Medicines and Healthcare products regulatory Agency logoEvaluation report

Report 05061ATOM V-2100GIncubatorSeptember 2005

Health and social care working together

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About evaluation reports

The Centre for Evidence-based Purchasing provides independent and objectiveevaluations of medical devices available on the UK market. Specialist centres,mainly in NHS Trusts, do the evaluations under contract to the NHS Purchasingand Supply Agency (NHS PASA). Results are available on our website(www.pasa.nhs.uk/cep).

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Visit our website for a comprehensive list of publications, details of forthcomingevaluations, services and contacts.

Miss SC Peirce, Miss NG Greene, Mr SD Edwards, Dr DC Crawford

CEDAR

Cardiff MedicentreUniversity Hospital of Wales

Heath ParkCardiff

CF14 4UJ

Tel: 029 2068 2120Fax: 029 2075 0239

E-mail:diane.crawford@cardifandvale.wales.nhs.uk

For more information on CEDAR visit www.cedar.wales.nhs.uk

ATOM V-2100G Incubator

© Crown Copyright 2005

Apart from any fair dealing for the purposes of research or private study, or criticism, or review, aspermitted under the Copyright, Designs & Patents Act, 1998, this publication may only be reproduced,stored, or transmitted in any form or by any means with the prior permission, in writing, of theController of Her Majesty’s Stationery Office (HMSO).

Information on reproduction outside these terms can be found on the HMSO website(www.hmso.gov.uk) or e-mail: hmsolicensing@cabinet-office.x.gsi.gov.uk.

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Vertical Height Adjustment. . . . . . . . . . . . . . . . . . . 2Baby compartment. . . . . . . . . . . . . . . . . . . . . . . . . 3X-ray tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Humidification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Optional extras. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Weighing scales . . . . . . . . . . . . . . . . . . . . . . . . . . 7Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7User manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

User evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9User comments . . . . . . . . . . . . . . . . . . . . . . . . . . 17Technical support . . . . . . . . . . . . . . . . . . . . . . . . . 17CEDAR comments. . . . . . . . . . . . . . . . . . . . . . . . 17

Technical evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Warm up tests . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Temperature stability . . . . . . . . . . . . . . . . . . . . . . 19Temperature uniformity . . . . . . . . . . . . . . . . . . . . 19Relative humidity . . . . . . . . . . . . . . . . . . . . . . . . . 20Open ports and doors . . . . . . . . . . . . . . . . . . . . . 21Simulated mains failure . . . . . . . . . . . . . . . . . . . . 23Sound levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Weighing scales. . . . . . . . . . . . . . . . . . . . . . . . . . 23CEDAR comments. . . . . . . . . . . . . . . . . . . . . . . . 24

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . 25References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26User questionnaire. . . . . . . . . . . . . . . . . . . . . . . . 26User comments . . . . . . . . . . . . . . . . . . . . . . . . . . 30Product data - costs. . . . . . . . . . . . . . . . . . . . . . . 31Product data - physical . . . . . . . . . . . . . . . . . . . . 32Product support . . . . . . . . . . . . . . . . . . . . . . . . . . 32Manufacturer’s Comments. . . . . . . . . . . . . . . . . . 33

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The “National Service Framework for children, young people and maternityservices” includes the Department of Health’s standards for the provision ofmedical services for children in hospital and mothers and babies post-birth [1].Neonatal incubators provide a thermo-regulated environment that facilitate thephysical development of severely premature and sick infants. CEDAR's recentevaluation of the Dräger Caleo [2] revealed that some neonatal intensive careunits have significant space restrictions and need a more compact incubator.Evaluation of products from other manufacturers also supports theCompetition Commission's recommendation that increased marketcompetition should be encouraged following Dräger's acquisition of Hill-Rom'sAir-Shields business.

This evaluation of the ATOM comprises a description of the device, results ofa user survey and a technical assessment. Three neonatal intensive careunits, in which the ATOM is in regular clinical use, took part in the user survey.The technical assessment was carried out using CEDAR performance testsbased around the requirements of the harmonised European Standard forBaby Incubators [3], and previously used in assessments of the Dräger Caleo[2] and the Ohmeda Giraffe Omnibed [4].

The ATOM is available in three models with increasing functionality (oxygencontrol and weighing scales). It was considered by users to be reliable andprovide a well-controlled environment for the premature neonate although itscompact size means that it may not be suitable for larger, full-term babies.Technical testing confirmed the device's ability to quickly achieve and maintaina range of suitable temperature and humidity levels and to maintain or recoverthese levels following various environment challenges. Despite this, themaximum value of relative humidity (95%) was not achieved. In the userevaluation, staff expressed concerns regarding the lack of storage spaceavailable and the vigorous self-closing mechanism of the drawers. However,several combinations of drawers are available, including newer swing-outdesigns.

The low water-level alarm is not auditory and this caused difficulties in somecases. Also, although the use of in-built X-ray trays is not common, wherethese were used the feeding port hole in the canopy roof was visible on theimages. Other issues appeared to be due to inadequate training, user error orgeneral procedure.

Overall, the ATOM represents a well-designed and effective incubator thatcould benefit from small improvements in storage and alarm design and morethorough user training.

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Introduction

There are three models of ATOM V-2100G incubator (A,B and C), all of whichincorporate the usual features of a modern incubator: air temperature control,baby-skin temperature (servo) control, humidity control, an X-ray tray,mattress tilt and powered vertical height adjustment. Type B and C unitsadditionally have oxygen control and Type C have weighing scales. The modelevaluated was a Type C and therefore comprised all the optional featuresavailable to purchasers. Specifications and detailed pricing information arecontained in the Product Data section in the Appendix.

General

The incubator separates into two sections; the upper unit, consisting of thebaby compartment and incubator controls, and a mobile base unit with fourwheels (two fitted with wheel locks). They have separate power cables, so twosockets are required for each unit. The two sections are correctly positionedby metal fittings on the connecting surfaces and secured by two interlockinghooks on either side. Various drawer and shelf configurations are available.

Two metal rails with rubber ends are attached to the ends of the top unit.These are useful handrails when assembling and manoeuvring the incubator.Oxygen tubing and power leads may be wound around these rails duringtransportation.

Vertical Height Adjustment

VHA is an option for the base unit (Hi-Low or HL stand), the alternative is afixed height cabinet with large storage areas. The height of the incubator

Description

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Figure 1: ATOM front view

Upper unit

Lower unitVHA foot

pedals

Mattresstilt/height

adjust

Controlpanel

Humidity waterchamber cover

compartment can be adjusted electrically by using two foot-pedals, located atthe front and back of the base unit (Figure 1). The mattress height could beraised from 92 to 112 cm above the ground on the Type C model evaluated,but would be a couple of centimetres lower without the weighing scales.

Baby compartment

The baby compartment is a conventional shape, with the roof and side wallsconstructed as a single unit in clear polycarbonate. Curved front and rearedges provide good visualisation of the baby compartment from all angles(Figure 2), although some ATOMs may have squarer edges than shown here,on one side. The long side panels include large front and back access doors,the front access door being above the display panel. Each door featuresinternal panels which direct the flow of warmed air towards the canopy roofand ensure the internal surface walls are warm. These are attached to thedoor by two hinges and two clips, which can be released to facilitate accessfor cleaning. CEDAR NOTE: Warm internal surfaces reduce radiant heat lossfrom the baby's skin.

Both access doors are balanced to pull the door closed if they are nearlyupright, ensuring the door release knob is clicked shut. The top corners of thedoors are also fitted with twist locks for added security and to ensure theaccess door is well sealed (Figure 3). Four access ports are provided, twolocated in each large access door. The port catches can be conveniently andquietly opened by the elbow, permitting aseptic access (Figure 4). The rubberseals minimise noise on closure and are comfortable for the arm to rest on.

One iris port is usually fitted as standard, at the foot end. In the evaluationmodel the circular port at the head end was fitted with a circuit introductionholder, incorporating a tubing port assembly with tubing holders (Figure 2).

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Figure 2: Front access door openand mattress raised

Iris port

X-ray tray

Sensor unit

Circuitintroduction

holder

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Nine further tubing ports were provided, two in each corner and one close tothe sensor module. A feeding port (24 mm diameter) is positioned centrally inthe roof.

The sensor unit is fitted at the head end of the baby compartment. Airtemperature, humidity and oxygen level sensors (where included) are withinthe baby compartment. Externally there are two sockets for the core (yellow)and peripheral (white) temperature probes (Types B and C only). The socketswill only allow the plug of the correctly colour coded sensor to be inserted.Releasing the catch at the top of the sensor unit permits rotation of theoxygen sensor for calibration in normal air (20% oxygen).

The bed area comprises a plastic foam mattress (72 x 36 x 2 cm) coveredwith a white plastic cover. This is held in a plastic tray having a clear raisededge at the foot end.

The mattress tray is positioned on an adjustable platform. The mattress trayand platform can be withdrawn by pulling the front edge whilst the frontaccess door is open. The height of the mattress ends can be independentlyadjusted to achieve a head-up or feet-up tilt of up to 12° by rubber-coveredknobs located above the control panel (Figure 1). The height of the wholemattress within the baby compartment can also be raised, for example, toreduce phototherapy treatment distance (Figure 2).

X-ray tray

As a standard feature an X-ray tray is supplied, which can only be used whenthe front access door is open (Figure 2). It will take X-ray plates up to 340 x290 mm and two indented areas of 250 x 200 mm and 290 x 240 mm help tocentrally position smaller X-ray plates.

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Figure 3: Access door catch andtwist locks

Figure 4: Access port

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Control panel

The display and control panel is located under the front access door. Theoverall layout of the screen can be seen in Figure 5 and shows displays of thepre-set and monitored values and alarm indicators. A hinged plastic stripbeneath the display panel conceals the push button control panel, preventinginadvertent changes to the environmental controls, whilst allowing access tothe alarm silence button. On the reverse side of the plastic strip a briefsummary of each alarm message is provided.

Figure 5 also shows all the temperature controls and the display panel. Air(manual) or skin (servo control) temperature control can be selected and thedesired temperature is displayed on the central temperature display. Themeasured air temperature is displayed on the right and, if the probe isconnected, the core skin temperature is displayed on the left. Set temperatureranges are 23-37°C for air and 35-37.5°C for skin, in 0.1°C increments.Pressing the '>37°C' or '>37.5°C' buttons will override these upper limits andallow the maximum set temperature in each case to be increased to 39°C. Aninternal memory ensures the temperature setting is restored to the last pre-setvalue when the incubator is turned on. Measured air temperature is displayedin the range 20-42°C and skin temperature in the range 30-42°C, in 0.1°Cincrements. A graduated indicator provides additional information about theheater output in the range 1-100.

When the incubator is in air temperature mode the baby's core skintemperature remains displayed. This facilitates monitoring during nursingoutside the incubator whilst continuing to warm the cabinet ('kangaroo care').However, alarm conditions in air temperature mode are only based on the airtemperature in the incubator and not on the baby's skin temperature. Thetemperature reading of a second, peripheral probe is only displayed when therelevant control button is pressed (icon is a baby, thermometer and '2').

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Figure 5: Control panel with cover open

Airtemp

Settemp

Skintemp

HumidityOxygen

Scales

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Humidification

The humidity chamber is located on thefront of the unit, to the left of the controlpanel (Figure 1). When the cover isopened the chamber can be pulled outas a drawer and the tank removed fromthe top. The tank is inverted to refillwith sterilised water and replaced withthe lid downwards (Figure 6). A smallboiler at the back of the chambergenerates steam which passes into thewarming chamber under the mattress.Relative humidity levels of 40-95% (40-90% for Type A) can be pre-set. The monitored relative humidity value isdisplayed above the pre-set value. A low water level will trigger a visual alarm.The manufacturers recommend emptying and refilling the humidity chamberwith sterile water every 24 hours. When the power is turned off the set relativehumidity will be cleared. The incubator can be operated without humiditycontrol by not filling the chamber, in which case the low water level indicatorwill remain on.

Optional extras

Additional control sections to the left of the temperature panel are used for theoptional oxygen control and weighing scales (Figure 5).

Oxygen

Oxygen enrichment of the incubator can be regulated up to around 65% usingthe internal oxygen controller on Types B and C incubators. Alternatively allmodels can be externally controlled using a manually adjusted flowmeter inthe oxygen supply and a separate oxygen monitor in the chamber. Bothmethods require a supply of dry oxygen and the manufacturer states that ittakes approximately 40 minutes to stabilise the oxygen concentration withinthe canopy. There are two oxygen sensors in the inbuilt sensor unit (Figure 1)and the oxygen control activation is preceded with a calibration in room air.Measured oxygen concentration is displayed above the pre-set level. Whenthe power is turned off the set oxygen level will be cleared.

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Figure 6: Humidity chamber andwater tank (inverted)

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Weighing scales

Two modes for weighing the infant are available. A single measurement canbe made whereby visual and audible cues are provided to prompt the user tolift the baby off the mattress, hold the baby and then place them back on themattress. Changes from a reference weight value can also be monitored.Thismode can provide output to a printer. CEDAR NOTE: Changes in weightmeasured will include variations in anything that is supported by the mattressplatform - blankets, clothes, toys, etc.

Accessories

Two deep storage drawers were fitted on the ATOM model evaluated. Thesecannot be used when the front access door is fully open. The base unit canalternatively be fitted with smaller double drawers with either a pull-out orswing-open action. The lower drawers may then be accessed at all times. Anaccessory pole and drip stand can be fixed to a corner bracket.

Alarms

Two tones of audible alarm are used. One when the power is disconnectedwhilst the power switch is on, the other being used for all operational alarms.Individual visual alarm indicators are located in a strip on the display panel,just above the control buttons. The icon labelling of each indicator light isbriefly explained on the reverse of the control cover. A red light on top of thesensor unit is also illuminated each time an operational alarm is activated.This is not turned off when the 'silence' button is pressed, only when theproblem is resolved. Most operational audible alarms can be silenced for threeminutes by pressing the silence/reset button.

Cleaning

Rubber seals and tubing portsare all removable for immersionin disinfectant solution. Themanufacturer recommends useof a soft clean cloth dampenedwith a disinfectant solution forcleaning and disinfection of hardsurfaces, including the sensorunit.

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Figure 7: Canopy open showingconditioning chamber and fan cover

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The canopy can be raised by lifting the handle above the display panel,providing good access for cleaning the mattress platform. A metal bracketholds the canopy securely in place. All internal parts are easy to remove forcleaning. The conditioning chamber is made of stainless steel (Figure 7). Theheater is hinged and both fan and fan cover can be removed for immersion indisinfectant solution. The humidity chamber and boiler may be wiped with acloth dampened in disinfectant solution, while the water tank and boiler lid canbe immersed in solution. Changing the air filter is straightforward as the unit iseasily accessible on the back panel (Figure 8) and the sheet filter is simple toreplace. The manufacturers recommend changing the filter approximatelyevery three months.

User manual

Instructions and guidance are concisely written with plenty of informativediagrams. The number of large text boxes containing cautions and warningscan make the pages seem busy and daunting at first, but the text becomeseasier to follow when you are accustomed to it.

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Figure 8: Air filter

Respondents to the User Survey were located in three neonatal units atlocations around the UK. Two of these had ten ATOMs each that had been inuse for 2 or 3 years, and the third had four ATOMs that had been in use forjust under a year. Of the forty-seven respondents there were forty-threenurses, two doctors and two service technicians.

Our questionnaire asked users to rate features of the ATOM V-2100G asbeing unacceptable, poor, satisfactory, good or excellent. Other questions hadyes/no answers. All questions included space for users to make comments.There were also general questions about the user's experience and training,other incubators they had used and what they considered to be the mainadvantages and disadvantages of the ATOM. To clarify issues raised by thequestionnaires each neonatal unit was visited by an evaluator.

The results can be seen at a glance in the following bar charts. Points ofparticular interest are discussed in the following text, especially where usershave made comments about specific features. The questions and numericaldata from the questionnaire are reproduced in the Appendix for interestedreaders.

There were 56 questions in the questionnaire asking for a feature to be rated.The percentage of respondents who provided a score of satisfactory or betterfor that feature was determined in each case. (Note that not all respondentsanswered every question.) For all of these 56 questions the majority ofrespondents (>50%) rated the features as satisfactory or better. For 19questions, 100% of the respondents rated the feature as satisfactory or better.For two questions the most common response (median) was poor. Theserelated to the drawer space and weighing scales instructions.

General mobility was liked by all respondents except four who rated it aspoor. Two respondents listed mobility under advantages and one other underdisadvantages. Everyone rated the wheel locks, stability and poweredvertical height adjustment as satisfactory or better. Thirteen rated the VHAas excellent. Eighty-nine percent found the mattress height adjustmentacceptable, but five rated it as poor. The two medical respondents commentedthat the mattress was "high in comparison to the doors". (Also, see commentsabout access ports below.)

Most of the ATOMs in use in the hospital units had one large drawer on oneside of the base unit and two smaller pull-out drawers on the other. Otherincubators had one swingout and two pull-out drawers. Many unfavourablecomments were made about the drawers, including in the disadvantagessection of the questionnaire. These were commonly about the lack of space inthe smaller drawers and the self-closing mechanism on the pull-out drawers("drawers slam shut and startle baby"). Twenty-four respondents rated the

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drawers as satisfactory or better and twenty-three as unacceptable or poor.Included in this latter group were eight out of twelve respondents in the onehospital unit that had the swingout drawer combination. (See Manufacturer’scomments.)

In many instances ancillary equipment was not fixed to the ATOM, so thisquestion was not answered by twenty-one staff. Of the others, 88% rated it assatisfactory or good. Forty-four out of forty-six respondents thought theaesthetic appearance of the unit was satisfactory or better.

Most users were happy with the control and display screen; thirty-nine(91%) rated it as satisfactory or better and the same number agreed that itwas easy to move between options. Comments included those about anincreased learning curve ("took some getting used to", "new staff take longerto adapt to the control panels than other incubators") and one respondentstated that the keys required "a lot of pressure". There were also commentson the proximity of the different displays which was thought to be confusing.However, two other respondents commented on the "easy to use controls" inthe advantages section.

The air temperature control was generally liked, with all respondents rating itas satisfactory or better. Comments included "good temperature control" and"holds temperature and humidity well". Forty-three respondents out of forty-five agreed that it was easy to set the required temperature.

The skin temperature control (servo control) was not used by two of thehospital units in the survey but was rated as satisfactory or better by twentyout of twenty-one respondents. One person rated it as poor, but this was in a

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No of Respondents

0 5 10 15 20 25 30 35 40 45 50

Mobility 1

Wheel-locks 2

Stability 3

VHA 4

Mattress height adjust 5

Cupboard/drawer space 6

Fix ancillary eqpt 7

Aesthetic appeal 8

Control & display screen 9

Easy to move betw options 10

Unacceptable Poor Satisfactory Good Excellent Yes No

Figure 9: Questions 1 to 10

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unit that did not use this procedure and they commented that it was "veryeasy to hit wrong button when hurrying".

The visibility and clarity of the temperature displays were liked by almost allrespondents. Only one person rated the visibility as poor but this appeared tobe related to the learning curve for new staff.

Forty-five respondents had used the relative humidity control. Thirty-onerated is as good or excellent and forty-three agreed that the level was easy toset. Adverse ratings and comments were related to the water tank and lowwater alarm and will be described in those sections. Nine users listed thehumidity operation in the advantages section.

One hospital unit did not use the internal oxygen controller. Twenty-sevenrespondents had experience of controlling the oxygen in the incubator.Twenty-six of these used the built-in controller. All of these rated the controland range of values as satisfactory or better.

Opinion was very mixed regarding the weighing scales. One hospital unit didnot use the in-built scales at all, leaving twenty-five respondents who did. Onthe positive side, nineteen staff rated the scales as satisfactory or better andfourteen rated the instructions the same (70% and 52%). Thirteen agreed thatthey were easy to operate from the control screen but the same numberdisagreed. The scales and instructions were rated as poor or unacceptable byeight and thirteen staff respectively. The division of opinion was split betweenthe two hospitals using the scales, i.e. most of the negative scores andcomments came from one neonatal unit. The comments from the disapprovingunit included "inaccurate" and "confusing". The service technician at this unit

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No of Respondents0 5 10 15 20 25 30 35 40 45 50

Air temp control 11

Easy to set the reqd air temp 12

Skin temperature control 13

Easy to set the reqd skin temp 14

Visibility of temp displays 15

Clarity of temp displays 16

Use relative humidity 17

Opinion of RH 18

Easy to set RH level 19

Use oxygen control 20

Use internal O2 control 21

Opinion of O2 control 22

Opinion of range of O2 23

Easy to set O2 level 24

Unacceptable Poor Satisfactory Good Excellent Yes No

Figure 10: Questions 11 to 24

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commented that he "had to alter the instructions so the staff couldunderstand". From the approving unit were such comments as "scales easy touse compared to other incubators" and "the sound is helpful to know when toraise and lift baby". However, staff on this unit also found the scales"unreliable" and claimed they "went on the blink occasionally". Difficulties werealso related to the different weighing modes ("not easy to work out which keyto press").

Thirty-seven out of forty-three respondents used the control panel cover,thirty-six rated them as satisfactory or better and one described it as "ideal".However, eight respondents commented on the ease with which thesebecame broken or fell off.

The mattress tilt and height adjustment mechanism was generally likedalthough there were several comments that the range of tilt should be greater,especially for babies with gastric reflux. Forty out of forty-five rated the tilt assatisfactory or better. Less than half (21) used the same mechanism to raisethe mattress height, although twenty-two rated this feature as satisfactory orgood. One user commented that the rubber knobs were "occasionally stiff". Inone hospital unit Spenco mattresses were used in addition to the ATOM onesand from this department there were several similar comments about accessto the baby - "difficult sometimes to get arms into port holes when tilted".CEDAR NOTE: Premature neonates are commonly maintained in a head-upposition as this is thought to assist with reflux and blood-pressure control andtherefore access will often be required in this position.

As mentioned above, skin temperature control was not commonly used.Thirty respondents stated that they did not use either of the skin temperature

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No of Respondents

0 5 10 15 20 25 30 35 40 45 50

Use in-bed scales 25Opinion of scales instructions 26

Opinion of scales 27Easy to use from ctrl screen 28

Use control panel cover 29Opinion of control panel cover 30

Opinion of tilt knobs 31Range of mattress tilt 32

Use mattress height adjust 33Opinion of MH adjust 34

Use w hich skin sensor 35Opinion of tw o skin sensors 36

Shape & size of skin sensors 37Length of lead 38

Ease of f ixing sensor on baby 39Patient lead connection 40

Unacceptable Poor Satisfactory Good Excellent Yes No/Neither Both White Yellow

Figure 11: Questions 25 to 40

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probes. Thirteen used the yellow core temperature probe, one used the whiteperipheral probe and three had used both, all of whom were from one hospitalunit. Three of these staff members indicated by their comments that peripheraltemperatures were not measured and another commented that probes were"often thrown away by mistake". As the lead connectors are colour coded andthe two probes cannot be interchanged, this suggests that the peripheraltemperature sensors are being used as replacements for missing coresensors. Continuous display of the infant's temperature will not then bepossible as peripheral temperature must be selected manually from thecontrol panel.

All eleven respondents who rated it liked the option to have two skintemperatures. Fifteen out of sixteen approved of both the sensor dimensionsand the lead length, although one commented that longer leads would makekangaroo care easier. Two staff members commented that humidity couldinterfere with the sensor attachment and two also commented that thesensors "slide out" from under the gel pads. All eighteen respondents ratedthe lead connectors as satisfactory or better.

Thirteen staff rated the baby compartment as satisfactory and 32 as good orexcellent. Comments suggested the compact size was most appropriate forsmaller babies. One user rated this as poor but gave no reason.

The iris port was generally liked by all respondents. General access to thebaby was considered satisfactory or better by 94% of respondents. Mostusers found all the access features (access ports, doors and catches) to beacceptable. Three users rated the ports as poor and there were commentsregarding the low height relative to the mattress, but these all came from the

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No. of Respondents0 5 10 15 20 25 30 35 40 45 50

Opinion of baby compartment 41

Iris port 42

Access to baby 43

Hand ports 44

Hand port catches 45

Access doors 46

Access door catches 47

Access door locks 48

Open more than one access door 49

Opinion of multiple doors 50

Security of access doors 51

Opinion of 10 tubing ports 52

Feeding port 53

Unacceptable Poor Satisfactory Good Excellent Yes No

Figure 12: Questions 41 to 53

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hospital unit that used additional Spenco mattresses. Five out of forty-five staffrated the port catches as poor, but three of these were from a single hospitalunit. Users from here commented that they were "noisy". As this unit has hadpossession of their ATOMs for the longest length of time (3yrs) and no similarcomments were made by users at other sites, this issue may have beenresolved with improvements to later models.

Negative comments and low rating of the access doors, catches and locksagain came mostly from a single unit. They found the access doors difficult toopen by a lone nurse for sterile procedures. Other units did not mention thisas a difficulty. Another user commented that they "like the extra catch". Oneservice technician considered the door locks to be “flimsy” and poor. Overall,87-97% of respondents rated all these access features as satisfactory orbetter and 8 or 9 rated most as excellent. Two access doors were not fitted onall the models in use and were not always used where available, but wereliked by all respondents.

Many of the models in use had five tubing ports rather than ten as on theevaluation model. Two out of the three poor ratings were due to this beingconsidered inadequate but thirty-six users rated this facility as satisfactory orbetter. The feeding port in the canopy roof was not used at all or not used forfeeding by 18 out of 44 respondents. Twenty-nine rated it as satisfactory orbetter but 6 rated it as poor or unacceptable. This was described as "badpractice in nursing" and nurses were "not encouraged to use very often".Several users commented that a port at the head end would be more useful,as canopies are often covered. Five out of the six low ratings were due to thefeeding port being visible on X-ray images. CEDAR NOTE: The feeding portdoes not contain any radio-opaque materials. However, this feature is visiblebecause soft X-rays are used for imaging neonates because their bones arerelatively low density.

All the nursing and medical users (46) rated the mattress as satisfactory orbetter. One service technician commented that the mattresses weresometimes too large for the tray. Although 36 out of 41 users rated the traywithdrawal mechanism as satisfactory or better, five users in two hospitalunits rated it as poor. Comments were "flimsy" and "can feel unstable" duringintubation procedures. However, comments from other users indicated thatthis problem might be caused by "usually operator error at having not beencorrectly put together".

The relative humidity feature was universally liked, with all respondentsrating the effectiveness and range as satisfactory or better. Negative viewswere limited to the lack of an audible low water alarm. Ten users includedaspects of the RH system in the advantages section. The water tank system,however, received a more mixed response. Five users rated it as poor, while

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eight thought it excellent. Comments ranged from "very unreliable, watereverywhere" to "outstandingly superb". Such a range of views indicate thatproblems may be related to user technique or faulty product and should beaddressed by training or replacement of the parts.

As mentioned above, the X-ray tray was only used in one hospital unit. Allrespondents from here rated the ease of use as satisfactory or better althoughthe visibility of the feeding port on the images was again mentioned. In theother units it was standard practice to lay the baby directly on the cassette forbetter visualisation of placement and improved image quality.

Ten users complained that the auditory alarms were "too loud", although thisdid not prevent thirty-eight from rating them as satisfactory or better. One usercommented that they were "sometimes not loud enough"! Five users ratedthese as poor and two as unacceptable. At least 89% of respondents ratedthe visual alarms and captions as satisfactory or better. Users commentedhowever, that the low water level alarm was "not noticed easily" and that theuse of incubator covers meant that visual alarms and captions were oftenobscured. Also, captions would not be available where the control panel coverhad broken off (see page 12).

Ease of patient care was satisfactory or better for 96% of the respondentsalthough one comment was "not for bigger babies". All 41 respondents foundease of feeding to be acceptable. Nurses at one hospital unit suggested thatexternal clips/syringe holders at the head end would be more helpful than thecurrent feeding port in the canopy roof. Ease of nursing and medical accessand operator comfort were acceptable to 98-100% of respondents.

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No. of Respondents

0 5 10 15 20 25 30 35 40 45 50

Opinion of mattress 54

Mattress withdrawal 55

Opinion of RH option 56

Range of RH settings 57

Opinion of water system 58

Ease of performing X-rays 59

Use X-ray tray 60

Auditory alarms 62

Visual alarms 63

Alarm captions 64

Visibility of alarm captions 65

Unacceptable Poor Satisfactory Good Excellent Yes No

Figure 13: Questions 54 to 65

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Many of the users questioned had no experience of cleaning the ATOMs asthis was most often carried out by HCAs. All 27 respondents rated this assatisfactory or better. Several users in one hospital unit commented that it was"easy to clean" in the advantages section and "much improved on previousmodel", although another user described it as "time consuming and takesexperience to put back together".

Seventeen out of 46 had received training from the manufacturer, 17 out of43 had read the manual (or parts of it) and 37/46 had received training fromcolleagues. No-one found the training unsatisfactory, although one usercommented "V quick training but it didn't all sink in in one session. No moreavailable". On one unit, regular training appeared to be carried out by thetechnical staff. (See Manufacturer’s comments.)

With the exception of one hospital unit, where the ATOMs had been in use forless than a year, most users had between one and three years experienceusing these devices. Almost all used them frequently and recently (within aweek) and only five did not comment that they had experience with othertypes and makes of incubator.

Comments about the overall size of the ATOM were divided between sites. Inone unit staff were complimentary about the "nice compact design". In thesecond reaction was more mixed: "compact" and "larger than otherincubators". In the third, reception was lukewarm and the ATOM was regardedas "no worse than any other incubator" and "adequate", although "quite bulkyaround the control panel area".

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No of Respondents0 5 10 15 20 25 30 35 40 45 50

Ease of general patient care 66

Ease of feeding 67

Ease of nursing access 68

Ease of medical examination 69

Operator comfort 70

Cleaning 71

Receive training from manf 72

Opinion of training 73

Read user manual 74

Opinion of user manual 75

Receive training from colleagues 76

Unacceptable Poor Satisfactory Good Excellent Yes No

Figure 14: Questions 66 to 76

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User comments

A table of the features that were commented on by users is included in theAppendix. This contains features that were commented on by at least twousers, both positive and negative. Other comments were encountered duringthe follow-up visits. These included the air filters being easy to change and theease of cleaning. It was noted that the base of some incubators is larger thanthe top unit and can lead to trips and bumping into door frames, etc. This wasnot the case with the ATOM. For cleaning, the small size of the ATOM was anadvantage, making reaching all the parts easier. Also the hinged canopyreduced the space required for dismantling.

Technical support

In addition to the questionnaire responses, the support technicians at eachhospital unit were interviewed during the follow up. It was considered thatthere were generally few callouts required in comparison to other models.However, two MTOs and a senior nurse commented on the slow serviceresponse when parts were required. Delivery took between 4 and 12 weeksand one hospital experienced recurrent problems with damaged canopiesnear the door catches. This latter problem may relate solely to earlier models.One technician also noted that there were familiarisation problems with theuse of the control panel as the controls are not lined up with the displays, butthat this was resolved with training. They also commented on the need for twopower sockets, which is unusual and could cause difficulties where largenumbers of powered devices are in use. (See Manufacturer’s comments.)

CEDAR comments

Several of the points raised by the User Evaluation questionnaire might beattributable to procedural or training issues at individual hospital units. Forexample, only the unit that used additional mattresses experienced problemswith accessing the baby via the ports. One unit was particularly disapprovingof the weighing scales out of the two that used them. This indicates either aproblem with the hardware or software of the version they are using, orpossibly poor training. During technical evaluation the weighing scales werefound to be very accurate, although CEDAR appreciate that weighing a sickinfant will be a more demanding procedure.

The catch (but not the twist locks) on the access doors can be operated usingan elbow, but the door is weighted to remain closed. Thus the access ports,but not the doors, can be operated aseptically.

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The performance of the ATOM V-2100G Type C was assessed using tests,based around the requirements of the harmonised European Standard forBaby Incubators (BS EN 60601-2-19, [2]), and previously used in theassessment of other enclosed incubators. These comprised:

1. warm up tests2. temperature stability over 1hr during steady conditions3. temperature uniformity across the mattress when flat and tilted in both

head-up and feet-up positions 4. temperature and humidity response to opening of 4 ports and one

access door5. simulated mains failure 6. humidity accuracy over full range (40-95%) at 39ºC7. sound levels during normal and alarm conditions8. weighing scales accuracy

The control of oxygen levels in the incubator was not assessed.

The first four tests were each carried out at three settings intended to replicateconditions suitable for babies of varying maturity:

• 34ºC and 50% humidity - full term baby• 36ºC and 70% humidity - medium pre-term baby (~34wks)• 38ºC and 95% humidity - extremely premature baby (~24wks)

Additionally, warm up to 11ºC above ambient temperature at maximumhumidity (95%) was tested, as per the European Standard.

All temperature settings were air temperature. Air temperature and humiditywere measured at the centre of the mattress unless otherwise stated. Ambientconditions in the evaluation centre were also measured and were generally23-26ºC and 43-46% humidity, with the exception of the tests at 38 ºC and thewarm up to 34ºC where the humidity was around 36-40%.

Warm up tests

The incubator was set to 12ºC above ambient conditions and 95% relativehumidity as per the European Standard test. The time to reach 11ºC aboveambient was 33 mins. For the various baby settings, the warm up curves andtimes for the measured temperature to initially reach the set temperature areshown in Figure 15. Temperature overshoot following warm up was typicallyless than 0.5ºC, although for the 12ºC above ambient test it was 1.5ºC. This iswell within the limit of 2ºC imposed by the Standard. The ATOM thereforeachieves its set temperature within the 60mins stated in the manual. Thegraph indicates that the time to achieve the set temperature will depend onthe ambient temperature when the device is switched on.

The maximum difference between the measured temperature and thatdisplayed on the ATOM panel was 1.4ºC during the warm up, but much less

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than this during steady conditions (up to 0.2ºC). The Standard requires thatthe difference between measured and displayed temperatures be within 0.8ºCduring steady conditions.

Temperature stability

The average measured values during one hour of steady operation are shownin Table 1. Also shown is the maximum difference from the mean at any timeduring the hour, giving an indication of the variation in temperature. Theagreement with the set value and stability over time are very good as theStandard requires that the actual temperature be within 1.5ºC of the settemperature and should not vary by more than 0.5ºC

Temperature uniformity

Temperatures were measured 10 cm above the mattress at the centre andtowards the four corners. When the mattress was fully tilted in either directionthe mean temperature measured at the centre was slightly higher than whenlevel, typically around 0.4ºC. This is well within all relevant requirements, and

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26

28

30

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34

36

38

40

-10 0 10 20 30 40 50 60 70 80 90 100

Time (minutes)

Tem

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48mins

42.5mins

34°C 50%

36°C 70%

38°C 95%

settemperature

measuredtemperature

maximumdifference

34 33.76 0.06

36 36.04 0.12

38 37.79 0.10

Table 1: Mean incubator temperatureand variation over time (ºC)

Figure 15: Temperature warm up times

may be due to the centre of the mattress being raised when tilted. In allpositions the maximum difference between the centre and the other fourmeasurements was 0.34ºC. The limit set by the Standard is 0.8ºC when flat or1ºC when tilted.

Relative humidity

The relative humidity was measured during all the warm up and stability testsand in steps from 40-95% at 39ºC. Figure 16 shows that humidity increasesquickly and achieves a level close to the steady value within ten minutes.During the warm up and stability tests at set levels of 50% and 70%, the

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Table 2: Measured and displayed values of relativehumidity in different tests

RH (%) RH Steps Warm up Stability

set valuemaximummeasured

displayed measured displayed measured

40 37.7 41

50 47.5 50 50.6 51 50.9

60 57.3 60

70 67.1 69 68.6 71 70.3

80 74.8 80

90 81.2 89

95 84.5 94 84.8 94 86.1

30

40

50

60

70

80

90

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Time (minutes)

Rel

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34°C 50%

38°C 95%

36°C 70%

Figure 16: Relative humidity increases from switch on

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ATOM performed very well, achieving differences between measured,displayed and set values within 4% (Table 2). Moderate amounts ofcondensation were found towards the end of the increasing humidity step testbut the baby compartment was still clearly visible.

However during the step increases in humidity the measured results wereconsistently below the set and displayed values. For set humidity values of upto 70% the maximum difference was still within 4%, but for higher values thisdifference increased. The displayed humidity agreed with the set value within1% but the actual value measured at the centre of the mattress was around 9-10% below this.

The ATOM did not reach 95% relative humidity at any point during the tests.The maximum value measured was 87.4%. The Standard requires that theindicated value be within 10% of the measured value. Therefore, when themeasured value is 84.5% the maximum value on the display should be 93%.The manufacturer claims that values of >90% relative humidity are achievablewith the B and C models when the ambient conditions are 25ºC and 50%humidity and when the incubator is set to an air temperature of 37ºC. Theconditions in the evaluation laboratory and incubator settings were possiblymore challenging than this, however the underperformance at a set humidityof 95% was very consistent.

CEDAR NOTE: The feeding port in the centre of the canopy does not have aflexible grommet as the other tubing ports do – it is simply a small hole. It islikely that this may lead to reduced humidity above the centre of the mattressas the warm, moist air escapes from the baby compartment. The ATOM’s ownsensors are located at the head-end of the compartment and it is possible thatrelative humidity values in that position were much closer to the set andindicated values. However, the position of the measurements carried out byCEDAR were in accordance with the Standard and this is how the limitsshould be applied. (See Manufacturer’s comments.)

Open ports and doors

Four access ports and one access door were opened for five minutes to testthe temperature and humidity response at each of the three baby settingsdescribed on page 18. Table 3 lists the decreases in temperature and relativehumidity for each setting. Figure 17 shows the effect of these tests at settingsof 38ºC and 95% relative humidity. The drop in temperature whilst the portsand door were open ranged from 0.3-2.8ºC, the larger temperature dropsbeing at the higher set temperatures. The humidity decreases for the openports were between 7-44%. The highest humidity decreases were found at the70% humidity setting.

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35.0

36.0

37.0

38.0

39.0

40.0

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170

Time (minutes)

Tem

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60

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access door open4 ports open

Temperature

Relative humidity

Figure 17: Open ports and doors for 5mins at 38°C and95% relative humidity

Temperature 34ºC 50% 36ºC 70% 38ºC 95%

4 ports open 0.3ºC 0.9ºC 1.5ºC

access door open 1.3ºC 2.0ºC 2.8ºC

Humidity

4 ports open 6.7% 28.3% 25.9%

access door open 11.7% 44% 26.6%

Table 3: Temperature and humidity dropduring challenges

32.5

33.0

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10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170

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0

10

20

30

40

50

60

Rel

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Temperature

Relative humidity

4 ports open access door open

Figure 18: Open ports and doors for 5mins at 34°Cand 50% relative humidity

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In all cases the temperature and humidity recovered to pre-challenge levelswithin five minutes. There were slow oscillations in the measuredtemperatures after these levels had been regained, but these were within the0.5ºC limit required and were smaller at higher set temperatures. The humiditytended to overshoot following recovery, the largest overshoot of almost 10%was found at the 50% setting following the closure of the access door (Figure18). A steady level was achieved approximately 13mins after the door wasclosed. The size of the overshoot was smaller when the ports were used andat higher humidity settings.

Simulated mains failure

The response of the temperature and humidity to a simulated mains failurewas tested by switching off the power at the mains socket for five seconds.The ATOM was set to 37ºC and 95% humidity. Both variables dropped for 3.5mins and then began to recover. The temperature dropped 0.3 ºC and thehumidity by 5%. The humidity recovered within approximately 7 mins with noovershoot. The temperature overshot by 0.3 ºC and returned to a steady levelby 15 mins post-challenge. The displayed values also revealed thesedecreases, although the temperature overshoot was not indicated. Asmentioned above there was a discrepancy of almost 8% between themeasured and displayed humidity values at this setting. The presence of adecrease was demonstrated by the ATOM displayed value but was less thanthat measured at the centre, i.e. the discrepancy was smaller at lowermeasured values.

Sound levels

Sound levels inside the baby compartment were 45 dBA during normaloperation and 55-62 dBA during alarms (A indicates that the measurement isweighted to respond in the same way as human hearing). The Standardstipulates maximum sound levels of 60 and 80 dBA respectively under theseconditions. Alarm levels outside the incubator were 72-73 dBA. The Standardrequires a minimum of 65 dBA, although government regulations [5] indicatethat average occupational noise levels should be below 85 dBA. The ATOMtherefore complies with all relevant legislation in this regard.

Weighing scales

The accuracy of the scales were tested using standard weights between 0.5and 4 kg. The maximum discrepancy was 2 gm for both weighing modes. Thisis a very high level of accuracy.

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CEDAR comments

The temperature control of the ATOM incubator is generally very good, as alsocommented upon in the User Evaluation section. However, overshoot andoscillations in the measured temperature appear to be larger and morecommon when the difference between initial and set temperatures is smaller.This is found during the warm up at 34ºC and the challenge tests andindicates that the damping of the temperature control is greater at highertemperatures. The relative humidity control was good up to values of 70% andset values were initially achieved very quickly from start-up. However, theaccuracy of the indicated value and actual humidity attained was poor athigher settings.

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Acknowledgements

We would like to thank Inspiration Healthcare Ltd for their loan of the ATOM V-2100G Type C that was used for the description and technical evaluation. Alsofor their co-operation and advice in the production of this report. We wouldalso like to thank the staff of the neonatal units that provided their time andopinions for the user evaluation: Hope Hospital, Salford; Southmead Hospital,Bristol; St Mary’s Hospital, Manchester.

References

[1] www.doh.gov.uk > Policy and Guidance> Health and Social Care Topics> Children’s Services

[2] MHRA Evaluation 04020

[3] European Standard EN 60601-2-19:1997

[4] MDA Evaluation 02090

[5] Noise at Work Regulations, 1989

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PART 1 General

What is your opinion of the:

1 general mobility of this device 4 17 21 5

2 wheel locks 17 21 9

3 stability of the device 10 30 7

4 incubator vertical height adjustment 8 26 13

5 mattress height adjustment mechanism 5 16 19 4

6 cupboard / drawer space 3 20 11 11 2

7 fixing of ancillary equipment 3 14 9

8 aesthetic appeal of the unit 2 17 22 5

PART 2 Control and display screen

9 Please give your opinion of the control and display screen 4 17 17 5

10Do you find it easy to use and move between options on thecontrol screen

Yes = 39 No = 6

Temperature control

11 What is your opinion of the air temperature control 9 26 7

12 Do you find it easy to use and set the required temperature Yes = 43 No = 2

13 What is your opinion of the skin temperature control 1 6 10 4

14 Do you find it easy to use and set the required temperature Yes = 27 No = 3

15What is your opinion of the visibility of the temperaturedisplays

1 12 22 10

16 How clear do you find the temperature displays 12 22 12

Relative humidity control

17 Do you use the relative humidity option Yes = 45 No = 1

18What is your opinion of the ease of use of the humiditycontrol

4 9 21 10

19Do you find it easy to use and set the required level ofhumidity

Yes = 45 No = 1

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Oxygen control

20Do you control the oxygen level in the whole babycompartment

Yes = 27 No =20

21 If YES, do you use the internal oxygen controller Yes = 26 No = 1

22 If YES, what is your opinion of the internal oxygen controller 9 12 5

23What is your opinion of the range of oxygen settings (22 to65%)

15 9 4

24Do you find it easy to use and set the required level ofoxygen

Yes = 26 No = 0

In-bed scales

25 Do you use the in-bed scales option Yes = 25 No = 20

26 What is your opinion of the scales instructions 1 12 10 2 2

27 What is your opinion of the scales option 2 6 10 7 2

28Do you find the scales easy to operate and use from thecontrol screen

Yes = 13 No = 13

Other controls

29 Do you use the control panel cover Yes = 37 No = 6

30 What is your opinion of the control panel cover 1 3 13 18 5

31 What is your opinion of the two knobs for tilting the bassinet 1 21 19 4

32 What is your opinion of the range of mattress tilt 5 19 17 4

33 Do you use the knobs to adjust the height of the mattress Yes = 21 No = 23

34If you adjust the mattress height, what is your opinion of thefeature

1 12 10 1

Skin sensor

35Two temperature sensors are available, yellow for coretemperature and baby temperature control and white forperipheral temperature. Which do you use

Yellow = 13, White = 1Both = 3, Neither = 30

36 What is your opinion of this facility 4 6 1

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PART 3 Baby compartment/bassinet

37 What is your opinion of the skin sensors’ size and shape 1 6 7 2

38 What do you think of the length of lead 1 6 7 2

39 How easy do you find it to fix the sensor to the patient 7 6 2

40What is your opinion of the patient lead connections to thesocket

9 8 1

Please give your opinion of the:-

41 baby compartment 1 13 29 3

42 iris port 20 18 4

43 ease of access to the baby when in the incubator 1 2 14 22 8

44 hand ports 3 14 21 8

45 hand port catches 5 12 19 9

46 access doors 3 16 20 8

47 access door catches 3 15 20 8

48 access door locks 1 5 12 21 8

49 Do you ever open more than one access door at a time Yes = 27 No = 18

50 If YES, what is your opinion of the feature 14 13 1

51 What is your opinion of the security of the access doors 1 15 23 6

52 What is your opinion of the 10 tubing ports 3 10 22 4

53 What is your opinion of the one feeding port 2 4 14 12 3

54 What is your opinion of the mattress 1 25 18 2

55 What is your opinion ot the mattress withdrawal mechanism 5 22 12 2

PART 4 Relative humidity

56 What is your opinion of the humidity option 13 24 7

57What is your opinion of the range of relative humidity values(40 to 95%)

13 23 9

58What is your opinion of the ease of setting up the watersystem for the humidity option

5 13 19 8

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PART 5 X-rays

59 What is your opinion of the ease of performing x-rays 1 20 12 2

60 Do you (or the radiographers) use the x-ray tray Yes = 10 No = 35

61 If NOT, please explain why

PART 6 Alarms

62 How do you find the auditory warnings 2 5 22 15 3

63 How do you find the visual warnings 1 3 26 13 2

64 How clearly do you understand the alarm captions 2 26 15 2

PART 7 Nursing and medical procedures

65How easy do you find it to handle the infant and providegeneral patient care

5 22 15 3

66 How easy do you find it to feed the infant 2 13 24 6

67 How easy do you find it to feed the infant 14 22 5

68What is your opinion of the ease of access to the infant fornursing procedures

1 14 22 6

69How easy is it to perform a medical examination while theinfant is in the unit

1 17 22 4

70What is your opinion of the operator comfort when providingnursing and general care

17 22 4

71Please indicate your experience of cleaning and disinfectingthe ATOM

10 15 2

PART 8 Training and use of the device

72Did you receive training from the manufacturer/supplier/salesrepresentative

Yes = 17 No = 29

73 What was your opinion of that training? 12 4 2

74 Have you read the user manual? Yes = 17 No = 26

75 What is your opinion of the user manual? 11 5 1

76 Did you receive training from colleagues in your hospital? Yes = 37 No = 9

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User comments

This table lists the features of the ATOM that were commented on by at leasttwo questionnaire respondents. Hospital Unit 1 had swingout drawers on theirATOMs and used additional pressure-reducing mattresses. Unit 1 was alsothe only unit that used the X-ray tray. Unit 3 was the only unit that used theperipheral temperature probes, and also the only one that did not use theweighing scales.

Advantage Unit 1 Unit 2 Unit 3 Total

size/baby access 5 4 3 12

humidity 6 1 1 8

scales 5 1 6

cleaning 6 6

easy to use 1 2 2 5

temperature control 3 2 5

(2) access doors 3 3

appearance 1 2 3

tubing ports 2 2

VHA 1 1 2

door catches 1 1 2

mobility 1 1 2

water system 2 2

Disadvantage

lack of drawer space 5 6 3 14

drawers (shutting) 6 6 12

scales 2 2 4

alarms too loud 1 2 3

mattress tray 1 1 1 3

small port holes 2 2

door catches (opening when sterile) 1 1 2

canopy visibility 1 1 2

parts / service backup 1 2 3

feeding port 2 2

low water alarm 1 1 2

only one access door 1 1 2

water system 2 2

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Product data - costs

Manufacturer ATOM

Country of Origin Japan

Prices Basic Type AIncludes: humidity control, air and skin (servo)temperature control, VHA (HL) stand, tilting mattressplatform, X-ray tray, 2 access doors, one set of skintemperature probes (reusable), access port cover (2), airfilter, dust cover, oxygen sensor (2), user manual

£7,400

Basic Type BAs for Type A with additional servo oxygen control

£9,000

Basic Type CAs for Type B with additional weighing scales

£12,500

1 layer drawer (deep) £300

2 layer drawer (shallow) £425

Swing out drawer £425

IV pole £220

2yr extended warranty (total 3yrs) £500

Feeding syringe holder £135

Circuit introduction holder with support arm £270

Connecting cable for white (peripheral) disposabletemperature probes

£23

Connecting cable for yellow (core) disposabletemperature probes

£23

Yellow temperature probe (5mm dia) £250

White temperature probe (5mm dia) £250

White temperature probe (10mm dia) £250

Disposable yellow temperature probes (x10) £250

Disposable white temperature probes (x10) £250

Air filters (x5) £95

Iris port sleeve £18

Access port seal £12

O2 fuel cell (sensor unit) £43

Tubing grommets £16

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Product data - physical

Product support

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Size (L x W x H) 100 x 63 x 135-152 cmMaximum width with two access doors open is 73cm

Mattress height 92-113cm (89.5 to 109.5cm without weighing scales)

Weight 88kg with HL stand83kg with cabinet

Mattress size 72 x 36 x 2cm

Tilt ±12°

Access doors 85 x 28cm

Access ports 16 x 11.5cm

Iris port 13cm

Wheelbase height 12cm (minimum at VHA pedals)

Castors Two lockable

X-ray tray 34 x 29cm maximumIndented areas: 25 x 20cm, 29 x 24cm

Canopy flat area 83 x 23cm

Mattress slide 18cm

Supplier Inspiration Healthcare LtdUnit 14, Barshaw Park, Leycroft Road,Beaumont Leys, Leicestershire, LE4 1ETTel: 0116 235 1010Fax: 0116 235 0150Website: www.inspiration-healthcare.co.uk

Guarantee 1 year (extendable a further 2yrs)

Servicing Fully comprehensive - 2 planned maintenance visits peryear plus callouts. Price per incubator.

£790

2 planned maintenance visits per year. Calloutscharged. Price per incubator.

£650

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Manufacturer’s Comments

A number of the survey respondents mentioned the lack of training. We atInspiration Healthcare offer as much training as required, provided free ofcharge, to all level of users. In addition, training times can be arranged 'out-of-hours', at weekends or evenings.

When enquiring about training needs, we always liaise with the Clinical NurseManager, Unit Technician or Ward Sister to determine the amount of trainingrequired. It is often answered that 'everyone seems happy', when the resultsof the survey clearly suggest that further training could be beneficial. To thisend, we have developed an ATOM incubator competency form, which can becompleted by every user in a unit. Whilst we offer continual support andtraining we also encourage a program of 'Train The Trainer', so there is atleast one member of staff in each unit who is expert in the operation, use andcleaning of the incubator.

Since mid-2005 all ATOM incubators that incorporate the high/low stand aresupplied with one power cord as standard rather than two.

We note with interest the variations in the measured and set humidity,particularly at the higher levels. All new ATOM incubators are supplied with arubber bung which blocks off the feeding hole in the canopy. We speculatethat this may have some bearing on the humidity performance.

As mentioned in the report, there are a variety of drawers on offer. Thefollowing are available in any combination:

• Pull out single layer drawer• Pull out double layer drawer• Swivel drawer incorporating swivel shelf

In addition, up to 4 IV poles can be fitted to any V2100G, one in each corner.We are also able to supply custom-made shelving to accommodate variousmonitors or modes of operation.

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