BD 9002TIG03, Directions For Use Manual

Page 1: ...Alaris GP Guardrails Volumetric Pump with Plus Software Models 9002TIG03 9002TIG03 G Directions For Use en ...

Page 2: ...10 Using Collapsible bags Glass Bottles Semi Rigid containers 10 Steps for the Collapsible bags 10 Steps for Semi rigid containers 10 Operating Environment 10 Operating Pressure 11 Alarm Conditions 11 Electromagnetic Compatibility and Interference 11 Earth Conductor 11 Hazards 12 Getting Started 13 Initial Set Up 13 Power Input 13 Factory Default Data Set 13 Pole Clamp Installation 14 Docking Stat...

Page 3: ... SmartSite Needle Free System Instructions 26 Secondary Piggyback Infusions 27 Setting up a secondary infusion 27 Typical Secondary infusions 27 Service Configuration Mode 28 Alarm Presets 28 Configured Options 28 Date Time 28 Pump Reference 28 Language 28 Backlight Contrast 29 Pump Configuration available via the Alaris Editor Software 29 Data Set Configuration Settings 29 General Pump Configurat...

Page 4: ...tions 48 Battery Specifications 48 Memory Retention 49 Alarm Conditions 49 IrDA RS232 and Nursecall Specification 50 IrDA RS232 Nursecall Feature 50 RS232 Nursecall Connection Data 50 IrDA 50 Infusion Specifications 51 System Accuracy 51 Occlusion Alarm Limits 51 Maximum Pumping Pressure 51 Maximum Occlusion Alarm Pressure 51 Post Downstream Occlusion Bolus 51 Bolus Volume Accuracy 51 Maximum time...

Page 5: ...ions The Alaris GP Volumetric Pump and Alaris GP Guardrails Volumetric Pump are indicated for the infusion of fluids medications parenteral nutrition blood and blood products through clinically acceptable routes of administration such as intravenous IV subcutaneous or irrigation of fluid spaces The Alaris GP Volumetric Pump and Alaris GP Guardrails Volumetric Pump are indicated for use on adults a...

Page 6: ...00 unique drug protocol set ups 2 Master List Using the Alaris Editor Master Drug List A BD defined drug is a usability aid to pre populate drug names for the Master Drug Lists Alternate drug names and concentrations can be created 3 Review approve and export data set Review and Approve Entire data set report to be printed reviewed and signed as proof of approval by an authorised person according ...

Page 7: ...Hold Options AC power indicator Softkeys Chevrons Mute Pressure Battery indicator On Off Door Door Lever Flow sensor connector RS232 Nursecall connector cover removed for clarity Release lever for rotating cam Folded pole clamp Rotating cam to lock onto horizontal rectangular bars Mains fuses cover Mains inlet IR communications port Potential Equalisation PE Connector Handle Medical device interfa...

Page 8: ...ss 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 is not connected to a patient Volume infused VI is not added to the total volume infused displayed BOLUS fluid or drug delivered at an accelerated rate Pump is infusing Infusion set is connected to patient Volume infus...

Page 9: ...ied part Degree of protection against electrical shock IP33 Protected from solid objects greater than 2 5mm Protected against direct sprays up to 60 from the vertical r Alternating Current Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC T Date of Manufacture t Manufacturer Connector for Flow Sensor U Not for Municipal Waste W Fuse rating 40 C 0 C Opera...

Page 10: ... Identifiers Clear Volume Infused Set VTBI Option ADRENALINE RATE VOLUME VTBI 25 0 ml h µg kg 24h 16 7 1h 48m 00s VTBI VOLUME ml ml 45 0 50 0 c ON HOLD RATE SET RATE WITH ON HOLD RATE RATE TOO LOW ON HOLD RATE RATE TOO HIGH If programmed rate is greater than the Infusion Rate Max in drug protocol message c will be shown Screen Icons Symbol Description Time remaining display icon Indicates time rem...

Page 11: ...ies 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 Follow steps 1 to 3 as shown for the semi rigid containers however do not open vent as in step 4 but prime the set as per step 5 Ensure the bag outlet is fully pierced before filling the drip chamber Steps for Semi rigi...

Page 12: ...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 BD representative for further guidance Accesso...

Page 13: ...re 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 Qualified Service Personnel 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 Warning ...

Page 14: ...l for investigation Power Input The Pump is powered from the AC supply through a standard IEC AC connector When connected to the AC supply the AC Power indicator is illuminated w To isolate the Pump from AC supply remove the AC connector from the source socket The Pump should be positioned to allow access for disconnecting the AC connector Factory Default Data Set The Pump is supplied with the fol...

Page 15: ...not in use Docking Station Workstation or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or equipment rails measuring 10mm by 25mm 1 Align the rotating cam on the rear of the Pump with the rectangular bar on the Docking Station Workstation or the equipment rail Rectangular bar Release lever push to release Rotating cam Alaris GP...

Page 16: ...p slider out as shown To move the slider into the non occluded position manually push up Safety Clamp Tab and push Safety Clamp Slider completely into Frame NO FLOW Clamp is in OCCLUDED POSITION Æ Ê 1 Push up 2 Push w w 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...

Page 17: ...e closed clamped Opening the air vent too soon can wet the filter and prevent flow 2 Spike fluid container ensuring spike is fully inserted into the container Where possible the fluid in container should be at room temperature Spike being fully inserted ensures the fluid path from the container is fully open 3 Fill the drip chamber to at least full Do not overfill the drip chamber when using a flo...

Page 18: ...Pumping mechanism Safety Clamp retainer Orange Air in line sensor Tubing guide Alaris Safety Clamp Orange i Fit top adaptor of infusion set into top set retainer Top Set Retainer ii Insert Safety Clamp into retainer Avoid any stretching of the silicone segment when loading priming and re loading the infusion set Safety Clamp w Pushing on the Safety Clamp Slider may lead to uncontrolled flow to the...

Page 19: ...Ensure infusion set is fully inserted into tubing guide and all air is removed from the infusion set Tubing Guide 8 Close door and open roller clamp Ensure no drops are falling in the drip chamber 9 Ensure all air is removed from the set 10 Connect the infusion set to the patient access device ...

Page 20: ...and profile name a Press YES softkey to confirm current profile and go to step 6 b Selecting NO will display the profile selection screen select correct profile usingf keys and press OK softkey to confirm Confirm profile screen will display again press YES softkey and SELECT screen will be displayed go to step 6 Note The CONFIRM PROFILE screen is only shown if more than one profile For Alaris GP G...

Page 21: ...T 1 Select DOSING ONLY from the list using the f keys 2 Press OK to confirm 3 Select the dosing units from the list using the fkeys press OK to confirm 4 Enter DRUG AMOUNT using the f keys and if units need to be changed select UNITS which will scroll through the units available Press OK to confirm selection 5 Use the fkeys to select the TOTAL VOLUME2 press OK to confirm 6 Enter WEIGHT1 using the ...

Page 22: ...c Select the END RATE using the f keys to scroll through the on screen choices d Press the OK softkey to confirm and exit the END RATE menu or 2 Using the BAGS softkey a Press the VTBI softkey on main display to enter the volume to be infused screen b Select the BAGS softkey select the required bag volume using the f keys and press OK to confirm the selection c Press OK to confirm again or adjust ...

Page 23: ...button allows the delivery of a limited volume of fluid in order to prime the infusion set prior to being connected to a patient 1 Press a key to switch the Pump on 2 Load the infusion set Refer to Loading an infusion set section 3 Follow the Starting the Infusion section but do not connect the infusion set to the patient until the set has been primed 4 Open the roller clamp 5 Press i button to di...

Page 24: ... delivery rate 4 Press the flashing BOLUS softkey once to begin the delivery of the preset bolus The display will show the bolus being delivered by the bolus counting down and will revert to the main display upon completion of the bolus 5 To terminate a bolus being delivered press STOP softkey This will stop the bolus and continue infusing at the set rate Press the h button to stop the bolus deliv...

Page 25: ...recisely 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 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 select the set by flowrate option the arrow on the display will automatically select the flow...

Page 26: ...softkey to confirm 3 Select HIGH MEDIUM or LOW using the fkeys 4 Press OK softkey to confirm or QUIT to exit screen Event Log This option allows the event log to be reviewed The event log holds up to 99 960 events When the log is full the oldest events will be overwritten by the newest occurring events 1 Press the d button to access the options menu 2 Select EVENT LOG using the fkeys and press OK ...

Page 27: ...ner use aseptic technique according to hospital protocol It is recommended that infusion sets are changed in accordance with the Directions For Use Carefully read the Directions For Use supplied with the infusion set prior to use SmartSite Needle Free System Instructions SmartSite Needle Free Valve is designed to permit safe gravity flow and automated flow injection and aspiration of fluids withou...

Page 28: ...o 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 1 Ensure Primary infusion has been setup in ml h rate 0ml h 2 Press h to put the Pump ON HOLD 3 Press d to access the OPTIONS screen 4 Select SECONDARY SETUP press OK to confirm 5 Select either ml h or DRUGS A Z Press OK to confirm ei...

Page 29: ...ty alarms on the Workstation beacon and a low priority alarm on the Pump Additionally for certain information signals e g those associated with Add Drug Not Complete and Titration Not Confirmed the Workstation beacon will illuminate while the beacon on the pump will not In the event of an alarm priority mismatch the User should refer to the alarm on the Pump for the correct priority Configured Opt...

Page 30: ...erved for restoration at the next power up Battery Icon Controls whether or not the battery icon which indicates state of charge is displayed Callback Time The time that is allowed to elapse between the user s last recorded interaction with the Pump and generation of a callback alarm Drug Override Mode Always Any changes made to the dose rate that are outside of the Guardrails Soft Alerts will req...

Page 31: ...n limit Infusion Rate Max The maximum permissible infusion rate KVO Rate The maximum infusion rate when performing KVO delivery Near End of Infusion Point The point defined in terms of remaining time at which the infusion is deemed to be Near end i e nearly complete Primary VTBI Max The maximum VTBI for primary infusions Prime Rate The rate at which priming is performed Prime Volume Max Determines...

Page 32: ...y method 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 weight based units are enabled or disabled for use Bolus Dose Default The default bolus dose for this drug Applies to Hands free bolus Bolus Dose Soft Min For Alaris GP Guardrails Volumetric ...

Page 33: ...eptions are DO NOT USE and BATTERY EMPTY Display Infusion Status Cause s Action AIR IN LINE Infusion stopped Single air bubble exceeds alarm limit Set not fitted correctly into air in line detector Assess the amount of air detected by air in line detector Opening the door may cause an air bubble to rise in the set Check set for air Remove air according to hospital policy Ensure set is fitted corre...

Page 34: ... SAFETY CLAMP Pump on hold Safety clamp broken or missing Clamp infusion set using roller clamp Replace infusion set Investigate and correct set loading SET MISLOAD Pump on hold Set loaded incorrectly Clamp infusion set using roller clamp Investigate and correct set loading FLOW SENSOR DISCONNECT Infusion stopped Flow sensor unplugged during infusion Check replace flow sensor or set VTBI WRONG SET...

Page 35: ...on If pump was on hold the alarm will still be activated but this message will not be displayed Attention Tones Attention tones 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 See the Alarm Priority Level Indicators table for more details on how Attention tones are indicated 1 Check the display for m...

Page 36: ...he 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 have exceeded alarm limit Multiple bubbles smaller than the single bubble alarm limit have been detected at 1ml over a rolling 15 minute window period Review infusion set for air bubbles and take appropriate action Check level of fl...

Page 37: ...ate and correct set loading SET MISLOAD Pump on hold Set loaded incorrectly Clamp infusion set using roller clamp Investigate and correct set loading FLOW SENSOR DISCONNECT Infusion stopped Flow sensor unplugged during infusion Check replace flow sensor or set VTBI WRONG SET Pump on hold Safety clamp not detected Clamp infusion set using roller clamp Check set and close door Replace infusion set I...

Page 38: ...the Alarm Priority Level Indicators table for more details on how low priority alarms are indicated 1 Check the display for message Press R to silence the sound for 2 minutes or press a second time to re enable alarm audio CANCEL to clear the message 2 Rectify the cause of the alarm or proceed with caution Display Infusion Status Cause s Action ATTENTION Pump on hold Pump left on hold for 2 minute...

Page 39: ...ting and adjust to appropriate required rate RATE NOT PERMITTED Pump on hold If titration is disabled Infusion continues If titrating Infusion rate set exceeds a hard limit Check infusion setting and adjust to appropriate required rate CONCENTRATION NOT PERMITTED Pump on hold Concentration set exceeds hard max limit or is under hard minimum limit Check concentration and adjust to a more appropriat...

Page 40: ...rugs or fluids which are known to have a tendency to degas are being infused with a potential consequence of an increase of air accumulation within a patient s circulation At an elevated risk of suffering potential consequences of air ingress are patient groups with Atrial Septal Defects It is therefore recommended for this group that in addition to the existing air in line detection mechanism of ...

Page 41: ...BI Alaris Guardrails GP Alaris Guardrails GPplus IVAC Model 180 Flow Sensor Handles Drip chamber Flanges Pull back handles 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 ...

Page 42: ...ons in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use Alaris GP standard infusion sets with filter 60093E 2 SmartSite Needle Free Valve Ports 15 Micron Filter 1 Backcheck Valve Length 270cm 60693 1 Injection Port 15 Micron Filter Length 255cm 60693E 1 SmartSite Needle Free Valve Port 15 Micron Filter Length 255cm 60793 2 Inje...

Page 43: ...rtSite Needle Free Valve Port 1 Backcheck Valve No Filter Length 265cm 63420EB 2 SmartSite Needle Free Valve Ports 1 Backcheck Valve No Filter Length 295cm Model Number 63420E Artwork Number 1000AW03038 Change History Issue Change Order Change description Drawn by Date 1 7208 Introduction Angela Coles 13 10 06 63423BE 3 SmartSite Needle Free Valve Ports 1 Backcheck Valve No Filter Length 285cm Ala...

Page 44: ...12 10 06 Alaris GP syringe adapter infusion sets 63280NY Length 270cm wRestricted to maximum infusion rate of 150ml h Model Number 63280NY Artwork Number 1000AW03037 Change History Issue Change Order Change description Drawn by Date 1 7208 Introduction Angela Coles 13 10 06 Alaris GP oncology infusion sets 60950E 5 SmartSite Needle Free Valve Ports 15 Micron Filter Length 260cm 60951E 3 SmartSite ...

Page 45: ...0VA Maximum Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115 230V 50 60Hz 60VA The Alaris DS Docking Station Product SKU 80283UNS00 xx Supply Voltage 230VAC 50 or 60Hz Electrical Rating 500VA nominal Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 20VA max 230V 50 60Hz y Connectivity option 1 2 or 3 xx...

Page 46: ...f charge by contacting your local BD representative An estimated delivery time will be provided when the order is placed w Please refer to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI The International System of Units units Battery Operation The internal rechargeable battery allows continued operation when the AC pow...

Page 47: ...e single use item and should be discarded after use according to hospital protocol Cleaning the Flow Sensor Before the transfer of the flow sensor to a new infusion set and periodically during use clean the flow sensor by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Ensure the connector does not get wet Dry flow sensor before us...

Page 48: ...ng 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 Usymbol is only valid in the European Union The product should be disposed of taking environmental factors into consideratio...

Page 49: ... 100µA Protective Earth Resistance 200mOhms Classification Continuous mode of operation Portable Equipment AC Power Supply 100 230 VAC 50 60Hz 60VA Maximum Fuse Type 2 X T 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 IP33 Protected against direct sprays up to 60 from the vertical Environmental Specifications C...

Page 50: ...BI DONE SET VTBI DOSE UNDER DOOR OPEN BATTERY LOW SET NOT FITTED DOSE NOT PERMITTED DOWNSTREAM OCCLUSION AIR IN LINE LOCKED RATE NOT PERMITTED UPSTREAM OCCLUSION TITRATION ADD DRUG WEIGHT ABOVE LIMIT NO FLOW SET CLOCK WEIGHT BELOW LIMIT FLOW ERROR RATE LOCK CONCENTRATION NOT PERMITTED FREE FLOW LOG FAILURE BOLUS DOSE NOT PERMITTED BATTERY EMPTY SET SERIAL NUMBER BOLUS DOSE WOULD EXCEED SAFETY CLAM...

Page 51: ...re should include detection of the disconnection or other failure 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 signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 To c...

Page 52: ...reshold is reached 0 95 ml Bolus Volume Accuracy Typical 4 1 Max 3 2 Min 5 5 1ml 10ml h Typical 1 3 Max 0 9 Min 1 6 100ml 1200ml h 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 82 35 minutes Maximum 112 min At Maximum Pressure time to alarm at 1 0ml h ...

Page 53: ...sposable 60593 Needle 18 gauge x 40 mm Solution Type De ionized 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 3 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 contin...

Page 54: ...p 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 Af...

Page 55: ...er 24 Hours Flow Rate ml h 5 0 5 10 15 20 25 30 35 40 45 50 0 10 20 30 40 50 60 70 80 90 100 110 120 Error Trumpet Graph at 25 0 ml h After 24 Hours 15 10 5 0 5 10 15 0 5 10 15 20 25 30 35 Time minutes Observation Window minutes Maximum Error Minimum Error Overall Mean 0 4 Trumpet Graph at 25 0ml h Initial Period Trumpet Graph at 25 0ml h After 72 Hours Error 15 10 5 0 5 10 15 0 5 10 15 20 25 30 3...

Page 56: ... technical A username and password are required to access our manuals Please contact a local customer services representative to obtain login details Part Number Description 1000SP00487 Internal Battery Pack 1000SP01183 RS232 Cable 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European Alaris Editor Software Part Number Description 1000SP01462 Alaris Editor and Alaris Transfer Tool Softwa...

Page 57: ...Italia 39 02 48 24 01 customer service italy bd com Magyarország 36 1 488 0233 info cfn export bd com Nederland 31 0 20 582 94 20 info benelux bd com New Zealand Freephone 0800 572 468 NZ_customerservice bd com Norge 47 64 00 99 00 bdnorge bd com Polska 48 22 377 11 00 Info_Poland bd com Portugal 351 219 152 593 dl pt geral carefusion com South Africa Freephone 0860 597 572 27 11 603 2620 bdsa_cus...

Page 58: ...kinson and Company 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 Becton Dickinson and Company or one of its affiliates is strictly forbidden t BD Switzerland Sàrl Route de Crassier ...