Alaris Asena GW Volumetric pump
Contents
1. clear infusion parameters on power on e maximum VTBI in Micro mode bolus rate e maximum bolus volume The pump has a teach learn facility which allows downloading of configuration from a master pump to others This feature was not evaluated but is potentially labour saving to technical staff and promotes uniform configuration of all pumps which will contribute towards minimising user error Manuals A comprehensive 27 page A4 manual referred to as the Directions for Use is provided with each pump This manual is very well laid out with a contents list on the front cover There is no index but the manual was nonetheless easy to refer to the material being arranged in logical and labelled order Diagrams are provided showing all parts of the pump and administration sets An illustrated list of all the controls is also given which is excellent Clear advice excepting use of Hold key is given on how to proceed in the event of alarm The technical performance of the MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics pump is presented at the rear of the manual in unusually comprehensive and accurate format e g conditions of testing are given The technical manual is similarly accessible and good with clear exploded diagrams showing disassembly and reassembly procedures The list of default configurations and instructions on how to change these are also provided in the technical manuals Once2. 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics potentially delivered to the patient is small at around 0 02 ml for all flow rates with occlusion alarm level set at Lo Air in line alarm is given for both single bubbles greater than the limit configurable but not by the user between 50 and 500 yl and a cumulative volume of smaller bubbles passing the detector amounting to more than 500 yl in 15 minutes Neither air detection system can be disabled and the two systems run in parallel The drop sensor if used provides reliable alarm for upstream occlusion A rudimentary upstream occlusion alarm operates in its absence which depends on the air detector registering the reduction in the diameter of the set as air Configurable options The default configuration of the pump is provided in the technical service manual along with instructions on how to change each parameter The restriction of access to technical personnel of configurability is appropriate MHRA strongly recommends that configuration changes are made centrally by technical staff not at the bedside and that all pumps in one clinical area are configured identically This removes the possibility of user confusion and error caused by unexpected key functions In addition to the features already mentioned the following parameters and facilities can be altered in the configuration menu e volume time or rate VTBI maximum priming volume
3. 2 4 024 6usviceseosnes 13 Technical assessment 15 Long term accuracy 22 5 244u cer ente gu ses 15 Short term accuracy test and startup 16 Volume to be infused 17 Back BIBSRUEB Lu ood dor C sees donaei 14 Battery UBI ccs ais bn pS hae ens ehse nese pi ges 18 Container height test 2 25 45 18 Ocdusiun testing 322r cu trn rZ 19 Air in line testing llli 20 Faults during testing i322 RE 93 21 Manufacturer s Data 22 PIEOUDLIISE a uarie oo ee Rd XE Pere Oo pod 22 Product SUpport 2232022 2 ta pripbpi nno 503 23 Appendix 1 anaana aaa 24 User assessment questionnaire 24 Test methods and protocols 29 Methodology Mee NUN 29 Manufacturer s comments 32 MHRA 04103 Alaris Asena GW Volumetric pump Summary Brief description The Alaris Asena GW LVP Large Volume Pump is an unusually compact volumetric pump being both small and light The pump can be integrated into a multi pump infusion system including Asena syringe pumps and other GW volumetric pumps An Asena docking station is necessary to achieve this The pump can also be mounted on Draeger bar or vertical pole The pump uses dedicated sets with or without anti free flow valve and has a simple user interface allowing setting of basic infusion parameters Secondary infusions can be programmed and bolusing enabled in the con
4. 50 ul 100 ul 250 ul or 500 ul the default configuration being 100 ul It is not a bedside user configurable parameter as it requires information contained within the technical manual for the pump The cumulative air alarm was not tested specifically It runs in parallel with the single bubble detection system neither can be disabled Bubbles detected are of unspecified size but the implication of the technical manual is that all bubbles including those smaller than the individual bubble alarm limit are summed for the cumulative alarm 20 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment Faults during testing During air in line testing it was noted that the injected bubble was sequentially compressed and then expanded by the action of the pump during start up checks It was also noted that a leak resulted at the junction with the upper Y site see Figure 10 The explanation for this lies with the back check valve that is present above the pump in the piggyback set This valve intentionally prevents backwards flow The pump s initial startup routine checks the Se ee integrity of the set by pumping first backwards and then forwards re aa a Unfortunately the presence of the back check valve causes the pressure upstream of the pump to exceed the bursting pressure for the Y site with the result that fluid squeezes out This is only the case where the piggyback set is being used without an
5. Technical performance of the pump is detailed in the technical assessment section of this report User views are summarised in the user assessment section User Interface Front panel indicators The main display comprises an assembly of four bright red seven segment LEDs This measures 50 x 16 mm and indicates numeric parameters such as rate and when requested Volume to be Infused VTBI or volume infused A separate illuminated text to the left of the main display indicates the parameter currently being displayed and or changed The main display is easily visible from a wide field of view and characters are not excessively recessed The main display is bright and easily legible whereas the illuminated text indicators are somewhat dim and not easily seen especially in bright ambient lighting conditions The texts rate volume and time appear appropriately to the left of the main display and the illuminated text ml hr appears beneath the main display Green LEDs illuminate the texts ml hr or the whole text ml hr The difference between these visual indicators beneath the display is too subtle to be useful Since rate is displayed by default however and display of any other parameter involves user action by pressing the enter key there is unlikely to be any significant confusion caused Front panel controls See photographs for controls There are relatively few as the pump has a basic but straightforward
6. The volume of the bolus is added to the volume infused and subtracted from the volume to be infused It is not possible to exceed the set VTBI using the bolus button Rate can also be titrated without stopping the pump This requires two key presses the first to increment or decrement the displayed rate and the second to confirm and implement the change The double key press is a safeguard against tampering MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics Setting the rate and initiating the infusion Rate and other parameters such as time volume to be infused are set using the increment keys Micro mode if configured on allows setting of rate in increments of 0 1 ml h The minimum rate remains 1 ml h in both micro and standard modes with a maximum of 99 9 ml h in micro mode and 999 ml h in standard mode Normally rate increments in 1ml h steps increasing to 10 ml h steps depending on how long the increment key is pressed The rate decrease chevron has no effect from the default display of 0 ml h so that a rate of 999 ml h cannot be inadvertently set by decrement from low rates This is a safety feature to prevent inadvertent setting of maximum rate when a low rate is intended When setting the rate the increasingly rapid rollover rate can cause overshoot For instance overshoot by 100 ml h returns the user to the decrement key operating in steps of 1 ml h increasing to 10 ml h with sustained pressur
7. again there is a contents list with page numbers but no index There are no brief instructions provided on the body of the pump A quick reference guide which includes instructions can be attached to the pump but this was not provided for evaluation A list of alarm causes is given on the side of the pump History logging The pump stores approximately six months worth of events The technical manual states that software is currently under development to enable users to download Event Logs and advises contacting a local Alaris representative Alaris state that this software is now available It was not provided for evaluation Cost The list price for the pump is 2680 ex VAT The set used for evaluation Administration set 273 004 15 um filter in drip chamber no y site with back check valve is 251 70 per 100 10 MHRA 04103 Alaris Asena GW Volumetric pump User assessment To provide a user assessment for the Alaris Asena GW LVP pump two Trusts were contacted Both Trusts have a significant number of pumps in use in an Intensive Care Unit Three senior nursing staff responded from one Trust and 9 nursing staff with a range of responsibilities from the other The pump is used on a daily basis in both units Appendix 1 gives a sample of the questionnaire used The results of the questionnaires have been collated and the following sections represent a summary of findings from both centres Users views have not been edited but
8. appear as stated by the individual users In some cases users views were contradictory particularly between the two centres This emphasises the need for on site evaluation by users prior to purchase The context in which the device is used is significant to whether the device is found suitable Users were also asked to grade each feature on a scale of 1 to 5 where 5 was very good and 1 was very poor These results are presented graphically on the left with user comments E very poor E poor adequate good Bi very good Key Very poor Name of feature given on the right Full width of graphs 100 of respondents Very poor Clinical suitability Battery life Name of feature Very good Training and user instructions e User instructions not used as machine instruction given by a previously trained colleague e Coverage of instructions was clear and concise BIME Note Product training was general ly provided by the manufacturer A few users had been trained by a previously trained colleague Alaris state that manu facturer training is available to all users but is not always taken up Appropriateness of device and set e Unable to comment on robustness as the pump has never been dropped e The device was suitable for our application because compact e Easy to handle hold whilst clamping to stand e Weight is satisfactory to hold with one hand e Device not used on battery power e Ba
9. infusion pump should alarm for each test volume Tests are performed at 125 or maximum if less ml h If the test is failed a larger volume of air is injected until a pass is obtained The test is for functionality rather than sensitivity 31 MHRA 04103 Alaris Asena GW Volumetric pump Test methods and protocols Syringe recognition system The syringe pump is tested systematically to find the worst case of incorrect recognition of syringe size and a flow delivery accuracy test is run at 5 ml h to estimate the worst case error that this user error can cause All available syringes recommended for use with the pump are also tested to assess the response to misloading of the barrel plunger or ears Line tugging test The delivery line is tugged sharply in a variety of directions and potential hazards assessed Testing of device ergonomics Most Adverse Incidents are eventually denoted as user error Good design can contribute to minimising user error Work has been initiated to develop a formal ergonomic testing procedure for application to all devices At present User instructions are assessed for clarity and readability conciseness indexing Procedures for using the device are systematically worked through on the bench after other testing is completed Any hazardous potential misuse is noted For all available alarms the reliability readability of text displayed the alarm tone quality the positioning of alarm lights and met
10. note should be taken of dilution instructions and the risks associated with the dilution procedure e g contamination or miscalculation Short term accuracy and startup time Table 2 Short term accuracy results for Asena GW Constancy index Startup time 7 5 minutes at 1 ml h 2 5 minutes Short term accuracy of infusion pumps is expressed in terms of constancy index The constancy index can be translated as the shortest half life of a drug that would be recommended for administration at this flow rate with this pump Constancy index is measured at 1 ml h and indicates the minimum period of time over which the flow rate remains within 1096 of the mean flow rate The constancy index for the Alaris Asena GW is 7 5 minutes which is reasonable for a volumetric pump Short half life drugs are unlikely to be candidates for administration on general wards The above result indicates that drugs with half life shorter than 7 5 minutes would not be recommended to be delivered using this pump at low flow rates around 1 ml h The startup performance 2 5 minutes is short compared with most syringe pumps Startup time is a measure of the time at the start of an infusion that is taken for flow rate to stabilise at the set rate 16 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment Volume to be infused Table 3 Volume to be infused results for Asena GW Target Actual 1 ml in 60 minutes t 7 596 volume error ov
11. prevent gravity flow when the set was outside the pump but could allow flow when pumping started The result was a gross underdelivery without upstream occlusion alarm The flow sensor should pick up this level of gross under delivery and it is therefore advisable to use it 19 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment Figure 8 Time to alarm on occlusion Figure 9 Bolus released after occlusion Alaris Asena GW Alaris Asena GW Occlusion alarm set at 250 mm Hg Occlusion alarm set at 250 mm Hg 15 w a E E E E 2 o E um 100 1000 10 100 1000 Set Flow Rate ml h Set Flow Rate ml h Air in line testing The Alaris Asena GW air in line detection system provides both single bubble detection configurable and cumulative air detection not configurable The air in line alarm is activated if a single air bubble of the pre set volume is detected or if the cumulated volume of smaller bubbles over a 15 minute period reaches 0 05 ml The minimum setting for detection of single air bubbles for the Asena GW is 50 ul and this configuration was used for testing A single air bubble of 50 ul was introduced into the administration set upstream of the pump and the pump was set running at 125 ml h a typical rate for a volumetric pump The pump reliably detected the 50 ul air bubble triggering the alarm and ceasing delivery The sensitivity of the single bubble alarm can be set to
12. set of functions The keyboard is well laid out there are separate On Off and Start Stop buttons Where keys are multi functional the dual functions are related and not difficult to predict In general the user interface is simple and intuitive The pump supplied for evaluation had the default configuration with secondary infusions boluses and micro mode disabled see infusion modes which renders the PRI SEC key redundant but this should not cause any problems MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics Use of the keys is accompanied by a beep whether or not the key is in a functional state for instance attempts to increment the volume infused using the increment key clearly a nonsensical procedure generates beeps for key press but no resulting change in the volume infused display This is not the case in the sister pumps the Asena syringe pumps where non functional keys provide no beep when pressed There is therefore some small potential for confusion here when the two types of pump are used together such as in the docking station All keys are of a good size and easy to operate Conventional symbols are used for On Off and Enter and the function of other keys is also clear The only potentially confusing key press is the use of the Start Stop key to put the pump on Hold during an alarm situation see above Set Loading Loading the set is very easy once the user has understood
13. to set and clear to see The visual displays are clear The messages provided by the pump are easy to understand It can take a little while to set the rate or VTBI Pressing the arrows causes rate to suddenly go up very quickly then down too far etc MHRA 04103 Alaris Asena GW Volumetric pump User Assessment Monitoring the Infusion Very poor verygood Do not know of any safeguards 7 TA against tampering What safeguards against tampering Sines There is no lock BIME Note Users were evidently not Display of rate aware of some of the security features such as the panel lock Alarm messages e The pump is quiet in operation e The alarm messages give clear indications of the cause of any problem e The display of rate VTBI is inadequate Prefer to be able to see figures rather than having to press button s e The noise level whilst running was too noisy e The alarm tone was noisy e Alarm tone good it can be adjusted Alarm tone Name of feature Alarm appropriateness Safeguards against tampering Very poor Very good Ease of cleaning Infusion complete Ease of charging the battery Name of feature No comments on this section by users General comments On starting the device the alarm is loud The switch on alarm is very loud Could be a little quieter or shorter Not good within night time setting however the alert alarms are adequate The pump would be im
14. October 2004 Medicines and Healthcare products Regulatory Agency MHRA 04103 Alaris Asena GW Volumetric pump DH Department of Health best choice best practice www mhra gov uk nww medical devices nhs uk About MHRA evaluation reports What you can expect The Device Evaluation Service DES aims to provide independent and objective evaluations of medical devices available on the UK market Specialist centres mainly in NHS Trusts do the evaluations under long term contract to and in accordance with protocols approved by the Medicines and Healthcare products Regulatory Agency MHRA The evaluations are usually of a unit supplied by the manufacturer We would expect this unit to be representative of the product on the market but cannot guarantee this Prospective purchasers should satisfy themselves with respect to any modifications that might be made to the product type after MHRAS evaluation The reports are intended to supplement not replace information already available to prospective purchasers MHRA DES does not have access to any information held by the Agency in its capacity as the Competent Authority for the UK apart from any information already in the public domain The reports will contain data given by the manufacturer on the regulatory status of their devices but apart from this they are not an indicator of the regulatory status of a product Occasionally DES refers products to the regulatory arm of the MHRA
15. acturer claims the pump achieves 9596 charge in under 24 hours reconnection to the mains This claim was not tested Container height test The directions for use state that the fluid container should not be placed more than a metre above the patient s heart however there is no locating key on the pump or set to prevent this from happening The pump was set to run at 125 ml h with the bag normally positioned drip chamber approximately 30 cm above the pump Flow during this period showed a 2 7 error over an hour of established flow The bag was then raised drip chamber 85 cm above pump and flow error was not significantly changed being 2 6 error over one hour The bag was then lowered so as to be 50 cm below the drive mechanism of the pump in order to simulate the bag being left on the bed or some other such adverse non recommended set up The flow rate was reduced slightly flow error of 1 4 All results remain well within the manufacturers claims and are acceptable 18 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment In general however it is not good practice to hang a container lower than the pumping mechanism of a volumetric pump Occlusion testing Patient side occlusion Table 5 Patient side occlusion results at 1 ml h for Asena GW Time to alarm Post occlusion bolus 14 minutes 49 seconds at 1 ml h 0 03 ml at 1 ml h The pump was tested to establish the speed of response to occlus
16. additional container attached at the Y site a scenario which is possible prior to setup of the often smaller second infusion bag This additional container is frequently added to the main line after the start of an infusion on the order of a physician and is referred to as the piggyback container 21 MHRA 04103 Alaris Asena GW Volumetric pump Manufacturer s Data Manufacturer and Supplier CE Marking on Product Country of origin manufacture Price ex VAT Size H x W x D Weight Power supply Battery operation battery capacity battery charging facilities Facilities pumping mechanism administration set accessories flow rate range flow rate increments delivery options volume infused indicator KVO rate Bolus rate and volume claimed accuracy occlusion detection system alarms and alerts air in line detection drug libraries type of display Product Data Alaris Medical U K Limited The Crescent Jays Close Basingstoke United Kingdom RG22 4BS Tel 01256 388200 Fax 01256 330860 www alarismed com UK Customer Service alarismed com Yes MD Directive UK 2 680 Administration set 273 004 15 um filter in drip chamber no y site back check valve cost 251 70 for Qty 100 140 mm H x 137 mm W x 105 mm D approx 1 5 Kg 220 240 VAC 50 60 Hz 10 VA nominal Rechargeable NiMH gt 6 hours 25 ml h gt 2 hours 999 ml h Automatically charges when pump is connected to AC pow
17. by any means with the prior permission in writing of the Controller of Her Majesty s Stationery Office HMSO Information on reproduction outside these terms can be found on the HMSO website www hmso gov uk or e mail hmsolicensing cabinet office x gsi gov uk The MHRA is an executive agency of the Department of Health ISBN 1 84182 880 7 MHRA 04103 Alaris Asena GW Volumetric pump Contents SUMMA 222 ck vesecddwuw ERR RS REE Ee E cans 1 Brief description 0000020000 1 Advantages osetia dud uUa d ad E x E d es Egi jaws 1 Disadvantages iusso aoa darent deus wea 1 Faults during testing 2 2 2 1 Main Features ies das died Pee en 2 Photographs ciosasue eee ERA RYE RC a d RR 3 Evaluator assessment of ergonomics 4 Alaris Asena GW L seskxx 545 E OXDRRAROREOR RERO 4 User Interface iua v odas aa or RERO ACER CR 5 Configurable options icicusa ceived dA Rm n 9 Manuals u eae oust euees 45a she ee eee ee us 9 History MOGGWIG iade dd RR EO EG COR EROR OR ER 10 COSE eree bec ud Nds Gees esse bd dead dard 10 User assessment 000000005 11 Training and user instructions 11 Appropriateness of device and set 11 Longino We S8l ossa en eri cdrno bi RE Rum 12 Setting the parameters 12 Monitoring the Infusion 13 Infusion complete auc cece dine sw deans aee 13 General comments 13 Summary COMMONS lt
18. comprising 2 hours at ambient back pressure followed by 3 hours at 100 mmHg and then 3 hours at 29 MHRA 04103 Alaris Asena GW Volumetric pump Test methods and protocols 100 mmHg At the points when the back pressure is changed the pump is not stopped and settings are not altered The long term accuracy is calculated for each period of the test The parameters resumption time pump height bolus and pump height negative bolus are calculated Volume to be infused VTBI accuracy The infusion pump is set to the required rate with the VTBI facility set such that the infusion will last one hour Errors for both time and volume delivered are measured Tests are performed at 1 ml h and 25 ml h for all pump types Changes in fluid container height volumetric pumps only The pump is set up to infuse with the drip chamber of the fluid container positioned at a nominal 30 cm above the top of the pump After a control period of 2 hours the fluid container is elevated to the maximum height obtainable above the pumping mechanism for 1 5 hours and then lowered to the minimum height while still remaining operable or 0 5 m if less for a final 1 5 hours Accuracy is measured and compared over each of these three periods The pump is not stopped and settings are not altered when moving the fluid container Rate 125 ml h Battery performance After appropriate discharge and recharge cycling the delivery accuracy is measured at 1 ml h for
19. e Stopping pressing the key at the right time to prevent overshoot and allow quickest homing in on the desired rate comes with practice Starting the infusion initiates a self check routine for the pump This includes a period of pumping first backward and then forward to check the integrity of the set The backward pumping caused difficulties for the administration set with one way valve above the pump see Faults during testing A very small bolus is also delivered during this period and flow backwards in the cannula occurs but this is too small to show up on the flow graphs when viewed over the first 30 seconds and is unlikely therefore to be clinically significant Security features The On Off key has a 3 second delay requiring the user to continue pressing for this period before it is effective This serves to prevent accidental turning off of the pump Titration of rate and administration of boluses if enabled require two key presses once again to prevent tampering The panel can be locked by the user by pressing the two chevron keys simultaneously The lock is released using the same two keys The pump configuration is largely protected from inadvertent changes by requiring a double key press for access There is no numeric configuration code the double key press for access to the configuration menu is described in the technical manual which complies with MHRA recommendation that configuration changes should be made centrally b
20. ent Additional comments 26 MHRA 04103 Alaris Asena GW Volumetric pump Appendix 1 5 Loading the Set V good Good Adequate Inadequate Poor 5a The loading procedure for the 5 4 3 2 4 i No comment set syringe was Additional comments 5b The priming procedure for the 5 4 3 2 1 No comment set syringe was Additional comments 5c The ease of setting syringe brand and size was syringe pump 5 4 3 2 1 No comment only Additional comments 6 Setting parameters and Starting Infusion V good Good Adequate Inadequate Poor 6a e ease of setting the rate 5 4 3 2 4 was No comment Additional comments 6b The ease of setting the VTBI 5 4 3 2 1 No comment was Additional comments 6c The ease of navigating the 5 4 3 2 4 No comment control panels was Additional comments 6d The visual displays were 5 4 3 2 1 No comment Additional comments 6e The clarity of messages were 5 4 3 2 1 No comment Additional comments 27 MHRA 04103 Alaris Asena GW Volumetric pump Appendix 1 7T Monitoring the Infusion V good Good Adequate Inadequate Poor 7a The noise level whilst running Was 5 4 3 2 1 No comment Additional comments 7 6 The running indicator clarity was 5 4 3 2 1 No comment Additional comments 7c The display of rate VTBI during 5 4 3 2 1 No commen
21. ent The 1 ml h tests using the main recommended disposable are repeated 5 times each for three nominally identical disposables For PCA pumps the number of attempted bolus deliveries before alarm is recorded and the bolus delivered on release of the occlusion Back off Pumps commonly have a facility to run the pumping mechanism backwards on occurrence of an occlusion alarm Line pressure is recorded at one second intervals for an occlusion response at 1 ml h and 5 ml h A graphical display of the pressure variation over time is produced to indicate the operation of a back off system Any anomalous behaviour such as a pressure falling below atmospheric is noted Pressure at alarm is also recorded for one of these tests as a rough check of the manufacturer s claims and correct functionality Fluid side occlusion response The response of the pump to an upstream occlusion is observed and recorded whether or not an alarm system is provided The response is assessed for patient safety as examples tubing rupture or air entry represent significant hazards The time to alarm is recorded 3 times at each test flow rate Tests are performed at 1 ml h and maximum rate on volumetric pumps only Air in line detection Significant uncertainties exist in the testing of this feature The air detector sensitivity is set to 50 ul or minimum if greater Three consecutive test volumes of air are introduced immediately up stream of the infusion pump The
22. er Peristaltic Standard set has anti reflux valve set with anti free flow valve can be purchased Drop sensor Asena DS docking station 1 to 999 ml h in standard mode 1 0 ml h to 99 9 ml h in micr mode Standard mode 1 ml h initially increasing to 10 ml h and 100 ml h increments if pressure sustained on chevron Micro mode 0 1 ml h initially increasing to 1 ml h and 10 ml h increments rate and volume volume over time primary secondar infusions bolus rate titration requires key press to confirm micro mode allows setting of rate in resolution of 0 1 ml h increments KVO VTBI VI 1 to 9999 ml in standard mode 0 1 to 999 ml in micro mode Configurable OFF 1 0 to 5 0 ml h Rate 1 999 ml h volume 0 1 99 ml 10 over one hour at 1 999 ml h Lo 250 mmHg Nor mal 350 mmHg Hi 500 mmHg Alarms Air in line upstream occlusion battery depleted doo open system fault flow error if flow sensor in use flow senso connection error downstream occlusion misloaded o otherwise incorrect administration set Warnings bolus being administered end of infusion pump priming low battery pum on hold pump unattended automatic set checking Configurable single bubble of 50 100 250 500 ul cumulative gt 500 ul over 15 minutes No 7 Segment display and LEDs 22 MHRA 04103 Alaris Asena GW Volumetric pump Manufacturer s data Product Data continued Fluid to be infused is dependent on the user
23. er 59m 59s 25 ml in 60 minutes 0 5 volume error over 59m 59s These results indicate typical levels of accuracy for a volumetric pump Delivery of small volumes over a short period e g 1 ml h over 1 hour is unlikely to be achieved with high accuracy and is not an appropriate application for a volumetric pump Back pressure Table 4 Back pressure results for Asena GW Back pressure Accuracy Bolus when back pressure changes Resumption time 0 mmHg 1 7 96 Not applicable 100 mmHg 1 8 96 0 11 ml 100 mmHg 1 9 96 0 14 ml 2 minutes The pump was set up to deliver at 1 ml h for 8 hours The pump was positioned so as to align the pumping with the level of the cannula outlet After two hours the pump was raised by 136 cm to simulate a drop in back pressure of 100 mmHg below ambient After a further three hours the pump was lowered by 272 cm to increase the back pressure to 100 mmHg above ambient The pump was not stopped during repositioning Figure 7 shows the flow rate of the pump during this 8 hour test Figure 7 Back pressure test at 1 ml h over 8 hours Alaris Asena GW 0 mm Hg 100 mm Hg 100 mm Hg AMEN ERREUR Jy ted pete PPM WM non o o o 420 480 Time minutes E o 5 z 2 ian 17 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment The flow graph Figure 7 illustrates the potential hazard to the patient of moving a pump vertically in relation to the venous acces
24. figuration Alarms occur for usual causes including occlusion and air in line Advantages The pump is small and light The set is easy to load and the pump very easy to operate Additional features such as piggyback infusions can be added in the configuration The pump is compact and can be integrated in the Asena docking station with Asena syringe pumps Disadvantages No anti free flow device in some of the administration sets MHRA recommends the use of anti free flow sets for critical care When present in the set the anti free flow valve is of a kind which requires the use of the pump to prime the set Also it prevents use of the set for gravity infusions Upstream occlusion alarm is fully functional only if the drop sensor is purchased Pump shown here without sensor Faults during testing Ruptured administration set a piggyback set was caused to leak by pressure generated during the pump s routine startup check This could recur as the piggyback set has a one way valve deliberately included to prevent back flow MHRA 04103 Alaris Asena GW Volumetric pump Summary towards the secondary container The pump pumps backwards briefly during startup checks in order to assess the integrity and correct positioning of the set The problem is only relevant where a piggyback set is used with only one container attached Sets other than the piggyback set are also unaffected as the absence of the one way valve above the pump al
25. for considerations of breaches of the legislation governing medical devices DES plays no further part in any regulatory investigation that ensues and does not have advance notification of any regulatory action that may follow How to obtain MHRA reports To order evaluation reports a copy of the publications catalogue or to sign up for our e mail alert service contact MHRA Orders Department Room 1207 Hannibal House Elephant amp Castle London SE1 6TQ Tel 020 7972 8181 Fax 020 7972 8105 E mail des mhra gsi gov uk Visit www mhra gov uk for a comprehensive list of publications details of forthcoming evaluations services and contacts Colour reports Full colour versions of all reports published after 2002 are available from the NHSNet nww mda nhs uk pumpevaluation Infusion device web only reports nww medical devices nhs uk Paper only reports Alaris Asena GW Volumetric pump Teresa Dunn Centre Manager Bath Institute of Medical Engineering BIME The Wolfson Centre Royal United Hospital Combe Park Bath BA1 3NG Tel 01225 824106 Fax 01225 824111 E mail t s dunn g bath ac uk For more information on BIME visit www bime org uk A SIME Crown Copyright 2004 Apart from any fair dealing for the purposes of research or private study or criticism or review as permitted under the Copyright Designs amp Patents Act 1998 this publication may only be reproduced stored or transmitted in any form or
26. h ac uk Disclaimer For all tests only one pump and a limited number of disposables is tested The quoted results are a measure of the performance of this one pump It cannot be assumed that other devices of the same type will behave identically Long term accuracy Rates tested minimum 1 5 25 125 for volumetric pumps and maximum Test durations are generally 2 hours except the 1 ml h test 24 hours and minimum rate test 4 hours Accuracy is assessed over the last hour for all tests excepting the 24 hour test where each of the last 18 hours is assessed Flow accuracy is monitored over the second and last hours of the manufacturer s recommended maximum life of the administration set The test is run at 500 ml h or maximum if lower for volumetric pumps Syringe pumps are run for 48 hours at 1 ml h Any change in the measured hourly delivery rate over the lifetime of the set syringe is noted Short term accuracy Short term accuracy is characterised using a new parameter known as constancy index The constancy index provides a guide to the minimum half life of drugs suited for administration with the pump undergoing evaluation Constancy index is measured at 1 ml h for all pumps during a test run of 24 hours duration A discussion of this new concept is included in Evaluation report 02110 and can be provided on request by BIME Flow accuracy under back pressure The pump is set up to infuse for a continuous period of 8 hours
27. he user at one of three levels Air in line detection limits are only settable using the technical manual as a coded key combination is required A large range of dedicated administration sets can be purchased for use with this pump exclusively from Alaris The set has no particular key or locating feature which ties its design specifically to use in this pump or vice versa The pump assesses during its startup routine whether a set of the correct specification has been loaded There will be a margin for error on this measurement so that the use of incorrect or third party sets is theoretically possible MHRA strongly recommends that correct sets as recommended by the manufacturer are used MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics It is also strongly recommended by MHRA that pumps are used with sets having anti free flow valve It is unfortunate that this is an optional feature for this pump set The greatest cause of patient harm from adverse incidents involving volumetric infusion pumps is due to free flow A set with anti free flow valve can be purchased however 273 001 The type of anti free flow valve offered is opened only by increased delivery pressure so that priming of the set outside the pump is not possible Anti free flow valves which are automatically activated by the pump but can be opened by the user for priming leave the user with more options whilst still protecting the patient
28. hods of silencing alarms are tested as part of the ergonomic assessment of the device Manufacturer s comments The report compiled by BIME is a reasonable assessment of the Asena amp GW Volumetric pump We have at the time this report was finalised yet to complete our investigation into the cause of the ruptured administration set reported during this assessment this failure mode has not been previously reported to us or observed during testing of the device and associated disposable 32
29. ion and the volume of bolus on release of occlusion The occlusion alarm pressure was set to the minimum level LO which is roughly equivalent to 250 mmHg Figures 8 and 9 demonstrate the change in time to alarm and post occlusion bolus volume with flow rate Alarm time at 1 ml h is relatively long for a volumetric pump at 14 minutes 49 seconds although the post occlusion bolus potentially delivered to the patient on release of the occlusion is small 0 03 ml The pump mechanism backs off after occlusion alarm in order to minimise this bolus The back check valve effectively prevents suck back during this period so that no negative boluses were observed during testing Fluid side occlusion Fluid side occlusion is most efficiently detected if the flow sensor is in use however this is an optional accessory and the pump was tested as supplied in the default configuration and without accessories Fluid side occlusion can still be detected without the optional flow sensor although not as reliably Provided the occlusion was complete our tests showed that an occlusion above the pump was reliably detected at maximum flow rate and 1 ml h Detection of upstream occlusion at 1 ml h took 1 hour 8 minutes so should not be relied upon where immediate alert is essential The alarm given is AIR OCCL Pumping stops when the alarm is given It was noticed however that partial upstream occlusions e g a not very tight roller clamp could successfully
30. ion is indicated by the message HI PrES This message is only viewable from the front of the pump When viewed from other angles the only indication of alarm is the audible tone Alerts indicate non critical warnings such as volume infused complete with KVO operating Once again an audible beep is given but the user can silence the tone and pumping continues Alerts referred to as warnings by Alaris are listed on page 2 An explanatory list of alarm texts and warnings is given on the side of the pump a quick reference card can also be attached to the pump Advice on the appropriate remedial action to take during alarm is given in the Directions for Use DFU but does not include mention of the rather counter intuitive necessity to press Run Hold twice in order to restart the infusion The first press of this key cancels the alarm message display and places the pump on HOLD despite the fact that pumping has already stopped A second press is required to resume pumping The occlusion detection system detects the pressure within the administration set just downstream of the pumping mechanism The alarm pressure can be set at three levels Hi 500 mmHg NOR mal 350 mmHg and Lo 250 mmHg The user can change alarm pressure settings with the help of a series of key presses described in the DFU The default limit is Hi The pump has a backoff function programmed to reduce occlusion bolus on occurrence of occlusion alarm the bolus MHRA
31. l incorporate existing Trust policies and Guidelines Provided on demand at no charge Familiarization training is available on site at no cost This training is recommended to be requested early upon devices being issued to the user or during the commissioning process Fully Comprehensive training courses are available on site or at manufacturers premises Cost 950 per course with up to 8 engineers accommodated Course is externally accredited and certificated Two year on site warranty extended warranty can be purchased at any time from the point of purchase up to six months after the existing warranty cost 130 per pump year Annually Alaris offer many types of on site maintenance contracts from PPM coverage to fully comprehensive Please contact Alaris for further information Available at supplier s discretion Maximum two days from receipt of order Prices available on request Free of charge with purchase of pump Additional copies available from the Alaris Webpage www alarismed com 23 MHRA 04103 Alaris Asena GW Volumetric pump Appendix 1 User assessment questionnaire Please complete the attached questionnaire without conferring with colleagues The results should represent your own opinion All assessors identities are confidential and are not used in the evaluation report We may need to contact you to clarify your responses and have requested some personal details in order to balance the survey pop
32. lows some backwards movement of fluid Main Features Power Supply Administration set Flow rate range Pump mechanism Occlusion detection Air detection Alarms and alerts Price ex VAT CE Marking Notified Body Certified to Standard 100 120 V AC 50 60 Hz 10VA nominal 220 240 V AC 50 60 Hz 10 VA nominal rechargeable NiMH battery The pump was tested with the 273 004 with 15um filter in drip chamber no y site back check valve there are also burette secondary opaque anti syphon valve sets 1 to 999 ml h in standard mode 1 0 ml h to 99 9 ml h in micro mode peristaltic Lo 250 mmHg Nor mal 350 mmHg Hi 500 mmHg Configurable single bubble of 50 100 250 500 ul cumulative gt 500 ul over 15 minutes Alarms Air in line upstream occlusion internal battery depleted door open system fault flow error if drop sensor in use flow sensor connection error downstream occlusion misloaded or otherwise incorrect administration set Warnings bolus being administered end of infusion pump is priming low battery pump on hold pump unattended automatic set check in progress 2 680 Alaris Medical U K Limited The Crescent Jays Close Basingstoke United Kingdom RG22 4BS Tel 01256 388200 Fax 01256 330860 0086 BSI Product Services Hemel Hempstead UK IEC 60601 1 IEC 60601 2 24 MHRA 04103 Alaris Asena GW Volumetric pump Photographs Figure 1 Front of pump do
33. mps The presence of two clamps at 90 degrees to each other makes possible the clamping of the pump incorrectly with the flow channel positioned vertically rather than horizontally This is a use error which is very unlikely to occur and is mentioned here only because the Directions for Use DFU warn against using the pump in this orientation It is hard to imagine an authorised user would ever make this mistake The pump can operate in either rate volume mode or volume over time mode only one of these modes is enabled in the configuration at any time By default this is usually rate volume mode In addition piggyback programming user administered bolus and Keep Vein Open KVO modes are available Instructions for configuring these additional modes are included in the technical manual Rate can normally be set in the range 1 999 ml h and rate is incremented in steps of 1 ml h or larger dependant on how long the increment key has been pressed It can take some practice to avoid overshoot when setting the rate This lengthens the time taken to set an intermediate rate starting from the default in the early stages of use but the problem would probably disappear with time and practice Rate can be incremented in steps of 0 1 ml h if the optional micro mode is enabled in the configuration In this mode rate is limited to values between 1 and 99 9 ml h Precision but not accuracy is improved in this mode Occlusion alarm pressure can be set by t
34. or closed Figure 2 Front of pump door open Key to Figures 1 2 and 3 On Off Illuminated text messages volume or rate Primary Secondary Main display Enter key Run Hold Chevrons increase and decrease 8 Door latch Figure 3 Back of pump No NOOO BO 9 Door in closed position showing flow direction arrow 10 Clear Silence alarm 11 Prime Bolus button 12 RS232 Nurse call and flow sensor sockets 13 Flow stop mechanism 14 Air sensor 15 Tubing Guide 16 Pressure sensor 17 Flow direction arrow 18 Release lever for horizontal bar clamp 19 Horizontal rectangular bar clamp can also fix pump to docking station 20 AC fuses 21 AC power connector 22 Potential Equalisation PE connector 23 Extended pole clamp for vertical pole can be folded back into recess 24 Infra Red communications port IrDA MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics Alaris Asena GW The Alaris Asena GW LVP Large Volume Pump is an unusually compact volumetric pump being both small and light The pump can be integrated into a multi pump infusion system including Asena syringe pumps and other GW volumetric pumps An Asena docking station is necessary to achieve this This docking station was not assessed during this evaluation The pump can be mounted on either a vertical drip stand or a Draeger horizontal rail using one or other of the two cla
35. proved by easier volume to be infused settings There are no features present which are unsuitable for our application Display of drug or infusion as the syringe drivers do would be useful We don t really use the clock feature that enables you to set the time of the infusion Bolus very slow Filling giving set very slow Summary comments This is the best IV or syringe pump have had the opportunity to use n an emergency it appears to be lengthy when giving a bolus Slow to prime and give bolus doses this is poor in an ITU situation where you need to give extra sedation quickly 13 MHRA 04103 Alaris Asena GW Volumetric pump User Assessment Summary comments continued have found the pumps alarming infusion complete when there is sometimes up to 150ml left to infuse This is NOT a user fault it tells me that the pump is not recording accurately have noticed this more over the last few months It makes me unhappy to use these pumps Bolus often difficult to give The pump is very easy to use Very precise when in micro mode It takes up only a small amount of space and is very lightweight On occasions large volumes still left in infusion bag despite volumes of 500 shown to have been delivered On two occasions very experienced nurses found their infusion which had been checked and set ran through very quickly and it was felt it was the pump however no problem was found with the pumps returned
36. ring use of the device Yes No If No go to question 3 V good Good Adequate Inadequate Poor 2a The overall quality of the user instructions for this device was 5 4 3 2 1 No comment Additional comments 2b How would you assess the readability of the manual s 3 4 3 2 1 No comment Additional comments 2c The coverage of the instructions was 5 4 3 2 1 No comment Additional comments 2d The user instructions on the 5 4 3 2 4 Nocominerit body of infusion pump were Additional comments 25 MHRA 04103 Alaris Asena GW Volumetric pump Appendix 1 3 Appropriateness of Device V good Good Adequate Inadequate Poor 3a The device s suitability for your application was 5 4 3 2 1 No comment Additional comments 3b The battery life was No comment Additional comments 3c The size of the pump was No comment Additional comments 3d The weight of the pump was No comment Additional comments 3e The ease of moving pump when disconnected from patient and stand was No comment Additional comments 3f The robustness of the pump was No comment Additional comments 3g The pole clamp was No comment Additional comments 4 Administration Set V good Good Adequate Inadequate Poor 4a The suitability of the supplied administration set was 5 4 3 2 1 No comm
37. s site whilst the pump is delivering When the pump is raised a bolus is delivered to the patient resulting in a temporary overdose When the pump is lowered flow from the pump temporarily ceases due to the backwards flow of fluid in the administration set The back check valve prevents fluid from being sucked back through the cannula however this fluid would be blood in the case of venous access Flow does not resume for 2 minutes after this change in height has been made The performance of this pump is similar to other volumetric pumps It is important to know of this phenomenon in order to minimise patient pump relative movement during infusion Battery test The Asena GW has a Nickel Metal Hydride NiMH battery with estimated capacity to drive the pump at 125 ml h for more than 2 hours The life of the battery was tested from a point of maximum charge and it was found the pump operated accurately at 125 ml h for 525 minutes 8 hours 45 minutes which substantially exceeds the manufacturer s claims A Lo bAt alarm message and intermittent audible beep were given approximately 30 minutes prior to shutdown This alarm could not be silenced but occurs only once every 4 minutes or so Final continuous audible alarm was given with bAt message displayed on battery exhaustion and the pump shut down safely The pump resumed accurate operation and was able to recall previously set parameters on reconnection of the mains The manuf
38. selecting the appropiate giving set choosing compatible material set make up y sites filters and back check valves type of infusion fluids Nurse call facility Computer interface Mounting method Protection against fluid ingress Electrical safety classification Model identification Serial number Software version number Servicing and training Provisions for staff training initial in service training e follow up in service training e first line maintenance training e full service maintenance training Warranty Maintenance provisions recommended service interval contract service maintenance e temporary loan equipment Spare parts spares availability cost of parts and materials Accompanying manuals operations manual and or technical service manual Yes Yes RS232C Pole horizontal or vertical and in docking station IPX 1 Class 1 CF IEC 601 1 250412127 V5R1F Product Support Address as for manufacturer Clinical Training 0800 9178776 Technical Support amp Training 0800 3896972 Fax 01256 330860 UK Technical Support alarismed com UK Customer Service alarismed com for Clinical Training Yes provided at no charge The Alaris Clinical Training team will work with the trust or hospital to devise an appropriate training schedule which addresses all identified user needs and accommodates any ideas or training programs already established The training programme utilised wil
39. syringe pumps and 125 ml h for volumetric pumps with mains supply disconnected until the infusion pump stops due to battery depletion Long term accuracy over the second and the final hour of the test are calculated to assess any performance impairment due to battery depletion The duration of operation is noted The equipment is also tested for accurate delivery upon re application of mains power It is noted whether infusion settings are retained and whether the pump shuts down safely Bolus volume accuracy Where the equipment is intended to administer a discrete bolus volume to the patient the accuracy of this feature is measured To test lockout facilities on PCA pumps a 5 minute lockout time is set A bolus is demanded and then subsequent demands are made periodically to establish when the next bolus is permitted 0 1 ml 1 0 ml and 5 0 ml target bolus volumes are tested for all pump types 30 MHRA 04103 Alaris Asena GW Volumetric pump Test methods and protocols Body temperature test A 2 hour flow test at 1 ml h is performed with the pump and delivery fluid contained within an incubator at a temperature of 37 C Patient side occlusion alarm response Time to alarm and bolus on release of occlusion are measured at 1 5 and 25 ml h for syringe pumps 1 5 and 125 or maximum if less ml h for volumetric pumps Pressure at alarm is not measured during these tests Pressure per se is not considered a hazard to the pati
40. t an infusion was Additional comments 7d The alarm messages were 5 4 3 2 1 No comment Additional comments 7e The alarm tone was 5 4 3 2 1 No comment Additional comments Tf mne appropriateness of alarms 5 4 3 2 4 were No comment Additional comments 7g The safeguards against E 4 3 2 4 tampering were No comment Additional comments 8 Infusion Complete V good Good Adequate Inadequate Poor 8a The ease of cleaning was 5 4 3 2 1 No comment Additional comments 8b The ease of charging was 5 4 3 2 1 No comment Additional comments 9 General Questions 9a List any features that you would like to see which are not present on this pump 9b List any features that are present but which are unsuitable for your application 9c Are there any additional comments that you would like to make on your experience of using this pump 28 MHRA 04103 Alaris Asena GW Volumetric pump Test methods and protocols Methodology Tests are undertaken in accordance with the techniques outlined in BS EN 60601 2 24 1998 with variations where indicated A new administration set or syringe is used for each test The parameters constancy index resumption time pump height bolus pump height negative bolus are new concepts and are proposed variations to the Standard IEC 60601 2 24 Algorithms used for their calculation can be provided on request from bime bat
41. that the flow stop mechanism within the pump needs to be opened first The set is threaded through the flow channel from left to right in the conventional direction Flow direction arrows are present both on the door and inside the door to assist in placing the set correctly It is possible to load the set in the wrong direction If this is achieved despite the arrows then flow occurs briefly in the wrong direction and a bad set alarm is given This alarm occurs more rapidly if the pump is being set up for the first time since switch off Subsequent attempts to run the pump with set misplaced result in slightly longer alarm time In either case alarm occurs within a minute Infusion options Rate can be set either in ml h with obligatory Volume to be Infused VTBI or as a volume over time The two modes are alternatives and are enabled within the configuration menu which appropriately is not available to the bedside user In addition primary secondary infusion can be programmed if enabled in the configuration The display shows SEC whilst the secondary infusion runs through It then reverts to normal display and emits a beep when the primary rate initiates Boluses if enabled in the configuration can be administered using the dual function prime bolus button This requires two key presses the first key press displays the message bol and the second administers a bolus accompanied by an incrementing display of the volume of the bolus
42. to EBME etc We now have the anti syphon giving sets that we were not aware of until the above incidents Generally we felt dissatisfied that both incidents were unexplained However overall we find the Asena GW a good user friendly general use pump There are no features that are present on the pump which are unsuitable for our application 14 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment Long term accuracy Table 1 Long term accuracy results for Asena GW Accuracy at minimum flow rate 1 to 999 ml h 5 3 at 1 ml h 4 9 at 500 ml h 5 3 at 1 ml h Flow rates tested Greatest over delivery Greatest under delivery The Asena GW was tested over the full range of flow rates from 1 to 999 ml h The default administration set provided with the pump for evaluation is 273 004 a standard set with 15 um filter in the drip chamber no y site and a back check valve but no anti free flow valve Results of the long term accuracy tests are presented above The worst cases of over and under delivery errors measured over any hour period during the recommended period of use of the set 24 hours were 5 3 and 4 9 In general results were centred around zero error fairly closely This level of accuracy is appropriate for general ward use Figures 5 and 6 show flow at 1 ml h plotted over 24 and 2 hours It was also noted during testing that the back check valve closely resembled an anti syphon val
43. tteries appear to run down quickly but are probably not kept plugged in properly 11 MHRA 04103 Alaris Asena GW Volumetric pump User assessment Much prefer gravity fed set for priming do not understand need for two different sets Prefer gravity fed set Have changed to anti syphon set did not initially know this was available Loading the set Very poor of feature lt E lt e o o 2a Loading the set Priming the set Name of feature Very poor Very good Setting rate Setting Control panels for setup Display during setup Messages during setup 12 Whilst using the device to infuse a sedative medication the line was initially fitted correctly and infused the medication appropriately Shortly after setting up the device the situation and environment had to be changed slightly the device had to be stopped and the line disconnected for a short time When refitting the line the line became trapped in the hinge The device continued to infuse at a quicker rate than set and did not alarm it was noted by staff only when the patient s blood pressure decreased and staff noted the rapid use of the medication This only happened on the one occasion Loading of the set is easy The set loading procedure is slow The priming procedure is easy The priming procedure is slow The priming procedure is time consuming Setting the parameters Rate and VTBI are easy
44. ulation The results of this survey will be used as the basis of a user assessment forming part of an MHRA device evaluation Thank you in advance for your assistance Assessor information Circle as appropriate Name Gender Male Female Handedness Left Right Clinical speciality Number of months using the pump How frequently do you use this pump weekly The questionnaire is divided up into sections covering different infusion processes All questions require evaluation on a scale of 1 to 5 where 5 Very good could not realistically be any better 4 Good but could be improved d Adequate 2 Less than adequate but could be worse 1 Extremely poor There is also space for additional comments These are often the most valuable source of information from the assessment so please take the time to add any comments that occur to you 24 MHRA 04103 Alaris Asena GW Volumetric pump Appendix 1 1 Product Training Was specific training received for this device Yes No If No go to question 2 V good Good Adequate Inadequate Poor 1 The specific training for this 5 4 device was 2 1 No comment Additional comments Training was supplied by Please tick all that apply a manufacturer b tuition by a previously trained colleague c tuition by a Trust based trainer d other 2 User Instructions Were user instructions available to you du
45. ve If the set is removed from the pump whilst attached to the patient under the mistaken impression that free flow is prevented by the back check valve it is possible for free flow to occur The use of the set with anti syphon valve would be strongly recommended to prevent accidental free flow Very low flow rates less than 1 ml h should be used with caution Performance at such low flow rates is erratic for any pump and is more likely to be inaccurate than at higher flow rates Stringent efforts should be made to adjust therapy so that the lowest flow rate used with any infusion is appropriate to the type of pump in use Volumetric pumps generally provide more discontinuous flow patterns than syringe pumps Where possible flow rates in excess of 5 ml h should be used if drugs with Figure 5 Long term accuracy at 1 ml h over 24 hours Alaris Asena GW N in N o tn o E o B z 9 u o in o o 240 720 960 1200 1440 Time minutes e Set flow rate 1 ml h Max error over any hour 5 3 15 MHRA 04103 Alaris Asena GW Volumetric pump Technical assessment Figure 6 Long term accuracy at 1 ml h over 2 hours Alaris Asena GW EN in Flow rate ml h o AMY ud hA rd Uli T Tin nmm jn W dll I In MM alba yi 120 Time minutes Set flow rate 1 ml h short half lives are in use with a volumetric pump This can sometimes be achieved by dilution but appropriate clinical
46. y technical staff rather than by the bedside MHRA 04103 Alaris Asena GW Volumetric pump Evaluator assessment of ergonomics Configuration changes available to the user are limited to occlusion pressure alarm level alarm volume enabling micro mode or changing to time volume mode from rate time mode The Enter key is pressed and held to access these changes It is possible to disable these user accessible configuration changes See below Configurable options for other configurable features Alarms and alerts The alarm tone is distinctive and volume can be adjusted Visual messages are displayed on the LED screen and are clear and unambiguous Messages prompting the user to remedial action are not provided Alarm and alert both provide visual and audible signal to the user Alarm is given for upstream occlusion internal battery depleted door open system fault flow error flow sensor connection error downstream occlusion and incorrect or badly loaded administration set Alerts are given for bolus being delivered end of infusion pump priming low battery pump on hold pump unattended for more than 2 minutes and test indicating an automatic test sequence is being executed When the pump detects any of the alarm conditions the infusion is stopped and the audible and visual alarms are activated The audible alarm is accompanied by display of an abbreviated text message on the seven segment display for instance an occlus
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