Neonatal Incubator / Infant Radiant Warmer

DescriptionNeonatal Incubator Modeby pressing the "open incubator" icon again.CEDAR Note: For conditions under which thehigh speed fan is activated see Manufacturer'sComments.Temperature Control: The Giraffe OmniBedtemperature controls are on the left hand side ofthe main control panel, see Photo 4 and Photo 6.Air temperature control mode is selected bypressing the air temperature control button. Whenswitched on in incubator mode the Giraffe promptsfor a "set temperature". This can be set at anyvalue in the range 20 C to 39 C (using the overide37 C button) in increments of 0.1 C by pressingthe arrow keys as shown in Photo 6, here the settemperature is being increased by pressing the button. The measured air temperature and the setair temperature (23.7 C and 33.3 C respectively inPhoto 6) are displayed at the bottom right of thetemperature control panel, the measuredtemperature is a larger display.Photo 7: The water reservoirHumidification : The Ohmeda Giraffe OmniBedhas an integral humidification system option. Thewater reservoir is built into the end of the bassinet,furthest from the controls and contains a heatercolumn see Photo 7. The heater column in thehumidity system is designed to heat the water toboiling point and then release water vapour intothe warm air stream conveying it into the patientchamber. The water boiling mechanism isdesigned to prevent infection reaching the patientfrom the humidity system. The water in thereservoir itself does not boil. The reservoir andheater column are marked with minimum andmaximum water levels. When the reservoir istilted open, the heater column marker correspondsto the maximum level on the plastic reservoirwhen it is closed.Photo 6: Control Panel - setting air temperaturein incubator mode.Baby skin temperature may also be used to controlthe incubator. The patient sensor should beattached to the baby as described in themanufacturer's instructions and the deviceswitched into baby mode by pressing the "baby"icon. When baby mode has been selected, atemperature range of 35 C to 37.5 C in 0.1 Cincrements is available, the incubator will adjustthe level of warm air to achieve this temperature.The fan speed may be increased to enhance the airflow through the double walled side panels of theGiraffe OmniBed by pressing the Boost AirCurtain button. This extra flow of warm air isdesigned to help reduce heat loss and increase therate at which the incubator achieves the settemperaure. This feature is also designed to helpreduce heat loss when the access door is open, asdemonstrated by the icon for activation. Onceactivated the fan operates at high speed for 20minutes and then automatically switches back tonormal speed, it may be manually switched backTo activate the servo-controlled relative humidityoption the "three drops" icon is selected on the ELcontrols and information screen and the knobpressed, see Photo 8. The level of relativehumidity can then be set in the range 30% to 95%in 5% increments by turning the knob clockwise,or deactivated by selecting "off". To confirm achoice the knob must be pressed again.5MDA evaluation 02090, July 2002

Descriptionso the device no longer complies with the safetyStandard for infant radiant warmers, BS EN60601-2-21. CEDAR Note: On contacting themanufacturer they confirmed that this refers tosection 46.104 and "Appendix AA GeneralGuidance and Rationale" of BS EN 60601-2-21. Aradiant warmer is required to activate an alarmevery 15 minutes if it is in manual mode, unlessthe infra-red (IR) irradiance, as measured at themattress, is less than 10mW.cm-2. Datex-Ohmedastate that at 25% power this criteria is fulfilled. Itmust be noted that the heater is rated as 450W.When a skin sensor is connected the baby's skintemperature is displayed on the temperature panelon the left of the control panel. On switching tobaby control mode by pressing the baby icon atemperature between 35 C and 37.5 C can be set,in the same way as in incubator mode.Photo 8 Activating the relative humidity optionTo leave the EL control and display screen EXITmust be selected by turning the knob, whichshould then be pressed to confirm the choice.However, it will default to the EXIT position aftera short time.Two skin sensors may be connectedsimultaneously for example to measure thetemperature at two sites on the baby's skin or iftwin babies are co-bedded. The Giraffe OmniBedwill not then operate in baby mode but will displaythe second skin temperature at the top right handcorner of the EL control and display panel.Radiant Warmer ModeThe radiant heater is only activated and poweredwhen the canopy is at its topmost position and theheater doors are fully open. The heater is a coiledmetal element located behind a guard see Photo 9.A hemispherical reflector behind the heater isdesigned to focus the heat onto the mattress.Alarms: The alarm tone volume may be set at oneof four levels and a bank of LEDs provides abright visual display. All alarms usually found onan incubator or radiant warmer are present on theGiraffe OmniBed. In addition an alarm activates ifthe canopy is stopped in its path for more than 30seconds while opening or closing. This is to alertthe user that no heat is being generated.Cleaning: The Giraffe dismantles down to theheater level for cleaning.ManualsAn Operator's Manual and a Service Manual areavailable. Both appear quite comprehensive andthe Service Manual contains useful explodeddiagrams.Photo 9: Radiant heaterTemperature Control : On switching into radiantwarmer mode the control panel will prompt for atemperature setting. The heater can be setmanually in 5% increments. If no temperature orpower level is selected the Giraffe OmniBed willdefault into an automatic warm up mode of 100%power for 10 minutes followed by 25% power prewarm heater settingHowever, one important omission noted was thatthe service schedule indicated that the air filtershould be changed quarterly or more frequently ifused with an infectious patient, but neither theService Manual nor the Operator's Manualexplains where to find the air filter or how tochange it. On closer examination of explodeddiagrams in the Service Manual the air filter wasfound to be located behind the humidity system'swater reservoir and could only be accessed whenthis was removed.The factory setting of 25% pre-warm mode, up towhich no alarms will be activated, can be adjustedup to 50%, using the procedure in the servicemanual, however, the user is warned that in doingMDA evaluation 02090, July 20026

User AssessmentUSER ASSESSMENTThe data has been displayed graphically below togive the reader an overview of the users' response.Points of particular interest are discussedespecially where users made comments aboutspecific features.One Senior House Officer (SHO) and 35 neonatalnurses in three hospitals and participated in ouruser assessment. Five Medical Technical Officers(MTOs) who had worked with the GiraffeOmniBed were also invited to comment. All threehospitals had owned at least one Giraffe OmniBedfor a minimum of six months. 32 users stated thatthey had used the device for at least severalmonths. Three users completed the questionnaireafter using the device for the first time and onlyone user gave no indication of how long they hadbeen using the device.Figure 1, below, shows the user response toquestions 1 to 12, which concerned generalfeatures of the Giraffe. Most users considered themobility, wheel locks and stability to besatisfactory or better, however, two nurses ratedthe mobility as poor and another commented thatit was "ungainly to manoeuvre". The verticalheight adjustment (VHA) was considered good orexcellent by most users although some users wereconcerned that it was easy to confuse the two setsof foot pedals. The range of VHA was commentedon favourably; the nurses found that the VHAlowered the bassinet enough for mothers seatedbeside the Giraffe or in a wheelchair to be able tosee their child.Our questionnaire asked users to rate features ofthe Giraffe OmniBed as unacceptable, poor,satisfactory, good or excellent and writtencomments were invited in a space beside eachquestion. The questionnaire contained over 80questions relating to the use of the Giraffe in bothmodes of operation and included general questionsto ascertain the users' training and experience ofthe Giraffe OmniBed. Users were also askedwhich other incubators and radiant warmer devicesthey had used and then what they considered to bethe advantages and disadvantages of this device.To clarify issues raised by the questionnaire anevaluator visited each neonatal unit. The numericaldata response from the questionnaire is reproducedin the Appendix for interested readers.Some nurses found the drawer difficult to use andanother noted that it could not be opened when theaccess doors (sides) of the bassinet were down.Fixing ancillary equipment was also a problem,although it was only rated by 25 respondents outof a possible 36. Many were dissatisfied with thespace available and some interpreted this questionas relating to the availability of ancillaryequipment. They were disappointed that manyFigure 1 User response, Questions 1 to 12Number of Respondents0510152025303540M o b ility 1Wheel locks 2Stability 3VHA of stand 4VHA mechanism 5Cupboard/drawer space 6Fixing ancillary eq 7Aesthetic appeal 8UnacceptableCanopy foot pedals 9PoorCanopy finger switches 10SatisfactoryCanopy rise speed 11GoodExcellentHeight of device 127MDA evaluation 02090, July 2002

User Assessmentitems they considered essential, for exampleshelves and poles, were not included in the priceof the Giraffe. CEDAR Note: see Manufacturer'sway as the VHA pedals (see Description).More users scored the canopy finger switches asexcellent but one user commented that they weresmall and "difficult to access if lots of equipmentaround".CommentsIn a later question one user commented thatbattery powered syringe drivers had to be securedto the Giraffe "by tape".The speed at which the canopy rose was well likedand considered good for accessing the baby in anemergency. The height of the device (maximum2.36m) was not a problem for most users and onenurse noted that it was high and "out of headhitting height".The general appeal of the unit was well spreadwith the majority rating it as satisfactory or goodbut a few users rated it as unacceptable or poor.The foot pedals for raising the canopy weregenerally rated well although in all three units theywere disabled, either permanently or using the usersettings menu. The main reason was that accidentshad occurred where the canopy had been raisedand had collided with other equipment attached tothe wall, damaging both. One Giraffe had acracked canopy as a result of such an accident.Nurses were also concerned that small childrencould step on the pedal. Disabling the foot pedalsreduced the risk of their inadvertent activation.CEDAR Note: Once the pedal has been pressed thecanopy rises in one uninterrupted movement, thepedal does not have to be held down in the sameFigure 2, shows the response to questions 13 to 25concerning the temperature controls and the easeof use.The temperature controls were considered good bymost users, some of whom commented that theyfound them easier to use when they were morefamiliar with them. However, some considered thecontrols hard to reach because they were behindthe canopy.Most users were at least satisfied with thetemperature displays both in incubator mode andFigure 2 User Response, Questions 13 to 250510Number of Respondents152025303540Accessibilty of controls 13Ease of use, temperature controls 14Clarity of controls 15Visibility of controls 16Heater power range 17Heater power visibility 18UnacceptablePoorIRW mode changing modes 19SatisfactoryEase of use (IRW mode) in manual mode 20GoodEase of use (IRW mode) in ‘baby’ mode 21ExcellentVisibility of set and measured baby temperature 22Ease of use (NI mode) ‘air temperature’ mode 23Ease of use (NI mode) ‘baby temperature’ mode 24Displayed set and measured baby temperature 25MDA evaluation 02090, July 20028

User AssessmentFigure 3 User Response, Questions 28 to 31 and 51 to 570510Number of Respondents152025303540Skin sensor’s size and shape 28Length of lead 29Ease to fix the sensor to the patient 30Patient lead connection to the socket on the Giraffe 31UnacceptablePoorRange of relative humidity values (30% to 95%) 51SatisfactoryEase of use of relative humidity 52GoodEase of filling the water reservoir 53ExcellentAuditory warnings 54Visual warnings 55Understanding the alarm caption 56Visiblility of the alarm caption 57radiant warmer mode. The unacceptable responsewas accompanied by a comment that it wasdifficult to see the display when the patient neededphototherapy. One of the users who rated thedisplay as poor commented that they could be"larger/brighter".the water in the water reservoir increasing thelikelihoodofbacterialgrowth.SeeManufacturer's Comments.The response to the auditory and visual warningswere split very similarly with the majority of usersrating these as satisfactory or good. Those whorated the auditory alarms as poor found it toonoisy, but stated that they later found that thevolume could be turned down. The visual captionson the alarm conditions were thought to be a littlesmall.Figure 3 considers the skin sensor, the relativehumidity system and the alarms. Both reusable anddisposable skin sensors were used. Users indicatedthat they thought they were satisfactory or good but neither type elicited a specific comment. Thelead was thought to be a little too long and thesensor head a little large for very small babies.More nurses commented that connecting the leadto the Giraffe socket was awkward. The relativehumidity feature was well liked by all the users,some thought that this was the best feature. It wasconsidered easy to use but many nursescommented that it was not easy to open the waterreservoir to refill it. One user reported that therehad been "some hot water spills". A techniciancommented that one of the water reservoirs ontheir Giraffes was cracked, possibly due to theforce applied to remove it.Figure 4 is a little different from the other charts.Here, in addition to displaying the user ratings forthese features we also indicate whether therespondents have used a feature of the Giraffe ornot. Those who had used a feature were asked, inthe next question, to rate it. The ratings are shownin the section along the bar after the blockindicating those who hadn't used it.The fan boost was a feature, that many nurses hadnot used. One technical comment received queriedwhy the fan boost was not automatic on closingthe incubator canopy in the transition from radiantwarmer mode to incubator mode. It was very easyto forget to switch the fan boost on to enhance thespeed at which the incubator attained the settemperature.One consultant who saw the Giraffe OmniBed buthad not used it commented that he was concernedthat the heater within the water would warm all of9MDA evaluation 02090, July 2002

User AssessmentFigure 4 User response, Question 26, 27, 32 to 50Number of Respondents05Fan boost 26Not usedReusable or disposable skin sensor 27Disposable1015303540Not usedNoUsed/YesHelp screens 34 & 35Not usedTimer 36 & 37Not usedApgar timer 38 & 39Not usedTrending 40 & 41Not usedTemperature settings 43 & 44Not usedUser settings 45 & 46Not usedIn-bed scales 47 & 48Not usedHumidity 49 & 50Not usedPoorSatisfactoryGoodExcellentA few users rated the Electroluminescent (EL)screen poor, but most said that they found it easyto use. The help screens were found to be helpfulespecially when the nurses were new to using theGiraffe. None of the nurses used the Apgar timer,this feature is more appropriate for delivery suite.Neither did they use the other timing facility. Onlythree nurses used the trending facility and they allconsidered it satisfactory or good, one commentedthat they liked the trending facility but found thatthey were liable to lose the trend informationbetween shifts when other users used the Giraffe.The in-bed scales were well liked and a highproportion of users rated them as excellent but twousers commented that they had obtained threedifferent readings when taking measurementsconsecutively. It was not clear whether this wasuser unfamiliarity or a problem with the scales.Care must be taken to follow the weighingprocedure prompted by the EL display screen. Allthe users who had used the humidity facility ratedit satisfactory or better.The mattress area was large and this wasconsidered good by many nurses, although somefelt that the baby looked very small in the middle.The mattress tilt was considered good and twousers commented that they would like more tiltsince some babies require it. The tubing ports werea problem for some nurses. They complained thatthe grommets that fitted in the tubing port holesfell off after a while and also that they claspedventilator tubing too tightly. They preferred to use"iris" ports to route and support ventilator tubingbut these were not available on their GiraffesThe use of tubing ports was also a problem in oneunit where they administered oxygen directly intothe canopy to provide a higher ambient level. Nooxygen port was available on their Giraffes so theyhad to use one of the port-holes.Mattress rotation was well liked and one userthought that this was the best feature. However,another nurse stated that mattress rotation was"easy when the bed empty. V difficult with wires,drips, ventilator tubing etc." [attached to the baby].None of the features considered in Figure 4 wererated as unacceptable.Figure 5 shows the responses to questions aboutthe patient area, the mattress and the tubing ports.Again, generally these features were well liked.MDA evaluation 02090, July 200225ReusableEL screen ease of use 32Moving between options easy 332010

User AssessmentFigure 5 User Response, Questions 58 to 680510Number of Respondents152025303540Ease to access the patient 58Mattress size 59Mattress tilt mechanism 60UnacceptableRange of mattress tilt 61PoorMattress tray withdrawal 62SatisfactoryMattress rotation 63GoodSecurity of the side panels 64ExcellentSuitability of the tubing ports 65Suitability of hand ports 66Security of access doors in incubator mode 67Ease of performing X-rays 68Figure 6 User Response, Questions 70 to 79Number of Respondents05IRW mode : ease to provide general patient care 7010152025303540UnacceptablePoorIRW mode : ease to feed infant 71SatisfactoryIRW mode : ease of access for nursing 72GoodExcellentIRW mode :

Neonatal Incubator / Infant Radiant Warmer Ohmeda Giraffe OmniBed SUMMARY Advantages : Incubator and infant radiant warmer in one device. Relative humidity option, swivel mattress, all around access, uniform central thermal environment. Disadvantages : Car