected to an AC power supply also operat
37. ets The user is responsible for verifying New sets are continuously being developed for our customers Please contact your local CareFusion representative for availability the suitability of a product used if it is not recommended by CareFusion Alaris GP standard infusion sets 63200NY e No Filter Length 260cm 63110V 2 Split Septum Injection Ports No Filter Length 290cm 63401E 1 SmartSite Needle Free Valve Port No Filter Length 275cm 63420E 2 SmartSite Needle Free Valve Ports 1 Backcheck Valve No Filter Length 295cm Alaris GP blood infusion sets 60393 e 2 Injection Ports 200 Micron Filter e Length 270cm 60393E 2 SmartSite Needle Free Valve Ports 200 Micron Filter e Length 270cm 60893 1 Injection Port 200 Micron Filter Length 255cm 60894 e 1 Injection Port 200 Micron Filter Length 255cm 60980 e Twin Spike 1 Injection Port 200 Micron Filter Length 250cm 63477E 2 Non Vented Spikes e 180 Micron Filter Length 305cm 1 SmartSite Needle Free Valve Port Check infusion set materials and drug compatibility before selecting an infusion set It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use
38. fusion Sets Continued The Alaris GP Guardrails Volumetric Pump uses standard single New sets are continuously being developed for our customers use disposable infusion sets The user is responsible for verifying Please contact your local CareFusion representative for the suitability of a product used if it is not recommended by availability CareFusion Alaris GP syringe adapter infusion sets 63280NY e Length 270cm E Restricted to maximum infusion rate of 150ml h Alaris GP oncology infusion sets 60950E 5 SmartSite Needle Free Valve Ports 15 Micron Filter e Length 260cm Alaris GP secondary infusion set 72213N 0006 e Male luer and hanger e Length 76cm 72951NE For use with 1 SmartSite Needle Free Valve Port 60950E Male luer with Backcheck Valve e Length 71cm Do not use with pump in secondary infusion mode when infusing critical drugs Check infusion set materials and drug compatibility before selecting an infusion set It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use Please note these drawings are not to scale 1000DF00498 Issue 1 32 42 Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation 1000DF004
39. gm Maximum Rate Error A Overall Mean Error 1 0 Trumpet Graph at 25 0ml h After 24 Hours 15 10 5t 0 Dp 4 5 asd H i i d d 0 5 10 15 20 25 30 35 Observation Window Minutes oo Minimum Rate Error RM Maximum Rate Error A Overall Mean Error 0 4 Trumpet Graph at 25ml h After 72 Hours 150 7 10 0 5 0 0 0 e 50 10 0 15 0 i i i i i i 0 5 10 15 20 25 30 35 Observation Window Minutes Minimum Rate Error Maximum Rate Error A Overall Mean Error 0 7 Note The typical flow rate and trumpet curves are achieved using a recommended infusion set 1000DF00498 Issue 1 40 42 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 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 1000SM00013 is now available in electronic format on the World Wide Web at www carefusion com alaris intl A username and password are required to access our manuals Please contact a local customer services representative to obtain login details Guardrails Editor Software 1000SP01389 Guardrails Editor v3 1 Data Set Editor and Transfer Tool Software Kit
40. he infusion and are indicated by an audible sound a flashing amber warning indicator and a message on the display or both 1 Checkthe display for a warning message Press to silence the sound for 2 minutes CANCEL to clear the message 2 Rectify the cause of the warning or proceed with caution Warnings Display Infusion Cause Action Status BATTERY LOW Infusion continues Less than 30 minutes of battery Connect to power supply life remaining Check power cable AC POWER FAIL AC power disconnected or failed Reconnect to power supply VTBI DONE Infusing KVO Intended VTBI completed Set new VTBI or clear VTBI AIR IN LINE Pump on hold Air detected in infusion set at e Ensure set is fitted correctly in the air in line the start of infusion detector Set not fitted correctly into air in Assess air in infusion set line detector Check fluid level in drip chamber e Check level of fluid in container SET CLOCK Pump on hold Date time not set A qualified service engineer must set date time Press cancel softkey to continue TITRATION Infusion continues Rate titration not confirmed e Confirm or cancel new rate RATE LOCK Infusion continues Rate lock not confirmed Select YES or NO as required LOG FAILURE Pump on hold Unable to update event log A qualified service engineer may need to service the pump SET SERIAL NUMBER Pump on hold e Contact a qualified service engineer to set the serial number If pu
41. he voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are Alaris GP Guardrails Volumetric Pump Directions For Use CD AC Power Cable as requested Protective Packaging Guardrails Editor software and or Data Set Transfer Tool per hospital 3 Connect the pump to the AC power supply for at least 2V2 hours to ensure that the internal battery is charged verify that the OE is lit The Guardrails Editor software can be used to create an approved data set that can be uploaded into the pump However a default data set is already installed in the pump See details below 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 a qualified service engineer for investigation Factory Default Data Set The Alaris GP Guardrails Volumetric Pump is supplied with the following factory default data set Parameter Default Units Enabled for Dosing Only AC Fail Warning Hug min Alarm Volume ug h Alarm Volume Adjustable mg h Occlusion Limit Default g h Rate Titration mmol h Infusion Rate Max ng kg min Rate Lock ug kg min Bolus Mode ug kg h Bolus Rate Default 500ml h mg kg min Bolus Rate Max 1200ml h mg kg h Bolus Volume Max U kg h Weight Soft in mmol ig SE E
42. ically 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 we recommend use of a flow sensor wherever possible excluding secondary infusions IVAC Model 180 Flow Sensor M A UOS Flanges Handles A Pull back handles y H B lt L L bxc chamber Flow sensor interface 1 Plug the flow sensor into the flow sensor interface located on the top rear part of the pump 2 Attach the IVAC 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 Always attach the flow sensor before you start an infusion Avoid using the flow sensor in direct sunlight Always ensure lens is clean Interface Cover 1000DF00498 Issue 1 28 42 The Alaris GP Guardrails Volumetric Pump uses standard single New sets are continuously being developed for our customers use disposable infusion sets The user is responsible for verifying Please contact your local CareFusion representative for the suitability of a product used if it is not recommended by availability CareFusion Alaris GP standard infusion se
43. ing a VTBI 1500ml 1000ml 1 Using the ADV D keys a Press the VTBI softkey on main display to enter the volume to be infused screen m b Enter the volume to be infused using the CS AG Y keys and press OK to confirm 100ml OR 50ml 2 Using the BAGS softkey Dm OFF a Press the VTBI softkey on main display to enter the volume to be infused screen SELECT WITH AN VY b Select the BAGS softkey select the required bag volume using the SETA keys and OK press OK to confirm the selection c Press OK to confirm again or adjust the VTBI using the CS oe keys NOTE On completion of VTBI pump will continue to infuse at KVO rate KVO Keep Vein Open Rate At the end of VTBI the pump will first display VTBI DONE INFUSING KVO Press CANCEL to display KVO screen 0 ml h The pump continues to infuse at a very low Default rate KVO is used to keep the patients vein open in order to prevent blood clots and catheter VTBI 00 ml occlusions VOLUME 20 ml NOTE If the KVO rate Default 5ml h is greater than the set 0h 00m00s infusion parameters then the pump will continue to infuse at the set infusion rate The KVO rate will flash on screen to indicate this is not the usual infusion rate The pump will beep every 5 seconds while in KVO mode To check and adjust the pressure level press the button The display will change to show the current pumping pressure level and the pressure alarm limit The pressure alarm limit can be set
44. is GP Guardrails 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 air vent for semi rigid containers should take place after the spiking of the container and priming of the drip chamber Steps for the Collapsible bags Steps for Semi rigid containers Follow steps 1 to 3 as shown for the semi rigid containers however do not open vent as in step 4 but prime the 2 3 4 l set as per step 5 Ensure the bag outlet Spike the Fl drip 3 Open the alr vent g ee i chamber to to allow pressure is fully pierced before filling the drip fill line equalisation ready chamber for infusion 1 Close 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 fluid channels of such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications T container Prime the set by opening closing the roller clamp The pump is suitable for use in all establishments including domestic establishments and those directly connected to the public lo
45. l 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 is a minimum of 6 hours When connected to the AC power supply for 4 hours whether the pump is in use or not a new battery pack will be fully charged The battery is maintenance free sealed Nickel Metal Hydride and requires no routine servicing However to achieve optimum operation ensure that the battery is fully recharged after full discharge before storage and at regular 3 month intervals during storage Charge retention will eventually degrade Where retention is critical the internal battery should be replaced every 3 years It is recommended that only a qualified service engineer replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual The battery pack used in this Alaris Volumetric Pump is manufactured by CareFusion and includes a proprietary PCB printed circuit board designed specifically for the Alaris Volumetric Pump and in conjunction with Alaris Volumetric Pump software controls battery use charge and temperature Any use of battery packs that are not manufactured by CareFusion in the Alaris
46. lammable 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 removed Refer all servicing to qualified service personnel 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 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 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 If this pump behaves abnormally remove from service and contact a qualified service engineer Care should be taken to ensure power leads and RS232 cables do not present a trip hazard Care should be taken in the placement of power leads and RS232 cables to prevent accidental tugging 1000DF00498 Issue 1 9 42 Getting Started 1 Before operating the pump read this Directions For Use DFU manual carefully Initial Set Up Check that the pump is complete undamaged and that t
47. lamp Tab and push orange Safety Clamp Slider completely into Frame to enable flow The gravity infusion can be regulated using the roller clamp on the set 1000DF00498 Issue 1 Hereinafter referred to as to as Safety Clamp 12 42 Loading an Infusion Set Ensure the appropriate infusion set for the fluid drug to be infused has been selected Follow the instructions supplied with the individual infusion set Only use Alaris GP Guardrails Volumetric Pump infusion sets Refer to Infusion Sets section of the DFU Position the fluid container to avoid spillage onto the pump Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any slack Loading an Infusion Set Alaris Safety Clamp in the NON OCCLUDED position FLOW ENABLED Adaptor on infusion 1 set Blue Top set retainer Blue Remove infusion set from package and close roller clamp 2 Insert the bag spike into the fluid container and hang appropriately Pressure sensor At a minimum height of 300 mm above the pump 3 Fill the drip chamber to the fill line if shown Approximately half full Refer to operating precaution Pumping section Using Collapsable bags Glass Bottles amp Semi Rigid mechanism containers 4 Open roller clamp and prime set slowly to prevent air bubbles ensuring all air is removed Pressure sensor DOWNSTREAM 6 Switch the pump on Open door and load infusion s
48. lower to allow the secondary infusion to run and primary infusion to restart on completion of the secondary infusion Secondary Fluid Container Usually a smaller container e g 50ml 100ml 200ml or 250ml Secondary Infusion Set e g 72213N 0006 Usually shorter tubing to reach the Y site on the primary Infusion set Primary Fluid Container Primary Infusion set e g 63420E with an upper Y Site SmartSite Needle Free Valve In line Clamp Check Valve Prevents secondary infusions from flowing back up the primary Infusion set instead of to the patient Y Ensure primary set has a backcheck valve upstream from the Y site In line Clamp e g roller clamp Upper Y Site SmartSite Needle Free Valve on Primary Infusion Set IT The secondary set connects to the upper Y connection on the primary Infusion set 1000DF00498 Issue 1 21 42 Service Configuration Mode This section comprises of a list of options which can be configured Some can be entered via the pump SERVICE CONFIGURATION menu available in Technician Mode and others through the Guardrails Editor Software Enter the access code on Alaris GP Guardrails Volumetric Pump for SERVICE mode then select SERVICE CONFIGURATION see the Technical Service Manual for details Use Guardrails Editor to configure the pump configuration drug list and units enabled for each data set bg Access codes should only be entered b
49. mp was on hold the alarm will still be activated but this message will not be displayed 1000DF00498 Issue 1 26 42 Prompts and Advisories Prompts alert the user but may not stop the infusion and are indicated by an audible sound a flashing amber warning indicator and a message on the display or both 1 Check the display for a prompt message Press to silence the sound for 2 minutes CANCEL to clear the message 2 Rectify the cause of the prompt or proceed with caution Prompts Display Infusion Action Status Review pump setup Start infusion or turn off pump Pump left on hold for 2 minutes without starting the infusion s SET VTBI Pump on hold No VTBI flow sensor Set VTBI or fit flow sensor LOCKED Rate change attempted whilst e Unlock rate to adjust infusion settings locked Advisories DOSE WOULD EXCEED DOSE UNDER DOSE NOT PERMITTED RATE NOT PERMITTED CONCENTRATION NOT PERMITTED WEIGHT ABOVE LIMIT WEIGHT BELOW LIMIT Infusion Status Pump on hold If titration is disabled Infusion continues If titrating Pump on hold If titration is disabled Infusion continues If titrating Pump on hold If titration is disabled Infusion continues If titrating Pump on hold If titration is disabled Infusion continues If titrating Pump on hold Pump on hold Pump on hold Infusion rate set exceeds a Guardrails soft limit Infusion rate dose rate set is unde
50. nominally 4 16 mmHg at 5 C and 41 18 mmHg at 40 C respectively High Pressure nominally 4 14 mmHg at 5 C and 38 21 mmHg at 40 C respectively The specified accuracy may not be maintained if the above conditions are not met see notes 1 to 4 38 42 Trumpet amp 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 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 and the degree of inter vascular integration the clinical effect cannot be
51. ntifiers VOLUME VIR Clear ame Infused Set VTBI Option ADRENALINE RATE Screen icon a d ONHOLD SETRATE WTH A A v M RATE If the rate has not been set and is show ng at 0 Oml h then message a will be displayed If programmed rate is between 0 0ml h and 0 1ml h exclusive in drug protocol message b will be shown ONHOLD RATE TOOHGH RATE If programmed rate is greater than the Infusion Rate Max in drug protocol message c will be shown TIME REMAINING DISPLAY icon Indicates time remaining before VTBI will be completed If the time is greater than 24 hours then 24 will be displayed PRESSURE INFORMATION icon Shows the pressure from level 0 being the first bar to level 8 Alarm limits level 2 5 or 8 Indicates that a Guardrails safety protocol is not in use CareFusion recommends the use of Guardrails safety limits when setting infusions as standard practice Indicates that the value entered is outside of the soft limits The warning can be overridden Indicates Guardrails safety protocol is in use Indicates that the value entered is outside of the hard limits The warning can NOT be overridden This symbol is also used to prompt the user to set the rate Indicates Guardrails safety protocol is in use 1000DF00498 Issue 1 7 42 Operating Precautions a fusion Set QUT meum To ensure correct and accurate operation only use CareFusion single use infusion sets d
52. old is reached 0 45 ml Bolus volume generated at 25 ml h when the maximum occlusion alarm threshold is reached 0 95 ml Bolus Volume Accuracy Typical 4 196 Max 3 2 Min 5 5 1ml 10ml h Typical 1 396 Max 0 996 Min 1 696 100ml e 1200ml h Administering a Bolus 10 1200ml h in steps of 10ml h Bolus Volume 0 0ml 100 0ml in steps of 0 1ml Displayed Starting the Infusion Set up Infusion Rate 0 1 99 9ml h in steps of 0 1ml h amp 100 999ml h in steps of 1ml h 1000 1200ml h in steps of 10ml h VTBI Primary 0 OFF 1 9999ml VI Total 0 1 9999ml Maximum time for activation of occlusion alarm At Maximum Pressure time to alarm at 0 1ml h is nominally 735 50 minutes Maximum 883 min At Minimum Pressure time to alarm at 0 1ml h is nominally 234 25 minutes Maximum 309 min At Maximum Pressure time to alarm at 1 0ml h is nominally 65 4 minutes Maximum 95 min At Minimum Pressure time to alarm at 1 0ml h is nominally 16 2 minutes Maximum 28 min At Maximum Pressure time to alarm at 25ml h is nominally 119 7 seconds Maximum 3 min At Minimum Pressure time to alarm at 25ml h is nominally 29 3 seconds Maximum 50 sec 1000DF00498 Issue 1 Air Sensor Integral Ultrasonic Sensor Air in line detection Single Bubble configurable Soul 100ul 250ul amp 500yl Bubble accumulation 1ml over a 15 minute window Critical Volume The maxim
53. on the configuration in the Data Set Editor Units can be displayed as U or units depending upon the configuration in the Data Set Editor 1000DF00498 Issue 1 24 42 Alarms stop the infusion and are indicated by a combination of an audible sound flashing red alarm indicator 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 sound for 2 minutes CANCEL to clear the message 2 When the cause of the alarm has been rectified press the key to resume the infusion Exceptions are DO NOT USE amp BATTERY EMPTY Display Infusion Status AIR IN LINE Infusion stopped Single air bubble exceeds Assess the amount of air detected by air in line alarm limit detector Set not fitted correctly into Opening the door may cause an air bubble to rise air in line detector in the set Check set for air Remove air according to hospital policy e Ensure set is fitted correctly in the air in line detector Check level of fluid in container Check enough fluid left in drip chamber Restart infusion AIR IN LINE Infusion stopped Accumulated air bubbles Review infusion set for air bubbles and take exceeds alarm limit appropriate action Multiple bubbles smaller Check level of fluid in container than the single bubble Check enough fluid left in drip chamber alarm limit which has been Restart infusion detected over a 15 min window and
54. r a Guardrails soft limit Dose rate entered is greater than the dose rate hard maximum set Infusion rate set exceeds a Guardrails hard limit Concentration set exceeds hard max limit or is under hard minimum limit Patient weight set exceeds a Guardrails soft limit Patient weight set is under a Guardrails soft limit Check infusion setting To confirm OVERRIDE LIMIT press YES To deny OVERRIDE LIMIT press NO e Check infusion setting To confirm OVERRIDE LIMIT press YES To deny OVERRIDE LIMIT press NO e Check infusion setting and adjust to appropriate required rate e Check infusion setting and adjust to appropriate required rate e Check concentration and adjust to a more appropriate amount e Check weight setting To confirm CONFIRM press YES To deny CONFIRM press NO e Check weight setting To confirm CONFIRM press YES To deny CONFIRM press NO Restarting an Infusion following an Air in Line Alarm The pump may be restarted by opening the door assessing and removing any air from the tubing guide area and in the infusion set on the patient side of the pump if required according to hospital policy Close the door and cancel the air in line alarm Restarting the infusion will reactivate the air in line system and will alarm if the preset air in line limit is exceeded 1000DF00498 Issue 1 27 42 How Sensor Operation Optional The flow sensor automat
55. refully read the Directions For Use supplied with the infusion set prior to use The set change interval is up to 72 hours with the following exceptions e Transfusion Blood Sets 60953 Alaris GP Low Sorbing Infusion Set 60033E Alaris GP Low Sorbing Infusion Set 60950E Alaris GP Oncology Infusion Set Changing the Fluid Container Press to put the pump ON HOLD Remove bag spike on infusion set from empty used container Discard empty used container according to hospital protocol Insert spike into new container Squeeze the drip chamber approximately half full or up to fill line if the drip chamber is marked with fluid Restart infusion see Getting Started af wh It is recommended that infusion sets are changed in accordance with the Directions For Use LJ When changing the infusion set or the fluid container use aseptic technique according to hospital protocol 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 Precautions Discard if packaging is not intact or protector caps are unattached If Needle Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage Replace Needle Free Valve immediately
56. rence 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 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 2 24 and IEC EN60601 1 2 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation Earth Conductor The Alaris GP Guardrails 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 of the 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 An explosion hazard exists if the pump is used in the presence of f
57. rid Espana Tel 34 902 555 660 Fax 34 902 555 661 FR CareFusion Parc d affaire le Val Saint Quentin 2 rue Ren Caudron 78960 Voisins le Bretonneux France T l 33 1 30 05 34 00 Fax 33 1 30 05 34 43 November 2009 1000DF00498 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 42 42 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
58. rinted reviewed and signed as proof of approval by an authorised person according to hospital protocol Signed printout to be kept safe by hospital Data set status to be set to Approved Password is required Export Export data set for use by the Data Set Transfer Tool or to back up a data set or to move the data set to another PC 3 Upload data set to Alaris GP Guardrails Volumetric Pump Using Data Set Transfer Tool 4 Verify that the correct data set is loaded into the pump and accept it 5 Switch the pump off The pump is now ready to use 6 Switch the pump on and verify that the software version screen displays the correct data set version Data set transfers should only be performed by qualified technical personnel The pump serial number and the hospital name are stored in the event log Drug parameters have to be in accordance with local regulation and prescribed information 1000DF00498 Issue 1 3 42 Features of the Alaris GP Guardrails Volumetric Pump Alarm indicator Alaris Softkeys Chevrons Mute Pressure Battery indicator On Off AC power indicator Door Lever Handle Release lever for rotating cam Flow sensor connector RS232 Nursecall connector cover removed for clarity dug Rotating cam to lock onto horizontal rectangular bars Folded pole clamp Medical device Mains fuses cover interface MDI Mains inlet
59. s 29 ges is SEENEN reu EELER e RIESEN CP TERM EE EE EFE PED EISE RE 27 e Flow Sensor Operation Optional e 28 XEEDUUHPIDMIACENSTEDTTTOT TIL DIY IUD 29 Associated Products i oe soeer i ve ses Axe UH Eege ZE 33 e Maintenance ilooccesoceeosie eese eyes p E RR 06 Sioa ig 6 POR ud Ee Fee C P EIC RN E E ge geg 34 CleaningandStorage cc cece cee ccc e cece reece eee eee eee ence hh nnn 35 CH sm 35 s Specifications coercere Eie es s e EE w Ft erus esu Mes Pese ow ne sxnsie evita e ri V e e ume M e ee s Ere 36 e IrDA RS232 and Nursecall Specification eseu rr hr orrrr erre rre rever reve E ELE EE ses 37 INFUSION Specifications 5eoses vero eeteeev oU e EDO deeg elec 38 Trumpet amp Flow Rate Curves sissies e CNN dE ev Ue RN S S ERU SUUS 08 09 VE NEE ONE e EE ea 39 e Productsand Spare Parts Sgr a sore me wie eR wisi wi IRE RC RUP UR Rn cute Uo eral eid EN RUIN aR 41 EE aie mee rmm 42 e Document History c 5 5 5 SEES ERE Ss Sain EH ER NORD URN EUNDEM mii TNT ON lid ln STR NEKEAK 42 1000DF00498 Issue 1 1 42 Introduction The Alaris GP Guardrails Volumetric Pump hereinafter referred to as Pump is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates The Guardrails Editor software is a medical device accessory which allows the hospital to develop a best practice data set of IV medication dosing guidelines for patient specific care areas referr
60. sing a secondary infusion where the primary infusion is limited to maintenance fluid If intending to use the secondary infusion facility the primary infusion should be a maintenance fluid only and is not indicated for drug therapy The application of secondary infusions for delivery of critical drugs particularly those with a short half life is NOT indicated for use These drugs should be administered through a dedicated pump channel Dependent upon factors such as fluid viscosity the secondary infusion rate head height between the secondary and primary fluid containers and the use of clamps flow may occur from the primary fluid container during a secondary infusion This could result in drug remaining in the container at the end of the secondary infusion delaying its delivery for a period of time which is dependent upon the primary infusion rate For example a secondary infusion of 250ml at 300ml h could result in approximately 33ml remaining requiring up to 25 minutes additional time to complete the delivery assuming a primary infusion rate of 80ml h and the use of a 72213N 0006 secondary infusion set and its supplied extension hook Therefore it is recommended that flow sensors if used are disconnected from the pump during secondary infusions Regular monitoring for unexpected primary flow is recommended If flow from the primary fluid container is not desired during secondary infusion and or the patient is sensitive to fluid balance
61. the clamp on the primary infusion set should be closed Check that no drops fall in the primary drip chamber On completion of the primary infusion the pump will continue at Keep Vein Open rate KVO rate Setting up a secondary infusion Ensure Primary infusion has been setup in ml h rate Oml h Press to put the pump ON HOLD Press to access the OPTIONS screen Select SECONDARY SETUP press OK to confirm Select either NO DRUG NAME or DRUGS A Z Press OK to confirm either selection Enter the secondary RATE using the G o keys Press OK to confirm ore NS ION 12 Press to start the infusion in secondary mode An ADVISORY screen will be displayed ENSURE SECONDARY INFUSION SET OPEN 13 Press OK to start infusing at the displayed rate Setting up a subsequent secondary infusion On completion of the secondary VTBI the pump will automatically transition to the primary infusion An audible 8 Set VTBI using the G oe keys Refer to Setting a VTBI section 9 Press OK to confirm 1 Press to place the primary infusion ON HOLD 10 Review PRIMARY SECONDARY setup summary 2 Follow instructions 3 to 13 of Setting up a secondary infusion 11 If correct press OK to continue or BACK to adjust VTBI or RATE of the SECONDARY mode BEEP will be heard Typical Secondary infusions IV Pole Extension Hook approx 26cm Normally included with the secondary Infusion set Primary fluid container must hang
62. ts 60073 2 Injection Ports No Filter Length 260cm 60093E 2 SmartSite Needle Free Valve Ports 15 Micron Filter e 1 Backcheck Valve Length 260cm 60123E 2 SmartSite Needle Free Valve Ports 1 2 amp 15 Micron Filter Length 265cm 60293E 2 SmartSite Needle Free Valve Ports 1 Backcheck Valve e No Filter Length 260cm 60693 e 1 Injection Port 15 Micron Filter Length 255cm 60693E 1 SmartSite Needle Free Valve Port e 15 Micron Filter e Length 255cm 60793 e 2 Injection Ports 15 Micron Filter Length 255cm 60793E 2 SmartSite Needle Free Valve Ports 15 Micron Filter e Length 255cm 60903 e 15 Micron Filter e Length 250cm 60593 e 15 Micron Filter Length 260cm 60173E 1 SmartSite Needle Free Valve Port No Filter Length 260cm 63120V e 1 Split Septum Injection Port 1 Backcheck Valve e No Filter Length 305cm It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section LJ Check infusion set materials and drug compatibility before selecting an infusion set Carefully read the Directions For Use supplied with the infusion set prior to use Please note these drawings are not to scale 1000DF00498 Issue 1 29 42 Infusion Sets Continued The Alaris GP Guardrails Volumetric Pump uses standard single use disposable infusion s
63. um volume infused following a single fault condition is for rates 10ml h 0 25 ml rates 100ml h 0 5ml rates 2100ml h 2 ml Set based pump activated Safety Clamp Device to prevent free flow Notes 1a Nominal conditions are defined as Set Rate 1 to 1200 ml h Recommended disposable 60593 Needle 18 gauge x 40 mm Solution Type De ionized amp Degassed Water Temperature 23 C 2 C Fluid Head Height 300 30 mm Back Pressure 0 10 mmHg 1b Low flow conditions are defined as Set Rate less than 1 0ml h Recommended disposable 60593 Needle 18 gauge x 40 mm Solution Type De ionized amp Degassed Water Temperature 23 C 2 C Fluid Head Height 300 30 mm Back Pressure 0 10 mmHg 2 The system accuracy will change by the following percentages Temperature nominally 5 7 1 5 at 5 C and nominally 0 3 1 7 at 40 C Fluid Head Height nominally 3 4 1 3 at 0 5 m and 0 0 1 1 at 0 5 m Duration nominally 1 1 0 2 over 24 hours of continuous use Back Pressure nominally 2 0 1 3 at 100 mmHg 13 4 1 8 at 800 mmHg respectively Atmospheric pressure 5 at 25ml h at 700hPa 3 Tested using Distilled water 2096 lipid 5096 glucose 0 996 Normal Saline and 596 Alcohol solutions 4 The occlusion pressure accuracy will change by the following Temperature Low setting nominally 7 12 mmHg at 5 C and 24 17 mmHg at 40 C respectively Normal setting
64. using ml h or dosing only options 1 Press the button to access the options menu 2 Select DRUG NAME ONLY 3 Press the OK softkey to confirm the drug name or press the QUIT softkey to exit the option 1000DF00498 Issue 1 18 42 Basic Features continued Clear Drug Name Clearing the drug name is only available if drug name only has been selected 1 Press Oto put the pump ON HOLD 2 Press the button to access the options menu 3 Select DRUG NAME ONLY using the amp amp Y keys press OK to confirm 4 Select CLEAR DRUG NAME displayed if a name only is selected using the amp amp keys Press the OK softkey to confirm the selection Primary Setup If a secondary infusion has already been setup see Secondary Piggyback Infusions section then access to the primary infusion setup is as follows 1 Press Wo put the pump ON HOLD 2 Press the button to access the options menu 3 Select PRIMARY SETUP and press the OK softkey to confirm Make changes to the primary setup as necessary Setting 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 button to access the options menu 2 Select the SET VTBI OVER TIME option using the CS AG keys and press the OK softkey 3 Adjust the volume to be infused using the CS oe keys Or select BAGS softkey
65. via the Guardrails Editor 1 Press the AAG 3 keys to increase or decrease the alarm limit L2 L5 or L8 The new limit will be indicated on the display 2 Press OK to exit the screen The pressure alarm limit is auto adjusted and is fixed at level 8 L8 for rates above 200ml h The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application Occlusion levels for the Alaris GP Guardrails Volumetric Pump are configured in the Data Set Editor by profile only 1000DF00498 Issue 1 16 42 BOLUS RATE Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic SETWITH ANVY purposes The pump should always be infusing and always attached to the patient Drugs given by 80 an IV bolus could achieve immediate and high drug concentration levels ml h The bolus feature can be configured via the Guardrails Editor to VOLUME a Bolus Mode Disabled 0 0 iil b Bolus Mode Hands On Only A HOLD KEY BELOW Bolus Mode Disabled If configured to Disabled pressing the button will have no effect and the pump will continue to infuse at the set rate A Bolus cannot be administered if the feature is disabled for the selected data set or specific drug During BOLUS the pressure limit alarm is temporarily increased to the maximum level L8 Bolus Mode Hands On
66. w voltage power supply network that supplies buildings used for domestic purposes 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 The pumping pressure alarm system is not designed to provide protection against or detection of extravasation or tissuing complications which can occur Alarm Conditions gt 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 1000DF00498 Issue 1 8 42 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 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 oth
67. y qualified technical personnel Date amp Time Select DATE amp TIME from the SERVICE CONFIGURATION menu using the amp Y keys and press the OK softkey Press the OK softkey to confirm Use the amp XCV keys to adjust the date displayed pressing the NEXT softkey to access the next field When the correct date and time are displayed press the OK softkey to return to the SERVICE CONFIGURATION menu St d p NO Press the QUIT softkey to return to the SERVICE menu and press to exit and power down Pump Reference Text This option is used to add reference text to be shown on the pump start up display 1 Select PUMP REFERENCE from the SERVICE CONFIGURATION menu using the amp C keys and press the OK softkey Use the amp amp keys to enter the text and NEXT to move to the next character When the desired text has been selected press OK softkey to return to the SERVICE CONFIGURATION menu Press QUIT to exit back to the main SERVICE menu and press to exit and power down Je wg LE TT UEL 3 This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the SERVICE CONFIGURATION menu using the amp SCV keys and press the OK softkey Use the amp XC keys to select the language When the desired language has been selected press OK softkey to return to the SERVICE CONFIGURATION menu Press QUIT to exit back to the main SERVICE menu and press to exit and power down PWN Ba

Alaris ® GP Guardrails ® Volumetric Pump - Directions

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Alaris &reg; GP Guardrails &reg; Volumetric Pump - Directions

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Alaris ® GP Guardrails ® Volumetric Pump - Directions