CareFusion Alaris CC Guardrails 80033UND1-G, Directions For Use Manual

Page 1: ...s Alaris CC Guardrails Syringe Pump Models 80033UND1 G Directions For Use en ...

Page 2: ...rating Precautions 8 Getting Started 10 Syringe Loading 12 Starting the pump 15 Basic Features 17 Alarms and Warnings 21 Prompts 22 Configured Options 23 Specifications 26 Recognised Syringes 27 Associated Products 28 Compatible Extension Sets 29 Maintenance 31 Occlusion Pressure Limits 33 IrDA RS232 and Nurse call Specification 34 Trumpet Curves and Start up Curves 35 Products and Spare Parts 36 ...

Page 3: ...ithout the need for the pump to be connected to a PC or network Intended Purpose The Alaris CC Guardrails Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume Conditions of Use The Alaris CC Guardrails Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post placement management of intravenous cathete...

Page 4: ... Only 3 Review Approve and Release Data Set Using Guardrails Editor Review and Approve Entire Data Set Report to be printed reviewed and signed as proof of approval by an authorised person according to Hospital protocol Signed printout to be kept safe by hospital for use during verification procedure Release Data Set status to be promoted to Released Password is required 4 Upload Data Set to Alari...

Page 5: ...OLD PURGE BOLUS MUTE PRESSURE OPTION Extension set hook Pressure transducer Finger Grips Extension set hook Release lever for Rotating Cam Carrying Handle IR Communications port RS232 Connector Folded Pole Clamp Potential Equalisation PE connector Rating Plate see Symbol Definitions for an explanation of the symbols used Pressure transducer Rotating Cam to lock on to horizontal rectangular bars Me...

Page 6: ...n set is not connected to the patient l Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate l Pump is infusing l Extension set is connected to the patient l VI is added d OPTION button Press to access optional features see Basic Features e PRESSURE button Use this button to display the pumping pressure trend display and alarm level f CHEVRON keys Double or single fo...

Page 7: ...l l Defibrillation proof type CF applied part Degree of protection against electrical shock O Protected against vertically falling drops of water r Alternating Current s Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC T Date of Manufacture t Manufacturer U Not for Municipal Waste W Fuse Rating EC REP Authorised representative in the European Community ...

Page 8: ...echarging Guardrails SOFT ALERT icon Indicates the pump is running at a rate above pointing up or below pointing down a Guardrails Soft Alert Number of arrows vary depending on drug name length Guardrails LIMIT WARNING icon Indicates the setting entered is not permitted as it is under or exceeds a Guardrails Hard Limit Pump Status Syringe type fitted Profile Drug name Pressure Information Infusion...

Page 9: ...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 cl...

Page 10: ...ts 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 K In so...

Page 11: ... that the S is lit Language Selection 1 On initial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the f keys 3 Press the OK softkey to confirm your selection w An approved Guardrails Safety Software Data Set must be uploaded to the Alaris CC Guardrails Syringe Pump prior to use Guardrails Editor PC Software is available separa...

Page 12: ...cam Release lever push to release Getting Started continued 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 w Ensure the pole clamp is folded away and stored within the recessed area at the rear of the pump before connecting to a Docking Station Workstation...

Page 13: ...ice Recommendations Ensure that the Pump is as close to level of patient s heart as possible Patient s heart level should be in line with the middle of the Pump or the pressure disc for the Alaris CC Syringe Pumps w Warning Adjusting the Alaris Enteral Plus Syringe Pump s height relative to the patient s stomach level can lead to temporary increases or decreases in delivery w Caution If using mult...

Page 14: ... accuracy of the infusion rate and may also affect pump performance When drawing fluid into the syringe draw enough to compensate for any dead space volume in the extension set and syringe at the end of infusion as this cannot be fully infused Syringe Flange Clamp Syringe Clamp Barrel Flange Plunger Grippers Plunger Flange Plunger Holder Plunger Finger Grips Syringe Barrel Place the pump on a stab...

Page 15: ...original position 7 Ensure that the syringe type and size match those displayed on the pump then press CONFIRM If required the make of syringe can be changed by pressing the TYPE softkey CONFIRM TYPE IVAC 50 ON HOLD Note If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the exten sion set can be purged as required however ensure that the extension set is...

Page 16: ...o to step 5 Note Drugs are listed in alphabetical groups as follows A F G M N S and T Z Select group containing the drug name required and then the required drug and all other drugs can be seen 4 DOSING ONLY a Select Dosing unit and OK to confirm b Select Concentration Amount and OK to confirm Use Units softkey to change concentration units c Select Diluent Volume and OK to confirm d Adjust Weight...

Page 17: ... If the infusion settings are within the Guardrails Soft Alerts then the AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is in operation If infusion rate exceeds the Guardrails Hard Limit then the pump will not start and the display will show DOSE NOT PERMITTED If infusion rate exceeds or is under the Guardrails Soft Alerts then check infusion setting ...

Page 18: ... delivered or the bolus volume limit is reached release the softkey The bolus volume is added to the total volume infused BOLUS Enabled Hands On and Hands Free The Hands Free Bolus is delivered with a single press of the flashing BOLUS soft key The bolus rate and bolus volume are set by drug profile in the Data Set and can be changed within limits set by the Data Set 1 During infusion press the i ...

Page 19: ...n press the YES softkey Press the NO softkey if the rate lock is not required When rate lock is enabled the following are unavailable l Changing the infusion rate titration l Bolus purge l Switching the pump off l VTBI over time infusions To disable the rate lock if selected 1 Press the d button to access the options menu 2 Select the UNLOCK RATE option using the f keys and press the OK softkey To...

Page 20: ... stable pressure has been achieved over a short period of infusion If AUTO Pressure has been enabled the automatic pressure alarm level is calculated and set by pressing the AUTO softkey 4 Press the TREND softkey to view the pressure trend of the previous 12 hours The pressure trend can be viewed at 15 minute intervals by using the softkeys The pressure trend graph displays the pressure at a given...

Page 21: ...oftkey 3 Scroll through the log using the f keys Press the QUIT softkey to exit the log 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed 1 Press the d button to access the options menu 2 Select the 24H LOG option using the f keys and press the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the total volume infused since...

Page 22: ...ressure disc has been removed from the pressure transducer during the infusion The infusion will stop Replace the pressure disc then restart the infusion BATTERY LOW Battery charge low with 30 minutes operation remaining Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to the AC power supply to continue operation and...

Page 23: ...MIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose below Guardrails Soft Alert BOLUS DOSE UNDER The bolus dose has been set to a value which is under a Guardrails Soft Alert Check the bolus setting to continue with the bolus confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose a...

Page 24: ...enu using the f keys and press the OK softkey 2 Use the f keys to select a contrast ratio value The contrast of the display will change when scrolling through the numbers 3 When the desired value has been reached press the OK softkey to return to the Configured Options menu Language This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the Configured ...

Page 25: ...t Pressure Automatic feature to set the occlusion pressure alarm level to an amount mmHg above the current in line pressure 15 minutes after starting the infusion Auto Offset The automatic offset value in mmHg used by auto pressure and auto set pressure Back Off An automatic feature which is activated following an occlusion The pump action reverses and pumps backwards to release the pressure which...

Page 26: ...ired Soft Alert Min HANDS FREE only The bolus dose value below which override confirmation is required Default HANDS FREE only The default bolus dose offered Bolus Rate Default The default value for bolus rate in ml h Occlusion Alarm Pressure The default occlusion alarm pressure in mmHg w The approved Data Set contains configurable option values per profile The originator and approvers of the Data...

Page 27: ...normal conditions 95 confidence 95 of pumps Specifications System Accuracy Volumetric Mean 2 nominal Derating Temperature 0 5 5 40ºC High Rates 2 0 rates syringe volume h eg 50ml h in a 50ml syringe Important System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in EN IEC60601 2 24 at rates of 1 0ml h 23ºC and above when the pump is used with the recommende...

Page 28: ...ctomat ü ü Monoject ü ü ü ü ü Pentaferte ü ü ü ü Rapiject ü Terumo ü ü ü ü ü w To minimise the risk of incorrect confirmation of the syringe type it is recommended that only syringe types available in the hospital are configured on the pump w CareFusion has characterized a range of syringes as identified in the Recognised Syringes table CareFusion cannot guarantee the continued system accuracy of ...

Page 29: ...1000DF00333 Issue 6 28 38 Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation ...

Page 30: ...on Set with occlusion sensing disc 200 cm Priming Volume 1 5ml G302EP Extension set with pressure sensing disc Luer lock connectors Kink resistant DEHP free PVC yellow striped tubing Bore 0 9mm Length 200cm Priming volume 1 5ml Low Sorbing Sets G40615 Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml G40620 Polyethylene Syringe Extension Set 200 cm Priming Volume 2ml G30303M Polyethyl...

Page 31: ...ps 183 cm Priming Volume 1 8ml 30862 PVC Syringe Extension Set with anti siphon valve and clamp 156 cm Priming Volume 0 6ml 04102215162 PVC Syringe Extension Set with rotating luer 150 cm Priming Volume 2 9ml 04100010162 PVC Syringe Extension Set 105 cm Priming Volume 7 2ml Light Protected Sets G40215 Amber PE Syringe Extension Set 150 cm Priming Volume 1 2ml G40320 White PVC Syringe Extension Set...

Page 32: ...wise operates incorrectly as a result of use with a battery pack that is not manufactured by CareFusion 95 lower confidence interval of 5 hours 50 minutes Battery Operation 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 Procedur...

Page 33: ...pump in any fluid Ensure the pressure transducer is free from residues which may prevent correct operation of the disc detector The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged Store in a c...

Page 34: ...the occlusion alarm needs to be set with an operating margin of at least one level between the alarm and normal infusion levels The ability to set a small operating margin permits short time to alarm and small potential bolus volumes to be achieved Bolus volumes can be minimised as described in the Alarms and Warnings Occlusion or by enabling the back off general option Without IVAC Pressure Set f...

Page 35: ...yringePump Communications Protocol 1000PB01088 and is for general information only Any connected analogue and digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additionaldevicestothesignalinputoroutput is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 Nurse call Sp...

Page 36: ... curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore the clinical eff...

Page 37: ...ernal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual The Technical Service Manual 1000SM00001 is now available in electronic format on the World Wide Web at www carefusion co uk alaris technical A username and password are required to access our manuals Please...

Page 38: ... Pacific Mesa Blvd San Diego CA 92121 USA Tel 32 0 2 267 38 99 Tel 34 902 555 660 Tel 31 0 30 2289 711 Tel 1 800 854 7128 Fax 32 0 2 267 99 21 Fax 34 902 555 661 Fax 31 0 30 2289 713 Fax 1 858 458 6179 CA FR NO ZA CareFusion 235 Shields Court Markham Ontario L3R 8V2 Canada CareFusion Parc d affaire le Val Saint Quentin 2 rue René Caudron 78960 Voisins le Bretonneux France CareFusion Fjordveien 3 1...

Page 39: ...1000DF00333 Issue 6 38 38 Page Intentionally Left Blank ...

Page 40: ...Corporation or one of its affiliates 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 affiliates is strictly forbidden t CareFusion Switzerland 317 Sarl A One Business Cent...