evaluation - cedar draeger cal… · mhra evaluation 04020, march, 2004 2 ... outside the incubator...

March 2004

evaluation NUMBER

04020

© crown copyright £ 35 (Free to the NHS)

Neonatal IncubatorDraeger CaleoMAIN FEATURESl Air temperature control mode

l Baby temperature control mode

l Powered vertical height adjustment (VHA)

l 2 long access doors, 2 small access doors

l Storage drawer

l 4 portholes, 10 tubing ports, 1 feeding port

l Mattress withdrawal

l Mattress/Bassinet tilt

l X-ray tray

l Lid lift & tilt or remove

l Electroluminescent control/display screen

l Controls lock button

l Trending facility

l “Kangaroo mode”

l 4 wheel locks (incl. 1 directional lock)OPTIONAL FEATURES

l Humidity controlreservoir or waterbag options

l Oxygen level control

l Scales

SUMMARYAdvantages: Easy to use control screen, cleardisplays, good vertical height adjustment, largepatient area and good temperature control. Ithas a smooth tilt mechanism and users liked thevisual alarm indicator and the two access doorseither side. Many accessories are available.

Disadvantages: Large device, can be cumber-some to move. Some users reported awkwardpatient access due to the width. Poor visibilitydue to canopy lid shape especially with doublewall. Difficult to use with most overhead pho-totherapy lights due to width and tilt.

Overall: Technically a good incubator and mostusers rated its features as satisfactory or better,but some aspects of using the Caleo wereunpopular.

BRIEF DESCRIPTION

The Draeger Caleo neonatal incubator is builtwith a new style having a more curved structureand shape. It has increased access facilitieswith access doors in all four sides and the toppart of the canopy can be raised and supportedat an angle or completely removed.

Price (ex VAT) £9,947 (Basic)£14,447 (Basic + oxygen,humidity & scales options)

Supplier/Manufacturer

Draeger Medical Ltd, The Willows, HemelHempstead, HP2 7BW

CE Marking? Yes, MD Directive

Notified Body TUV no.0123

Manufactured toStandard?

Certified by CSA to 601-1& 601-2-19

Copies of this and other evaluation reports canbe downloaded in colour from nww.medical-devices.nhs.uk

Description Draeger Caleo

CONTENTS Page

Description 2User Assessment 5

Technical support response 11Technical Assessment 12Manufacturer’s comments & Data 18Appendix 20About MHRA reports 24

Acknowledgments 24How to obtain MHRA reports 24

DESCRIPTION

MHRA evaluation 04020, March, 2004 2

The Draeger Caleo incubator is a completely newdesign for this type of device. It incorporates allthe usual features of a modern incubator: air tem-perature control, baby-temperature control, coreand peripheral temperature monitoring. Poweredvertical height adjustment (VHA), powered bedtilt, an x-ray tray below the mattress and a storagedrawer are also all part of the standard Caleopackage. It has optional humidity control, oxygencontrol and weighing scales.

Baby compartment: The baby compartment is anew design, rounded polycarbonate capsule: seeFront Cover Photo. It has four access doors, twolong ones in each side 23cm x 66cm, and twoshorter squarer ones, 22cm x 25cm, in each end.The longer ones have two portholes with catchesin the centre. In addition there are 10 tubing portssited around the baby compartment and a roundtubing port in the roof of the canopy.

The roof section of the canopy can be lifted andtilted to allow greater access to the baby. It maybe tilted from either of the longer sides and held inplace with a small plastic prop, see Photo 1. Thelid section may also be lifted off completely shouldincreased access be necessary.

At one end of the baby compartment a sensorunit, containing detectors for air temperature andhumidity, projects over the mattress. To the rightof this are two small circular vented holes; if theCaleo has the optional oxygen facility then theoxygen sensors are fitted behind these vents.

On the outside of the sensor unit there are twosockets for the core (yellow) and peripheral(white) temperature probes. The yellow and whitesockets will uniquely allow only attachment of thecorrectly coloured sensor cable plug.

Mattress & mattress tray withdrawal: The mat-tress was made of gel sponge foam and coveredin a cream plastic mattress cover. The bed areawas 48.5cm x 65cm. The mattress tray can bewithdrawn, see Photo 2, by opening the sideaccess door, setting both knobs on the front of theCaleo to the vertical “withdraw the baby” position,(for symbol see Photo 3), and pulling on the trayusing the inset handle.

An x-ray tray and (optional) in-bed scales were fit-ted below the mattress.

Mattress tilt: The mattress can be tilted at anyangle up to 13° in the head up or feet up position.This function is electrically powered and is activat-ed from the control panel. On pressing the curvedarrow buttons (see Photo 4) the whole of theincubator capsule tilts (see Photo 5).

VHA: The height of the Caleo can be adjustedelectrically using two pairs of foot-pedals sited oneach side of the base (see Photo 5). The mat-tress height can be varied between 83.5cm and113.5cm above the ground.Photo1: Caleo lid raised and supported

Photo 2: Caleo mattress withdrawn

PropSensor

O2 sensor

Draeger Caleo Description

MHRA evaluation 04020, March, 20043

Control screen: The control and display screenmay be attached at either end of the Caleo. Thelayout on the screen can be seen in Photo 4.

The majority of the panel is taken up with a 9.5cmx 11cm electroluminescent screen which displaysinformation as orange text and lines on a blackbackground. Labelled buttons access additionalfunctions. The in-bed scales, if fitted, are activat-ed by the bottom left button, marked with a scalesicon. The tilt mechanism is activated using thecurved arrow buttons sited either side of an ide-alised picture of the incubator. The alarm silencebutton is marked with a struck out bell symbol.The keypad lock button, marked with a padlocksymbol, is sited below the alarm silence button.

The control screen accesses many informationscreens and level setting screens. Two differenttop level menus may be accessed by the menubutton. The first menu appears when this button ispressed briefly. This menu allows the user toselect kangaroo mode or cleaning mode.

Kangaroo mode allows the baby to be nursedoutside the incubator whilst their temperature con-tinues to be monitored; different alarm conditionsmay be selected to apply during the kangaroosession. Cleaning mode is available if the Caleois equipped with the humidity option. This is aspecial cleaning cycle in which the water heater isboiled dry and then allowed to cool. This shouldonly be activated when the incubator is empty.

The second menu is activated when the menubutton is held in for 4 seconds. This menu, calledthe configuration menu, allows the user to setthe language displayed on the screen, the dateand the time. System settings (temperature units,weighing units, the altitude above sea level whichis important for the accuracy of oxygen sensors),alarm settings, oxygen sensor information andsoftware information are also available.

The Air Skin button allows the user to togglebetween air temperature control mode and skintemperature control mode.

The trend key, showing an icon of a trendedgraph, toggles between the main display screenand a graphical display of a chosen parameter.The parameters air temperature, skin tempera-ture, humidity, oxygen and weight may be chosento be displayed graphically, and the time periodover which they can be displayed is alsoadjustable. By holding the trend button in for 4seconds trend analysis is activated. This screen

Photo 3: Mattress or x-ray tray withdrawalknob - here in x-ray tray withdrawal position.

Alarm silence

Keypad lock

TiltScales Selection andconfirmationbutton

Powerfailure

Menu

Air / skin control buttonTrending

Photo 4: Control and display screen

Photo 5: Caleo tilted, sensor up position

Description Draeger Caleo


displays past information about up to two chosenparameters. Again, the time interval for the chosendisplay is adjustable.

The large round rotary knob/button is multifunc-tional and enables selection of options on themenus and adjustment of environmental values onthe display/control screen. Pressing this buttonconfirms the selection.

Directly below the electroluminescent screen arefour touch buttons referred to as “Soft Keys” in theDraeger user manual. These are not labelled buttheir function is indicated by the display screenarea immediately above them. These activate andaccess the functions shown on the screen. InPhoto 4 the air temperature setting is active, buthumidity and oxygen are not. To select a functionthe appropriate button is pressed, and the rotaryknob is turned to set the required level. Pressingthe rotary knob confirms the level set.

X-ray tray: An x-ray tray 39.5cm x 49.5cm is sitedbelow the mattress. It may be withdrawn by turningthe two knobs on the front of the incubator to the"eye" position (see Photo 3) and pulling on theinset handle. The tray may be withdrawn withoutopening the access door. With the tray withdrawnan x-ray film may be placed on the marked grid offour 17cm squares.

Temperature control: The incubator temperaturecan either be controlled by using air temperaturecontrolled mode (range 20°C to 39°C in 0.1°Cincrements) or baby skin temperature controlledmode (range 34°C to 38°C in 0.1°C increments).The yellow temperature sensor must be attachedto the baby in order to use the baby skin tempera-ture controlled mode.

Humidification: The Draeger Caleo has optionalhumidification. The water is delivered into theheater chamber using a “giving set”, a water tubewith a luerlock. Sterilised water is used in mostclinical situations. The water may be channelledeither from a waterbag or the water reservoirwhich fits at the sensor end of the incubator struc-ture (see Photo 6).

Oxygen: Automatic oxygen concentration controlis also available as an option. When connected toa supply, oxygen is delivered into the incubator’swarm air circulatory system; the range available is21% (normal air level) to 40% (standard range)and 41% to 75% (extended range) in incrementsof 1%.

Alarms: The Caleo has five variations of alarmnote as described in the user manual. Device faultand Power failure alarms cannot be muted. Theother three types of alarm vary in their “tune”. If analarm is not muted or cancelled (or the situationdealt with) then the volume increases through aseries of five volume levels from an initial levelwhich can be set by the user. In addition a visualalarm sited on the top of the sensor unit alerts theuser to the alarm condition.

Water reservoir

Giving set

Luerlock

Photo 6: Humidification reservoir

Clamp

Draeger Caleo User Assessment


USER ASSESSMENTOur user survey covered eight neonatal unitsaround the UK. 98 nurses, one clinical fellow andone Medical Technical Officer (MTO) completedour questionnaire. Six MTOs, who had workedwith the Draeger Caleo, from six of the eight hos-pitals surveyed, were also invited to comment. Alleight hospitals had owned at least two Caleos formore than one year.

Our questionnaire asked users to rate features ofthe Draeger Caleo as unacceptable, poor, satis-factory, good, or excellent and written commentswere invited in a space beside each question. Itincluded general questions on the training theyhad received, how often they had used the Caleoand what they considered to be the advantagesand disadvantages of the Caleo. Users were alsoasked which other incubators they had used, toindicate any unspoken comparisons they mayhave been making. To clarify issues raised by thequestionnaire responses each neonatal unit wasvisited by an evaluator.

User response can be seen at a glance in the fol-lowing 7 bar charts. The key below each chartindicates the rating; from left to right each bar con-sists of : Black for unacceptable, grey for poor,white for satisfactory, light blue for good and darkblue for excellent. Points of particular interest arediscussed especially where users have madecomments about specific features. The numericaldata response from the questionnaire is repro-

duced in the Appendix for interested readers.

The majority of respondents (ie >50%) rated allfeatures as satisfactory or better with four excep-tions, aesthetic appeal (question 8), scales (ques-tions 27 & 28) and the prop (question 57).

Mobility was considered to be satisfactory or goodby 62 users and one user rated it as excellent;however, 37 users rated it as poor or unacceptable(see Figure 1). Those who worked in neonatalunits with small nurseries commented that it wasdifficult to steer and awkward to move betweennurseries without knocking it against the walls anddoors. Typical user comments were: “heavy” and“need two people to manoeuvre”

In two neonatal units visited the Caleos are movedto the Sterile Services Department for cleaning.This journey was made difficult by the awkwardmobility. CEDAR Note: a directional wheelupgrade may improve the steering.

Wheel locks were rated as satisfactory or betterby 86 users but none of these made any com-ments. The 11 users who rated them as poor com-mented that they found them “difficult to pushdown”, and “stiff”. One commented that the wholeincubator “moves when braked on/off - not idealwith ventilator tubing, drips etc”. These Caleos hadbeen in use for over a year and the wheel lockshad not become easier to use with time. CEDARNote: The evaluator also found the wheel-locksstiff. Babies in incubators should not be subjectedto a jolt when the wheel-locks are put on or off.

Figure 1: Response to questions 1 to 8

User Assessment Draeger Caleo


Figure 3: Questions 18 to 30




The Vertical Height Adjustment (VHA) and itsmechanism were thought to be smooth and easyto use. However, one user rated the VHA mecha-nism as unacceptable but this related to theirimpression of the the whole unit tilting and not totheir views on the VHA.

Users thought the storage drawer was good butwas very low down making it awkward to accessthe contents. (see Manufacturer’s Comments).

Fixing ancillary equipment rated as satisfactory orbetter by 47 users, however, 31 users rated it aspoor or unacceptable. One user was unhappy withadditional cost of ancillary equipment and otherusers noted that attaching extra equipment madethe Caleo even more bulky.

Half of the respondents rated the general aesthet-ic appeal as unacceptable or poor. Many consid-ered it big and cumbersome. Whilst technical abil-ity and usability of the Caleo are important it isimpossible to separate these from the aestheticappeal, much of which is subconscious.

The control screen was rated as satisfactory orbetter by 92 users and the visibility and clarity wererated as satisfactory or better by 92 and 95 usersrespectively (Figure 2). The majority of users alsofound it easy to move between options on thescreen. However 23 rated positioning the screenas poor or unacceptable. Some commented that it“got in the way” and “juts out”. A user noted that“controls in a fixed position are more aesthetic”;and one senior nurse said that her unit preferred tohave the controls in a fixed position on the front ofthe incubator.

Air temperature control was used by all of theusers but only a few nurses used the baby skintemperature control, or the baby skin temperaturesensor. CEDAR Note: During the user visits it wasfound that skin temperature sensors were not usedon any type of incubator. Either a separate skintemperature sensor was used, often for historicreasons, or the babies treated in the units did notneed constant temperature monitoring, their tem-perature being taken at regular intervals andrecorded elsewhere.

Most of the nurses used the relative humiditysystem, using either the water reservoir or a waterbag and found it easy to use (see Figure 3).Negative comments received were related to thebuild up of condensation on the walls of the cap-sule and the visibility problems this caused espe-cially if the double canopy was used. One usercommented as an overall disadvantage that “theinner sheet inside the canopy makes visibilityimpossible when using humidity - not able to wipe

between them”. In addition some comments relat-ed to the “giving set” being an unexpected con-sumable cost. CEDAR Note: The water specifiedin the Draeger user manual is not generally avail-able but the nurses usually use sterilised water,which is acceptable to Draeger (Manufacturercorrespondence).

Oxygen setting was considered easy (see Figure3). The oxygen level range maximum was 75% butone user noted that the maximum they hadachieved was 68%, however, usually a lower levelwas required. One user also noted how much oxy-gen was being consumed and considered it waste-ful. CEDAR Note: See Table 4, TechnicalAssessment.

The in-bed scales were generally consideredinaccurate by the 28 nurses who had used them.However, one user thought that they were not inac-curate but were difficult to use accurately with allthe other equipment needed around the baby.CEDAR Note: see Technical Assessment.

The trending screens were used by only 8respondents. One nurse commented that sincethey monitored the baby’s temperature using aseparate thermometer, used at regular intervals,any trending was recorded elsewhere. The fewusers who had used the trending screens ratedthem as satisfactory or better (see Appendixquestions 31 to 33 are not shown on the graphs).

The control panel lock button was used by only37 respondents (Figure 4) and was consideredgood by most users. The nurse who rated it asunacceptable felt the lock should include the tiltmechanism. CEDAR Note: A child visiting theneonatal unit with parents may inadvertently pressbuttons, activating the tilt accidentally is a potentialhazard.

The tilt buttons question elicited comments on thetilt feature as a whole. The novel way in which theCaleo capsule/bassinet tilts rather than just themattress was rated as good by 45 users but pooror unacceptable by 15 users. Some found that thewhole capsule tilt made “it difficult to use with pho-totherapy”. Use of in-house covers to reduce thenoise and light for the babies was difficult when tilt-ed. Positive comments indicated that the nursesthought that the tilt was smooth and that integratedspirit levels were helpful for ensuring the mattresswas horizontal.

The menu button was not used by many nurses.

Following on from the responses to the baby skin-temperature control, few nurses used the skinsensors, but those who did rated them favourably(see Figure 4).



While 55 users rated baby compartment as satis-factory or better, 39 nurses rated it as poor orunacceptable (Figure 5). Some commented that itwas “too wide” or “too big”. Nurses found it espe-cially difficult to assist during procedures requiringone person to hold the baby because they had to“really stretch to reach small babies”.

Visibility through the canopy was considered aparticular problem and was highlighted by severalusers as an overall disadvantage. They comment-ed “light reflection of lid causes problems when sit-ing IV lines”. This was related to the curvature ofthe canopy reflecting light and making it difficult toview the baby. Visibility was made more difficultwhen the double canopy was used at high humidi-ty levels see relative humidity section.

Over 40 users rated access to the baby, as unac-ceptable or poor. They felt that this was “difficult”especially for small babies and in an emergencysituation. The difficulty of access was compoundedby the width of the baby compartment. The handports were liked by most users and weredescribed as “roomy”.

Nurses reported that the portholes were difficult toopen aseptically using their elbows. One userexplained that this was partly due to the “lip” of thelid being directly over the catches making it difficultfor elbow access. The catches also required atwisting motion to unlatch. The springs in the port-holes also appeared to break easily so that even ifthe catches were successfully unlatched theywould still not spring open as intended, again mak-ing it difficult for a user to open them aseptically.

The door catches were considered noisy. Thiswas the case if they were shut without lifting thecatch. CEDAR note: Thick rubber stoppers on theportholes reduce the noise on closing. Some otherincubators’ portholes close without having to lift thecatch.

Access doors on both sides of the incubator wereliked, but, many nurses thought that the doorswere too restricted in height and found it difficult toplace big babies on the mattress through them.

Extra door flaps at the head and foot ends of thebassinet were used by many users who foundthem helpful for assisting during procedures andchanging bedding.

The Caleo roof tilt was liked by the majority ofusers although the prop mechanism was not.Users felt that when the canopy lid was raised atan angle and held in place with the prop it “doesn’tappear very strong/stable”, the lid “wobbles” andthe prop looked “flimsy”. All units reported break-

age of at least one prop. Most users rated thecanopy lid removal as satisfactory or better but itwas considered heavy and difficult to remove; gen-erally requiring two people and space on the wardto put it down. Furthermore the “temperature alarmsounds constantly” when the lid was removed dueto heat loss. The removable lid was considered“not necessary with slide out mattress feature”.

General security was rated by over 80% of theusers as satisfactory or better, see Figure 6.

The mattress was rated as satisfactory or betterby 79 of the users (Figure 6). Comments receivedrelated to the softness, some commented that itwas “lovely and soft”. Comments on its size indi-cated that it was thought to be too big which is inkeeping with other comments on the Caleo. All theunits visited use additional mattresses and bed-ding. Some units used “fleeces” and another usedSpenco TM mattresses.

Mattress tray withdrawal was rated as satisfacto-ry or better by 55 users, however, 18 users rated itas poor and unacceptable. Some commented thatit was “jerky” and “difficult” compared to theDraeger 8000 model. Cedar Note: the withdrawalmechanism may be adjustable, seeManufacturer’s Comments.

Mattress tilt range (±13°) was rated as satisfacto-ry or better by 81 users. A few users consideredthe range of tilt unacceptable and some users didnot like the fact that the whole incubator tilted asthis makes overhead phototherapy difficult.

The tubing ports were liked by most nurses butthe rubber grommets within the tubing ports werethe main reason that 22 users rated this feature aspoor or unacceptable. Comments received indicat-ed that they were thought to be “too soft and flim-sy” and did not grip tubing securely.

Most nurses (38) rated the feeding port as satis-factory or better but 26 nurses rated it as poor orunacceptable (Figure 6). Their comments indicat-ed that they thought it was too high above thepatient because of the size of the canopy.

The humidity system was rated favourably by 68users although there were technical problems (seeTechnical support response at the end of UserAssessment). Some users found that at high tem-perature and humidity settings the Caleo could notachieve the high humidity level set. Of more con-cern was the Rainout (excessive condensationinside the incubator) at high levels of relativehumidity on the double canopy, as already dis-cussed in the canopy section. Excessive conden-sation was also reported to have caused malfunc-



tions of the sensor inside the incubator. Water drip-ping on the floor during high humidity was alsonoted. Cedar Note: Water also dripped on the floorduring Technical Assessment.

In some units they had been told by Draeger rep-resentatives that they did not need the innercanopy and had discarded it. In other units theyhad not received this advice and had continued touse it. CEDAR Note: The inner canopy wall will bewarmer than the outer Caleo canopy wall and isdesigned to reduce the baby’s radiant heat loss.

Setting up the humidity system was consideredsatisfactory or better by 58 users and poor or unac-ceptable by 21 of the users. The “giving sets” wereconsidered an extra expense as they were “singleuse”. Both the water reservoir and the waterbagsystems were used by the respondents. In generalthose who used the waterbag system rated it high-er than those who used the reservoir system. Oneunit noted that “systems errors” occurred more fre-quently if the reservoir was used.

Ease of performing x-rays was rated by 50 nurs-es as satisfactory or better (Figure 6); 15 nursesrated this lower but no comments were received.Very few nurses (6) said that they had used the x-ray tray. A primary reason for not using it was thatradiographers were not satisfied with the quality ofthe x-ray pictures. Bedding and additional mat-tresses produced bubbles and other artifactsdegrading the image. In addition several usersreported that it was difficult to place the x-ray platewithin the drawer accurately; if the image was notacceptable it would have to be repeated. Only verysick babies who could not be safely lifted were x-rayed using the tray. CEDAR Note: In general,dose must be increased to maintain the picturequality if the x-ray tray is used. Any additionalpatient dose requires strict justification. This prob-lem is not specific to the Caleo, see Evaluation02090, all incubator x-ray trays must be used onlyafter careful consideration.

Auditory and visual alarms (Figure 7) were gen-erally well-liked, and several users listed the visualalarm as an overall advantage. However, someusers commented that the auditory alarms wereunnecessarily urgent and loud. CEDAR Note:Initial alarm volume was adjustable.

Most users rated ease of patient care, ease ofnursing access, ease of performing medicalexaminations and operator comfort as satisfac-tory or better but one quarter to one third of usersrated these as poor or unacceptable (see Figure7). Some users found it difficult to access the babybecause the greater width of the Caleo often

required an uncomfortable stretch across the mat-tress, raising manual handling problems.

Kangaroo mode was used by only 9 nurses, themajority of whom liked it. No comments werereceived. (see Manufacturer’s Comments).

Only 30 users, located in 3 neonatal units, hadcleaned the Caleo. In three other units it wascleaned by healthcare assistants and in two unitsby the Sterile Services Department. The majority ofthe nurses rated cleaning as satisfactory or betterbut one third did not. Nurses who had cleaned theCaleo commented that they found it “difficult toclean” and “parts are heavy and awkward toremove”. Other users said there were “too manyloose parts” and “a large space is needed to put allthe parts on during cleaning”.

Air filter: The questionnaire did not cover thisaspect of the Caleo but following queries raisedduring the first user visit each subsequent uservisit included verbal questions to both the nursingand the technical staff as to the policy of air filterreplacement. Changing the air filter requires tiltingthe incubator and then crouching down and care-fully removing the filter and holder. The nursesfound this difficult and in some cases they had notbeen made aware of it during their user training.The user manual states that the air filter should bereplaced every two months Clinical Engineeringstaff at most of the hospitals changed the filter, butmany of the users visited acknowledged that it wasa nursing job. Changing the filter is reported to bemore difficult with the storage drawer in placeCEDAR Note: The evaluator also found it difficultand awkward to change the air filter.

The overall response of the users was expressedin the free text area at the end of the questionnaire.A few users in 2 (newly built and spacious) neona-tal units liked the Caleo but the overall responsefrom these newer units and the other 6 was one ofdissatisfaction and disappointment. Many userssaid that they couldn't understand why Draegerhad thought it necessary to change a popular andeasy to use incubator. CEDAR Note: Some issuescan be addressed by further user training. seeManufacturer's Comments.

Some users commented that Draeger had beenhelpful in trying to address the problems they hadexperienced with the Caleo. CEDAR Note:Draeger are upgrading several aspects of theCaleo (see Technical Assessment andManufacturer's Comments).



Technical support responseNHS Medical Technical Officers (MTOs) wereavailable for comment at six of the eight sites vis-ited. Most sites had purchased a Draeger servicecontract and the Clinical Engineering depart-ment/EBME provided first line maintenance andrepair. The other two sites visited were directlyunder a Draeger service contract.

The Draeger technical training course wasreported to be helpful and comprehensive and thesupport received from Draeger was good.Physical access to the Caleo for servicing wasmore difficult than the Draeger 8000 incubator, butthe servicing menu was better.

All of the MTOs reported problems with plasticparts of the Caleo breaking. One or more prophad broken in all units visited and in one unit clipsfor holding the inner roof canopy had also broken.The canopy of the Caleo was considered fragileand many nurses agreed with this view.

The relative humidity system was reported tomalfunction if a small ‘o’ ring became dislodgedthereby not cutting off the water supply once theinner boiler had reached capacity. In addition ifthe hard water connection pipe was not replacedproperly water could not then get through.

Problems were noted with the oxygen sensors.Once calibrated they are due to be recalibratedone year and 10 days later and the date for recal-ibration is held in the oxygen sensor informationscreen. A delay of just one day is recognised bythe Caleo software and an “oxygen sensor X inop-erable” error is produced. This was deemed dan-gerous to a patient needing oxygen therapy sincethe Caleo would have to be taken out of servicewhile the oxygen sensor was calibrated. CEDARNote: Shutting down the out of calibration oxygensensors seems an excessive precaution. No indi-cation of impending shut down is given.

One MTO noted that “It [Caleo] is the most rapidwarm up and best temperature control incubator Ihave used.”

One MTO discovered that the heater will cut outif the skin sensor develops a fault while the Caleois operating in air mode. The control panel indi-cates a sensor fault but does not warn that theheater has switched off so users may be unawarethat the baby is cooling down. Nurses would notexpect that the heater will cut out if a temperaturesensor, which is not used to control temperaturedevelops a fault. CEDAR Note: The heater cut-ting out without prompting a suitable alarm canseriously endanger a very pre-term baby.

The Caleo was observed to cool and then rewarmslowly after a mains failure. The temperaturedropped over a period of approximately 10 min-utes and then took over an hour to regain the settemperature. Nurses are trained to observe thebabies at regular intervals but during quiet restperiods this may not be as frequent as every 30minutes. In addition the alarm is usually set to trig-ger if the temperature drops by 1.5°C below theset temperature. For details testing this observa-tion see the Technical Assessment.

Draeger Caleo Technical Assessment


TECHNICAL ASSESSMENTThe performance of the Draeger Caleo incubatorwas assessed using tests derived from theEuropean Standard for Baby Incubators BS EN60601-2-19 (1997). The Caleo tested arriveddirectly from Germany in December 2002 withhumidity, oxygen and scales options, a drawer, apole attachment and software upgrade 2.01.

To simulate the performance under clinical condi-tions the Caleo was heated to three temperaturesfrom an ambient temperature start. An air controltemperature of 34°C and relative humidity (RH)level of 50% were chosen to simulate conditionsfor a medium pre-term baby (~34 weeks gesta-tion). An air control temperature of 36°C and RH of70% for a more pre-term baby and 38°C, maxi-mum RH level, in this case 99%, for an extremelypremature baby (~24 weeks gestation) were used.

The temperature stability of the Caleo was testedfor at least one hour after it had warmed up.Performance of the incubator was then tested byopening four hand ports for 5 minutes, one accessdoor for 5 minutes and the lid section for 5 min-utes. Temperature uniformity across the mattresswas assessed when the mattress was horizontal,tilted to one extreme and then the other.Temperature and relative humidity response wasmonitored throughout all of the performance tests.

Where possible the temperature and relativehumidity tests were carried out using the singleand double canopy to distinguish any difference inperformance.

The automatic oxygen level control function wastested for accuracy and oxygen consumption.Measurement accuracy of the scales was testedwith weights traceable to national standards.

Temperature responseWarm up time: The Caleo warmed up smoothlywith minimal overshoot (see Figure 8), however,when using the single canopy it could not attainthe set temperature of 34°C. After one hour it hadwarmed to 33.7°C while the Caleo display indicat-ed that the air temperature was 34°C. The differ-ence between the measured temperature and theset temperature are within the limits set by theStandard. With a double canopy the Caleowarmed to 34°C in 18 minutes. At higher temper-ature settings the Caleo took longer to warm up.In three warm up tests it did not achieve the settemperature but was within 0.3°C one hour afterbeing switched on. The double canopy improvedthe warm up performance see Figure 8 and Table1. The improvement is evident from thedecreased time to achieve the set temperatureand the slightly higher temperature reached afterone hour of warming. The temperature controlsystem is highly damped and tightly controlled,perhaps a little too highly damped where theCaleo has not achieved the set temperature. Afurther example of this can be seen in the nextsection where we consider temperature stability.

The Caleo was also tested to the manufacturingStandard warm up protocol. With a double canopyit took 15 minutes to warm to 11°C above ambient(room) temperature (21.3°C), while set to 12°C

20

22

24

26

28

30

32

34

36

0 10 20 30 40 50 60

Figure 8: Comparison of warm up to 34°C 50%RH for: Caleo with a single canopy and double canopy.

Single Canopy

Double Canopy

Time (Minutes)

Technical Assessment Draeger Caleo


above room temperature. With a single canopythe warm up test took only 12 minutes. Both ofthese are good results since the user manualstates that the Caleo should warm up from 20°Cto 31°C in 20 minutes.

Temperature Stability: The neonate needs a sta-ble thermal environment in which to thrive. Tryingto maintain their temperature reduces the energythey have available for growth and maturity.

Temperature stability, the variation above andbelow the average temperature over an hour, wasvery good. In all tests the temperature variationwas of the order of ±0.1°C and well within the±0.5°C limit set by the Standard.

The average incubator temperature at the cen-tre of the mattress is shown in Table 2 for eachperformance test. Overall the general tempera-ture response was good although the Caleo tend-ed to be slightly cooler than the set or indicatedtemperatures. None of the measured tempera-tures differ from the Caleo set air temperature bymore than 0.6°C. This is well within the ±1.5°Climit set by the Standard.

The Caleo was positioned at maximum tilt ineach direction for each of the three temperatureregimes. The variation of temperature across themattress was well within the Standard’s limit of1°C for all tilts and temperatures.The maximum

variation seen during any tilt test was 0.5°C. Thisis a very good result.

Opening the hand ports, access doors andcanopy during care of a patient in the incubator,reduces the temperature inside. The effect of“challenging” the stable environment inside theCaleo when set to 38°C, 99% RH with a doublecanopy is shown in Table 3. As can be seen fromFigure 9 the temperature and humidity recoverquickly. The results here show a good temperaturecontrol in both cases.

The Caleo air temperature display was recordedduring these “access” tests and an overshoot sim-ilar to that measured and shown in Table 3 wasobserved.

Setting Single canopy Double canopy

Standard warm up test: time to11°C above ambient temperature

Time = 12 minutesAmbient = 23.8°C

Time = 15 minutesAmbient = 21.3°C

34 °C 50% RH Temperature = 33.7°C after 1 hour 18 mins

36 °C 70% RH Temperature = 35.7°C after 1 hour Temperature = 35.8°C after 1 hour

38 °C 99% RH 51 mins 41 mins

Actual temperature measured °C

Single canopy Double canopy

34 33.6 34.1

36 35.7 35.9

38 37.9 37.9

Table 1: Warm up times

Table 2: Average incubator temperature at thecentre of the mattress over 1 hour.

Table 3: Temperature “challenge” results

Performance test

38°C 99% RH usingdouble canopy

Four hand ports opened for 5 minutes

Temperature drop 2.8°C

Recovery time 3 mins

Overshoot 0.5°C

One access door opened for 5 minutes

Temperature drop 5°C

Recovery time 5 mins

Overshoot 0.4°C

Canopy lid lifted and propped open for 5 mins

Temperature drop 8.9°C

Recovery time 6.5 mins

Overshoot 0.6°C



Temperature response after a mains failure: Amains failure was simulated by briefly switching offthe power to the Caleo at the socket. The Caleotemperature prior to the mains failure was set to37°C with an actual average temperature of36.5°C. After the power had been restored theCaleo continued to display the set temperature(37°C) but the temperature in the Caleo droppedsmoothly over approximately 10 minutes to35.4°C, the Caleo measured air temperaturedropped to 36.1°C, and then took 90 minutes toregain the set temperature. Figure 10 shows acomparison between the temperature response onswitching the Caleo off at the mains for 5 secondsand the temperature response on switching it off atthe on/off switch and leaving it off. Cedar Note:The only indication that the mains had been

switched off or that there had been a very shortmains failure would be the clinical observation ofgradual cooling and rewarming of the Caleo. seeManufacturer’s Comments.

Relative humidity: The accuracy of the relativehumidity system was good at set values over 40%and below 80%, being within 5% when measuredindependently.

The maximum set level was 99% and at no pointwas this achieved, either as measured indepen-dently or as displayed on the Caleo control screen.The maximum level displayed during all technicaltesting was 96%.

Rainout was a particular problem at high temper-ature settings and high humidity levels. Duringtests involving high humidity it was found thatwater ran off the Caleo onto the floor, especiallywhen it was in tilted positions.

The Caleo Auto Humidity facility was used bysome of the nurses. This feature, when activated,automatically sets an appropriate level of relativehumidity related to the temperature setting. Agraph of the relation between the two can be foundin the user manual. This feature was checked todemonstrate that it functioned correctly (seeFigure 11). A linear relationship between the settemperature and the humidity level calculated isshown on the graph.

Problems with low water pressure occurred whenusing the Caleo water reservoir with the incubatorin a tilted position. When the reservoir water level

Figure 9: The effect of opening door and lid on the temperature and relative humidity. Using doublecanopy, 38°C 99% RH setting

20

25

30

35

40

45

100 120 140 160 180 200 220 240 260 280 300 3200

10

20

30

40

50

60

70

80

90

100Relative Humidity

Temperature

4 ports openfor 5 minutes

One access dooropen for 5 minutes

Canopy lid openfor 5 minutes

RH = 35%RH = 30%

30

31

32

33

34

35

36

37

0 10 20 30 40 50 60

Figure 10: Temperature response on switchingoff mains for 5s and switching off

Switch off at mains for 5 seconds

Switch off Caleo

Time (minutes)

Time (Minutes)

Technical Assessment Draeger Caleo


was just below full capacity, and the Caleo fullytilted in the sensor “up” position the water couldnot reach the humidity system boiler chamberbeneath the mattress. An air-lock formed in thetubing and the low water alarm sounded. Thisproblem was not encountered with the water-bagsystem, since it was suspended above the Caleoand the water pressure was sufficient at all times.

From a practical point of view the humidity “givingset” could be difficult to connect without air bub-bles getting into the tubing. The giving set wasattached to the bottom of the water reservoir orthe water-bag and the clamp opened allowing thewater to run through the tubing. When the tubehad been bled and the line clamp closed the luerlock was attached to the rigid water connectiontube. The line clamp was then reopened.

During cleaning the rigid water connection pipeshould be removed Cedar Note: Initially the eval-uator found removal of the pipe difficult but it iseasy when the technique has been demonstrated.

Oxygen: The Caleo has an oxygen control optionand the ability of the Caleo to achieve and main-tain a range of oxygen settings was tested seeTable 4. The Caleo manual states that when oxy-gen is supplied to the Caleo the concentrationwithin the canopy should rise from ambient airlevel of 21% to a set level of 60% in less than 10minutes. In our tests the Caleo was able toachieve 60% in less than 10 minutes.

The ability to achieve and maintain oxygen levelsin the range 25% to 75% (maximum) was moni-tored. With the Caleo connected to pipeline oxy-gen, the Caleo was set to 25% and allowed 10minutes to stabilise, the Caleo oxygen display andthe independent oxygen analyser display werethen recorded and are shown in Table 4. In order

30

40

50

60

70

80

90

30 31 32 33 34 35 36 37 38 39

Figure 11: Auto Relative humidity function, as shown by the Caleo display and as measured by inde-pendent instruments

Actual relative humidity

Caleo displayed relative humidity

25% 25.0% 25.3% 3.5

30% 30.0% 30.4% 6.9

40% 40.0% 40.9% 13.5

50% 50.0% 51.2% 19.9

60% 60.0% 60.5% 27.6

70% 67.5% 69.1% 34.0

75%Caleo unable to achieve

Table 4: Oxygen response test results

Temperature (°C)



to estimate oxygen consumption, a weighed cylin-der then replaced the pipeline oxygen and wasused for five minutes to supply the oxygen at thelevel selected. The cylinder was then removed andthe pipeline replaced. After re-weighing the cylin-der the oxygen used during the five minutes wasestimated and the oxygen consumption in litres perminute (L.min-1) calculated, see Table 4.

For the range 25% to 50% there is good agree-ment between the oxygen level set, the level dis-played by the Caleo and the level displayed by theindependent oxygen analyser (see Table 4).

The Caleo could not achieve 70% but attained avalue of 67.5%.

At the 40% setting the Caleo consumed 13.5 litresper minute. Oxygen has a specific cost which oftenmay not be passed on to users, but it is importantto be aware of how much is being used. This isespecially important in situations where much oxy-gen is lost through leaking out of the incubator.Some clinical protocols require the incubator cap-sule to be an oxygen rich atmosphere and otherssupply oxygen directly to the patient.

Additional tests on the oxygen sensors were car-ried out following the user assessment. In particu-lar notice is drawn to the test of the oxygen sensorafter the re-calibration date, (see end of UserAssessment).

Noise levels: measurements were taken of thenoise levels inside Caleo using a single canopyduring normal running and several other conditionsas shown in Table 5. The overall noise level of theCaleo was low. However, users had complained ofnoisy ports and doors. The noise level on closingthe port is shown to be 80dB(A) inside the incuba-tor. CEDAR Note: Thick rubber stoppers designed

to reduce the noise when the ports are closed arein place on the Caleo. However, if the catch is lift-ed the door will close even more quietly.

Scales: the accuracy of the optional in-bed scaleswere tested with weights of 1kg, 2kg, 3kg and 4kgcalibrated against national standards. Three mea-surements were made with each weight and theCaleo control screen displayed weights to within5g, of the calibrated weight. The in-bed scalesare, therefore, considered to be accurate as theyare within accepted clinical limits. Many userscommented that they found them inaccurate, seeUser Assessment, but this is considered to bebecause the nurses did not find them easy to use.

Stripping down & cleaning mode: The Caleowas dismantled to fan level. The parts were largeand heavy and considerable space was neededto temporarily store them. Ideally two people areneeded to perform this task.

Cleaning mode for the humidity system’s internalreservoir and boiler was activated following theinstructions on the screen. This worked well with-in the timescale indicated.

Manuals: The Instructions for Use manual,referred to in this report as the user manual, anda technical manual were supplied with the Caleo.The user manual was thought to be clear andcomprehensive with good annotated illustrations.The latest version included the upgraded featuresavailable on the Caleo, such as the directionalwheel lock.

The technical manual was not comprehensiveand there were no instructions on how to calibratethe oxygen sensors, relative humidity system orscales. The technical manual also caused someconfusion. It states that the display screen adaptsto lighting conditions, but no evidence could befound of this. The screen was viewed in the labo-ratory under normal lighting conditions and againwith the overhead fluorescent lights off. No differ-ence in the screen luminosity was discerned.

The location of the air filter in the operator’s man-ual and the technical manual differ. The operator’smanual shows it to be at the sensor end of theincubator, as was found to be the case on themodels seen. The technical manual diagram isambiguous and could represent either end of theCaleo.

Table 5: Noise levels

Situation testNoise leveldB(A) +/-1dB(A)

Background noise level32

On mattress during warm up 50

Alarm lowest = 65highest = 78

Opening hand port58

Closing hand port80


MANUFACTURER’S COMMENTS

Draeger Medical thank CEDAR for preparing this report which identifies topics which have already been addressed andremedied in the New Caleo to be launched in April 2004 about the time this report is published.

Since Caleo was launched in 2001, over 300 improvements have been made. Many of the changes should have beenincorporated into the original design. Draeger Medical has ensured that every such upgrade has been provided to cus-tomers who bought the original Caleo. Draeger Medical has apologised for the time taken to deliver these upgrades.

The need for some changes only becomes evident after customers have used the machine on their own units with realbabies inside. The success of our Incubator 8000 series was built on listening to our customers and evolving themachine over time.

The New Caleo eradicates nearly all of the faults highlighted in this report and it contains modifications that have beenmade in response to the needs of our customers. These include: Redesigned hood with external double wall for bettervisibility even in rainout conditions; Redesigned Air Filter Box for easy access; New silent door closure mechanism;Tubing clamps incorporated into tubing ports; Modified humidifier unit; Modified column elements and hood prop; Easierto use scales. The majority of these upgrades is retrofittable.

These and other unlisted modifications will also improve what is already an excellent technical assessment by CEDAR.

Draeger Medical recognise that some resource needs to be put into Education and Training for Caleo users since manyof the valuable features of Caleo were clearly underused or misunderstood by those users interviewed by CEDAR.

Draeger Medical are delighted to receive input from technical staff. The New Caleo has redesigned components thatgive the hood a feeling of strength. These components are, in all cases compatible with our original machines and somehave already been replaced at the expense of Draeger Medical.

Calibration of Oxygen cells at six monthly intervals will remove the perceived problem of loss of oxygen function in Caleo.Draeger Medical believes that the need to calibrate oxygen cells only at service is a wonderful benefit to the nurse userand to the neonate.

Draeger Medical is enjoying the challenge of working with the engineer who has reported heater problems as a result ofusing faulty skin sensors or transient mains shut down. Since accurate measurement and monitoring of core tempera-ture is essential to good patient management, Draeger Medical, will ensure that adequate training is given to users withthis localised problem.

In conclusion, if any Draeger incubator user has a problem they need to discuss, our Customer Services and SpecialistNeonatal Team are available to give users help and advice. Please call us on 01442 213542.

PRODUCT DATA

Manufacturer’s Comments & Data Draeger Caleo

Physical Data

Size (H x W x D)

Weight

Bed size

Tilt

Access door size

Screen size

Wheelbase height

Castors

X-Ray tray width

Heater Power

Air heater

Water heater

124cm to 155cm (top of canopy min & max vha) x 64cm x 170cm

230 kg (max) 130 kg (basic equipment)

48.5cm x 65cm

13° continuously adjustable

Height = 23cm Width = 66cm (long side of incubator)

Control screen = 26cm x 22.5cm Electroluminescent screen = 11.5cm x 9cm

12.3cm

Caleo sampled had 3 locking and one directional castor.

39.5cm x 49.5cm marked in 4 17cm squares

500W

140W

Draeger Caleo Manufacturer’s Data


Manufacturer Drager Medical, Lubeck, Germany

Country of Origin Germany

Prices (ex VAT) Basic Caleo with :

Front & rear doors, 6 large hand ports, detachable hood,Electronic bed tilt, large tubing ports, integrated x-ray tray, integrat-ed 4 socket mains box, large EL display, central alarm light, vari-able height, storage drawer, skin servo, core & peripheral temper-ature measurement, core and peripheral probe and hydro pads.

£ 9,947

Caleo as above plus servo humidity option. £10,947

Caleo as above plus oxygen and humidity options £12,947

Caleo as above plus oxygen, humidity and scales options £14,447

Skin probes (white or yellow) Pack of 5Thermopads for skin probes (pack of 50)Water container (humidifier)Nozzle for water containerGiving set (box of 20)Water connection pipeCaleo fresh air filter (pack of 20)Oxy trace incubator cellsTubing grommets (large)Tubing portFeeding Grommet (hood)Caleo softbedDouble wallDrawerPole 600mm 38mm diameter (others available)ShelfCompact railInfusion supportSwivel shelf

£95.20£54.90£94.00£5.70£48.50£90.40£29.10£110.20£19.00£11.20£8.50£160.00£205.40£262.60£87.10£243.10£31.92£81.58£157.30

Supplier Draeger Medical Ltd, The Willows, Mark Road, Hemel Hempstead,Hertfordshire, HP2 7BWTel: 01442 213 542 Fax: 01442 240 327 Web : www.draeger.co.uk

Guarantee 1 year

Servicing Comprehensive Contract

Includes routine visits & service checks, calibration and part replacement inaccordance with manufacturer’s recommendations. All parts (excluding consum-ables) and unscheduled engineer visits.

Standard Contract

Includes routine visits & service checks, calibration and part replacement inaccordance with manufacturer’s recommendations. Parts are chargeable at listprice. Unscheduled engineer visits are charged at the following rate:

Labour on-site/travel time £65.00

Mileage £0.70 per mile

£1,284

£634

PRODUCT SUPPORT

Procurement Issues Draeger Caleo

MHRA evaluation 04020, April, 2004 20

CERTIFICATION, STANDARDS ANDPROCUREMENT ISSUESMedical devices placed on the market in theEuropean Union are required to comply with therelevant European Union Medical DevicesDirective. Manufacturers must display the CE markon the device as a declaration that it meets theappropriate provisions of the relevant legislationincluding those related to safety and whererequired has been assessed in accordance withthese.

The Draeger Caleo carries the CE mark in respectof the Medical Devices Directive(MDD). Draegersubmitted a certificate confirming compliance withthe European Council Directive 93/42/EEC, statingthat the Caleo is in compliance with the essentialrequirements of Annex I of the Directive and thatan examination of the quality management systemhas been carried out following Annex II of thedirective. The Notified Body was TUV, Germany(0123), and device classification is IIb. Draegeralso submitted a Certificate of Compliance from(Canadian Standards Authority) CSA stating thatthe Caleo had been evaluated against CSA andANSI/UL Standards for use in Canada and theUnited States. This certificate stated that the Caleohas been certified to 601-1 and 601-2-19 and is aClass 1 device with Type BF applied part.

Compliance with Safety Standards: If a devicecomplies with the relevant harmonised internation-al standard this will be accepted as evidence thatthe device meets the Essential Requirements ofthe MDD.

Controls Assurance Standard: Trust Boardsmust take full responsibility for ensuring there aresafe systems in place to minimise risks associatedwith the acquisition and use of medical devices(www.casu.org.uk)

Procurement Issues: Manufacturer’s may contin-ue to modify a product after this report is pub-lished. Please note the version you buy may differfrom the one evaluated. You are encouraged tocontact Draeger for details on the latest productinformation and prices.

Purchasing Agreement: It is intended that thisreport should assist purchasers in carrying out arigorous specification and assessment process.Draeger should be contacted for the latest productinformation and prices. Product demonstrationsand trials may also be arranged prior to purchas-ing. Thought should be given to the lifetime cost ofthe incubator including accessories, consumablesand maintenance.

Training: user knowledge and skills have majorimplications for safety. Procurement of a new med-ical device should include a resource allocation foruser training and also any technical training for theClinical Engineering/EBME technical staff shouldthey be required to maintain it.

Draeger Caleo Appendix


Table A1: User assessment data from questionnaire. The number of users sharing the same opinion abouta feature is recorded, e.g. 17 users thought general mobility was good. The most common response ismarked in Bold. For some features only a few users scored their opinion on their questionnaire.

Question

PART 1 General

1 What is your opinion of the general mobility of this device? 5 32 45 17 1

2 the wheel-locks? 11 52 32 2

3 the stability of the device? 2 12 46 31 3

4 the vertical height adjustment? 30 48 19

5 the height adjustment mechanism? 1 29 52 15

6 the cupboard/drawer space of the unit - if applicable? Device upgraded userresponse out of date

7 the fixing of ancillary equipment to this device? 12 19 37 10

8 What do you think of the aesthetic appeal of the unit? 12 35 31 15 1

PART 2 Control and Display screen

9 Please give your opinion of the control and display screen. 1 6 41 44 7

10 What is your opinion of the ease of positioning the screen? 6 17 37 37 311 Do you find it easy to move between options on the control screen? Yes = 97

12 What is your opinion of the air temperature control? 2 2 40 47 4

13 Do you find it easy to use and set the required temperature? Yes = 97

14 What is your opinion of the skin temperature control? 3 33 11 1

15 Do you find it easy to use and set the required temperature? Yes = 71

16 What is your opinion of the visibility of the temperature displays? 5 45 43 4

17 How clear do you find the temperature displays? 4 48 41 6

18 Do you use the relative humidity option? Yes = 80

19 What is your opinion of the ease of use of the humidity control? 2 4 40 35 4

20 Which type of humidity control have you used? Auto = 8, Manual = 57, Auto & Manual = 15

21 Do you find it easy to use and set the required level of humidity? Yes = 77

22 Do you use the oxygen control? Yes = 90

23 What is your opinion of the oxygen control? 9 3 39 35 5

24 What is your opinion of the range of settings on the oxygen control[21% to 75%]?

3 4 41 38 4

25 Do you find it easy to use and set the required level of oxygen? Yes = 85

26 Do you use the in-bed scales? Yes=28

27 What is your opinion of the scales instructions? 6 16 14 6 1

28 What is your opinion of the scales option? 7 15 9 8 3

29 Do you find the scales easy to operate and use from the controlscreen? Yes = 17

Appendix Draeger Caleo


Question

30 Trending is also available from the control screen: have you used thisfeature? Yes = 8

31 If “Yes” which functions have you trended? Air Yes = 5Skin Temp Yes = 4

Humidity Yes= 3

Weight Yes = 0

Trend analysis Yes= 1

32 What is your opinion of the trending screens? 7 4

33 What is your opinion of the trending analysis screens? 4 2 1

34 The control screen has a “lock” button to prevent inadvertent settingchanges: do you use this feature? Yes = 37

35 What is your opinion of the Lock button? 1 3 16 29 536 The control panel has two buttons for tilting the bassinet. Please indi-

cate your opinion of this feature. 5 8 22 45 9

37 The Menu button accesses two different screens depending on howlong it is pressed for. When pressed briefly the screen shows addition-al options of kangaroo mode and cleaning mode. Do you use thismenu?

Yes = 28

38 If you use this menu what is your opinion of the options? 1 18 9 139 On holding the Menu button for longer a configuration screen is

entered, from here you can set the alarm limits, time, date etc. Haveyou used this menu?

Yes = 15

40 If you have used the configuration menu what is your opinion of thisfeature? 6 8

41 Two temperature sensors are available: yellow for core temperatureand baby temperature control and white for peripheral temperature.Which do you use?

Yellow = 17White = 3Both = 8

42 What is your opinion of this facility of two temperature sensors? 1 12 12 243 What is your opinion of the skin sensors’ size and shape? 15 16 144 What do you think of the length of the lead? 12 2045 How easy do you find it to fix the sensor to the patient? 2 14 15 146 What is your opinion of the patient lead connections to the socket on

the Caleo? 14 15 1

PART 3 Baby compartment/Bassinet

47 Please give your opinion of the baby compartment? 10 29 34 18 348 the ease of access to the baby when in the incubator? 13 32 30 17 4

Draeger Caleo Appendix


Question

49 Please give your opinion of the hand ports. 5 18 50 22 350 the hand port catches 10 32 41 14 151 the access doors. 7 18 48 20 4

52 What is your opinion of the access doors’ catches? 6 27 50 11 1

53 Do you ever open more than one access door (flap) at a time (fouraccess doors are available - two long ones and two short ones)? Yes = 64

54 If you do, what is your opinion of this feature? 2 3 31 30 2

55 What is your opinion of the security of the access panels? 11 57 20 1

56 The canopy roof/lid can be raised and held in place at an angle overthe bassinet. What is your opinion of this feature? 10 27 22 16 2

57 What is your opinion of the “prop” to hold the canopy in place? 18 28 26 3 2

58 Do you ever lift the canopy roof/lid off the incubator for improvedaccess to the baby? Yes = 51

59 What is your opinion of this feature? 4 12 24 24 460 What is your opinion of the general security of the baby in this incuba-

tor? 7 52 31 1

61 Please indicate your opinion of the mattress. 3 11 49 26 462 What is your opinion of the mattress withdrawal mechanism? 4 14 32 23

63 What is your opinion of the range of mattress tilt? 4 2 42 35 464 The caleo has 10 tubing ports: what is your opinion of these? 10 12 36 28 365 The Caleo has one feeding port in the canopy roof: what is your opin-

ion of this port? 10 16 25 12 1

PART 4 Relative Humidity

66 If you have the relative humidity option, what is your opinion of this fea-ture? 8 39 27 2

67 What is your opinion of the auto humidity setting? (Range 30 to 75%) 2 34 19 168 What is your opinion of the range of relative humidity values (30% to

99%) in manual mode? 2 46 29 5

69 What is your opinion of the ease of setting up the water system for thehumidity option? 3 18 37 19 2

70 Which system do you use, the built in reservoir or a water-bag? Water bag = 44Reservoir = 30Both = 9

71 What is your opinion of the system you use? 3 10 32 24 2PART 5 X-rays

72 What is your opinion of the ease of performing x-rays? 3 12 33 1773 Do you (or the radiographers) use the x-ray tray? Yes = 674 If NOT please explain why? see User Assessment

Appendix Draeger Caleo


Question

PART 6 Alarm systems

75 How do you find the auditory warnings? 2 6 43 36 5

76 How do you find the visual warnings? 1 3 47 35 5

77 How clearly do you understand the alarm captions? 4 48 33 2

78 How visible is the alarm caption? 4 47 34 1

PART 7 Nursing and Medical Procedures

79 How easy do you find it to handle the infant and provide general patientcare? 6 32 42 15 3

80 How easy do you find it to feed the infant? 1 22 54 19 2

81 What is your opinion of the ease of access to the infant for nursing pro-cedures? 8 32 40 13 3

82 How easy is it to perform a medical examination while the infant is inthe unit? 6 19 35 14 2

83 What is your opinion of the operator comfort when you are providingnursing and general care using this device? 9 17 42 16 2

84 The Caleo kangaroo mode, where the parents can hold the baby andthe baby’s temperature is still monitored is available from the menubutton. Have you used Kangaroo mode?

Yes = 9

85 What is your opinion of this feature? 1 1 12 3 1

86 Please indicate your experience of cleaning and disinfecting the Caleo.3 8 15 4

87 Have you used cleaning mode for the humidity system? Yes = 20

88 If you have, what is your opinion of this feature? 1 11 9

PART 8 Training and Use of the Device

89 Did you receive training from the manufacturer/supplier/sales repre-sentative? Yes = 66

90 What was your opinion of that training? 5 38 23 1

91 Have you read the user manual? Yes = 56

92 What is your opinion of the user manual? 3 35 16

93 Did you receive training from your colleagues in your hospital?Yes = 61

About MHRA evaluation reports

HOW TO OBTAIN MHRA evaluation REPORTSMHRA evaluation reports are free of charge to NHS Trusts and Clinics, contact

or go to http://nww.medical-devices.nhs.uk

In England In Scotland In Wales In Northern IrelandMHRABusiness ServicesHannibal HouseElephant & CastleLondonSE1 6TQTel: 020 7972 8181

Mr H WaughHealth Planning & Quality DivisionScottish ExecutiveHealth DepartmentSt.Andrew’s HouseEdinburgh, EH1 3DGTel: 0131 244 6913

Ms L Welsby National Assembly for WalesHIMTE 3Cathays ParkCardiffCF10 3NQTel: 029 2082 3373

Mr Brian Godfrey Health EstatesStoney RoadDundonaldBelfastBT16 1USTel: 028 9052 3714

OTHER RECENT MHRA REPORTS ON SIMILAR NEONATAL DEVICES02090 Ohmeda Giraffe OmniBed July 2002

01044 Fisher and Paykel CosyCot, Infant Radiant Warmer Sept 2001

01043 Hill-Rom Resuscitaire, infant radiant warmer Sept 2001

These can be downloaded in colour from nww.medical-devices.nhs.uk or from nww.cedar.wales.nhs.uk


MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)The Medical Devices Agency has merged with the Medicines Control Agency to form the Medicines andHealthcare products Regulatory Agency. www.mhra.gov.uk

ACKNOWLEDGMENTSThis report was prepared by Dr S D P Wentworth, Dr D C Crawford and Mr S D Edwards of CEDAR, MedicalPhysics and Clinical Engineering Directorate, Cardiff and Vale NHS Trust, under contract to the MHRA

Enquiries to

l Dr Stephanie Wentworth at CEDAR, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJemail: [email protected] Tel: 029 2068 2120 Fax: 029 2075 0239INTERNET : www.cedar.wales.nhs.uk

l Mr Martin Glasspool, Programme Manager, MHRA, Hannibal House, Elephant & Castle, London,SE1 6TQ. email: [email protected] Tel 020 7972 8156 INTERNET : www.mhra.gov.uk

We would like to thank nursing and technical staff in the neonatal units at the following hospitals: SingletonHospital, Swansea; Royal Shrewsbury Hospital; Rotherham General Hospital; Harrogate General Hospital;Southmead General Hospital, Bristol; Royal United Hospital, Bath; Norfolk and Norwich Hospital andUniversity Hospital of Wales, Cardiff for their help with the user assessment. We would also like to thank MrTony Wilkes for his help with the oxygen measurements and Mrs Sue Hancock for her administrative helpprior to taking up another position in the NHS.

Finally we would like to thank Draeger Medical for loaning this device for evaluation free of charge.

WHAT YOU CAN EXPECT FROM MHRA EVALUATION REPORTS - DISCLAIMERThe Device Evaluation Service (DES) aims to provide independent and objective evaluations of medicaldevices available on the UK market. Specialist centres, mainly in the NHS, do evaluations under long termcontract to, and in accordance with, protocols approved by the MHRA. The evaluations are usually of a unitsupplied by a manufacturer. We would expect this unit to be representative of the product on the market, butcannot guarantee this. Prospective purchasers should satisfy themselves with respect to any modificationsthat might be made to the product type after MHRA’s evaluation. The reports are intended to supplement,not replace, information already available to prospective purchasers.

© CROWN COPYRIGHT 2003Apart from any fair dealing for the purpose of research or private study, or criticism or review, as permittedunder the Copyright, Designs & Patents Act, 1988, this publication may only be reproduced, stored or trans-mitted in any form or by any means with the prior permission, in writing, of the Controller of Her Majesty’sStationery Office (HMSO). Enquiries about reproduction should be made to the MHRA at the above address.

DISTRIBUTION OF THIS REPORTThis report should be distributed to the following departments: Clinical Engineering, EBME, libraries,Maternity, Medical Physics, Neonatal Units and Special Care Baby Units, Obstetrics and Gynaecology,Paediatrics, Procurement and Supplies.

About MHRA evaluation reports


evaluation - cedar draeger cal… · mhra evaluation 04020, march, 2004 2 ... outside the incubator...

Documents