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Alaris™ VP Plus Guardrails™ Volumetric Pump

Operating Precautions

1000DF00660 Issue 9

10/48

Alarm Conditions

•  Several alarm conditions detected by this Pump will stop the infusion and generate visual and audible 

alarms . Users must perform regular checks to ensure that the infusion is progressing correctly and no 
alarms are operating . The user must be within proximity to the pump so that they have the ability to 
recognize when the Pump is in an alarm state .

•  At power-up, the Pump will activate both the alert indicator and the audio alert function . A Pump that 

does not activate both must not be used and should be sent to qualified service personnel .

•  Should any alarm condition persist after all appropriate mitigations, it is recommended to replace that 

particular Pump and quarantine the Pump for the attention of qualified service personnel .

Mounting the Pump

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•  The most accurate pressure monitoring in the infusion set is achieved when the Pump is positioned close 

to the patient's heart level . 

•  Do not mount the Pump in a horizontal position or with the AC power inlet pointing upwards as this could 

affect electrical safety in the event of a fluid spill .

Electromagnetic Compatibility and Interference

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•  Therapeutic Radiation Equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation 

Equipment, such as Linear Accelerators . Levels of radiation generated by Therapeutic Radiation Equipment 
may severely affect functioning of the Pump . Please consult manufacturer’s recommendations for safe 
distance and other precautionary requirements . For further information, please contact your local 
CareFusion representative . 

•  Magnetic Resonance Imaging (MRI): The Pump contains ferromagnetic materials which are susceptible to 

interference with magnetic fields generated by MRI devices, therefore the Pump is not an MRI compatible 
Pump . 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 .

•  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 . Nevertheless, this Pump emits 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

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•  The Pump is a Class I device, therefore must be earthed when connected to an AC power supply .
•  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 .

•  This Pump also has an internal power source .

Содержание Alaris VP Plus Guardrails

Страница 1: ...s Alaris VP Plus Guardrails Volumetric Pump Directions For Use en...

Страница 2: ...igid Containers 9 Operating Environment 9 Alarm Conditions 10 Mounting the Pump 10 Electromagnetic Compatibility and Interference 10 Earth Conductor 10 Hazards 11 Getting Started 12 Initial Set Up 12...

Страница 3: ...uctions 23 Secondary Piggyback Infusions 24 Typical Secondary infusions 24 Setting up a secondary infusion 24 Service Configuration Mode 25 Date and Time 25 Pump Reference 25 Language 25 Backlight and...

Страница 4: ...eaning and Storage 42 Cleaning the Pump 42 Cleaning the Door 42 Cleaning the Flow Sensor 42 Storing the Pump 43 Disposal 43 Information on Disposal for Users of Waste Electrical and Electronic Equipme...

Страница 5: ...nd in the management of infusion therapy Clinical staff should determine the suitability of the device in their care area for its intended purpose References to user within this manual are intended to...

Страница 6: ...or Softkeys Chevrons Mute Pressure Battery indicator On Off Door Door Lever Flow sensor interface RS232 Nursecall connector cover removed for clarity Release lever for rotating cam Folded pole clamp R...

Страница 7: ...utton Press to access PRIME or BOLUS softkey Press and hold down softkey to operate PRIME primes the infusion set with fluid when setting up an infusion for the first time Pump is on hold Infusion set...

Страница 8: ...onnector RS232 Nursecall Connector l Defibrillation proof type CF applied part Degree of protection against electrical shock IPX3 Protected against direct sprays up to 60 from the vertical r Alternati...

Страница 9: ...24 will be displayed Also indicates pressure sample time on the Pressure Trend screen N Battery icon Indicates battery charge level to highlight when the battery will require recharging Line Pressure...

Страница 10: ...le Bags Glass Bottles and Semi Rigid Containers It is recommended that the air vent be opened on the Pump sets if using glass bottles or semi rigid containers to reduce the partial vacuum formed as th...

Страница 11: ...etic fields generated by MRI devices therefore the Pump is not an MRI compatible Pump If use of the Pump within an MRI environment is unavoidable then CareFusion highly recommends securing the Pump at...

Страница 12: ...nnel Care should be taken to ensure power cables and RS232 cables do not present a trip hazard Care should be taken in the placement of power cables and RS232 cables to prevent accidental tugging Warn...

Страница 13: ...e as requested Protective Packaging 3 Connect the Pump to the AC power supply for at least 2 hours to ensure that the internal battery is charged verify that the S is lit A A default data set is alrea...

Страница 14: ...measuring 10mm by 25mm 1 Align the rotating cam on the rear of the Pump with the rectangular bar on the Docking Station Workstation or the equipment rail Rectangular bar Release lever push to release...

Страница 15: ...essure Disc No Flow Clamp Is In Occluded Position Flow Clamp In Non occluded Position Manually Operating the Safety Clamp To move the slider into the non occluded position manually push up Safety Clam...

Страница 16: ...Pump 3 Fill the drip chamber approximately half full 4 Open roller clamp and prime set slowly inverting the pumping segment Massage the pressure disc in the direction of the fluid flow to ensure air r...

Страница 17: ...QUIT ml h DOSING ONLY DRUGS A B C D E F G H I J K L M N O P Q R S T U V W X Y Z SELECT WITH 1 Select ml h from the list using the f keys 2 Press OK to confirm 3 Enter the ml h rate as prompted on the...

Страница 18: ...been activated During PRIME the downstream occlusion alarm limit is temporarily increased to its maximum The i button allows the delivery of a limited volume of fluid in order to prime the infusion s...

Страница 19: ...I complete alarm or warning will sound Press c to silence the alarm or warning Press CANCEL to acknowledge the alert See VTBI section for more details on VTBI operation BOLUS Enabled HANDSON and HANDS...

Страница 20: ...keys to increase or decrease the pressure alarm limits followed by the OK softkey The new limit will be indicated numerically on the display screen Auto Pressure The Auto Pressure feature may be used...

Страница 21: ...f keys to scroll through the on screen choices e Press the OK softkey to confirm and exit the END RATE menu KVO Keep Vein Open Rate At the end of VTBI the Pump will first display VTBI DONE INFUSING K...

Страница 22: ...alculated from the flow rate Set By ml h 1 Press the d button to access the options menu 2 Select the SET BY ml h option using the f keys and press the OK softkey indicated on the screen This will sel...

Страница 23: ...led disabled via the Alaris Editor Event Log This option allows the event log to be reviewed 1 Press the d button to access the options menu 2 Select EVENT LOG using the f keys and press OK softkey to...

Страница 24: ...ir vent be opened on the Pump sets if using glass bottles or semi rigid containers see Operating Precautions for more details Always read the Directions For Use supplied with the infusion set prior to...

Страница 25: ...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 KVO rate Typical Secondary...

Страница 26: ...ference text to be shown on the Pump start up display 1 Select PUMP REFERENCE from the CONFIGURATION menu using the f keys and press the OK softkey 2 Use the f keys to enter the text and NEXT to move...

Страница 27: ...ser s last recorded interaction with the Pump and generation of an ATTENTION prompt Drug Override Mode Always Any changes made to the dose rate that are outside of the Guardrails Soft Alerts will requ...

Страница 28: ...rt of a given prime operation Secondary Infusion Allows the use of a secondary infusion in the same channel Sec Infusion Rate Max Set the maximum permissible infusion rate for secondary infusions Sec...

Страница 29: ...These settings override the Pump configuration settings in the profile Bolus Dose Units The unit for bolus dose parameters Applies to Hands on and Hands free bolus Weight based units Controls whether...

Страница 30: ...air bubbles and take appropriate action Remove air according to hospital policy Check fluid level in container Check fluid level in drip chamber Restart infusion DOOR OPEN Door was opened during an i...

Страница 31: ...loaded incorrectly Clamp infusion set using roller clamp Investigate and correct set loading FLOW SENSOR DISCONNECT Flow sensor unplugged during infusion Check replace flow sensor or set VTBI WRONG S...

Страница 32: ...w VTBI or clear VTBI AIR IN LINE Air detected in infusion set at the start of infusion Set not fitted correctly into air in line detector Ensure set is fitted correctly in the air in line detector Ass...

Страница 33: ...clear the message 2 Rectify the cause of the prompt or proceed with caution Display Cause Action ATTENTION Pump left on hold for 2 minutes without starting the infusion Review Pump setup Start infusio...

Страница 34: ...ired rate CONCENTRATION NOT PERMITTED Concentration set exceeds hard max limit or is under hard minimum limit Check concentration and adjust to a more appropriate amount WEIGHT ABOVE LIMIT Patient wei...

Страница 35: ...mber Flanges Pull back handles 1 Remove the Flow Sensor Interface Cover and store for future use 2 Plug the flow sensor into the flow sensor interface located on the top rear part of the Pump 3 Attach...

Страница 36: ...surements are for guidance only IEC EN60601 1 limits are defined below Earth Leakage Current Normal Condition 500 A Enclosure Leakage Current Normal Condition 100 A Protective Earth Resistance 200mOhm...

Страница 37: ...5 C 4 7 7 10 40 C 4 7 7 10 Note The Pump does not display negative pressure values Maximum Pumping Pressure 880mmHg Post Downstream Occlusion Bolus Bolus volume generated at 25ml h when the minimum d...

Страница 38: ...fined as Set Rate less than 1 0ml h Recommended infusion set 70593 Needle 18gauge x 40mm Solution Type De ionized and Degassed Water Temperature 23 C 2 C Fluid Head Height 300 10mm Back Pressure 0 10m...

Страница 39: ...60VA Maximum Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115 230V 50 60Hz 60VA The Alaris DS Docking Station Product SKU 80283UNS00 xx Supply Voltage...

Страница 40: ...ength 300cm 70693E SmartSite Needle Free Valve Port 15 Micron Filter Length 265cm 70793E 2 SmartSite Needle Free Valve Ports Length 265cm 70123E 2 SmartSite Needle Free Valve Ports Light protected Inl...

Страница 41: ...2946NE 1 SmartSite Needle Free Valve Port Length 30cm 72948NE 1 SmartSite Needle Free Valve Port Male Luer with Backcheck Valve Inline 0 2 micron Filter Length 50cm 72951NE 1 SmartSite Needle Free Val...

Страница 42: ...are referenced on www carefusion com Copies can be obtained by contacting your local CareFusion representative A Please refer toTechnical Service Manual for calibration procedures The units of measur...

Страница 43: ...ce discoloration Concentrated Isopropyl alcohol based cleaners will degrade plastic parts Aromatic Hydrocarbons such as chlorohydrocarbons e g Anti static foam cleaner Recommended cleaners are Brand C...

Страница 44: ...ectronic 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 informa...

Страница 45: ...e of the RS232 cable Any connected analogue and digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additional devices to the...

Страница 46: ...tered 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 therapeutic effect cannot...

Страница 47: ...5 30 35 Time minutes Observation Window minutes Maximum Error Minimum Error Overall Mean 1 0 Trumpet Graph at 25 0ml h Initial Period Trumpet Graph at 25 0ml h After 72 Hours Error 10 8 6 4 2 0 2 4 6...

Страница 48: ...on the World Wide Web at www carefusion co uk alaris technical A username and password are required to access our manuals Please contact a local customer services representative to obtain login detail...

Страница 49: ...e Molen 8 10 3994 DB Houten Nederland CareFusion 10020 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...

Страница 50: ...ntains proprietary information of CareFusion 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 produ...

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