BD Alaris neXus GPneXus1 Directions For Use Manual Download Page 4

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BD Alaris™ neXus GP Volumetric Pump

BDDF00558 Issue 5

3/72

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Summary of Contents for Alaris neXus GPneXus1

Page 1: ...BD Alaris neXus GP Volumetric Pump Model GPneXus1 en Directions For Use ...

Page 2: ... 13 Initial Set Up 13 Power Input 13 Wi Fi Configuration 13 Factory Default Data Set 14 Pole Clamp Installation 15 Workstation or Equipment Rail Installation 16 Alaris Safety Clamp 17 Operating Precautions 18 Operation 22 Loading an Infusion Set 22 Flow Sensor Operation Optional 25 Starting the Infusion 26 Changing the Infusion Set 28 Changing the Fluid Container 28 Advanced Features 29 Drugs and ...

Page 3: ... Piggyback Infusions 38 Alarms 40 ORIGINAL ALARMS 40 3RD EDITION ALARMS 45 Prompts 49 Advisories 49 Restarting an Infusion following an Air in Line Alarm 50 Configuration 51 Configured Options 51 BD Alaris neXus Editor Software Profile Configuration 52 Drug Library available via the BD Alaris neXus Editor Software 54 Display of Units 54 Associated Products 55 Alaris Gateway Workstation v1 3 x or v...

Page 4: ...BD Alaris neXus GP Volumetric Pump BDDF00558 Issue 5 3 72 Contact Us 72 Customer Service Information 72 ...

Page 5: ...nced in this manual for example Battery Indicator PURGE ON OFF button Single quotes Used to indicate cross references made to another section of this manual For example see Flow Sensor Operation Italics Used to refer to other documents or manuals For example refer to the relevant Directions For Use for further information Also used to define custom terminology specific to a manual e g The BD Alari...

Page 6: ... Gateway Workstation or via hospital Wi Fi Pump infusion data logs and configuration information will be automatically collected Note Any serious incident that occurs in relation to this Pump should be reported to the manufacturer and to the relevant local regulatory authority Intended Purpose The BD Alaris neXus GP Volumetric Pumps are used within hospitals healthcare facilities and during medica...

Page 7: ...metric Pump is contraindicated for enteral or epidural therapies Undesirable Side Effects The BD Alaris neXus GP Volumetric Pump has no undesirable side effects associated with its use when used in accordance with the Directions for Use Compatibility The BD Alaris neXus GP Volumetric Pump is compatible with the following The Alaris Gateway Workstation v1 3 x and v1 6 x see Associated Products Stan...

Page 8: ...ever Control keys and indicators See overleaf Flow sensor connector RS232 Nursecall connector cover removed for clarity Release lever for rotating cam Folded pole clamp Rotating cam to lock on to horizontal rectangular bars AC Power fuses cover AC Power inlet IR communications port Potential Equalisation PE connector Handle Medical Device Interface MDI ...

Page 9: ...tkey 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 infused VI is added to the...

Page 10: ...ge a will be displayed b ON HOLD RATE SET RATE WITH ON HOLD RATE RATE TOO LOW ON HOLD RATE RATE TOO HIGH If programmed rate is between 0 0ml h and 0 1ml h exclusive in drug protocol message b will be shown Main Display If VTBI is set Dose Rate Volume to be Infused Volume Infused Time remaining ADRENALINE RATE VOLUME VTBI 25 0 ml h µg kg 24h 16 7 1h 48m 00s VTBI VOLUME ml ml 45 0 50 0 WiFi Infusion...

Page 11: ...e value entered is outside of the Soft Limits as defined in the data set The warning can be overridden Indicates Guardrails safety protocol is in use Indicates that the value entered is outside of the Guardrails Hard Limits as defined in the data set The warning cannot be overridden This symbol is also used to prompt the User to set the rate Indicates that the Pump is running at a rate below point...

Page 12: ...an 2 5mm Protected against direct sprays up to 60 from the vertical Alternating Current Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Date of Manufacture Manufacturer Connector for Flow Sensor U Not for Municipal Waste Fuse rating 40 C 0 C Operating Temperature limit 20 C 50 C Transport and Storage Temperature limit 15 95 Transport and Storage Humidi...

Page 13: ...BD Alaris neXus GP Volumetric Pump Overview BDDF00558 Issue 5 12 72 Keep Dry Catalogue number Serial Number Medical Device ...

Page 14: ...eing connected to the power supply Should the Pump fail to perform correctly replace in its original protective packaging where possible and contact Qualified Service Personnel for investigation Power Input The Pump is powered from the AC Power supply through a standard IEC AC Power connector or the Alaris Gateway Workstation Workstation when docked When connected to the AC Power supply the AC Pow...

Page 15: ... Lock Disabled mg kg min Bolus Mode Hands On Only mg kg h Bolus Rate Default 500ml h g h Bolus Rate Max 1200ml h U h Bolus Volume Max 5ml U kg h Weight Default 1kg mmol h Weight Soft Min 1kg mmol kg min Weight Soft Max 150kg mmol kg h AIL Limit 100µL Primary VTBI Max 9999ml Secondary Infusion Disabled Prime Rate 200ml h Prime Volume Max 20ml Near End of Infusion 5 minutes KVO 5ml h Refer to Displa...

Page 16: ...e for examination by Qualified Service Personnel The pole clamp is fitted to the rear of the Pump and will provide secure fixing to vertical IV poles of a diameter between 15 and 40mm 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 Recessed area Never mount...

Page 17: ... the Workstation 4 To release push the release lever and pull the Pump forwards Note The Pump will stop communicating over Wi Fi once docked to a Workstation and will disable its internal wireless module The Pump will instead use the Workstation as a conduit for connecting to BD Alaris Communication Engine as long as the Workstation is powered on and is functional Alaris GP Rectangular bar Release...

Page 18: ...amp 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 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 p...

Page 19: ...ittings 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 and Semi rigid containers It is recommended that the air ven...

Page 20: ...l 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 The Pump is suitable for use in hospital and clinical environments other than domestic establishments that have access to single phase AC power supply This Pump is not intended to be used in the presence of a flammable anaesthetic m...

Page 21: ... local BD representative for further guidance The Pump is compatible with HF surgical equipment provided the Pump is located at distance greater than 15cm 6 inches from the active component of the HF surgical device Direct contact between HF surgical equipment and the Pump and or associated accessories and cabling must be avoided Accessories Do not use any non recommended accessory with the Pump T...

Page 22: ...humidity or high temperature or otherwise suspected to have been damaged remove it from service for inspection by Qualified Service Personnel When transporting or storing the Pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging If this Pump behaves abnormally remove from service and contact...

Page 23: ...ible Step Notes 1 Remove infusion set burette from packaging apply roller clamp ensure air vent s are 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 f...

Page 24: ...iner higher than the minimum height when possible to minimise loops and kinks in the infusion set tubing 45cm minimum 6 Close roller clamp 7 Open door and load infusion set as follows Ensure infusion set tubing above the Pump is as straight as possible with no kinks Top set retainer Blue Adaptor on infusion set Blue Pumping mechanism Safety Clamp retainer Orange Air in line sensor Tubing guide Ala...

Page 25: ...ion set Safety Clamp 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 iii 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...

Page 26: ...Flow Sensor Handles Drip chamber Flanges Pull back handles Flow sensor interface 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 the IVAC Model 180 Flow Sensor to the drip chamber of the infusion set by pulling back the handles Refer to the illustration above 4 Proceed with loa...

Page 27: ...00ml h VTBI 46 5ml VOLUME 3 5ml YES NO CLEAR SETUP VIEW WITH CLEAR SETUP PROFILE NAME CONCENTRATION 0 50mg 50ml 0 01mg ml RATE 150ml h 0 00mg kg min VTBI 100ml 1 00mg YES NO VIEW WITH CLEAR SETUP PROFILE NAME PRIMARY SETUP RATE 300 ml h VTBI 50 0 ml SECONDARY SETUP RATE 150 ml h VTBI 95 0 ml YES NO VIEW WITH DATA SET OK Name SCBU Data Set Released 11 Nov 2018 12 34 Version 10 ID 8033 NEW DATA SET ...

Page 28: ...ing VTBI over Time section 10 Enter or adjust the RATE if necessary using the f keys 11 Press b key to start the infusion INFUSING will be displayed Note The green run LED will flash to show that the Pump is infusing Note If the BD Alaris Communication Engine is deployed at the facility and the Pump is not docked to a Workstation it is recommended to wait until the Pump connects via Wi Fi prior to...

Page 29: ...r Use 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 Changing the Fluid Container 1 Press h to put the Pump ON HOLD 2 Remove bag spike on infusion set from empty used container Discard empty used container according to hospital protocol 3 Insert the bag spike into the fluid co...

Page 30: ...ss the OK softkey to confirm the selection ml h SELECT OK 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 if necessary 2 Press OK to confirm 3 Enter the ml h rate as prompted on the display in the next screen Dosing Only SELECT OK 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 SELEC...

Page 31: ...OLUME 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 Setting a VTBI VTBI OK BACK SELECT WITH 1500ml 1000ml 500ml 250ml 200ml 100ml 50ml 0ml OFF This feature allows a specific volume to be infused to be set...

Page 32: ...ould not be used 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 Pump are configured in the data set via BD Alaris neXus Editor by profile and by drug Priming the Infusion Set Ensure the infusion set is not connected to a patient before priming the set The pri...

Page 33: ... is temporarily increased to the maximum level L8 Bolus Mode Enabled HANDSON and HANDSON and HANDSFREE RATE SET WITH BOLUS QUIT VOLUME HOLD KEY BELOW 0 0ml 80ml h BOLUS BOLUS Enabled HANDSON Only In HANDSON bolus 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 data set via the BD Alaris neXus Editor 1 During ...

Page 34: ...top and the Pump will revert to infuse at the set infusion rate and continue infusing Note Rate may be restricted by the BOLUS RATE MAX which is configured in the data set via BD Alaris neXus Editor Note If the bolus exceeds the Guardrails Soft or Hard Limits a prompt will display Note The bolus rate will be automatically set to the current infusion rate when the default bolus rate is lower than t...

Page 35: ...e will be calculated from the dose rate To precisely set a flow rate the arrow must be pointing to flow rate ml h the dose rate will be calculated from the flow rate 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 flow rate option the arrow ...

Page 36: ...select BAGS softkey to set the VTBI When the desired volume has been reached press the OK softkey 4 Enter the time over which the volume is to be infused using the f keys The infusion rate will automatically be calculated 5 Press OK softkey to enter the value or BACK to return to the VTBI Adjust Alarm Volume This option allows adjustment of the volume if enabled in the data set via BD Alaris neXus...

Page 37: ...tatus This option allows information about the wireless network connection status to be viewed by Qualified Service Personnel Refer to the Technical Service Manual for the description of network data displayed on these screens 1 Press the d button to access the OPTIONS menu 2 Select Network Status using the f keys Press OK to confirm 3 Enter password to see the NETWORK STATUS information 4 Navigat...

Page 38: ...s swab top of Needle Free Valve port with 70 isopropyl alcohol 1 2 seconds and allow to dry approximately 30 seconds Note Dry time is dependent on temperature humidity and ventilation of the area 2 Prime valve 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 chang...

Page 39: ...mary 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...

Page 40: ...on Hook approx 26cm Normally included with the secondary Infusion set Primary fluid container must hang lower to allow the secondary infusion to run and primary infusion to restart on completion of the secondary infusion Primary Fluid Container Primary Infusion set e g 63420E with an upper Y Site SmartSite Needle Free Valve IV Pole Check Valve Prevents secondary infusions from flowing back up the ...

Page 41: ... how high priority alarms are indicated Alarms can be addressed in the following manner 1 Check the display for an alarm message and review table below for cause and action Press R to silence the sound for two minutes or press a second time to re enable alarm audio CANCEL to clear the message The CANCEL feature clears the alarm signal but the signal will return if the alarm condition still exists ...

Page 42: ...level in the drip chamber Consider if the 15µm filter in the drip chamber is blocked or partially blocked Ensure the infusion set has not been used for more than 72 hours If alarm continues consider changing the infusion set In the case of multiple alarms consider a blockage in the filter or air vent as a cause NO FLOW Infusion stopped Flow sensor detects no flow Check flow sensor Check fluid leve...

Page 43: ...VTBI WRONG SET Pump on hold Safety clamp not detected Clamp infusion set using roller clamp Check set and close door Replace infusion set If necessary DOOR CLOSE INCOMPLETE Pump on hold Safety clamp in non occluded position with door open or obstructed Clamp infusion set using roller clamp Investigate and correct set loading Close door DO NOT USE Pump on hold infusion stopped Internal error has oc...

Page 44: ...wer cable VTBI DONE KVO Continue Infusing KVO or set rate Intended VTBI completed Set new VTBI or clear VTBI AIR IN LINE Pump on hold 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 Assess air in infusion set Check fluid level in drip chamber Check level of fluid in container LOG FAI...

Page 45: ...uired Press d to access OPTIONS menu Select DRUGS A Z using the f keys Press OK to confirm TITRATION Infusion continues Rate titration not confirmed Confirm or cancel new rate RATE LOCK Infusion continues Rate lock not confirmed Note After five seconds the User will be notified by an auditory cue After two minutes have expired a medium priority alarm is generated Select YES or NO as required KVO I...

Page 46: ...e 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 correctly in the air in line detector Check level of fluid in container Check enough fluid left in drip chamber Restart...

Page 47: ... filter or air vent as a cause NO FLOW Infusion stopped Flow sensor detects no flow Check flow sensor Check fluid level in container Ensure all clamps above Pump are open Ensure drip chamber is half filled Ensure that the bag spike is inserted correctly Check flow sensor is clean FLOW ERROR Infusion stopped Gross difference between detected drops and expected amount of drops Clamp infusion set usi...

Page 48: ... hold Serial number not set Contact Qualified Service Personnel to set the serial number Medium Priority Alarms Medium priority alarms 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 medium priority alarms are indicated 1 Check the...

Page 49: ...m RATE LOCK Infusion continues Rate lock not confirmed Select YES or NO as required AC POWER FAIL Infusion continues AC power disconnected or failed Reconnect to power supply NEAR END OF INFUSION Infusion continues Less than XX Configurable minutes of infusion remaining Set new VTBI Prepare new fluid container Refer to Changing the Fluid Container section TITRATION Infusion continues Rate titratio...

Page 50: ...ing 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 appropriate...

Page 51: ...nown 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 the Pump an air venting fi...

Page 52: ...keys and press the OK softkey 2 Use the f keys to select alternative alarm tones 3 When the desired alarm tone has been selected press OK softkey 4 To cancel and return to CONFIGURATION menu press QUIT softkey All Pumps in a single care area should be configured with the same alarm tones to avoid User confusion The Hospital Facility is responsible for selecting and configuring the desired alarm sc...

Page 53: ...pse 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 require confirmation before starting infusion Smart Confirmation of setting will be required on first dose rate set outside of the Guardrails Soft Alert Any subsequent changes will not requi...

Page 54: ...x 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 the maximum volume that...

Page 55: ...ings 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 The minimum bolus dose that the Pump allows before the ...

Page 56: ...ateway Workstation v1 3 x or v1 6 x Product SKU 80300UNSy xx or 80223UNSy xx Supply Voltage 115 230V AC 50 60Hz Electrical Rating 460VA Maximum Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115 230V 50 60Hz 60VA y Connectivity option 1 2 or 3 xx Configuration ...

Page 57: ...the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use 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 I...

Page 58: ...duction Angela Coles 13 10 06 63402BE 1 SmartSite 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...

Page 59: ...o Filter Length 295cm Model Number 63260NY Artwork Number 1000AW03031 Change History Issue Change Order Change description Drawn by Date 1 7208 Introduction Angela Coles 12 10 06 Syringe Adapter Infusion Sets 63280NY Length 270cm w Restricted 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...

Page 60: ...ndary Infusion Sets 72213N 0006 Male Luer and hanger Length 76cm 72951NE For use with 60950E 1 SmartSite Needle Free Valve Port Male Luer with Backcheck Valve Length 35cm Do not use with Pump in secondary infusion mode when infusing critical drugs Note These drawings are not to scale ...

Page 61: ...our local BD representative An estimated delivery time will be provided when the order is placed 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 power is unavailable for exam...

Page 62: ...litate cleaning of the fluid path the use of a screwdriver Torx is required and should only be carried out by Qualified Service Personnel Cleaning and storing the infusion set The infusion set is a disposable single use item and should be discarded after use according to hospital protocol Cleaning the Flow Sensor Before the transfer of the flow sensor to a new infusion set and periodically during ...

Page 63: ...ronic products should not be mixed with household waste If you wish to discard electrical and electronic equipment please contact your BD 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 h...

Page 64: ...for guidance only IEC EN 60601 1 limits are defined below Earth Leakage Current Normal Condition 500µA Enclosure Leakage Current Normal Condition 100µA Protective Earth Resistance 200mOhms Classification Continuous mode of operation Portable Equipment AC Power Supply 100 to 230V AC 50 to 60Hz 60VA Maximum Fuse Type 2 X T 1 25H 250V Dimensions 148mm w 225mm h 148mm d Weight approx 2 85kg excluding ...

Page 65: ...ith the rules and regulations in the locations where the Pump is sold Network settings are programmed by Qualified Service Personnel using BD Alaris Technical Utility Wi Fi network standards 802 11a Wi Fi 2 802 11b Wi Fi 1 802 11g Wi Fi 3 and 802 11n Wi Fi 4 Frequency band of operation 2400 2483 5MHz for 2 4GHz effective radiated power 18dBm 5150 5350MHz and 5470 5725MHz for 5GHz effective radiate...

Page 66: ...T SERIAL NUMBER RATE NOT PERMITTED UPSTREAM OCCLUSION BATTERY LOW CONCENTRATION NOT PERMITTED NO FLOW VTBI DONE KVO Continue WEIGHT ABOVE LIMIT FLOW ERROR AIR IN LINE WEIGHT BELOW LIMIT FLOW ERROR Secondary mode LOG FAILURE BOLUS DOSE NOT PERMITTED FREE FLOW SET NOT FITTED BOLUS DOSE WOULD EXCEED BATTERY EMPTY AC POWER FAIL BOLUS DOSE UNDER SAFETY CLAMP NEAR END OF INFUSION SET MISLOAD ATTENTION F...

Page 67: ...de 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 EN 60601 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 EN 60601 1 1 To connect to the...

Page 68: ...s reached 0 16ml Bolus volume generated at 25ml h when the maximum occlusion alarm threshold is reached 0 95ml Bolus Volume Accuracy Typical 4 1 Max 3 2 Min 5 5 1ml at 10ml h Typical 1 3 Max 0 9 Min 1 6 100ml at 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 minutes At Minimum Pressure time to alarm at 0 ...

Page 69: ... 1b Low flow conditions are defined as Set Rate less than 1 0ml h Recommended Disposable 60593 Needle 18 gauge 40mm Solution Type De ionized and degassed water Temperature 23 2 C Fluid Head Height 300 30mm Back Pressure 0 10mmHg 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 ...

Page 70: ...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 EN 60601 2 24 standard Start up Graph at 0 1ml h Initial Period Trumpet Graph at 0 1ml h After 24 H...

Page 71: ...urs 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 35 Error ...

Page 72: ...d com int alaris technical A username and password are required to access our manuals Please contact a local customer services representative to obtain login details Part Number Description 1000SP00487 Internal Battery Pack 1000SP01183 RS232 Cable 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European Software Part Number Description 1000SP02156 BD Alaris Communication Engine v2 0 1000SP0...

Page 73: ...ervice Alaris bd com España 34 902271727 Info Spain bd com France 33 0 1 30 02 81 41 mms_infusion bd com Italia 39 02 48 24 01 customer service italy bd com Magyarország 36 1 488 0233 orders cee 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 35...

Page 74: ... Route de Crassier 17 Business Park Terre Bonne Batiment A4 1262 Eysins Switzerland BD the BD Logo Alaris Guardrails IVAC and SmartSite are trademarks of Becton Dickinson and Company or its affilates 2021 BD All rights reserved ...

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