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Hospital grade non-invasive blood pressure monitors

1. yes ESH amp ANSI AAMI SP10 independent study and peer reviewed publication derived BHS grade A A yes ANSI AAMI SP10 independent study amp unpublished report derived BHS grade A B yes ANSI AAMI SP10 amp ESH studies completed but not yet published derived BHS grade A A Market review Manufacturer Nonin Medical Inc Omron Healthcare Co Lid 20 Philips Medical Systems Model range no of models Avant 2120 1 HEM 907 1 SureSigns VS1 8 Parameters amp features Base model Other models Options in all models NIBP SpO printer NIBP none NIBP SpO temperature printer Power Battery charger ext 12 V DC mains adaptor rechargeable 7 2 V 4 0 Ah NiMH battery ext 8V DC mains adaptor rechargeable 4 8 V 1 6 Ah NiMH battery mains rechargeable 6 V 5 Ah SLA battery ext mains adaptor ext mains adaptor built in charger Display LED LCD LED amp LCD Memory up to 300 measurements up to 3 measurements in Average mode up to 400 measurements Printer recorder yes external no yes internal Connection interface RS 232 no RS 232 Pressure range 0 300 mmHg 0 299 mmHg 0 300 mmHg Systolic pressure range 40 260 mmHg not specified adult paediatric 60 250 mmHg neonate 40 120 mmHg Diastolic pressure range 25 200 mmHg not specified adult p
2. 625 1165 1280 1820 Information not provided Servicing costs annual PPM 93 fully comprehensive 185 field service call out 121 unscheduled repair 218 annual PPM 127 fully comprehensive 273 field service call out 121 unscheduled repair 218 annual PPM 155 fully comprehensive 310 field service call out 121 unscheduled repair 218 CEP 08018 May 2008 yes ANSI AAMI SP10 in house testing unpublished summary report BHS grade not derivable from summary yes ANSI AAMI SP10 amp BHS independent study and peer reviewed publication BHS grade A A yes ANSI AAMI SP10 in house study and unpublished report derived BHS grade A A Market review 23 Biosys Sentry Brief description Four models were available in the range The base model Sentry NS monitored NIBP including automatic timed measurements SpO and optionally temperature NIBP was indicated for use on all patient categories adult paediatric and neonate The other three models monitored the same parameters but included a printer module a trend display screen or both The monitor was operated by 16 control buttons in conjunction with nine numerical indicator displays that showed patient parameter information An LCD panel was provided on the two models with trend display capability A large clearly visible alarm indicator was mounted centrally above the display area Other indicator icons sh
3. yes recessed grip yes carrying case optional yes user training free of charge competency based training service training competency based training free of charge List price exc VAT 1000 1400 995 1395 1 850 Servicing costs 1 year warranty free maintenance contract not available 110 plus parts 2 year warranty free annual contract 96 or 165 inc repairs amp parts 5 year cover 260 or 445 inc repairs amp parts CEP 08018 May 2008 no evidence found yes ANSI AAMI SP10 independent study amp unpublished report derived BHS grade A A claimed due to similarity to Criticare Poet Plus 8100 according to independent study amp unpublished report derived BHS grade A B Market review Manufacturer Datascope Corp Datascope Corp 18 GE Medical Systems Model range no of models Accutorr Plus 5 Duo 3 Dinamap Pro 4 Parameters amp features Base model Other models Options in all models NIBP SpO Masimo or Nellcor trend screen temperature printer choice of battery type NIBP SpO Masimo or Nellcor temperature NIBP printer trend screen SpO temperature none Power Battery charger mains rechargeable 11 1 V 4 4 Ah Li ion battery rechargeable SLA battery recently discontinued mains rechargeable 7 2 V 6 6 Ah Li ion battery mains ext 12 30 V D
4. reusable child small adult adult long adult large adult disposable child small adult adult long adult reusable amp disposable infant child small adult adult large adult thigh a range of neonate sizes Physical size H x W x D 270 x 190 x 210 mm 243 x 130 x 140 mm 250 x 248 x 175 mm Weight 5 kg 2 1 kg 3 5 kg Mounting options integrated rear panel cam lock for pole mounting rolling stand wall mount universal mounting bracket table mount rolling stand rolling stand yes recessed grip yes yes recessed grip EBME technician training course user training courses EBME technician training course user training courses competency based training List price exc VAT 1495 2695 775 1575 2547 3252 Servicing costs 3 year warranty free warranty PPM contract 1 4 years 99 199 per annum non contract hourly rate 120 180 2 year warranty free warranty PPM contract 1 4 years 99 199 per annum non contract hourly rate 120 180 3 year warranty free extended warranty to 5 years 100 CEP 08018 May 2008 yes ANSI AAMI SP10 amp BHS independent studies and peer reveiwed publications BHS grade A A yes ANSI AAMI SP10 in house study and unpublished report unable to derived BHS grade from data in supplied report yes ANSI AAMI SP10 independent study
5. Failed overpressure test CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 42 Model tested Avant 2120 excellent SD 1 3 mmHg good SD 1 2 mmHg excellent SD 0 8 mmHg gave no misleading readings gave no misleading readings fail good satisfactory not available case material plastic good good calibration accuracy checks only replaceable CEo123 The monitor was supplied with a 1 85 m hose and reusable cuffs of size small standard and large The case had a recessed carrying grip not visible on photo which doubled as a battery compartment cover An RS 232 port the rear panel could be used with an external serial printer or for connection to a PC There were facilities for a range of mounting options Internally all assemblies were securely mounted Surface mount components were used on high quality circuit boards with good component labelling throughout There was a single pressure transducer and two pressure release valves Overpressure test We tested the monitor for overpressure with a simulated single fault condition applied The maximum cuff pressure recorde
6. Technical discussion Construction 48 Model tested NIBP SpO temp excellent SD 0 9 mmHg excellent SD 0 8 mmHg good SD 1 7 mmHg gave no misleading readings gave no misleading readings not tested excellent good good case material plastic excellent excellent excellent main assembly replacement replaceable CEo123 The device was supplied with a 3 m hose and an adult reusable cuff On the rear panel was a battery compartment a USB port for connection to a PC and an Ethernet port for networking On the base was a roll stand mounting point Internally all assemblies were securely mounted on a metal chassis surface mount components were used on high quality circuit boards with good component labelling throughout Overpressure test The device incorporated two pressure transducers and two release valves necessary to fulfil this requirement but we were unable to carry out our standard over pressure test due to inaccessibility of the pneumatic components Power supply The monitor was powered from the mains or a rechargeable11 V lithium ion battery but no operating time was specified It was recharged in situ wnen AC mains was connected the recharge time was not specified Serviceability The monitor carried out self tests when switched on The service menu had a system diagnostic function and access to the pressure test calibration accuracy check procedure The service manual contained an extensi
7. The battery compartment was located underneath Internally all assemblies were securely mounted surface mount components were used on high quality circuit boards with good labelling throughout Two pressure transducers were connected to a common manifold Overpressure test A simulated single fault condition was applied and the resulting overpressure was measured whilst the monitor attempted to perform an NIBP determination The maximum pressure recorded was 328 mmHg an acceptable outcome Power supply The monitor was powered from the mains or a rechargeable battery Two types of battery were available depending on the monitor purchased a 12 V SLA with a specified 4 5 hour capacity and an 8 hour charge time or 11 1 V Li ion with a specified 10 5 hour capacity and an 8 hour charge time Serviceability Monitor disassembly was very straightforward and was detailed in the service manual Repair of the unit was to circuit board assembly replacement level A service menu gave access to pressure transducer calibration accuracy checks and a leak test CEP 08018 May 2008 Market review 39 Nissei DM 3000 Brief description The Nissei DM 3000 was an NIBP device packaged to resemble a mercury spohygmomanometer and enabled a user to take blood pressure measurements by manual auscultation It also had an automatic setting in which the monitor measured blood pressure by the oscillometric method Cuff pressure was shown on a b
8. Witteman JCM Arterial stiffness as underlying mechanism of disagreement between oscillometric blood pressure monitor and a sohygmomanometer Hypertension 2000 36 1524 1563 Wood D de Backer G Faergeman O et al Clinician s manual on total risk management A guide to prevention of coronary heart disease Based on 1998 recommendations of the European Society of Cardiology European Society of Hypertension and the European Atherosderosis Society Science Press London UK 2000 http nome pasa nhs uk PASAWeb Guidance TOPPM LandingPage htm http www ogc gov uk procurement policy and application of eu rules eu procurement thresholds asp UK Government Strategy for Sustainable Development Securing the Future http www sustainable development gov uk publications uk strateqy index htm EC Directive on Waste Electrical and Electronic Equipment http www berr gov uk files file35992 pdf British standard BS EN 60601 2 30 2000 Particular requirements for the safety including essential performance of automatic cycling non invasive blood pressure monitoring equipment Bland J M and Altman D 1986 Statistical methods for assessing agreement between two methods of clinical measurement Lancet 1 8476 307 310 O Brien E Waeber B Parati G Staessen J Myers MG Blood pressure measuring devices recommendations of the European Society of Hypertension BMJ 2001 319 531 536 Anwar YA Tendler BE McCabe EJ Mansoor GA White WB
9. 59 CEP 08018 May 2008 Economic considerations 11 Additional costs To achieve best value when purchasing a hospital grade NIBP monitor users should consider the following costs Accessories Are additional accessories Supplied at extra cost required to use the monitor e g wall mounting brackets or roll stands Consumables Cuffs If disposable cuffs are to be used how many will be required and in what sizes If re usable cuffs are to be used what is their life expectancy Batteries What is the expected operating life of a battery How much are replacements Other parameters If the NIBP monitor has been specified with additional monitoring parameters what additional consumables are required e g SpO2 probes temperature probes probe covers and at what cost Training In the product information tables page 17 found in the Market review section we have listed what training the manufacturer supplier provides and at what cost Most manufacturers provide competency based training courses free of charge but some charge hourly rates Users should consider what training is required and take any costs into account Servicing Some manufacturers suppliers also provide training for service personnel to allow hospital EBME departments to carry out routine servicing and calibration Alternatively service contracts are available from the manufacturers supplier We have listed servicing costs in the product information t
10. A B for adult paediatric patients Good points Easy to use Well constructed Excellent measurement consistency across a range of pressures SD 0 8 mmHg Excellent measurement consistency at a fixed pressure of 120 80 mmHg SD 0 8 mmHg Gave no misleading readings in the presence of tremor artefact or low pulse strength Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 38 Model tested NIBP SpO2 excellent SD 0 8 mmHg excellent SD 0 8 mmHg satisfactory SD 2 3 mmHg gave no misleading readings gave no misleading readings pass excellent excellent good case material plastic excellent good good main assembly replacement replaceable CEo123 The monitor was supplied with a 3 m hose and an adult reusable cuff The unit had an integrated carrying grip not visible in the photo and the printer if specified was installed in the left hand side panel On the rear panel was a pole mounting point an RS 232 port for connection to a PC a nurse call connector and an Ethernet connector for use with a Mindray central monitoring system
11. consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 50 Model tested NIBP GoC good SD 1 7 mmHg excellent SD 1 0 mmHg good SD 1 3 mmHg gave no misleading readings gave no misleading readings pass excellent excellent satisfactory case material plastic excellent excellent good main assembly replacement replaceable CE 434 The monitor was supplied with a 1 8 m hose and an adult reusable cuff The rear panel had a battery compartment an RS 232 port for connection to a PC and underneath was a roll stand mounting point Alarm fault identification information was printed on the top panel Internally all assemblies were securely mounted Surface mount components were used on high quality circuit boards with good component labelling throughout The NIBP assembly had two pressure transducer and two pressure release valves Overpressure test We measured the cuff pressure with a simulated single fault condition applied The maximum pressure recorded was 297 mmHg an acceptable outcome Power supply The monitor could be powered directly by mains or by a rechargeable 6 V SLA battery operating time was stated by the supplier as two hours It was recharged in situ when A
12. disease The acceptable performance criteria were not defined explicitly in the MHRA report which left some users uncertain as to how to take action on the associated device alert 3 In practice acceptable performance criteria for validation have been published in international standards and in test protocols and acceptance criteria published by clinical groups These are summarised below CEP 08018 May 2008 Introduction 5 Devices placed on the market before June 2005 Prior to June 2005 manufacturers were required 9 to collect sufficient evidence to satisfy a notified body that the new device agreed with trained human observers to within a mean error of 5 mmHg with a standard deviation not exceeding 8 mmHg However the size or composition of the study population was not specified and the results of the trial were not required to be put in the public domain Whether to scrutinize the validation trial results is at the discretion of the notified body Some manufacturers opted to validate their devices according to one of several recognised protocols requiring 85 subjects 4 5 6 or 33 subjects 7 In many cases the trial results are available from the manufacturer or were published in peer reviewed journals Devices placed on the market after June 2005 The minimum criteria for a validation protocol including the number and composition of subjects are published in an EU standard 8 In June 2005 an amendment to EN 1060 3
13. specified capacity of up to 300 NIBP tests It was charged in situ when AC mains was connected taking up to 12 hours Serviceability Repair was via manufacturer s agents therefore no service manual was available However the instruction manual gave a basic procedure selected from the front panel mode switch to check accuracy against a calibrated pressure gauge Cleaning instructions and battery maintenance were also provided Standards do not require a single measurement device to comply with this test CEP 08018 May 2008 Market review Ap Philips SureSigns VS1 Brief description The VS1 range comprised eight models The base model monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal The other models added permutations of SpO2 temperature and internal printer Six numeric LED displays showed patient parameter information and cuff pressure during inflation An LCD panel showed trend data 400 data sets control menus user interface messages There were eleven control buttons five of which were used in conjunction with the LCD panel menus Other indicators icons included patient category alarm status NIBP measurement underway power on and battery charging red when charging green when charged The monitor had a battery power saving feature that invoked standby after five minutes of inactivity Summary Validation The
14. trends of intensive care patients CEP 08018 May 2008 Technical considerations 7 How oscillometric blood pressure monitors work 12 e When an inflated brachial cuff partially constricts blood flow pulsatile changes in blood volume during each heart beat induce small typically lt 3 mmHg pressure pulses in the cuff an oscillometric blood pressure device measures the size of these pulses e The device automatically inflates the cuff pressure above systolic pressure Some devices do this by detecting the absence of oscillometric pulses Others simply inflate to a pre determined level often this starting pressure is configurable e The device deflates the cuff at a controlled rate and measures the size of the oscillometric pressure pulses as a function of cuff pressure e Some devices measure the oscillometric pulses during inflation the measurement concluding after the systolic pressure is determined A proprietary algorithm is applied to the pressure pulse profile to calculate the systolic diastolic and mean blood pressure Problems of inaccuracy The intricate mechanical design of aneroid gauges makes them susceptible to damage caused by mechanical shock and to wear and tear of moving parts Where such damage does not lead to failure of the device there is a risk that the displayed pressure may be in error leading to inaccurate blood pressure measurement Electronic manual gauges have few moving parts and are less susceptibl
15. 0 300 mmHg not specified adult 30 300 mmHg paediatric 30 150 mmHg neonate 20 150 mmHg Systolic pressure range not specified adult 30 225 mmHg neonate 30 135 mmHg Diastolic pressure range not specified adult 15 220 mmHg neonate 15 110 mmHg adult 25 280 mmHg paediatric 35 130 mmHg neonate 25 130 mmHg Pulse rate range adult amp paediatric 30 250 bpm neonate 0 250 bpm adult 30 240 bpm neonate 40 240 bpm 30 240 bpm NIBP 20 300 bpm SpO Automatic measurement cycles 2 5 10 15 30 60 or 120 mins 1 2 3 4 5 10 15 30 60 or 90 mins 1 2 3 5 10 15 30 45 60 120 or 240 mins Paediatric neonate yes yes yes reusable infant child small adult adult large adult thigh neonatal disposable sizes 1 5 reusable and disposable infant small child child small adult adult large adult x large adult neonatal disposable 2 5 5 0 cm reusable infant child small adult adult large arm thigh disposable 3 6 cm 4 8 cm 6 11 cm 7 13 cm 8 15 cm infant child small adult adult large arm thigh Physical size H x W x D 248 x 180 x 175 mm 170 x 215 x 75 mm 220 x 180 x 165 mm Weight 2 9 kg 1 4kg 3 15 kg Mounting options rolling stand IV pole mount rolling stand swivelled hard mount ambulance application universal mount rolling stand IV pole mount
16. 0 Mean difference less than 5mmHg VitalCare 506N3 SD less than 8 mmHg Results Pass 0 2 5 5 0 4 6 6 mmHg BHS grade A B derived from SP10 data Datascope SP10 Mean difference less than 5 mmHg Accutorr Plus SD less than 8 mmHg Results Pass 0 0 7 9 0 4 5 8 mmHg BHS A A Datascope Duo SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 7 5 9 0 2 6 2 mmHg Unable to derive BHS grade from the SP10 data supplied GE Dinamap Pro SP10 Mean difference less than 5 mmHg SD less than 8mmHg Results Fail 0 5 9 8 2 9 6 6 mmHg BHS B C GE Dinamap SP10 Mean difference less than 5 mmHg ProCare SD less than 8 mmHg Results Pass 2 5 5 4 0 5 4 5 mmHg ESH phase 1 and phase 2 Results Pass BHS grade A A derived from SP10 data Mindray VS 800 SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 4 5 1 0 2 6 1 mmHg BHS A B derived from SP10 data Nissei DM 3000 SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 0 8 6 0 0 8 4 8 mmHg ESH phase 1 and phase 2 Results Pass BHS grade A A derived from ESH data CEP 08018 May 2008 Level of evidence We could find no evidence of a validation being performed on the device ANSI AAMI SP10 Unpublished independent report Validation claimed due to similarity with Criticare Poet Plus 8100 which meets the ANSI AAMI S
17. 10 was published which requires manufacturers to follow a validation protocol which meet these criteria Of the common protocols three 4 5 6 meet these criteria of 8 but one the International Protocol 7 does not Whether to scrutinize the results of the validation study remains at the discretion of the notified body Manufacturers are not required to place their validation results in the public domain In many cases the results are available from the manufacturer or were published in peer reviewed journals CEP 08018 May 2008 Technical considerations Blood pressure measurement The standard method for blood pressure measurement according to the World Health Organisation WHO guidelines is the auscultatory technique using a mercury column pressure gauge The auscultatory technique 11 Place the stethoscope over the brachial artery at the point of maximal pulsation The stethoscope should be held firmly and evenly but without excessive pressure as this may distort the artery producing sounds below diastolic pressure The cuff should be inflated rapidly to approximately 30 mmHg above the palpated systolic pressure and deflated at a rate of 2 3 mmHg per pulse beat or per second during which the Korotkoff sounds will be heard Phase The first appearance of faint repetitive clear tapping sounds that gradually increase in intensity for at least two consecutive beats is the systolic blood pressure Phase
18. 30 160 mmHg neonate 25 120 mmHg Diastolic pressure range 30 160 mmHg 30 160 mmHg adult 20 235 mmHg paediatric 15 130 mmHg neonate 10 105 mmHg Pulse rate range 40 200 bpm 35 199 bpm 30 220 bpm Automatic measurement cycles no no 1 3 4 5 10 15 30 45 60 90 120 or 240 mins also Stat Paediatric neonate paediatric only paediatric only yes durable and disposable ranges small child child small adult adult large adult thigh adult reusable child adult large adult thigh durable amp disposable ranges infant small child child small adult adult large adult thigh reusable neonate sizes 1 to 6 infant small child child small adult adult large adult thigh Physical size H x W x D 246 x 145 x 120 mm 270 x 203 2 Braun or 190 Welch Allyn x 133 4 mm 168 x 254 x 152 mm Weight 2 2 kg 3 4 kg 2 4 kg Mounting options options rolling stand wall mount IV pole mount rolling stand wall mount rolling stand wall mount IV pole mount Carrying handle yes yes yes recessed grip Training competency based training cost depends on quantity of units supplied and are dealt with individually competency based training cost dependent on quantity of units supplied sometimes FOC where quantities are large competency based training handbook supplied List price exc VAT
19. 6 a HR 80 HR 80 HR 80 HR 80 Pressure Range Tests Average sD Comments amp rating Measurement Consistency Test for a setting of 120 80 93 HR 80 Average 4 E Comments amp rating Simulator Heart Rate Setting bpm Variable Pulse Rate Tests for a setting of 120 80 93 Average SD Comments amp rating Hospital grade NIBP test protocol doc Issued 5 6 06 Page 2 of 4 CEP 08018 May 2008 Appendix 3 74 Regional Medical Physics Department Freeman Hospital Unit Evaluation amp Calibration section Simulator Artefact Setting Tremor Reading Level 1 Level 4 Level 8 Level 16 Artefact Tests for a setting of 120 80 93 HR 80 Average Zen Comments amp rating Simulator Pulse Strength Setting Reading Pulse Strength Tests for a setting of 120 80 93 HR 80 Average SD Comments amp rating Pneumatic layout to assess sketch pneumatic layout and perform overpressure test i e pinching off tubing to pressure transducer Assessed layout and Comments performed overpressure J test ser amp Service manuals if available complete checklist Completed user amp Comments amp ratings service manual checklist includi
20. C mains was connected the specified recharge time was up to 12 hours Serviceability The manufacturer included a troubleshooting guide and an error code list Repair of the unit was to board assembly replacement level The device had a dedicated service mode entered by pressing a combination of buttons at switch on Facilities provided included NIBP calibration accuracy checks and pressure tests CEP 08018 May 2008 Market review 51 Smiths Mini Torr Plus Brief description The Mini Torr Plus monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal There were model variants that included SpO2 and temperature some models also had a built in printer The monitor was operated by eleven control buttons in conjunction with six numeric LED displays on fully equipped models that showed patient parameter information Other indicator icons included an SpO gt pulse strength bar alarm condition with priority alarm silenced battery charge and low battery status Summary Validation The manufacturer claimed that the NIBP performance was clinically validated using the ANSI AAMI SP10 protocol However no published evidence was found to verify this claim Good points Excellent repeatability at a fixed blood pressure of 120 80 mmHg SD 0 8 mmHg Good measurement consistency across a range of simulated blood pressures SD 1 5 mmHg and a rang
21. C supply int rechargeable 12 V 2 3 Ah SLA battery built in charger built in charger built in charger Display LED LCD trend screen LED LED amp LCD Memory up to 100 measurements no up to 100 measurements Printer recorder yes modular no yes built in Connection interface RS 232 no RS 232 Pressure range adult 0 300 mmHg paediatric 0 220 mmHg neonate 0 165 mmHg 0 325 mmHg adult paediatric 0 290 mmHg neonate 0 145 mmHg Systolic pressure range adult 55 260 mmHg paediatric 55 160 mmHg neonate 45 120 mmHg adult 40 255 mmHg paediatric 40 200 mmHg adult paediatric 30 290 mmHg neonate 30 140 mmHg Diastolic pressure range adult 30 200 mmHg paediatric 30 150 mmHg neonate 20 100 mmHg adult 10 210 mmHg paediatric 10 150 mmHg ault paediatric 10 220 mmHg neonate 10 110 mmHg Pulse rate range adult paediatric 35 245 bpm neonate 70 245 bpm 40 240 bpm adult paediatric 30 200 bpm neonate 30 220 bpm Automatic measurement cycles off cont 1 2 5 5 10 15 20 30 60 120 or 240 mins no 1 2 3 4 5 10 15 20 30 45 60 90 or 120 mins Paediatric neonate yes paediatric only yes reusable amp disposable small child child small adult adult long adult large adult long large adult adult thigh neonatal disposable sizes 1 5
22. Claimed validated to ANSI AAMI SP10 We could find no evidence to substantiate the claim ANSI AAMI SP10 and BHS Submitted for publication in a peer reviewed journal 29 ANSI AAMI SP10 and BHS Peer reviewed publication 30 ANSI AAMI SP10 Unpublished in house report 61 Repeatability mmHg 30 measurements Good 121 1 1 2 78 4 0 9 92 6 0 9 Excellent 120 5 0 5 78 9 0 4 Satisfactory 119 1 2 8 77 7 2 1 88 9 1 9 Excellent 125 8 0 4 85 7 0 5 98 1 0 8 Excellent 122 3 1 0 82 9 0 8 93 8 0 5 Excellent 112 6 0 7 83 9 0 8 96 9 0 6 Excellent 119 6 0 7 81 4 0 5 94 2 0 4 Excellent 123 4 0 7 81 4 0 5 95 2 0 4 Excellent 122 4 0 8 84 7 0 7 94 9 0 4 Market review 62 Figure 1 Venn diagram of results Accuracy Level of evidence Passed ANSI AAMI SP10 Peer reviewed study and BHS grade A or B or equivalent for systolic and diastolic pressure Datascope GE Dinamap Pro Accutorr Plus CAS 740 GE Dinamap Nonin Avant 2120 ProCare Omron HEM 907 Welch Allyn Spot Welch Allyn A Spot LXi Criticare VitalCare 506N3 Mindray VS 800 Nissei DM 3000 Philips SureSigns VS3 Welch Allyn VSM 300 Datascope Duo Schiller Argus VCM Smiths Mini Torr Plus Repeatability Excellent SD lt 1 mmHg Others Biosys Sentry Philips SureSigns VS1 CEP 08018 May 2008 Acknowledgements We would
23. Evaluation of the Datascope Accutorr Plus according to the recommendations of the Association for the Advancement of Medical Instrumentation Blood Press Monit 1997 2 105 110 Ni K Wu C Prineas R Shea S Liu K Kronmal R Bild D Comparison of Dinamap Pro 100 and mercury sphygmomanometer blood pressure measurements in a population based study American Journal of Hypertension 2006 19 353 360 Reinders A Reggiori F Shennan A Validation of the DINAMAP ProCare blood pressure device according to the international protocol in an adult population Blood Press Monit 2006 11 293 296 White WB Anwar YA Evaluation of the overall efficacy of the Omron office digital blood pressure HEM 907 monitor in adults Blood Press Monit 2001 6 107 110 El Assaad M Topouchian JA Dame BM Asmar RG Validation of the Omron HEM 907 device for blood pressure measurement Blood Press Monit 2002 7 237 241 Alpert BS Validation of the Welch Allyn Spot Vital Signs blood pressure device according to ANSI AAMI SP10 2002 Submitted for publication in Blood Press Monit Alpert BS Clinical evaluation of the Welch Allyn SureBP algorithm for automated blood pressure measurement Blood Press Monit 2007 12 215 218 CEP 08018 May 2008 References 67 31 Sims AJ Menes JA Bousfield DR Reay CA Murray A Automated non invasive blood pressure devices are they suitable for use Blood Pressure Monitoring 2005 10 275 281 32 http Awww pasa nhs uk pasaw
24. II A brief period may follow during which the sounds soften and acquire a swishing quality In some patients sounds may disappear altogether for a short time auscultatory gap Phase Ill The return of sharper sounds which become crisper to regain or even exceed the intensity of phase sounds Phase IV The distinct abrupt muffling of sounds which become soft and blowing in quality Phase V The point at which all sounds finally disappear completely is the diastolic pressure When all sounds have disappeared the cuff should be deflated There is now a general consensus that the disappearance of sounds phase V should be taken as diastolic pressure When the Korotkoff sounds persist down to zero muffling of sounds phase IV should be recorded for diastolic pressure and a note made to this effect The clinical significance if any of phases II and III has not been established Alternatives to mercury There are two main alternatives to the use of a mercury sphygmomanometer One is to continue using the auscultatory technique but to use a non mercury gauge such as an aneroid in which changes in pressure are mechanically converted to the deflection of a needle or an electronic manual gauge in which pressure is measured by an electronic transducer and displayed numerically and or graphically The second alternative is to use the oscillometric technique This was originally developed in the 1980s to monitor blood pressure
25. On the monitor s rear panel was an integrated carrying grip not visible in photo the air hose connector and an RS 232 port for connection to a PC The battery was housed in the bottom panel and the printer when fitted in a side panel Internally all assemblies were securely mounted surface mount components were used on high quality circuit boards with good component labelling throughout There were two pressure transducers and two pressure release valves Overpressure test A simulated single fault condition was applied and the resultant cuff pressure was measured whilst an NIBP determination was performed The maximum pressure recorded was 304 mmHg an acceptable outcome Power supply The monitor was powered from the mains or a rechargeable 6 V SLA battery specified with a six hour operating time It was charged in situ when AC mains was connected the specified recharge time was approximately four hours Serviceability The service manual included a troubleshooting guide and a list of error messages Repair of the unit was to board assembly replacement level Monitor configuration performance tests and calibration accuracy checks were available from the service menu CEP 08018 May 2008 Market review AT Philips SureSigns VS3 Brief description The VS3 range comprised six models The base model monitored NIBP including automated timed measurements and was indicated for use on all patient categories adult paediatric and
26. P10 according to an unpublished independent report ANSI AAMI SP10 and BHS Peer reviewed publications 23 24 The device uses a Mindray 630B NIBP module which meets the ANSI AAMI SP10 according to an unpublished in house report ANSI AAMI SP10 Peer reviewed published study 25 showed equivalent AAMI and BHS results ANSI AAMI SP10 and International protocol ESH Peer reviewed publication 26 ANSI AAMI SP10 Unpublished independent report At the time of writing this report the International protocol ESH validation study had not been published but we were supplied with preliminary results 60 Repeatability mmHg 30 measurements Satisfactory 121 042 1 81 040 8 95 3 1 0 Good 124 4 0 9 85 9 1 0 97 8 1 1 Excellent 118 0 0 6 82 4 0 6 98 3 0 6 Good 120 0 1 5 78 7 0 9 93 5 1 0 Excellent 125 6 0 5 85 1 0 3 96 6 0 5 Good 124 8 1 3 85 8 0 6 98 7 0 5 Good 124 2 1 5 83 4 1 3 94 9 0 7 Excellent 120 1 0 8 84 2 0 4 94 2 0 8 Excellent 121 1 0 7 82 4 0 6 Market review Monitor Nonin Avant 2120 Omron HEM 907 Philips SureSigns VS1 Philips SureSigns VS3 Schiller Argus VCM Smiths Mini Torr Plus Welch Allyn Spot Vital Signs Welch Allyn Spot Vital Signs LXi Welch Allyn VSM 300 Series Accuracy SP10 Mean difference less than 5 mmHg SD less than 8 mmH
27. Purchasing and Supply Agency Centre for Evidence based Purchasing Buyers guide Hospital grade non invasive blood pressure monitors CEP 08018 May 2008 Informing procurement Encouraging innovation Contents 2 ew deiere E 3 Technical considerationS oc ateccecistesetescccssgnqnsstanedee DEER e eege 6 Operational COMSICST ANOS ins ictvennerresiivcenanncicdsnndcsspevumnncbeunGutindinnddanassedoess 8 Economic considerations eeccneececceeeeeeesneeeerecececeeeesseeeeeeerenees 11 dein Cl e eisrean EE erry E SAE AAE AAE e EAEE 12 Market KEEN 13 Acknowledgements bk 63 EotT EE 64 et 65 Appendix 1 Supplier contact details NEEN 68 Appendix 2 EU procurement procedure EEN 70 Appendix 3 Data Collection pro forma ccccccceeeeceeeceeeeeeeeeeaeeeeeeeeees 72 Author and report INTOMMNAUON wy vcisiccrsasasssvvvareenrieiasnvvesiesnacrdennssvvissseaventand esis 76 CEP 08018 May 2008 Introduction 3 General This buyers guide is intended to assist in the selection of automated non invasive blood pressure NIBP monitors for use in hospitals Information is presented in a standardised format to help purchasers prepare a short list of devices The eighteen models in this issue represent the state of the UK market from late 2006 to late 2007 Several manufacturers offer a range of related models We have attempted to represent the full range of current models and major optional additions or upgrades that
28. a rechargeable 6 V SLA battery with a specified minimum capacity of eight hours It was charged in situ when the mains was connected the specified recharge time was up to twelve hours Serviceability Error code information was given in the user manual and printed on the right hand side panel The scope of the service manual was for preventative maintenance and repair procedures to board replacement level A service menu gave access to an NIBP test routine and pressure measurement verification Service utility software provided further NIBP performance tests and downloading of event logs CEP 08018 May 2008 Market review 59 Recommendations Results The results obtained for each device in the report are summarised in Table 3 page 60 Three criteria were measured as described in Methods page 13 accuracy level of evidence and measurement repeatability To show which devices performed best against these criteria we have displayed the results diagrammatically in a Venn diagram Figure 1 page 62 It contains three overlapping circles labelled Accuracy Level of evidence and Repeatability Every device is located on the diagram according to which of the criteria it satisfied Those which satisfied all criteria are shown at the centre of the diagram where all three circles overlap we would recommend these NIBP monitors Devices which satisfied two criteria where two circles overlap should also be considered Devices that satisfied o
29. ables see page 17 Warranty Warranty periods vary from one to three years with the option to extend for an additional cost on some devices We have listed warranty periods and associated costs in the product information tables see page 17 Users should be aware of these costs especially if they do not have access to service personnel in their organisation CEP 08018 May 2008 Purchasing 12 Purchasing procedures PASA s Trust Operational Purchasing Procedures Manual provides details of the procurement process 17 European Union procurement rules apply to public bodies including the NHS The purpose of these rules is to open up the public procurement market and ensure the free movement of goods and services within the EU In the majority of cases a competition is required and decisions should be based on best value The EU procurement rules apply to contracts worth more than 90 319 from January 17 2008 18 Further details of the process are detailed in Appendix 2 NHS Supply Chain NHS SC offers national contracts or framework agreements for some products goods and services Use of these agreements is not compulsory and NHS organisations may opt to follow local procedures Sustainable procurement The UK Government launched its current strategy for sustainable development Securing the Future 19 in March 2005 The Strategy describes four priorities to progress sustainable development in the UK and in the wo
30. aediatric 40 200 mmHg neonate 20 90 mmHg Pulse rate range up to 200 bpm 30 199 bpm adult paediatric 40 200 bpm neonate 40 240 bpm Automatic measurement cycles 1 2 3 5 10 15 45 60 or 90 mins no 1 2 2 5 3 5 10 15 20 30 60 90 120 or 180 mins Paediatric neonate paediatric only no yes reusable small standard large reusable small medium large reusable amp disposable infant paediatric small adult adult large adult thigh neonatal disposable sizes 1 4 Physical size H x W x D 138 x 190 x 114 mm 203 x 139 x 131 mm 258 x 210 x 285 mm Weight 1 35 kg 1 0 kg 3 75 kg Mounting options rolling stand wall bracket pole clamp rolling stand wall bracket pole mount rolling stand Carrying handle yes recessed grip carrying case optional yes recessed grip yes recessed grip Training training for clinical amp technical staff free of charge competency based training free of charge training free of charge List price exc VAT 1595 298 58 1325 2525 Servicing costs 3 year warranty on main unit sensor amp NIBP module 1 year warranty on charger cord amp battery pack recalibration free of charge under 3 year warranty 30 after 3 years 1 year warranty CEP 08018 May 2008 yes ANSI AAMI SP10 in house study and unpublished report de
31. al Configuration changes can be saved no more than 90 times after which an error message is issued This can be reset only by returning the monitor to a GE service centre A pull out reference guide was slotted underneath the case Summary Validation The NIBP performance was clinically validated using the International Protocol of the European Society of Hypertension and ANSI AAMI SP10 It was supported by an independent study and a peer reviewed publication 26 From the data we derived its equivalent BHS grade to be A A Good points Very well constructed with good documentation and service facilities Good measurement consistency at a fixed pressure of 120 80 mmHg SD 1 5 mmHg Good measurement consistency across a range of pressures SD 1 9 mmHg Gave no misleading readings in the presence of tremor artefact or low pulse strength Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 36 Model tested 400 NIBP SpO temp good SD 1 9 mmHg good SD 1 5 mmHg satisfactory SD 3 5 mmHg gave no misleading readings gave no misleading readin
32. and peer reviewed publication BHS grade B C Market review Manufacturer GE Medical Systems Mindray Co Ltd 19 Nissei Nihon Seimitsu Sokki Co Ltd Model range oo ot models Dinamap ProCare 4 VS 800 5 DM 3000 1 Parameters amp features Base model Other models Options in all models NIBP SpO temperature printer NIBP trend screen SpO Mindray OxiMax or Masimo temperature printer choice of battery type NIBP Battery charger ext 12 V DC mains adaptor rechargeable 6 V 3 3 Ah SLA battery mains rechargeable 12 V 2 3 Ah sealed lead acid battery rechargeable 11 1 V 4 4 Ah Li ion battery ext 7 V DC mains adaptor rechargeable 4 8 V NiMH battery ext mains adaptor built in charger ext mains adaptor Display LED LED amp LCD LCD numeric amp column Memory up to 40 measurements up to 1200 measurements on up to 100 patients single last measurement Printer recorder yes modular thermal array printer no Connection interface RS 232 RS 232 nurse call ethernet no Pressure range adult paediatric 0 290 mmHg neonate 0 145 mmHg adult 10 270 mmHg child 10 200 mmHg neonate 10 135 mmHg 0 300 mmHg Systolic pressure range adult paediatric 30 290 mmHg neonate 30 140 mmHg information not provided 50 250 mmHg Diastolic pressure range ault paediat
33. anuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 34 Model tested 400 V2 NIBP SpO temp satisfactory SD 3 3 mmHg good SD 1 3 mmHg good SD 1 6 mmHg 1 misleading reading from 25 tests gave no misleading readings pass excellent good good case material plastic excellent excellent excellent main assembly replacement replaceable CEoose The monitor was supplied with a 3 66 m hose and a wide range of cuffs was available all were dual lumen This feature was claimed to reduce measurement errors in the event of air hose kinking since both lumens were less likely to kink simultaneously The monitor had an integrated carrying grip not visible in the photo The rear panel housed the battery and an integrated pole mounting rail with securing knob Also on the rear panel was an RS 232 port for connection to a PC Internally all assemblies were securely mounted Two pressure transducers and two pressure release valves were present All pneumatic components were encased in foam to reduce noise Overpressure test We performed an overpressure test whilst applying a simulated single fault condition The highest cuff pressure recorded was 301 mmHg within the allowable limit Power supply The device was powered from the mains an external 24 V DC supply or a rechargeable 12 V SLA batte
34. are available Models are presented alphabetically by manufacturer Abbreviations used in this report are defined in the Glossary page 64 Scope The guide reviews hospital grade monitors selected see Method page 13 from the large number of automated blood pressure monitors currently available in the UK All 18 of the devices assessed carried out automated measurements using the oscillometric measurement technique This works on the principle that when an inflated cuff partially occludes blood flow in the brachial artery pulsatile changes in blood volume during each heart beat induce small typically lt 3 mmHg pulses in the cuff Devices measure the size of these pressure pulses while inflating or deflating the cuff see box page 7 All 18 devices were capable of making single manually initiated measurements Twelve of them were automatic cycling types These can work unattended because they have a built in timer to allow repeated measurements to be made at intervals from 1 to 60 or more minutes Such devices must have overpressure safety mechanisms see page 14 and alarms Two devices provided the additional facility of allowing measurements to be made using manual auscultation see box page 6 National guidance British Hypertension Society BHS Guidelines 1 In 2004 the BHS issued guidelines for management of hypertension Those relating to blood pressure measurements are e Use a properly maintained calibrate
35. asurement device to comply with this test CEP 08018 May 2008 Market review 41 Nonin Avant 2120 Brief description The Avant 2120 monitored NIBP with automatic timed measurements and SpO2 The NIBP function was indicated for use on adult and paediatric patients only There were no model variants although a compatible external printer was available The monitor was operated by 11 control buttons and a set of LED numerical displays Five of them showed patient parameter information and a sixth showed a variety of other data including cuff pressure and timed measurement interval An SpO gt pulse strength bar graph doubled as a battery capacity indicator A set of LED icon indicators included sensor data alarm status and battery charging status The NIBP display was cleared five minutes after the last measurement Up to 300 NIBP readings 33 5 hours of SpO2 and pulse rate data not NIBP were stored and available for download to a PC Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an in house study and an unpublished report supplied From the data we derived its equivalent BHS grade to be A A Good points Excellent measurement consistency across a range of blood pressures SD 1 3 mmHg and pulse rates SD 0 8 mmHg Gave no misleading readings when subject to varying degrees of tremor artefact and low pulse strengths Disadvantages
36. atic timed measurements The other two models included either Masimo or Nellcor Go A temperature display was built in to the front panel of the supplied model but this option was not available at the time of this report The monitor was operated by four control buttons below the display area A set of numeric LED displays showed patient parameter information and alongside them were LED indicators that gave additional information e g pulse rate source SpOz or NIBP patient category battery charging status AC power and NIBP start stop The monitor had a battery power saving features e Standby invoked after 2 3 minutes of inactivity e Auto shutoff after 13 minutes in standby Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an in house study and an unpublished report supplied We were unable to derive a BHS grade from the data given in the supplied report Good points Very well built Excellent measurement consistency at a fixed pressure of 120 80 mmHg SD 0 5 mmHg and varying pulse rates pulse rates SD 0 9 mmHg Good consistency across a range of pressures SD 1 1 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave two misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressu
37. available software and hardware Standards do not require a single measurement device to comply with this test CEP 08018 May 2008 Market review 55 Welch Allyn Spot Vital Signs LXi Brief description Six models were available in the Spot Vital Signs LXi range The base model 450T0 monitored NIBP and temperature NIBP was indicated for adult and paediatric patient categories manually initiated only i e no automatic timed measurements The other five models included different permutations of SpO2 Nellcor or Massimo and temperature module An external printer was also available The monitor was operated by seven control buttons in conjunction with a monochrome backlit LCD which showed patient parameter information The user could scroll through the previous 50 NIBP readings Other indications were a battery level gauge and mains battery charge status A Body Mass Index calculator was included on all models NIBP measurements were performed during the cuff inflation phase followed by immediate cuff deflation when the measurement was complete this can be faster and more comfortable to patients than conventional measurement during deflation When pulse was weak or tremor artefact was present it made the measurement during the cuff deflation phase Summary Validation The NIBP performance had been clinically validated using the ANSI AAMI SP10 protocol the results were also classified against the British Hypertension S
38. ch that it no longer poses an infection risk it is again covered by the WEEE regulations and there may be potential to dispose of the unit through the normal WEEE recovery channels CEP 08018 May 2008 Market review 13 Method Starting in mid 2005 and continuing to the conclusion of the evaluation we carried out a market review of NIBP devices on the UK market We looked for information in medical literature from known suppliers validation reports and from the internet Establish device selection criteria A large number of devices were identified in the price range 30 to 1800 Some manufacturers produced several models within a product range A judgement was required to establish a dividing line between those indicated for personal home use and devices appropriate to a hospital setting Looking at the prices of the simplest model in each device range we noted that none lay in the price band 100 to 240 Thus there was a natural grouping into devices costing 100 or less and devices costing 240 or more The subjects of this report are those devices whose base model costs 240 or more Low cost devices will be the subject of a separate buyers guide Acquire devices All but one of the devices were borrowed from the manufacturers to carry out the assessment protocol The remaining device had been evaluated previously Sometimes suppliers provided devices with extra parameters and accessories compared with the simplest mode
39. d contained two pressure transducers Overpressure test A maximum cuff pressure of 299 mmHg was recorded when a single fault condition was applied below the permissible maximum limit Power supply The monitor was powered from the mains an external 12 V DC supply or a rechargeable 7 2 V NiMH battery with a specified capacity of 100 NIBP measurements when repeated at five minute intervals The battery was charged in situ when AC mains was connected the specified recharge time was four hours Serviceability The user manual gave details on cleaning and maintenance of the unit recommended intervals for pneumatic checks calibration accuracy checks and replacement of the battery pack A configuration menu enabled user preferences to be set The service manual was good enabling in house servicing to main assembly replacement level CEP 08018 May 2008 Market review 27 Criticare VitalCare 506N3 Brief description Eight models were available in the VitalCare range The base model monitored NIBP including automatic timed measurements indicated for use on all patient categories adult paediatric and neonatal and SpO3 The seven other models provided different permutations of temperature SpO2 technology Criticare or Nellcor and printer The monitor base model was operated using ten front panel control buttons Five numeric LED displays showed patient parameter information A small LCD text panel showed status messages and men
40. d and validated device e Measure sitting blood pressure routinely standing blood pressure should be recorded at the initial estimate in elderly and diabetic patients e Remove tight clothing support arm at heart level ensure hand relaxed and avoid talking during the measurement procedure e Use a cuff of appropriate size the bladder should surround at least 80 of the upper arm using too large a cuff will result in a underestimation of blood pressure while too small a cuff will lead to overestimation e When using the auscultatory method see box page 6 lower mercury column slowly 2 mm s read blood pressure to the nearest 2mmHg measure diastolic as disappearance of sounds phase V CEP 08018 May 2008 Introduction 4 e Take the mean of at least two readings more recordings are needed if marked differences between initial measurements are found e Do not treat on the basis of an isolated reading Medicines and Healthcare Products Regulatory Agency MHRA In 2005 the MHRA issued a report containing recommendations of the Independent Advisory Group on Blood Pressure Monitoring in Clinical Practice 2 and followed it up with a medical device alert 3 Those recommendations which are relevant to the selection of hospital grade NIBP monitors are e Recommendation 3 Where oscillometric blood pressure measurement is used it should not be assumed that a CE marked blood pressure monitor is automatically suitable for use in the
41. d to consider sustainable development issues whether EU directives apply the type and form of contract sourcing potential suppliers duration of contract and opportunity to review extend payment schedules how to minimise any risks with the chosen strategy including supplier appraisal and evaluation clarification of suppliers bids Preparing a business case A business case should be drafted and approved before conducting any procurement exercise Further guidance on preparing business cases is available from the Office of Government Commerce 33 and an illustrative example is provided in the NHS PASA Operational Purchasing Procedures Manual Procedure 1 01 34 CEP 08018 May 2008 Appendix 2 71 The EU tendering exercise EU procurements usually take between 4 and 6 months to complete This needs to be taken into account in the planning stages The length of the exercise depends on the chosen procedure open or restricted Further information is available from the Department of Health 35 The procurement panel A multidisciplinary team should be selected to guide the purchase Representatives from clinical user technical estates and financial areas should be considered Identifying potential suppliers Criteria for supplier selection must be established A supplier pre qualification questionnaire may be employed as an initial screen to exclude unsuitable suppliers which asks for details such as skills and experience of
42. d was 360 mmHg and would have continued increasing but at this point we released the pressure manually to prevent damage a poor result Power supply The monitor was powered by an external mains adaptor or a rechargeable 7 2 V NiMH battery specified with a five hour minimum capacity The battery was recharged in situ when AC mains was connected the specified recharge time was up to four hours monitor off Serviceability The user manual stated that repair was via manufacturer s agents only therefore no service manual was available The monitor performed self tests at power on with error codes and remedial action listed in the user manual Also listed was a calibration accuracy check procedure for the NIBP module Monitor configuration was via a set of miniature switches under the battery compartment cover CEP 08018 May 2008 Market review 43 Omron HEM 907 Brief description The HEM 907 measures NIBP using the oscillometric method and had facilities for users to measure blood pressure by manual auscultation There were no model variants In oscillometric mode it could be set to make a single measurement or provide an average of two or three readings taken at preset intervals 5 sec to 3 minutes Initial inflation pressure could be set by the user or left for the device to determine for itself In its manual auscultation mode inflation and deflation was not user controllable but occurred automatically while the user liste
43. de a log of supplied equipment amp accessories Completed acceptance Comments testing fal Production information complete product information specification spreadsheet to include available cuff sizes including disposables cuff prices and supplier servicing calibration costs Completed product Comments information spreadsheet O CE marking based on supplied documentation including the CE marking certificate of conformance CE marking information Comments CE marking ID number Notified body Listed standards Verification of claimed clinical validation based on supplied information scientific literature and reference to the www dableducational org website Validation protocol claimed Verified Comments BHS TT ANSVAAMISP 10 O DIN 58130 Ek BS EN 1060 4 O O Other C C e Number of subjects e Where clinical validation carried out Number of normal subjects Number of patients in each clinical group Hospital grade NIBP test protocol doc Issued 5 6 06 Page 1 of 4 CEP 08018 May 2008 Appendix 3 73 Regional Medical Physics Department Freeman Hospital Unit Evaluation amp Calibration section Simulator testing to include pressure range tests measurement consistency test variable pulse rate tests artefact tests and pulse strength tests Preset Simulator Setting di 100 65 120 80 150 100 200 150 Ges ing 76 93 116 16
44. ded We would expect devices complying with this standard to have two independent pressure transducers We would not expect non cycling devices to meet this requirement but since some did we applied the same test to them all We simulated single fault conditions on the NIBP monitors by pinching off the air supply to their pressure transducers prior to and during an NIBP determination and noted the resulting behaviour BS EN 60601 2 30 2000 21 states that the cuff pressure must not exceed 330 mmHg under single fault conditions Simulator testing We attached an NIBP simulator to the monitor under test and applied a series of simulated blood pressures to measure repeatability under normal conditions in the presence of tremor artifact and with weak pulse Measurement repeatability normal conditions Thirty measurements were taken with each monitor using the NIBP simulator set at 120 80 93 mmHg The repeatability of the simulator a Bio Tek BP pump is within 0 1 mmHg 13 The results were averaged and the standard deviation SD calculated A rating was given according to the consistency achieved for systolic diastolic and mean pressures Excellent SD lt 1 mmHg Good SD gt 1 lt 2 mmHg Satisfactory SD gt 2 lt 3 mmHg Poor SD gt 3 lt 4 mmHg Very poor SD gt 4 mmHg Measurement repeatability tremor artefact weak pulse Five measurements were taken at each of five different levels of tremor artefact 25 total and four dif
45. diagnosis of hypertension e Recommendation 4 In those clinical conditions where oscillometry is inappropriate e g arrhythmias pre eclampsia and certain vascular diseases an alternative method of pressure measurement auscultation arterial cannulation should be used e Recommendation 5 The MHRA in collaboration with the Committee on Blood Pressure Monitoring in Clinical Practice should define acceptable performance criteria against which automated non invasive blood pressure monitors should be evaluated Evidence for compliance with these criteria should be obtained from properly conducted clinical trials 4 5 6 7 8 The population characteristics for which the device has been evaluated should be specifically included e Recommendation 6 The NHS and other healthcare sectors should only purchase devices that meet the performance criteria in the recommendation above e Recommendation 7 Auscultation as a method of determining blood pressure should continue to be taught to healthcare workers as appropriate Calibrated non mercury devices which do not rely on oscillometry should be made available in all clinical areas These should be used to check oscillometric results and other non auscultatory alternative blood pressure measurement determination on individual patients These devices should also be used in clinical conditions where alternative methods may be inappropriate e g arrhythmia pre eclampsia or specific vascular
46. e ESH oscillometric validation these indicated that the device passed and also met the ANSI AAMI SP10 criteria From this we derived an equivalent BHS grade to be A A Good points Manual auscultation facility Excellent measurement consistency at a fixed pressure of 120 80 mmHg SD 0 7 mmHg Good measurement consistency across a range of pressures SD 1 1 mmHg provided that no tremor artefact was present Good measurement consistency across a range of pulse rates SD 1 3 mmHg Gave no misleading readings when subjected to low pulse strengths Inexpensive Disadvantages Gave ten misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 40 Model tested DM 3000 good SD 1 3 mmHg excellent SD 0 7 mmHg good SD 1 3 mmHg 10 misleading readings from 25 tests gave no misleading readings gt 370 mmHg oscillometric use good manual auscultation not assessed satisfactory not available case material plastic good good calibration accuracy checks only replaceable CEo123 The monit
47. e of pulse rates SD 1 3 mmHg Gave no misleading readings when subjected to varying degrees of tremor artefact or low pulse strength settings Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests e pressure range e measurement consistency e variable pulse rate e susceptibility to artefact e variable pulse strength e overpressure General MN usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 52 from Evaluation report 01030 May 2001 good SD 1 5 mmHg excellent SD 0 8 mmHg good SD 1 3 mmHg gave no misleading readings gave no misleading readings pass good excellent good case material plastic satisfactory good good main assembly replacement replaceable internal battery within enclosure CE oa73 The monitor was supplied with a 3 m hose and an adult reusable cuff The carrying handle not visible in photo flipped up and was shaped to hook over a hospital bed rail The case had a pole roll stand mounting point On the rear panel was an RS 232 port for connection to a PC Internally all assemblies were securely mounted Surface mount components were used on high quality circuit boards with good component labelling throughout The NIBP assembly had two pressure transducers and two pressure release valves O
48. e sohygmomanometers Test procedures to determine the overall system accuracy of automated non invasive sphygmomanometers British Standard BS EN 1060 3 1997 Non invasive sohygmomanometers Supplementary requirements for electro mechanical blood pressure measuring systems British Standard BS EN 1060 3 1997 with the incorporation of amendment A1 2005 Non invasive sohygmomanometers Supplementary requirements for electro mechanical blood pressure measuring systems O Brien E Asmar R Beilin L Imai Y Mallion JM Mancia G Mengden T Myers M Padfield P Palatini P Parati G Pickering T Redon J Staessen J Stergiou G Verdecchia P European Society of Hypertension recommendations for conventional ambulatory and home blood pressure measurement J Hypertens 2003 5 821 848 Sims AJ Non mercury sphygmos a practical guide for GPs Pulse 2004 19 07 34 35 Sims AJ Reay CA Bousfield DR Menes JA Murray A Oscillometric blood pressure devices and simulators measurements of repeatability and differences between models J Med Eng and Technol 2005 3 112 118 Lo C Taylor RS Gamble G McCowan L North RA Use of automated home blood pressure monitoring in pregnancy Is it safe Am J Obstet and Gynaecol 2002 187 1321 1328 CEP 08018 May 2008 References 66 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 van Popele NM Bos WJW de Beer NAM van der Kuip DAM Hofman A Grobbee DE
49. e to damage from mechanical shock Manufacturers of oscillometric devices use proprietary algorithms to calculate blood pressure systematic differences of the order of 10 mmHg between devices have been measured due to differences between algorithms 13 The oscillometric technique may not be clinically appropriateness of t for important patient groups including pregnant women 14 diabetics 15 and those with cardiac arrhythmias Some clinical bodies specifically state 16 that the use of oscillometric devices is not advised if blood pressure measurement is being used to determine treatment Strategies to improve accuracy Errors in the measurement of blood pressure can arise from observer or protocol or from the device used In auscultatory measurement errors of the former type can be minimised by good training and by adherence to a recognised protocol such as that published by the British Hypertension Society 4 Some recommendations such as choosing the correct deflation rate 2 3 mmHg s and correct cuff size are often ignored Errors due to devices can be minimised by good equipment management Aneroid gauges should be calibrated at least once a year and should at least have their calibration checked if they are dropped or suffer a similar accident Electronic manual gauges should also be calibrated once a year Oscillometric devices incorporate a pressure transducer and should in principle undergo a similar static pressure calibra
50. easurement at a fixed interval Automatic cycling devices are required to have an overpressure detection system independent of the normal pressure measurement system see page 14 We have listed the intervals for each monitor in minutes some also have continuous and STAT modes Users should consider whether they require a monitor capable of performing automatic NIBP measurements All of the monitors can carry out measurements on adults Most also offer a range of paediatric cuffs eleven of the models are indicated for use on neonates Automatic cycling devices are required to have an overpressure detection system that takes account of the patient category i e neonates should be safeguarded by a lower overpressure limit than adults Some devices also provide separate overpressure protection for paediatrics Users should consider whether they require a monitor capable of performing NIBP measurements on paediatric and neonatal patients Most of the manufacturers supply reusable and disposable cuffs in a range of sizes We have listed those cuffs which are available Users should check whether suitable cuffs are available for the monitor s intended application Operational considerations 10 Table 1 Device considerations cont Feature Description These factors may be important if the monitor is to be used for transfer transport purposes Sizes and Physical size and weight weights are as measured in our laboratory of a basic uni
51. eb productsandservices leasing 33 http Awww ogc gov uk stdtoolkit reference documentation p13_ buscase html 34 http home pasa nhs uk PASAWeb Guidance OPPM LandingPage htm 35 http Awww dh gov uk en Publicationsandstatistics Publications PublicationsProcurem ent DH 4070620 36 http Awww dh gov uk en Publicationsandstatistics Publications PublicationsProcurement DH 4109316 CEP 08018 May 2008 Appendix 1 Supplier contact details 68 Biosys No UK supplier At the time of writing the UK supplier had ceased supplying Biosys products CAS and Mindray Tel 44 0 1332 628877 Artemis Medical Ltd Butterly Avenue Questor Business Park Dartford DAT 1JG Fax 44 0 1322 628878 website www artemismedical co uk email info artemismedical co uk Criticare and Omron Tel 44 0 1786 446640 R L Dolby amp Co Ltd Monitor House Fax 44 0 1786 446630 Kerse Road website www dolby ltd co uk tirli ne email sales dolby ltd co uk Datascope Tel 44 0 1480 423600 Datascope Medical Co Ltd Lakeview Court Fax 44 0 1480 423638 Ermine Business Park website www datascope com Huntingdon PE29 XR email uksales datascope com GE Dinamap Tel 44 0 1707 263570 GE Healthcare 71 Great North Road Hatfield Hertfordshire AL9 DEN Fax 44 0 1707 271013 website www gehealthcare com email via website Nis
52. ed measurements and was indicated for use on all patient categories adult paediatric or neonatal The other models included different permutations of SpO2 Masimo or Nellcor temperature and printer The monitor had a 99 NIBP reading memory with review facility The monitor was controlled by a set of up to nine control buttons depending on model in conjunction with LED displays which showed patient parameter information A small LCD panel showed MAP configuration option NIBP timer interval alarm limits and status messages Other indicator icons used were patient category pressure units mmHg or kPa and battery status low charged or charging The configuration menu had facilities to enable the MAP display select pressure units and set date and time Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an in house study and an unpublished report supplied From the data we derived its equivalent BHS grade to be A A Good points Excellent repeatability at a fixed blood pressure of 120 80 mmHg SD 0 8 mmHg Good measurement consistency across a range of pulse rates SD 1 1 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave four misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pres
53. electrical serviceability in house o battery e CE marking Technical discussion Construction 28 Model tested base model NIBP SpO2 good SD 2 0 mmHg excellent SD 0 6 mmHg poor SD 11 9 mmHg 1 misleading reading from 25 tests no misleading readings fail gt 400 mmHg good excellent excellent case material plastic good good good main assembly replacement user replaceable CEoa13 The monitor was supplied with an adult reusable cuff and a 3 m coiled hose The unit s rear panel housed the battery printer module when specified and an RS 232 port for connection to a PC A roll stand pole mounting point was provided Internally all assemblies were securely mounted Surface mount components were used on high quality circuit boards with good component labelling throughout The NIBP components consisted of a single pressure transducer and two pressure release valves Overpressure test The maximum cuff pressure achieved with a simulated single fault condition was 412 mmHg before the cuff was manually deflated to prevent damage auto cycling monitors are required to limit pressure to 330 mmHg under single fault conditions Power supply The monitor was powered from the mains or a rechargeable 6 V SLA battery with an eight hour specified capacity with NIBP measurements repeating at five minute intervals The battery was charged in situ when AC mains was connected the specified recharge time was f
54. ended on the grounds of accuracy Table 2 BHS grading criteria see O Brien E et al 4 Absolute difference between standard and test device lt 5 mmHg lt 10 mmHg lt 15 mmHg Grade Cumulative percentage of readings A 60 85 95 50 75 90 40 65 85 O O D Worse than C Readings taken by the device under validation are compared with those independently taken by two trained observers using the auscultatory technique The observer s measurements are performed simultaneously the device measurements are performed sequentially to the observer measurements There are 85 subjects 255 measurements are taken in total Grades are derived from the percentage of device readings within 5 10 and 15 mmHg of the observers readings To achieve a particular grade all three percentages must be equal to or greater than the tabulated values above CEP 08018 May 2008 Market review 16 Where a BHS grade was not quoted in either a peer reviewed paper or in an unpublished report we used ANSI AAMI SP10 data to derive an equivalent BHS grade Criteria for recommendation Our general recommendations are based on three criteria which are important to consider when purchasing a device e Accuracy Passed ANSI AAMI SP10 and achieved a BHS grade A or B or equivalent in a clinical validation study for both systolic and diastolic pressure e Level of evidence in order of preference independent clinical validation study published in a peer
55. ervice manual Construction e mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 44 Model tested HEM 907 excellent SD 0 6 mmHg excellent SD 0 5 mmHg excellent SD 0 9 mmHg 1 misleading reading from 25 tests gave no misleading readings see test below oscillometric mode good manual auscultation not assessed satisfactory not available case material plastic good good calibration accuracy checks only replaceable CEo197 The monitor was supplied with a 1 m hose and a medium size adult reusable cuff The rear panel had a moulded grip not visible in photo a battery compartment and a pole roll stand mounting point Internally the monitor was well constructed with surface mount components and high quality circuit boards All assemblies were securely mounted The device had a single pressure transducer and single release valve There was no RS 232 port for connection to a PC Overpressure test single measurement device Standards do not require a single measurement device to comply with this test but the monitor addressed the possibility of complete transducer failure and hence the risk of overpressure by checking that a valid and increasing pressure reading occurred after a few seconds of inflation Our test confirmed that this worked correctly Power supply The monitor was powered from the mains or a 4 8 V rechargeable NiMH battery with a
56. ferent levels of weak pulse 20 total Using the criteria described below we counted how many of the measurements could be described as misleading Criteria for a misleading reading There is no widely accepted criterion for determining when a reading is misleading so we have adopted the following strategy When comparing two methods of measurement 22 e g an oscillometric device with human observers measuring blood pressures by auscultation the ANSI AAMI standard 5 requires that the bias must not exceed 5 mmHg and that the standard deviation of differences must not exceed 8 mmHg for 85 subjects For any given device which meets the ANSI AAMI criteria the bias and standard deviation are known from a clinical trial and the 95 limits of agreement can be calculated For a device chosen at random from a group of devices which meet the criteria we can be approximately 95 confident that a single measurement will lie within 21 to 21 mmHg 5 8x2 to 5 8x2 mmHg of a trained observer Therefore we have set a limit of 21 to 21 mmHg with respect to the simulator setting to define a misleading measurement for both systolic and diastolic pressures CEP 08018 May 2008 Market review 15 Documentation We assessed the user manuals for the presence of relevant information such as setting up operation calibration battery replacement cleaning and sterilization Where devices were capable of in house repair we assessed the service man
57. g Results Pass 2 3 5 3 0 9 4 5 mmHg BHS grade A A derived from SP10 data SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 6 4 4 3 5 4 6 mmHg ESH phase 1 and phase 2 Results Pass SP10 equivalent Pass 1 0 7 0 5 0 6 0 mmHg BHS equivalent grade A B stated in ESH validation paper SP10 results not supplied SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 1 6 0 0 5 5 9 mmHg BHS grade B A derived from SP10 data n a n a SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 0 4 0 0 4 6 1 mmHg BHS grade A A SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 0 9 47 2 2 2 6 7 mmHg BHS A A SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 2 2 7 0 1 4 5 1 mmHg BHS grade A A derived from SP10 data CEP 08018 May 2008 Level of evidence ANSI AAMI SP10 Unpublished in house report ANSI AAMI SP10 and International Protocol ESH Peer reviewed publications 27 28 ANSI AAMI SP10 FDA 510 k K022537 summary states that the Colin OEM NIBP module has passed ANSI AAMI SP10 The device uses a CAS NE OEM NIBP module which meets the ANSI AAMI SP10 according to an unpublished independent report Claimed validated to ANSI AAMI SP10 We could find no evidence to substantiate the claim
58. ge units of pressure mmHg or kPa LEI change time of day etc Summary Validation The NIBP performance had been clinically validated using the ANSI AAMI SP10 protocol the results were also classified against the British Hypertension Society BHS protocol under which an A A rating was achieved This was supported by an independent study and had been submitted for publication in a peer reviewed journal 29 Good points Excellent repeatability at a fixed blood pressure of 120 80 mmHg SD 0 7 mmHg Excellent measurement consistency across a range of pulse rates SD 1 0 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave four misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 54 Model tested 42NOB NIBP SpO2 good SD 1 5 mmHg excellent SD 0 7 mmHg excellent SD 1 0 mmHg 4 misleading readings from 25 tests gave no misleading readings gt 400 mmHg good good satisfactory case material plastic excellent satisfactor
59. good documentation and service facilities Good measurement consistency at a fixed pressure of 120 80 mmHg SD 1 5 mmHg Good measurement consistency across a range of pulse rates SD 2 0 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave two misleading readings from 25 tests when exposed to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical e electrical e serviceability in house o battery e CE marking Technical discussion Construction 30 Model tested base model NIBP satisfactory SD 2 1 mmHg good SD 1 5 mmHg good SD 2 0 mmHg 2 misleading readings from 25 tests gave no misleading readings satisfactory built in self test see below excellent excellent good case material plastic excellent excellent good main assembly replacement replaceable CE 0044 The monitor was supplied with a 3 5 m hose and a range of three adult reusable cuffs The battery was housed in the monitor s base On the rear panel was a pole roll stand mounting point a recessed carrying grip not visible in photo and an RS 232 port for connection to a PC Internally all assemblies were securely mou
60. gs not tested excellent good good case material plastic excellent excellent good main assembly replacement replaceable CEoos6 The monitor was supplied with a 3 66 m hose and a range of cuffs all were dual lumen This feature was claimed to reduce measurement errors in the event of an air hose kinking since both lumens were less likely to kink simultaneously The rear panel housed the battery a pole mounting bracket and an RS 232 port for connection to a PC Internally all the components were securely mounted with the NIBP assembly encased in foam to reduce noise Overpressure test We were unable to apply our standard simulated single fault to the NIBP assembly due to inaccessibility The NIBP assembly included two independent pressure sensors and two release valves that were broadly similar to those in the Dinamap Pro page 33 which we could test more easily and met the single fault requirements We were therefore reasonably confident the Dinamap ProCare also complied Power supply The device was powered by an external 12 V mains adapter or a rechargeable 6 V SLA battery specified with a five hour minimum capacity It was recharged in situ when AC mains was connected recharge time was five hours monitor off or eight hours monitor on Serviceability The service manual procedures were clearly described and dismantling was straightforward Fault identification was assisted by error codes following self tests T
61. handle partially obscured in photo was integrated into the rear panel Two RS 232 ports and a USB port were provided Internally all assemblies were securely attached Surface mount components were used on high quality circuit boards with good component labelling throughout The NIBP assembly had a single pressure transducer and a single release valve Overpressure test single measurement device We tested the monitor for overpressure with a simulated single fault condition applied We recorded a cuff pressure of 400 mmHg before releasing the pressure manually to prevent damage The device had satisfactory means for the user to deflate the cuff immediately Power supply The monitor was powered by a mains adaptor or a rechargeable 6 V SLA battery which was charged in situ when mains was connected the specified recharge time was up to six hours Serviceability The service manual described maintenance calibration accuracy checks and repair procedures to board replacement level but advised they should be carried out only by personnel approved by Welch Allyn The NIBP calibration accuracy procedure required manufacturer s separately available software via the USB port Standards do not require a single measurement device to comply with this test CEP 08018 May 2008 Market review 57 Welch Allyn VSM 300 Features and usability Twelve models were available in the VSM range The base model measured NIBP including automatic tim
62. he service menu gave access to functional checks including pressure transducer calibration accuracy checks and leak tests Any changes in this menu contributed to the tally of configuration changes referred to in the brief description page 35 CEP 08018 May 2008 Market review 37 Mindray VS 800 Brief description The VS 800 monitor had five model variants of which four measured NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal Other models monitored SpO Massimo Nellcor or Mindray and temperature Options for all models included a printer and a choice of battery type The monitor was operated by up to 12 front panel buttons depending on model in conjunction with a set of LED displays that showed patient parameter information A backlit LCD showed trend information on screen messages and SpO2 waveform Users could access simple configuration settings e g date and time through on screen menus Other indicators included SpO pulse strength external battery power LED alarm silence pressure units and patient category icons A large alarm indicator was positioned centrally at the top of the case Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an independent study and unpublished report supplied From the data we derived its equivalent BHS grade to be
63. ication procedures were given Replacement main assembly price lists were provided by the supplier CEP 08018 May 2008 Market review 25 CAS 740 Brief description Four models were available in the range The base model CAS 740 1 monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric neonate Other parameters available depending on model were SpO gt Masimo Nellcor or Nonin and temperature An optional external printer was available with data transferred via an infrared data port The monitor was operated by ten control buttons in conjunction with five numeric LED displays that showed patient parameter information there was also an LED message area A set of indicator icons were used to show adult or neonatal mode SpOz signal strength bar battery status and alarm status The battery indicator had three colours green when charging orange when running on battery power red when the battery was low The monitor had a data storage capacity of up to 480 data entries Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an independent study and an unpublished report supplied From the data we derived its equivalent BHS grade to be A A Good points Good construction Excellent user manual Good measurement consistency across a range of pressures SD 1 5 mmHg provided
64. is can either be an LED numerical display with accompanying indicators an LCD flat panel or a combination of the two Some displays are monochromatic whilst others are colour Users should consider whether high visibility or brightly coloured displays are important Parameters Power Display Most of the monitors have a measurement memory Some only recall the last measurement made whilst others can store several hundred readings for multiple patients All of the automatic cycling monitors i e those with timed measurements store the readings in memory for subsequent review Memory CEP 08018 May 2008 Operational considerations Table 1 Device considerations cont Feature Printer Connectivity Automatic cycling Paediatric Neonatal Cuff sizes CEP 08018 May 2008 Description These can be built in modular or external Modular printers are usually attached to one of the main device s side panels A typical printer produces a narrow format 50 mm thermal paper output with numerical data and waveform s where applicable Users should consider if a printer is necessary Most monitors have an RS 232 port that allows connection to a PC or printer for downloading measurement data Use with a PC normally requires additional software provided by the manufacturer Other interfaces can include infra red nurse call USB and Ethernet These are monitors which can be configured to automatically perform an NIBP m
65. l Assessment protocol In the evaluation laboratory we carried out an assessment protocol see below to acquire information and test each device On multi parameter models vital signs other than blood pressure were not tested We used the document reproduced in Appendix 3 to record results Recommendations We made recommendations based on the criteria described on page 16 Assessment protocol Product information Much of the information included in this document was sourced from the suppliers or manufacturers product data or specifications published in user manuals this was used as the basis of the comparative product information page 17 Since each had its own corporate style and format we have presented the information in its simplest common format and as consistently as possible to more readily allow comparison between manufacturers We gave suppliers an opportunity to check and comment on the report prior to publication CE marking and clinical validation We inspected the CE marking and noted compliance with relevant standards Where clinical validation was claimed we inspected any evidence the manufacturers provided including published peer reviewed evidence A short description of the validation process is given below CEP 08018 May 2008 Market review 14 Overpressure testing Automatic cycling monitors are required to have overpressure limitation mechanisms due to the possibility of failure when running unatten
66. like to thank all the manufacturers and suppliers for providing information and samples for evaluation free of charge CEP 08018 May 2008 63 Glossary 64 Terms and abbreviations used in this report AC BPM DC IBP NIBP LCD LED Li Li ion LiMnO NIBP NiCd NiMH MAP PPM SD SLA SMT SpO STAT Alternating Current Beats per minute Direct Current Invasive Blood Pressure Non Invasive Blood Pressure Infrared Liquid Crystal Display This type of display can be monochrome or colour Light Emitting Diode Lithium A type of non rechargeable battery cell Lithium ion A type of re chargeable battery cell Lithium manganese dioxide A type of non rechargeable battery cell Non invasive blood pressure Nickel cadmium A type of rechargeable battery cell Nickel metal hydride A type of rechargeable battery cell Mean Arterial Pressure Planned Preventative Maintenance Standard Deviation Sealed Lead Acid A type of rechargeable battery cell Surface Mount Technology A method for constructing electronic circuits in which the electronic components are mounted directly onto the surface of printed circuit boards thus reducing the overall size Oxygen saturation An abbreviation of the Latin statim meaning immediately CEP 08018 May 2008 References 65 10 11 12 13 14 Williams B Poulter NR Brown MJ Davis M Mclnnes GT Potter JF Sever PS McG Thom S Guidelines for manage
67. lue backlit LCD in the form of a 300 mm mercury column graduated in 2 mm steps A separate numeric LCD showed systolic diastolic pressure and pulse rate A rotary knob with settings 100 280 mmHg adjusted the initial cuff inflation pressure Once an NIBP determination had been performed the measurement readings were shown on both the column and the numeric LCD The device had a single last reading memory for automatic readings only An LED indicator showed battery charge status orange when charging and green when charged In manual auscultation mode the cuff was inflated automatically and cuff deflation was via the monitor s internal bleed valve The user could select a bleed rate of 2 5 4 5 or 6 5 mmHg sec A bulb inflator not supplied could be used with pump off selected This did not appear to disable the internal bleed valve but the instructions suggested that if the lowest bleed rate setting was selected then the deflation valve on the bulb inflator could be used effectively Summary Validation At the time of writing this report studies to validate performance with respect to manual auscultation and oscillometric measurements using the ANSI AAMI SP 10 protocol and the International Protocol of the European Society of Hypertension ESH had been made but not yet published The British Hypertension Society working party had approved and reviewed the auscultatory validation data We were supplied with preliminary results from th
68. manufacturer claimed in the user manual that the NIBP performance was Clinically validated using the ANSI AAMI SP10 protocol However no evidence was provided nor could any published evidence be found to verify this claim Good points Gave no misleading readings when subjected to varying degrees of tremor artefact Large trend data memory Good service facilities Disadvantages Poor measurement consistency at low lt 60 bpm pulse rates SD 6 8 mmHg Gave two misleading readings from 20 tests when subjected to low pulse strengths Note This device range is discontinued and has been superseded by the SureSigns VS3 page 47 CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 46 Model tested NIBP SpO temp satisfactory SD 3 6 mmHg satisfactory SD 2 8 mmHg poor SD 6 8 mmHg gave no misleading readings 2 misleading readings from 20 tests pass good good good case material plastic good good good main assembly replacement replaceable CEo123 The device was supplied with a 3 6 m hose and an adult reusable cuff Neonatal cuffs required a different hose
69. ment of hypertension report of the fourth working party of the British Hypertension Society 2004 BHS IV J Hum Hypertens 2004 18 139 185 Medicines and Healthcare products Regulatory Agency MHRA Report of the Independent Advisory Group on Blood Pressure Monitoring in Clinical Practice June 2005 Medicines and Healthcare products Regulatory Agency MHRA Medical Device Alert Ref MDA 2005 069 December 2005 O Brien E Petrie J Littler WA de Swiet M Padfield PL Altman DG et al The British Hypertension Society protocol for the evaluation of blood pressure measuring devices J Hypertens 1993 11 Suppl 2 S43 S63 Association for the Advancement of Medical Instrumentation Manual electronic or automated sphygmomanometers Arlington Virginia USA Association for the Advancement of Medical Instrumentation American National Standard ANSI AAMI SP10 2002 Mieke S Deutsches DIN 58130 1995 Non invasive spohygmomanometers Clinical Investigations Institut Fuer Normung E V German Institute for Standardisation O Brien E Pickering T Asmar R Myers M Parati G Staessen J Mengden T Imai Y Waeber B Palatini P with the statistical assistance of Neil Atkins and William Gerin Working group on blood pressure monitoring of the European Society of Hypertension international protocol for validation of blood pressure measuring devices in adults Blood Press Monit 2002 7 3 17 British Standard BS EN 1060 4 2004 Non invasiv
70. mmHg neonate 15 110 mmHg adult 20 235 mmHg paediatric 15 130 mmHg neonate 10 105 mmHg Information not provided Pulse rate range adult paediatric 30 240 bpm neonate 40 240 bpm 30 220 bpm adult 30 180 bpm neonate 40 180 bpm Automatic measurement cycles 1 3 5 10 15 30 60 90 mins also Stat 1 2 3 4 5 10 15 30 45 60 90 120 or 240 mins also Stat 1 2 2 5 5 10 15 20 30 45 60 or 90 mins Paediatric neonate yes yes yes reusable amp disposable infant paediatric small adult adult large adult thigh neonatal disposable sizes 1 4 reusable neonate sizes 1 to 4 infant small child child small adult adult large adult thigh reusable newborn infant small child child small adult adult large adult disposable neonate range of sizes Physical size H x W x D 215 x 255 x 150 180 x 278 x 130 mm 82 x 216 x 140 mm Weight 3 25 kg 2 7 kg 1 6 kg Mounting options rolling stand wall mount rolling stand rolling stand IV pole mount Carrying handle yes yes yes flip up Training training free of charge on site training cost depends on quantity provided Information not provided List price exc VAT not provided 994 1576 1550 2150 Servicing costs 1 year warranty annual ppm 65 ex warranty parts amp labour 126 repair 90 per hou
71. neonatal The other models added permutations of SpOz temperature and internal printer The monitor was controlled by six front panel buttons and a rotate push navigation wheel in conjunction with menus on the colour LCD panel The panel displayed all patient parameter information and waveforms depending on model or trend information Other screen information included patient category alarm status and battery gauge Two LED indicators show mains and battery status information Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol It was supported by means of an independent study and an unpublished report supplied From the data we derived its equivalent BHS grade to be B A Good points Excellent measurement consistency across a range of pressures SD 0 9 mmHg Good measurement consistency across a range of pulse rates SD 1 7 mmHg Gave no misleading readings when subjected to varying degrees of tremor artefact and low pulse strengths Excellent build quality and serviceability Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical electrical serviceability in house o battery e CE marking
72. ng cleaning and sterilization information Hospital grade NIBP test protocol doc Issued 5 6 06 Page 3 of 4 CEP 08018 May 2008 Appendix 3 Regional Medical Physics Department Freeman Hospital Unit Evaluation amp Calibration section Assessment of features and usability construction amp serviceability Rating Comments Features and usability Mechanical construction including cuff amp tubing Electrical construction Serviceability Photographs take photographs for publication and to highlight features of interest O Overall comments Notes 1 ANSI AAMI SP 10 Safety requirements 2 ANSI AAMI SP 10 Performance validation requirements 3 Standard Deviation is a measure of repeatability 4 Standard user assessment ratings Excellent Good Satisfactory Poor and Very Poor Hospital grade NIBP test protocol doc Issued 5 6 06 Page 4 of 4 CEP 08018 May 2008 Author and report information 76 Buyers guide Hospital grade non invasive blood pressure monitors C A Reay J A Menes D R Bousfield E S Colechin AJ Sims Regional Medical Physics Dept Freeman Hospital Freeman Hospital Newcastle upon Tyne NE7 7DN Tel 0191 2137787 Fax 0191 2130290 Email RMPDFHevaluation nuth nhs uk Web www rmpd org uk About CEP The Centre for Evidence based Purchasing CEP is part of the Policy and Innovation Directorate of the NHS Purcha
73. nly one criterion and devices which satisfied none of the criteria those shown outside of the circles are monitors we do not recommend to the NHS None of the monitors evaluated was rated worse than satisfactory for measurement consistency at 120 80 93 mmHg Devices are listed in alphabetical order Recommended Automatic cycling Omron HEM 907 no Welch Allyn Spot Vital Signs no Welch Allyn Spot Vital Signs LXi no Consider Criticare VitalCare 506N3 yes Datascope Accutorr Plus yes GE Dinamap ProCare yes Mindray VS 800 yes Nissei DM 3000 no Philips SureSigns VS3 yes Welch Allyn VSM 300 yes Evaluator s note All of the above devices except the GE Dinamap ProCare Mindray VS 800 and Philips SureSigns VS3 gave some misleading readings when subjected to varying degrees of tremor artefact using an NIBP simulator under test conditions care should be taken when measuring patients blood pressure in the presence of tremor Not recommended Biosys Sentry not currently available in UK April 2008 yes CAS 740 yes Datascope Duo no GE Dinamap Pro yes Nonin Avant 2120 yes Philips SureSigns VS1 discontinued yes Schiller Argus VCM yes Smiths Mini Torr Plus yes CEP 08018 May 2008 Market review Table 3 Summary of results Monitor Accuracy Biosys Sentry n a CAS 740 SP10 Mean difference less than 5 mmHg SD less than 8 mmHg Results Pass 1 2 5 8 1 4 6 3 mmHg BHS grade A A derived from SP10 data Criticare SP1
74. ns to the Korotkoff sounds A rapid deflate button could be used as appropriate to conclude the process The device was operated by five front panel buttons start stop etc and two rotary controls initial pressure and function selector switch An LCD display was used to show systolic pressure diastolic pressure and pulse rate There were additional indicators for device ready pulse level number of irregular pulses battery level battery charging and external power source connected Summary Validation The performance of the HEM 907 in automated mode was clinically validated using the ANSI AAMI SP 10 protocol and the International Protocol of the European Society of Hypertension ESH It was supported by independent studies and peer reviewed publications 27 28 From the data we derived its equivalent BHS grade to be A B Good points Excellent measurement consistency across a range of blood pressures SD 0 6 mmHg and pulse rates SD 0 9 mmHg Gave no misleading readings when subjected to low pulse strengths Manual auscultation was possible Inexpensive Disadvantages Gave one misleading reading from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e s
75. nted Surface mount components were used on high quality circuit boards with good component labelling Overpressure test The service menu overpressure test gave a satisfactory result but we were unable to apply our standard simulated single fault to the NIBP assembly due to inaccessibility It included two pressure transducers and two release valves that were broadly similar to those in the Duo page 31 which we could test more easily and met the single fault requirements We were therefore reasonably confident the Accutorr Plus also complied Power supply The monitor was powered from the mains or a rechargeable 11 1 V Li ion battery with a specified 9 5 hour capacity when measuring NIBP at five minute intervals The battery was charged in situ when AC mains was connected the specified recharge time was 4 hours Early models had an SLA battery option now discontinued Serviceability The service manual procedures were clearly described including NIBP calibration accuracy checks and performance verification via a service diagnostics menu Repair of the unit was to board assembly replacement level status and error codes were displayed to help identify faulty assemblies CEP 08018 May 2008 Market review 31 Datascope Duo Brief description Three models were available in the Duo range The base model monitored NIBP was indicated for use on adult and paediatric patient categories and was manually initiated only i e no autom
76. ociety BHS protocol under which an A A rating was achieved This was supported by an independent study and a peer reviewed publication 30 Good points Excellent repeatability at a fixed simulated blood pressure of 120 80 mmHg SD 0 7 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Poor response at higher 200 150 mmHg simulated blood pressure settings SD 8 0 mmHg Gave three misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 56 Model tested 45NE0 NIBP SpO temp poor SD 8 0 mmHg excellent SD 0 7 mmHg satisfactory SD 3 2 mmHg 3 misleading readings from 25 tests gave no misleading readings gt 400 mmHg good good good case material plastic excellent satisfactory excellent main assembly replacement replaceable CEoos0 The monitor was supplied with a 1 5 m hose and an adult cuff both of which were dual lumen The rear panel housed the battery and had an attachment point for pole or wall mounting A moulded carrying
77. om the mains or a rechargeable 7 2 V Li ion battery with a specified 14 hour capacity when measuring NIBP at seven minute intervals The battery was charged in situ when AC mains was connected the specified recharge time was 4 5 hours Serviceability The service manual procedures were clearly described and dismantling was straightforward Diagnostic tests occurred when the monitor was switched on if a failure occurred an error code was displayed to assist fault finding Repair of the unit was to board assembly replacement level Configuration calibration accuracy checks and testing were carried out from a menu accessible by pressing a combination of control buttons Standards do not require a single measurement device to comply with this test CEP 08018 May 2008 Market review 33 GE Dinamap Pro Brief description Four models were available in the Dinamap Pro range The base model Pro 100V2 monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal The other three models included temperature SpO Nellcor Masimo or both All models had a trend display and a printer An LCD panel showed trends alarms control menus and user interface messages A set of numeric LED displays showed patient parameter information Other indicators included an alarm silence icon a low battery warning and a battery charging indicator LED intensity was controlled b
78. or was supplied with two reusable cuff sets size adult and large adult each with a 1 5 m hose The monitor is shown in its base unit see photo which included an accessory compartment and a pole mounting point The case had a carrying grip not visible in the photo Internally surface mount components were used on high quality circuit boards with good component labelling There was a single pressure transducer and two pressure release valves There was no RS 232 port for connection to a PC Overpressure test single measurement device We tested the monitor for overpressure with a simulated single fault condition applied We recorded a cuff pressure of 370 mmHg before releasing the pressure manually to prevent damage The device had satisfactory means for the user to deflate the cuff immediately Power supply The monitor could be powered by an external mains adaptor or a rechargeable 4 8 V NiMH battery but no operating time was specified It was recharged in situ when the AC mains adapter was connected with a recharge time of up to four hours Serviceability No service manual was provided with the device but the user manual contained some service information including instructions for checking the accuracy of the pressure readings cleaning procedures and advice stating that the monitor should be returned to the manufacturer or authorised supplier every two years for a calibration accuracy check Standards do not require a single me
79. our hours Serviceability An excellent service manual covered configuration planned maintenance service testing and NIBP calibration accuracy checks Service menus gave access to the NIBP calibration accuracy procedure using a PC connection and additional manufacturer s software not supplied CEP 08018 May 2008 Market review 29 Datascope Accutorr Plus Brief description Five models were available in the Accutorr range The base model monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal Other parameters available were SpOz2 with a choice of Datascope Nellcor or Masimo and temperature modules Four models included a trend display and a printer module was available on all models The monitor was operated by 15 control buttons in conjunction with seven numeric LED displays that showed patient parameter information error codes and service information A set of indicator icons showed NIBP patient category alarm status AC power and battery status Models with trend option had an additional LCD up to 100 readings were displayed Summary Validation The NIBP performance was Clinically validated by independent studies using the ANSI AAMI SP10 protocol and the British Hypertension Society BHS protocol under which it was graded A A The work was supported by peer reviewed publications 23 24 Good points Well constructed with
80. owed NIBP patient category and mains battery status NIBP measurements were performed during the cuff inflation phase followed by immediate cuff deflation when the measurement was complete this can be faster and more comfortable for patients than conventional measurement during deflation Pressure readings were cleared after five minutes except when SpO was also being measured A pull out reference card was slotted underneath the case Summary Validation We could find no evidence of a clinical validation of this monitor against an appropriate protocol or standard Good points Well constructed Good measurement consistency across a range of pulse rates SD 2 0 mmHg provided that no tremor artefact was present Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave six misleading readings from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 24 Model tested NS NIBP SpO2 satisfactory SD 2 3 mmHg satisfactory SD 2 1 mmHg good SD 2 0 mmHg 6 misleading readings from 25 tes
81. r 2 year warranty CEP 08018 May 2008 yes ANSI AAMI SP10 independent study amp unpublished report derived BHS grade B A claimed ANSI AAMI SP10 no supporting evidence claimed ANSI AAMI SP10 no supporting evidence Market review Manufacturer Welch Allyn Inc Welch Allyn Inc 22 Welch Allyn Inc Model range oo ot models Spot Vital Signs 6 Spot Vital Signs Lxi 6 VSM 300 12 Parameters amp features Base model Other models Options in all models NIBP SpO Masimo or Nellcor temperature none NIBP temperature Welch Allyn or Braun SpO Masimo or Nellcor printer NIBP SpO Masimo or Nellcor temperature printer none Power Battery charger ext 7 2 V 1 A DC mains adaptor rechargeable 6 V 4 5 Ah SLA battery ext 9 V 1 5 A DC mains adaptor 6 V 6 Ah rechargeable SLA battery ext 8 V DC mains adaptor rechargeable 6 V 4 Ah SLA battery ext mains adaptor ext mains adaptor ext mains adaptor Display LCD LCD LED amp LCD Memory last measurement only up to 50 measurements up to 99 measurements Printer recorder no yes external yes internal Connection interface infra red RS 232 USB RS 232 nurse call Pressure range 0 300 mmHg 0 300 mmHg 0 300 mmHg Systolic pressure range 60 250 mmHg 60 250 mmHg adult 30 260 mmHg paediatric
82. re range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical e electrical e serviceability in house o battery e CE marking Technical discussion Construction 32 Model tested NIBP SpO good SD 1 1 mmHg excellent SD 0 5 mmHg excellent SD 0 9 mmHg 2 misleading readings from 25 tests gave no misleading readings pass excellent good good case material plastic rubber grip handle excellent excellent good main assembly replacement replaceable CE 044 The monitor was supplied with a 3 5 m hose and a range of three adult reusable cuffs The battery was housed in the monitor s base and a roll stand mounting bracket was available There was no RS 232 port for connection to a PC Internally all assemblies were securely mounted Surface mount components were used on high quality circuit boards with good component labelling throughout There were two pressure sensors and two pressure release valves Overpressure test single measurement device An overpressure test was performed with a simulated single fault condition applied The monitor halted cuff inflation at 320 mmHg and an error message was displayed a good result because standards do not require a single measurement device to comply with this test Power supply The device was powered fr
83. review journal independent clinical validation study with an unpublished report in house clinical validation study and report e Excellent measurement repeatability within 1mmHg from 30 consecutive measurements of 120 80 mmHg when tested using a repeatable 13 laboratory NIBP simulator CEP 08018 May 2008 Market review Product information Manufacturer BiOSYS Co Ltd CAS Medical Systems Inc 17 Criticare Systems Inc Model range oo ot models Sentry 4 CAS 740 4 506N3 8 Parameters amp features Base model Other models Options in all models NIBP SpO printer trend screen temperature NIBP SpO temperature printer RS 232 and nurse call Interface NIBP SpOz Criticare or Nellcor temperature printer none Power Battery charger mains ext 12 V DC supply rechargeable 7 2 V 3 Ah Li ion battery mains ext 12 V DC supply rechargeable 7 2 V 3 7 Ah NiMH battery mains rechargeable 6 V 7 2 Ah SLA battery built in charger built in charger built in charger Display LED amp LCD trend screen LED LED amp LCD Memory up to 100 measurements up to 480 measurements last 24 hrs all parameters single or multi patient data Printer recorder yes modular yes external printer via infrared interface yes built in Connection interface no infrared RS 232 amp nurse call RS 232 Pressure range
84. ric 10 220 mmHg neonate 10 110 mmHg information not provided 40 180 mmHg Pulse rate range adult paediatric 30 200 bpm neonate 30 220 bpm 40 240 bpm 40 160 bpm Automatic measurement cycles 1 2 3 4 5 10 15 20 30 45 60 90 or 120 mins 1 2 3 4 5 10 15 30 60 90 120 180 240 or 480 mins no Paediatric neonate yes yes no Cuff sizes reusable amp disposable infant child small adult adult large adult thigh a range of neonate sizes reusable infant child adult large adult thigh full range of neonate sizes reusable standard large Physical size H x W x D 247 x 254 x 135mm 240 x 170 x 170 mm 276 x 136 x 206 mm Weight 2 9 kg 3 25 kg 1 3 kg Mounting options rolling stand wall mounting plate wall mount rolling stand IV pole bed mount rolling stand Carrying handle yes yes recessed grip yes recessed grip Training competency based training competency based training training for technical staff free of charge not deemed necessary simple device with comprehensive user guide List price exc VAT 1240 2180 975 1195 249 Servicing costs 2 year warranty free extended warranty to 5 years 150 information not provided 2 year warranty free service charges 25 returned to supplier 400 day on site CEP 08018 May 2008
85. rived BHS grade A A yes ESH amp ANSI AAMI SP10 independent studies and peer reviewed publications derived BHS grade A B claimed ANSI AAMI SP10 no supporting evidence Market review Manufacturer Philips Medical Systems Schiller AG 21 Smiths Medical PM Inc Model range oo ot models SureSigns VS3 6 Argus VCM 4 Mini Torr Plus 1 Parameters amp features Base model Other models Options in all models NIBP SpO temperature printer NIBP SpO temperature printer none NIBP SpO temperature printer Power Battery charger mains rechargeable battery 11 1 V 6 Ah Li ion battery mains rechargeable 6 V 4 Ah SLA battery ext 24 V DC mains adaptor rechargeable 6 V NiCd battery buit in charger built in charger ext mains adaptor Display colour LCD LED LED Memory up to 400 measurements up to 200 measurements Information not provided Printer recorder yes internal yes internal yes internal or external Connection interface USB RS 232 nurse call via RS232 RS 232 Pressure range not specified 0 300 mmHg adult 20 250 mmHg neonate 20 135 mmHg Systolic pressure range adult paediatric 30 255 mmHg neonate 30 135 mmHg adult 30 260 mmHg paediatric 30 160 mmHg neonate 25 120 mmHg Information not provided Diastolic pressure range adult paediatric 15 220
86. rld as a whole e sustainable production and consumption working towards achieving more with less e natural resource protection and environmental enhancement protecting the natural resources and habitats upon which we depend e sustainable communities creating places where people want to live and work now and in the future e climate change and energy confronting the greatest identified threat facing the global community The strategy also highlights the key role of public procurement in delivering sustainability Energy consumption Suppliers manufacturers should offer guidance on energy efficient use of devices Where devices are in constant use mains and battery energy costs should be included in whole life cost calculations End of life disposal Consideration should be given to the likely financial and environmental costs of disposal at the end of the product s life Where appropriate suppliers of equipment placed on the market after the 13 August 2005 should be able to demonstrate compliance with the UK Waste Electrical and Electronic Equipment WEEE regulations 2006 20 The WEEE regulations place responsibility for financing the cost of collection and disposal on the producer Electrical and electronic equipment is exempt from the WEEE regulations where it is deemed to be contaminated at the point at which the equipment is scheduled for disposal by the final user However if it is subsequently decontaminated su
87. ry specified with a two hour minimum capacity It was recharged in situ when AC mains was connected the specified recharge time was two hours monitor off or eight hours monitor on Serviceability The service manual dismantling procedure was straightforward and clear diagrams were provided A troubleshooting guide and error codes helped to identify faults A pass code protected service mode was similar to Clinician Mode but with additional facilities including overpressure point adjustment and calibration accuracy verification CEP 08018 May 2008 Market review 35 GE Dinamap ProCare Brief description There were four models in the ProCare range The base model ProCare 100 monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal The other three models included temperature SpO2 Nellcor Masimo or both A printer module was optionally available on all models The monitor was operated by sets of buttons on both sides of the display area A set of numeric LED displays showed patient parameter information Other indicators included an alarm silence icon a low battery warning and a battery charging indicator The monitor detects the presence of neonate cuffs hoses and changes to neonatal mode automatically A protected access configuration mode included adjustments to date and time initial inflation pressure and the alarm silence interv
88. sei and Omron White Medical Meranti Lodge Hillmorton Lane Clifton upon Dunsmore Rugby CV23 OBA Tel 44 0 1788 553904 Fax 44 0 1788 560820 website www white medical co uk email enquiries white medical co uk CEP 08018 May 2008 Appendix 1 69 Nonin Tel 44 0 870 9097400 Proact Medical Ltd 9 13 Oakley Hay Lodge Fax 44 0 870 9097500 Great Folds Road website www proactmedical co uk Great Oakley eee email enquiries proactmedical co uk Philips Tel 44 0 1625 878999 Cardiac Services Ltd The Acumen Centre Fax 44 0 1625 878880 First Avenue website www cardiac services com Poynton BEE e email via website Schiller Tel 44 0 161 7764336 Amazon Medical Ltd Fax 44 0 161 7764339 Carrington Business Park 0 Carrington website www amazonmedical co uk Manchester 8 M31 4XL email sales amazonmedical co uk Smiths Tel 44 0 1233 713070 PULMOLINK Fax 44 0 01233 713859 Redwood House Canterbury Road website www pulmolink co uk Charing Kent email sales pulmolink co uk TN27 OEU Welch Allyn Tel 44 0 207 3656780 Welch Allyn UK Ltd GE Cublington Road 0 Aston Abbotts website www welchallyn co uk Buckinghamshire HP22 4ND email welchallynuk mail welchallyn com CEP 08018 May 2008 Appendix 2 70 EU procuremen
89. sing and Supply Agency We underpin purchasing decisions by providing objective evidence to support the uptake of useful safe and innovative products and related procedures in health and social care We are here to help you make informed purchasing decisions by gathering evidence globally to support the use of innovative technologies assess value and cost effectiveness of products and develop nationally agreed protocols CEP 08018 May 2008 Sign up to our email alert service All our publications since 2002 are available in full colour to download from our website To sign up to our email alert service and receive new publications straight to your mailbox contact Centre for Evidence based Purchasing Room 152C Skipton House 80 London Road SE1 6HL Tel 020 7972 6080 Fax 020 7975 5795 Email cep pasa nhs uk Web www pasa nhs uk cep Crown Copyright 2008
90. sure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction mechanical electrical e serviceability in house o battery e CE marking Technical discussion Construction 58 Model tested 53STP NIBP SpOz temp good SD 1 5 mmHg excellent SD 0 8 mmHg good SD 1 1 mmHg 4 misleading readings from 25 tests gave no misleading readings not tested excellent good satisfactory case material plastic excellent excellent good main assembly replacement replaceable CEo123 The monitor was supplied with a 1 85 m hose and an adult reusable cuff In the rear of the case was a Carrying slot not visible in photo a battery compartment a nurse call connector an RS 232 port for connection to a PC On the base was a pole wall mount attachment point Internally all assemblies were securely mounted to the case Surface mount components were used on high quality circuit boards with good component labelling Overpressure test The manufacturer specifies an overpressure limit of 295 330 mmHg The design incorporated two pressure transducers and two release valves necessary to fulfil this requirement but we were unable to carry out our standard over pressure test due to inaccessibility of the pneumatic components Power supply The monitor was powered by a mains adaptor or
91. t procedure Lease options National frameworks are in place for operating leases to help the NHS procure leases more cost efficiently and effectively The framework came into place on 1st April 2007 and runs for two years Further details are available from the PASA website 32 EU procedures The Public Sector Directive 2004 18 EC has been transposed into UK law This has been achieved by means of the following statutory instruments e the Public Contracts Regulations SI 2006 No 5 the regulations e the Utilities Contracts Regulations SI 2006 No 6 not relevant to this guide The regulations apply to contracts worth more than 90 319 from January 17 2008 18 over their whole life and specify the procedures to be followed for public sector contracting including adherence to strict timetables requirements for advertising invitation to tender and the award of contract Organisations undertaking a procurement exercise covered by the regulations must give all suppliers an equal opportunity to express an interest in tendering for the contract by placing a contract notice in the Official Journal of the European Union OJEU At all stages of the procurement process the purchaser must be demonstrably fair as any decision made can be challenged by the unsuccessful suppliers Establishing a procurement strategy To achieve a successful outcome decisions need to be made on whether an existing contract agreement can be used the nee
92. t without optional add on modules but including batteries All of the monitors evaluated in the buyers guide included a carrying handle but of differing designs Carrying handle e g top mounted handles integrated grips or flip up The type of handle may be important to consider depending on the monitors placement and main use We have listed the various mounting options which are available Users should check whether suitable options are available for the monitor s intended application and placement Mounting options We have listed what training the manufacturer supplier provides Most have competency based training courses Some also provide training for service personnel Users should consider what training is required and whether the manufacturer supplier training meets their needs Training We have shown the price excluding VAT of a base model or a price range of several models In most List price cases these can be taken as guide prices since actual prices paid will be dependent on commercial factors We have shown which monitors are clinically validated which protocol was used and whether the results have been published in a peer reviewed journal Where possible we have also shown the Validation BHS grade for systolic and diastolic pressure Users should carefully consider the validation information when choosing a monitor We would not recommend a device which had not been clinically validated see pages 16 and
93. that no tremor artefact was present Excellent measurement consistency across a range of pulse rates SD 0 9 mmHg Gave no misleading readings when subjected to tremor artefact or low pulse strength Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical electrical serviceability in house o battery e CE marking Technical discussion Construction 26 Model tested 740 2 NIBP SpOz temp good SD 1 5 mmHg good SD 1 1 mmHg excellent SD 0 9 mmHg gave no misleading readings gave no misleading readings pass good excellent good case material plastic good good good main assembly replacement replaceable CEoos6 The monitor was supplied with a 3 m hose an adult reusable cuff and a child size reusable cuff The rear panel housed the battery and an attachment point for a variety of mounting options An infrared data connection port was mounted on the lower panel an optional interface unit provided a nurse call connector and an RS 232 port for connection to a PC Internally the monitor was well constructed surface mount components were used on high quality circuit boards and all assemblies were securely mounted The NIBP circuit boar
94. the service engineers Evaluation criteria Performance specifications should be derived from local operational requirements and agreed by the procurement panel They will form the basis for assessing the adequacy of suppliers technical specifications provided in response to the technical specification questionnaire It is important to have agreed on the performance specifications of the product as they will be used in the adjudication against company specifications Requests for features which are supplier specific are not permitted under the regulations Very specific features which are not supported by operational requirements are also not allowed Award of contract Following award of the contract to the successful supplier unsuccessful suppliers may need to be debriefed This is at the supplier s request Buyers must be aware of the Alcatel procedure see the Trust Operational Purchasing Procedures Manual 17 Procedure No T 08 section 6 Mandatory Standstill Period For more information on procurement please refer to the Department of Health Website 36 CEP 08018 May 2008 Appendix 3 72 Data collection pro forma Regional Medical Physics Department Freeman Hospital Unit Evaluation amp Calibration section Hospital grade NIBP devices assessment protocol Device details Model amp serial number Manufacturer UK Supplier Launch date approx Acceptance tests to inclu
95. tion as an electronic manual gauge Many if not all of hospital grade NIBP monitors have dedicated service and calibration modes which allow this CEP 08018 May 2008 Operational considerations 8 Device selection should be based on matching device features to user needs Table 1 illustrates the range of NIBP monitor characteristics that should be considered These should be used along with the product information tables page 17 found in the Market review section Table 1 Device considerations Feature Description Some manufacturers have multiple models to cover all possible variants others have a model range and list of options In the Product information tables page 17 beside each model range is a figure in brackets which is our estimate of the distinct model variants on offer Model ranges As well as NIBP some devices include additional monitoring parameters such as SpO2 and temperature We have identified what is offered in the most basic model and additional features from other models in a range or options available Additional parameters usually at extra cost may not be important if the device is to be used solely as an NIBP monitor All of the devices in the buyers guide are mains and battery powered Some provide mains by a separate adaptor worth noting if space is limited All batteries are recharged in situ when mains power is provided Various battery technologies are employed e g Li ion NiMH etc Th
96. ts no misleading readings pass good satisfactory satisfactory case material plastic good good satisfactory main assembly replacement replaceable CEo470 The monitor was supplied with a 3 m hose and an adult reusable cuff The rear panel housed the battery a recessed carrying slot not visible in photo and an attachment point for a pole roll stand There was no RS 232 port for connection to a PC Internally the monitor was well constructed with a metal chassis and assemblies securely mounted Surface mount components were used on high quality circuit boards with good component labelling The NIBP pneumatic components consisted of two pressure sensors and two pressure release valves Overpressure test With a single fault applied to either of the two pressure transducers before or during a measurement the monitor immediately aborted the measurement and immediately displayed an error message an acceptable outcome Power supply The monitor was powered from the mains or a 7 2 V rechargeable Li ion battery specified to provide up to one hour of operating time It was charged in situ when AC mains was connected the specified recharge time was two hours Serviceability The user and service manuals stated that the device should be repaired by authorised personnel only but nevertheless provided some servicing information NIBP calibration accuracy checks and leak tests could be accessed from a service menu and fault identif
97. u information A further six LED icons indicated when AC power was connected battery status patient category and SpO sensor off An alarm silence indicator and an SpOz signal strength bar were provided NIBP measurements were performed during the cuff inflation phase followed by immediate cuff deflation when the measurement was complete this can be faster and more comfortable for patients than conventional measurement during deflation Summary Validation The manufacturer claimed clinical validation owing to similarity with the Criticare Poet Plus 8100 which meets the ANSI AAMI SP10 protocol according to an unpublished report supplied From the data we derived its equivalent BHS grade to be A B Good points Well constructed Good service facilities and documentation Excellent measurement consistency at a fixed pressure of 120 80 mmHg SD 0 6 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Poor measurement consistency at pulse rates below 60 bpm SD 11 9 mmHg Gave one misleading reading from 25 tests when subjected to varying degrees of tremor artefact Failed the overpressure test CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability Manuals e user manual e service manual Construction e mechanical
98. ual for fault finding guides dismantling procedures functional testing and calibration accuracy check instructions Some could be repaired only by the manufacturer In such cases service manuals if available were assessed on this basis This is a check only of the device s pressure transducer against a calibrated pressure gauge It is not a check of the device s clinical validation Clinical validation process The measurement accuracy of an NIBP monitor requires a clinical trial using human subjects There are a number of such protocols with different compositions of patient groups needed for the trial and different ways of presenting the results either as a grade or pass fail Devices in this report have been validated against protocols by the British Hypertension Society BHS 4 the US Association for the Advancement of Medical Instrumentation ANSI AAMI SP10 2002 5 and the European Society of Hypertension ESH 7 The first two of these require 85 subjects and the ESH requires 33 subjects Accuracy O Brien et al 22 made recommendations based on the following A device fulfilling the AAMI criteria and graded A or B for both systolic and diastolic pressure under the BHS protocol has been recommended on grounds of accuracy without equivocation one that fails the AAMI protocol for either systolic or diastolic pressure and has a grade of C or D for either systolic or diastolic pressure under the BHS protocol cannot be recomm
99. ve troubleshooting guide with a list and description of error messages CEP 08018 May 2008 Market review 49 Schiller Argus VCM Brief description The Argus VCM as supplied in the UK had four model variants The base model monitored NIBP including automatic timed measurements and was indicated for use on all patient categories adult paediatric and neonatal The other models added permutations of SpO gt and internal printer The monitor was operated by nine control buttons ten on models with printers labelled with symbols instead of text Patient parameter information was shown on a set of numeric LED displays Other indicator icons included patient category alarm status mains connection status and battery status Summary Validation The manufacturer claimed that the NIBP performance was clinically validated using the ANSI AAMI SP10 protocol However no evidence was provided nor could any published evidence be found to verify this claim Good points Excellent measurement consistency at a fixed pressure of 120 80 mmHg SD 1 mmHg Good measurement consistency across a range of simulated blood pressures SD 1 7 mmHg and across a range of pulse rates SD 1 3 mmHg Gave no misleading readings when subjected to varying degrees of tremor artefact and low pulse strengths Disadvantages None identified CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement
100. verpressure test We tested the monitor for overpressure with a simulated single fault condition applied The maximum cuff pressure achieved was 330 mmHg meeting the requirements of the performance standard Power supply The monitor was powered by a mains adaptor or an internal rechargeable 6 V NiCd battery with a specified capacity of six hours It was charged in situ when mains was connected the specified recharge time was up to four hours Serviceability The manufacturer provided a good service manual with the device Repair was to board assembly replacement level If a problem was detected by self tests error codes were displayed to aid fault finding The monitor had a system setting mode that allowed NIBP calibration accuracy checks procedures CEP 08018 May 2008 Market review 53 Welch Allyn Spot Vital Signs Brief description Six models were available in the Spot Vital Signs range The base model 4200B monitored NIBP and was indicated for adult and paediatric patient categories manually initiated only i e no automatic timed measurements The other five models included different permutations of SpO Nellcor or Massimo and temperature The monitor was operated by five control buttons in conjunction with a monochrome backlit LCD display Other indicators included a battery level gauge and battery charging icon A configuration mode could be accessed to preset the initial cuff inflation pressure chan
101. y good main assembly replacement replaceable CEo297 The monitor was supplied with a 1 5 m hose and a large adult reusable cuff The rear panel housed the battery and had an attachment point for pole or wall mounting A moulded carrying handle partially obscured in photo was integrated into the rear panel There was no RS 232 port but an IR port enabled connection to a PC Internally all assemblies were fixed securely Surface mount components were used on high quality circuit boards with good component labelling throughout The NIBP assembly had a single pressure transducer and a single release valve Overpressure test single measurement device We tested the monitor for overpressure with a simulated single fault condition applied We recorded a cuff pressure of 400 mmHg before releasing the pressure manually to prevent damage The device had satisfactory means for the user to deflate the cuff immediately Power supply The monitor was powered by a mains adaptor or a rechargeable 6 V SLA battery with a specified capacity of 130 NIBP measurements It was charged in situ when mains was connected the specified recharge time was up to twelve hours Serviceability The service manual described maintenance calibration accuracy checks and repair procedures to board replacement level but advised they should be carried out only by personnel approved by Welch Allyn The NIBP calibration accuracy procedure required manufacturer s separately
102. y automatic ambient light compensation The monitor was operated by four buttons and a rotary push control knob to highlight select menu items on the LCD panel It detects the presence of neonatal cuffs hoses and changes to neonatal mode automatically The monitor had a Clinician Model accessible by pass code which allowed initial cuff inflation pressure to be set NIBP calibration accuracy checks check and permanent silencing of alarms Summary Validation The NIBP performance was clinically validated using the ANSI AAMI SP10 protocol The work was an independent study described in a peer reviewed publication 25 The BHS grade was B C The publication acknowledged that the computational algorithm used by this device was derived and tested using intra arterial blood pressure measurements Good points Very well constructed with excellent documentation and service facilities Good measurement consistency at a fixed pressure of 120 80 mmHg SD 1 3 mmHg Good measurement consistency across a range of pulse rates SD 1 6 mmHg Gave no misleading readings when subjected to low pulse strengths Disadvantages Gave one misleading reading from 25 tests when subjected to varying degrees of tremor artefact CEP 08018 May 2008 Market review Results NIBP performance tests pressure range measurement consistency variable pulse rate susceptibility to artefact variable pulse strength overpressure General e usability M

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