Fisher & Paykel CosyCot ™ IW 930 - Cedar Fisher... · NUMBER 01044 Infant Radiant Warmer & Resuscitation Unit Fisher & Paykel CosyCot ™ IW 930 SUMMARY Advantages: Easy to use,

NUMBER

01044

Infant Radiant Warmer& Resuscitation UnitFisher & PaykelCosyCot™ IW 930

SUMMARYAdvantages: Easy to use, clear displayslarge mattress, easy access to bassinet.Even temperature in centre of mattress.Modular design.Disadvantages: Wide base, side panelsdifficult to lower, low down storage space.Temperature difference across the mattressexceeds limits specified in the internationalradiant warmer standard. Optional shelf whenpositioned over bassinet presents a hazard,see Page 11, see Manufacturer's comments.

Price ex VAT £13,340 inclusive of extrasseen in cover photograph.

Basic model £4,950 (seeBrief Description)

Supplier Fisher & Paykel Healthcare,Unit 16, Cordwallis Park,Clivemont Road,Maidenhead, Berkshire,SL6 7BU

CE Marking Yes (Annex II, QA route)

Notified Body TUV (0123)

Manufacturedto Standard?

Certified by Underwriter'sLaboratory to EN60601-1,EN60601-1-2 andIEC60601-2-21

BRIEF DESCRIPTIONThe Fisher & Paykel Cosycot IW930 is amodular high specification infant radiantwarmer for use in delivery suite or special carebaby units. The sample seen included all thefeatures described in the Main Featuressection. A basic IW930 model has babycontrol, a large or standard bassinet, a skinsensor and heat reflecting patches.

MAIN FEATURES

• Maximum heater power output 450W• Power display 0 to 100%,

adjustable in 5% increments• Heater modes : Pre-warm,

Manual,Baby

• Temperature display range 4°C to 50°C• Baby mode

temperature range 34.5°C to 37.5°C• Mattress size 65cm square• Heater head rotation - up to 130° left or right• Mattress tilt ± 10°• Apgar Timer - tones at 1,5 & 10 minutes

Optional• Vertical Height Adjustment (VHA)• Storage trays• X-ray tray• Phototherapy• Air/oxygen blender and flow meter• Neopuff™ infant resuscitator• Suction

Description

MDA evaluation 01044, September 2001 2

DESCRIPTION

The Fisher Paykel CosyCot IW930 is an integratedmodular style infant radiant warmer andresuscitation unit. It is designed for use in deliveryunits and special care baby units. The sampleevaluated incorporated all optional features aswould be used in a special care baby unit. Inaddition to the basic and integrated IW930 models,there is also an IW950 range. All IW950 modelsexclude baby mode temperature control and arebetter suited to delivery suites.

FACILITIES

Bassinet: The bassinet is 65cm by 65cm (seemanufacturer's data for other option) to allow easyaccess from three sides. The perspex sides may belowered by applying pressure on their top edgeand then folding them down; they are replaced bypushing back into position. Tubing slots wereavailable in all of the four panels. Small gaps atthe corners between panels also allow narrowtubing through. The panels can be easily removedfor cleaning. Beneath the removable mattress thebase of the bassinet is white ABS plastic and anoptional x-ray tray may be fitted below this. Thebassinet can be tilted up to ± 10° in the head-upand feet-up positions by grasping the two metalbars below the front of the bassinet as seen in theCover Photo.

VHA: The VHA mechanism is unusual in that thelegs are hinged on the frame, and move closertogether in order to raise the unit. The VHA isactivated by pressing one of the two foot switchesmarked é and ê on the leg of the warmer (seePhoto 1). To prevent inadvertent activation theVHA can be disabled by switching off the smallblack switch marked ¤ ¡� further up the leg of thewarmer.

Heater: The CosyCot IW930 heating controls areintegrated into the top section of the main column.The On/Off switch is marked ¤ ¡�(see Photo 3).

Photo 1: VHA footswitches and on/off control

Above these a 450W grill-covered heater projectsover the bassinet, (see Photo 2). The heater can berotated up to 130° to the left or right. Thismovement is restricted if poles for affixing extraequipment are attached to the warmer. The heateron the sample device, which had a long and shortpole fitted, could be swung up to 90° either way.The heater continues to heat at its set level when itis rotated out of the way.

Photo 2: Heater and Guard

Temperature control: The CosyCot IW930 hasthree modes for controlling the heater: pre-warm,manual and baby controlled. These are activatedby pressing the appropriate button on the heatercontrol panel, see Photo 3. A green light indicateswhich mode is active.

Pre-warm mode: This mode is commonlydesigned to warm the bassinet above the ambienttemperature in preparation for the baby. The unitwill not alarm in pre-warm mode, which is pre-setto 25% heater power, unless the temperature

CONTENTS Page

Description 2User assessment 5Technical assessment 7Manufacturer's comments 11Manufacturer's data 12Appendices

Questionnaire data 13Acknowledgements 16MDA information 16

Description

MDA evaluation 01044, September 20013

sensor is in use and detects a temperature in excessof 39°C.

Manual mode: Manual mode allows the user toselect any level of heater power from 0% to 100%in 5% increments. To adjust the power level thecentral disc, with two indentations for fingers (seePhoto 3), is rotated; clockwise increases powerand anti-clockwise decreases power. If the poweris set higher than 25% then a check baby alarmwill sound every 15 minutes. If this alarm is notsilenced the radiant warmer heater willautomatically decrease to 25% power. If the skintemperature sensor is used with the warmer inmanual mode it will monitor the baby's skintemperature, but not control the heater output. Thetemperature displays ranges from 4°C to 50°C in0.1°C increments.

Photo 3: CosyCot IW930 in Baby mode set at36.5°C. Heater power level automaticallycontrolled - here it is at 40%

Baby mode: Heater output is servo-controlled bythe microprocessor using measurements from theskin probe on the baby's skin. The targettemperature can be set in the range 34.5°C and37.5°C (in 0.1°C increments).

Skin temperature sensor: The reusable skintemperature sensor plug is inserted into a socketon the lower left corner of the heater control panel(see Photo 3). The temperature sensor must be

attached to the infant's skin using a reflective patchas described in the user manual.

Alarms: Alarms are auditory and visual. Inmanual mode a check baby alarm activates every15 minutes if the heater power is above 25%. Inbaby mode high skin temp or low skin tempalarms activate if the temperature is 1°C above orbelow the set baby temperature. The auditoryalarm may be silenced by pressing the mutebutton, the red light next to the legend willcontinue to flash until the temperature falls withinthe limits set.

The power fail alarm activates if the power supplyto the warmer is interrupted. The alarm can besilenced by switching the warmer off using theOn/Off switch above the control panel. A seemanual alarm activates if there is a software fault,an electronics fault, or a problem with the heater.

Timers: The IW930 model has two timers and anApgar timer. The two timers available for timingprocedures are activated by pressing either thetimer 1 or timer 2 button, which start a presetcount-down. The count-down time can be adjustedby pressing in and holding the timer button androtating the central control knob. The Apgar timercauses tones to sound at one, five and ten minutes,and is activated by pressing the Apgar button. TheIW950 model has only the Apgar timer.

Neopuff™ Resuscitator: The Neopuff™controls, limits and displays pressures used toinflate the lungs of apnoeic newborn infants. It isavailable in the CosyCot as an integrated moduleor as a stand alone device. In the sample evaluatedit was integrated into the main control column, seePhoto 4. (Detailed information on the stand aloneNeopuff™ was published in Evaluation 182.)

Oxygen, or oxygen-enriched air from the optionalblender, is delivered to the Neopuff™ and then onto the infant via a small face mask incorpororatinga T piece. Lung inflation is accomplished byoccluding the expiratory port on the T piece with afinger. The T piece incorporates an adjustable,resistive, positive end-expiratory pressure (PEEP)valve designed to vary the air pressure applied tothe lungs during expiration. The valve consists of asmall screw threaded cap and care must be takento adjust it to the required level. The deliveredpressure and maximum pressure are set separately.The maximum pressure control is shielded.

Description


Photo 4: Neopuff™ resuscitator

The delivered pressure is displayed on a pressuregauge marked in cmH2O. Coloured sectorsrepresent safe, cautious and dangerous pressures.

Bird™ 3800 Microblender: This optional blendersupplied with the CosyCot (see Photo 5), requirescompressed air and oxygen either from cylindersor pipelines. It incorporates a single mixed-gasflow meter to control and display output flow.

Photo 5: Bird™ 3800 Microblender

OxyLitre Suction System: This providesadjustable oxygen driven suction and a vacuumpressure gauge indicating the pressure in thereservoir. The suction control knob increases ordecreases suction when turned clockwise oranticlockwise respectively. The unit can besupplied either from the wall pipeline or cylinders.

Medela Phototherapy Lamp: This optional extrais powered from an integral socket located near thebottom of the main column. The lamp is mounteddirectly on the side of the main column on an armand it may be moved vertically and tilted in thehorizontal plane to position it for optimaltreatment (see Photo 6). It may be removedcompletely when not needed.

Photo 6: Medela Phototherapy light attached toCosyCot IW930

The four folded fluorescent tubes may be selectedin groups of two once the unit is powered up. Awarning light indicates when the tubes should bechanged. A diagram on the side of the unit warnsthat it should not be positioned directly below theradiant heater. CEDAR Note: Forthcomingevaluation on this phototherapy light.

Storage and Accessories The CosyCot IW930evaluated was equipped with two storage binsbeneath the bassinet, one deep and one shallow, asseen in the Cover Photo. A cover is available foreach of these. Two poles, long and short wereattached on opposite sides of the main column andan accessory hook was available on one side. Inaddition, a shelf was attached to the main columnon the same side as the phototherapy lamp.

User assessment


USER ASSESSMENT

Forty five staff in six hospitals participated in theuser assessment of the Fisher & Paykel CosyCot.The number of staff completing questionnaireswas evenly distributed between delivery units andneonatal units, as shown in Table 1. All samplestaff had used the CosyCot for at least one month.

Table 1 Participants in user assessment

Hospital Neonatal Staff MidwivesA 5B 9C 10D 8E 1 4F 8

Total 22 23

Hospital A used the CosyCot for a one month trialin the neonatal unit. Hospital E owned twoCosyCots which were used in the delivery suiteand theatre, and the neonatal unit had also used aCosyCot on trial for two months. Hospitals B, C,D and F already owned varying numbers ofCosyCots.

Midwives and neonatal nurses have differentexpectations of a radiant warmer/resuscitationunit. Most radiant warmers are used in deliveryunits. In a normal delivery they are often onlyneeded briefly to allow midwives to assess andquickly warm a newborn baby, whereas in morecomplex deliveries neonatal nurses may requireadditional facilities on the radiant warmer.

In neonatal units the use of radiant warmersdepends on local policies and protocols. Someunits used the CosyCot to nurse neonates overseveral days, others for a few hours while the babywas assessed prior to being transferred to anincubator. In a few units mobile radiant warmersmay also be used to transfer neonates to X-raydepartments and theatre.

Consequently the responses of these two groups,are presented separately. The same questionnairewas used with both groups. Each user rated thevarious features of the Fisher & Paykel CosyCotas either excellent, good, satisfactory, poor orunacceptable Their responses to our questionnaireare shown in Appendix 1 and are summarised inTable 2.

The CosyCot was well received in all unitssampled. Two of the delivery units had performedextensive comparative testing prior to purchasing.Staff in both were pleased with the CosyCot,

finding that it suited their needs and was well likedby the midwives. The most common response ofthe sampled users was to rate all features assatisfactory or good. The features grouped inTable 2, and the specific features which userscommented on, are discussed below.

The midwives tended to have a greater spread ofopinion than the neonatal staff, giving a higherproportion of ratings as good and excellent, but afew were scored as unacceptable. As these issuesmay be important for clinical practice in someunits, readers are encouraged to study thecomplete questionnaire and user response datawhich may be found in Appendix 1.

GENERAL FEATURES

Mobility More midwives than neonatal nursesrated the mobility as good. The neonatal nurseswere required to move the warmer more often thanthe midwives, although some delivery unitsrequire radiant warmers to be moved frequently. Awarmer in a neonatal unit may be used to takeneonates to theatre or X-ray. Some neonatal nursescommented that they found the CosyCot "difficultto move" and "mobile but unwieldy", but it wasconsidered stable by the majority in both groups.

The vertical height adjustment was well liked,particularly by the midwives, who particularlyliked being able to adjust the height of thebassinet. The CosyCot used by the midwives had,in all cases, replaced infant radiant warmers whichoperated at a fixed height. However, one midwifecommented that it was easy to activate the heightadjustment of the CosyCot accidentally whenresting a foot on the leg near the up and downswitches.

The CosyCot was considered a large devicecompared with older models of infant radiantwarmer. This was not a limitation in units withplenty of space but it was considered adisadvantage when used in a confined space.CEDAR Note: Space saving, wall mountedversions of the CosyCot are available and arebeing considered by some users.

Patient Area : More than 40% of the midwivesrated the size of the mattress as excellent, severalcommented on it as an "overall advantage".Examples of their comments are: "Large area fortreating and examining babies", "big surface forworking", "wide area for baby". The majority ofneonatal nurses rated the mattress area as good.

User assessment


Further questions associated with the patient areaelicited good responses.

Both groups commented that the patient was easyto access and that it was easy to provide generalpatient care. These questions were rated good orexcellent by over 55% of each group. Both groupsconsidered the side panels secure, but staff inseveral delivery suites found that they weredifficult to lower and in a few instances the forceused had damaged or broken them. * Some panelswere also inadvertently removed by pressing thetabs located on the underside. On being replaced

they snapped back into position. One neonatalnurse commented that "they make too much noisewhen clicked into place". *

Storage: The midwives rated few features asunacceptable or poor. However, thecupboard/drawer space beneath the warmerbassinet was not well liked by several of the users,who thought the drawers were "too open". Manymidwives commented that the drawers weresituated low down, forcing them to bend a lot inorder to access the contents. In one unit a problemwith the drawers swinging out was identified.

Table 2 : Summary of the user assessment questionnaire responses. User scores for each group offeatures have been summed and are expressed as a percentage. The most frequent response is marked inBOLD. User responses to each individual question can be found in Appendix 1.

Neonatal Staff Midwives

Una

ccep

tabl

e

Poo

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Sat

isfa

ctor

y

Goo

d

Exc

elle

nt

Fisher & Paykel CosyCotfeatures

Listed in the same order aspresented in the

questionnaire and inAppendix 1

Una

ccep

tabl

e

Poo

r

Sat

isfa

ctor

y

Goo

d

Exc

elle

nt

8% 39% 41% 12% General Features 1% 3% 26% 59% 12%

5% 21% 55% 19% Warmer Controls 2% 20% 65% 12%

4% 40% 44% 12% Skin Temperature Control 40% 60%

43% 48% 9% Warmer Alarms 7% 46% 35% 11%

6% 28% 56% 10% Patient Area 4% 16% 58% 23%

4% 38% 46% 13% Nursing Procedures 4% 25% 58% 13%

29% 59% 12% Medical Procedures 13% 65% 21%

2% 55% 35% 9% Phototherapy Not used

2% 50% 44% 4% Auxiliary Oxygen 1% 31% 59% 9%

75% 25% Blender Control 50% 50%

7% 69% 24% Pressure Control 33% 67%

19% 51% 31% Suction Facility 1% 1% 45% 44% 9%

User assessment


Both groups expressed dissatisfaction with thefixing of ancillary equipment to the device. Thesmall shelf was not considered adequate,especially by neonatal nurses who often requiremore ancillary equipment to be positioned close tothe neonate. *

Suction: The suction system was not consideredvery powerful and needed to be turned up. * Whenturned up to the desired level it was thought "verynoisy" by some midwives.

Heater Controls: The control panel was rated aseasy to use and the clarity of display was wellliked. Users found it straight-forward to changebetween warming modes. Most midwives thoughtthe range of heater control was good, but someusers found the controls difficult to reach. Use ofthe "baby mode"-skin temperature control modewas confined to neonatal nurses and wasconsidered satisfactory, good or excellent.

The three neonatal units sampled used CosyCotswith the "baby mode", i.e. the IW930 model asshown in the Cover Photo. Participating deliveryunits used the IW950 model, which does not have"baby mode".

A skin temperature sensor is available on both theIW930 and the IW950. Neonatal nurses use theskin temperature sensor far more than midwivesbecause babies are nursed in the CosyCot inneonatal units for longer. Staff in delivery suitesrarely used the skin temperature sensor. Mostaspects of the sensor were well liked. One problemhighlighted by both groups was sticking the sensoronto the baby. Some users found this difficult andused additional tape to ensure that it stayed inplace.

Alarms: The alarms, both auditory and visual,were considered satisfactory to good by theneonatal nurses. The midwives thought the alarmswere good but found the noise annoying. Thevisual warnings were quite small and missed bysome midwives.

Phototherapy: CosyCots used on two neonatalunits incorporated a Medela phototherapy unit (seePhoto 6). Those neonatal nurses who used itthought it was satisfactory. One group felt that ittended to get in the way as it was attached to themain column.

Cleaning: The unit was generally considered easyto clean. However, there was a problem with theside panels, in that they were difficult to clean if

fluids leaked inside them. When this occurred thestaining could not be removed and the panelsneeded to be replaced. * Two separate deliveryunits reported this problem and examples wereseen by the evaluator.

Neopuff™ Resuscitator: This was well liked bythe users. In one hospital the staff were unsurewhether the Neopuff™ was working correctly. Inresponse Fisher & Paykel supplied a small modeltest lung which could be affixed to the Neopuff™output to give a visual indication of its operation.One user commented that it was easy to confusethe disposable resuscitation tubing and thereusable Neopuff™ tubing. Some reusable tubinghad been inadvertently disposed of incurringunnecessary expense. Users felt that colour codingwould help. *

Training: Midwives and neonatal nursescommented that Fisher & Paykel provided goodtraining sessions and backup. In one instance theysupplied a "step by step guide" to using theCosyCot. In another unit the CosyCot was adaptedby the company to accommodate their suction jars.All of the users attended a training session byFisher & Paykel, were trained by their colleagues,or had read the user manual.

*- see Manufacturer's Comments.

TECHNICAL ASSESSMENT

Radiant WarmerThe performance of the Fisher & Paykel CosyCotwas assessed using tests devised to simulateclinical use in both delivery suites and neonatalunits. Both temperature and radiant energy weremeasured. During a normal birth, delivery unitstend to use an infant warmer for only a briefperiod. However, the device must be warm enoughto benefit the baby, easily accessible and requirethe minimum attention by the midwife.Maintaining a steady, even, temperature at themattress, both when horizontal and tilted, isimportant in neonatal units, which may use awarmer for prolonged periods.

Temperature was measured using five matt blackaluminium discs constructed and positioned on themattress as described in BS EN 60601-2-21, theStandard for infant radiant warmers.

The user manual advises the user to switch on theCosyCot "at least 5 minutes" before placing thebaby on the bassinet. In our tests the warmer, in

Technical assessment


pre-warm mode, took an hour to raise thetemperature by 3.2°C from ambient, 23.8°C, to27°C. Since users generally expect the heater towarm the blankets and bedding placed on themattress to a temperature acceptable for a new-born baby's skin this suggests that the warmerneeds to be switched on in pre-warm mode at leastan hour before the baby is delivered. The unit doesnot alarm in pre-warm mode.

When heated at 100% power, the time to raise thetemperature by 12.7°C, from ambient to 36.5°Cwas 43 minutes. The temperature rise after a setperiod when warming in each mode is shown inTable 3 for reference. Sometimes a warmer maybe used to raise the baby's temperature a fewdegrees higher than the temperature initially set.To simulate this we set up a performance test tolook at how quickly the CosyCot raised thetemperature of the sensors embedded in the discsfrom 32.5°C to 36.5°C.

Table 3: Summary data for radiant warmer

(a) Temperature rise using

Manufacturer’s Pre-warm mode

- after 30 minutes 1.7°C

Maximum heat (manual mode)

- after 15 minutes 4.7°C

(b) Time to warm test disc to 36.5°C

Maximum heat – from 23.8°C 43minutes

Maximum heat – from 32.5°C 16minutes

(c) Tilt – maximum temperaturedifference from central disc.

4.8°C

(d) Heater swung away from bassinet for 10minutes

Temperature drop 1.6°C

Time to regain temperature 7minutes

Uniform warming across the mattress is veryimportant in neonatal care. The neonate requires asteady warm temperature that does not stress itsenergy reserves. The temperature differencebetween the average temperature at the centre ofthe mattress and the individual averagetemperature of four out-lying points was measuredusing the method described in the Standard for

radiant warmers. The warmer was set at 36.5°C"baby-mode" with the mattress horizontal. Themaximum temperature difference was 2.2°C,exceeding the 2°C limit at 36°C described in theStandard. The other three discs were less than 2°Ccooler than the central disc. At the maximum tiltof 10°, the temperature of the central discremained unaltered but the outlying discs were upto 4.8°C cooler than the central disc. The coolestdiscs were furthest from the heater as would beexpected. CEDAR Note: There are no specificlimits for temperature variation in the tiltedpositions but 4.8°C is a large difference.

The heater is designed to rotate so that it can bemoved out of the way for procedures such as X-rays, or so the parents can hold the neonate andstill allow him/her to benefit from the heat of theradiant heater. The heater continues to be activewhen swung to the side. The CosyCot was set to36.5°C in "baby mode" and the disc temperaturesallowed to stabilise. The heater was then rotated tothe right hand side of the CosyCot for ten minutes.This caused a temperature drop, as measured in thecentral disc, of 1.6°C, shown in Figure 1. Whenthe heater was returned to its central position thetemperature rose back to its original level in sevenminutes. There was no evidence of an overshoot inthe temperature, but the temperature did continueto fluctuate as it had before the test.

Figure 1: Temperature change on swingingheater away from bassinet.

The first 20 minutes plotted in Figure 1 shows thatalthough the warmer was set to maintain a skintemperature of 36.5°C, the core temperature of thealuminium block fluctuated between 36.8°C and36.6°C. The fluctuation periodicity isapproximately 12 minutes. CEDAR Note: Thereare no specific limits on fluctuations oftemperature. This data is provided for comparisonwith other evaluation reports on infant radiantwarmers.

35

36

37

0 10 20 30 40 50 60

Time (minutes)

Tem

per

atu

re °

C Heater moved out

Heater moved back



Surface temperature: The uniformity of heatingacross the mattress was also assessed bymeasuring the surface temperature using acalibrated B&K Climate Analyser contact surfacetemperature probe. The mattress was covered witha black felt sheet marked at 5cm intervals toindicate positions for measurement. The radiantwarmer was set to 50% power and the "checkbaby" alarm was silenced every 15 minutes. Afterone hour the surface temperature was measured ateach of the marked intervals.

Figure 2 shows the temperature distribution acrossthe mattress with respect to the maximumtemperature measured, which was 33.8°C.Temperature variation in the central area of themattress, 20cm by 30cm as shown by the whitebox, is within 1°C of the maximum temperature.This is a good result as it indicates a uniformthermal environment. The slightly cooler section atthe end of the mattress closest to the controls isunexplained. The measurement environment wastypical of a delivery suite with no sources of airdisturbance.

Steep contours on the temperature plot show howthe temperature drops rapidly towards the sides ofthe bassinet. The cooler edges and side-wallscould contribute to radiant heat loss from the babybecause warm areas and bodies will radiatetowards cooler objects. CEDAR note: The size of

the bassinet in relation to the size and power of theheater may explain this effect and the largetemperature difference measured with the discs.

Radiant energy tests: The radiant energydetected at the mattress surface was measuredusing an International Light IL400A radiometercalibrated for 780nm and 1400nm. The IR energyfor wavelengths greater than 780nm is shown inFigure 3. The CosyCot is at 100% power and ascale of 5mW.cm-2 has been used. The pattern isquite regular and the area in which the baby wouldbe placed receives the highest irradiance. Themaximum IR irradiance measured was11.6mW.cm-2, which is slightly above the10mW.cm-2 limit in the Standard. This level isconsidered permissible for short periods as noharmful incidents had been reported at the time ofthe Standard's publication. The contour pattern issimilar for lower power settings.

Neopuff™: Measurements on the Neopuff™showed that it limited pressures accurately and thatset pressures were relatively independent of flow.No overshoot was observed on setting andachieving pressures. The simple PEEP device wasthought to be easy to use and gave a useful rangeof PEEP values. It consisted, however, of quite acrude screw cap type device which could easily bescrewed up inadvertently, thereby increasing thePEEP value to its maximum.

0 to 1 °C below max


2 to 3 °C below maxCo

ntr

ols



Figure 2: Surface temperature of mattress at 50% power in manual mode. Temperature below themaximum temperature, 33.8°C, measured in the centre of the mattress. White box 20cm x 30cm.



As the PEEP valve is a resistive device, thepressure value is determined by the flow of gas;therefore high levels of PEEP could be developedusing maximum flows from the gas outlets.CEDAR Note: It is important that the users areaware of this.

The pressure display was found to be accurate andwas always within 0 to +1.5 cmH2O of the truepressure. The display was adequately damped sothat it responded rapidly to pressure changes butdid not overshoot.

The gas supply flowmeters were accurate to within0.5 L.min-1 and the Bird™ blender producedoxygen mixtures to within 3% of the set oxygenconcentration level. Blender accuracy was notinfluenced by the gas flow through the blender, butthere was a relatively large bypass flow whichproduced an obvious hiss. This bypass could resultin unnecessary emptying of gas cylinders if theyare left on when the resuscitation unit is not beingused.

Suction: The suction gauge was always within5mmHg of the actual pressures.

Gas Supply: The gauges displaying the cylindercontent have pressure markings as well as sectorswhich clearly indicate full and empty. They aresited at the sides of the CosyCot and protectedfrom damage by projecting rods.

Photo 7 The gas attachments at the back of theCosyCot

The CosyCot is a modular design, so allaccessories and optional gas and suction devicesare attached externally, which gives the device acomplex look. The modular design, see Photo 7,permits relatively easy changing and removing ofcomponents.

Co

ntr

ols

0 to 5 mW.cm-2

5 to 10 mW.cm-2

10 to 15 mW.cm-2

Figure 3 : The infrared irradiance at wavelengths from 780nm upwards, at 100% power.



Photo 8: The small adjustable shelf canobstruct flow or disconnect a pipeline.

The small shelf attached to the model sampled washorizontally and vertically adjustable. In somepositions, see Photo 8, it could be swung acrossthe corner of the bassinet. This could causedamage to the gas components, inadvertentlyobstruct the flow or disconnect a tube. CEDARNote: Users need to be careful to avoid a seriousincident from interruption of the gas supply orobjects falling from the shelf.

CERTIFICATION AND STANDARDS

The CosyCot IW930 carries CE marking in respectof the Medical Devices Directive (MDD). Fisher& Paykel Healthcare submitted a copy of acertificate confirming compliance with93/42/EEC. The assessment route was a qualityaudit certified to ISO 9001 & EN 46001. Thenotified body was TUV, Munich, Germany,(0123). In addition the IW900 series were testedand approved by Underwriter's Laboratory Inc,Santa Clara, USA and EMC Technologies Ltd,Tullamarine, Australia, to the following standards:IEC 601-1,1998; IEC 60601-1-2,1993; IEC 60601-2-21, 1994.

MANUFACTURER'S COMMENTS

Thank you for the opportunity to comment on thedraft report.

Temperature Control: The CosyCot™ is shown tohave maintained a stable temperature to within±0.1°C. We believe this to be a good result. Figure1 shows that there is a difference of 0.2°C betweenthe aluminium block surface temperaturemeasured by the warmer and the core temperaturemeasured by the independent test equipment. Asmost sensors generally claim an accuracy of±0.1°C this difference between two independenttemperature-measuring systems is feasible.

Temperature Uniformity: Performing the standardIEC 60601-2-21 test in-house results in atemperature difference across the mattress of only1.8°C. The cooler patch shown in figure 2 does notcorrelate with the even irradiance map of figure 3and may have been influenced by a gas flow. Thiscould also explain the 2.2°C difference found inthe IEC 60601-2-21 aluminium block test.

Pipeline obstruction of shelf: The gas supply tubeprovided has internal ribs to prevent crushing. Tocrush the tube a horizontal force would have to beapplied to the shelf. A 5kg force actinghorizontally on the tube creates negligible flowdrop. The Neopuff™ has two check valves tocompensate for any pressure increases. We notethis concern and will investigate a remedy.

Side panels: From January 2001 a sealing stripwas added to the side panels to prevent fluidingress between the perspex side and thealuminium extrusion. A new side panel system isdue for release in early 2002 to address the noiseconcerns and ease of use.

Phototherapy: As of August 2000 an additionallabel warning the user to protect the infants eyeswhen the lamps are switched on has been affixedto the phototherapy unit.

Shelves: Up to four shelves can be fitted on theCosyCot™ column to provide sufficient storagespace.

Suction: The Oxylitre suction unit has lowersuctioning power specifically designed forneonates.

Tubing: The two types of tubing (disposable andreusable) are already colour coded: disposable isa clear corrugated tube and reusable is a heaviertube with external cream spiral reinforcing andlarge cream silicon cuffs at each end.

Pre-warm mode: This is designed to allow theelement and head to warm up, without anynuisance alarms, prior to the arrival of the baby.Many hospitals leave their warmers in this modeconstantly when not in use.

Manufacturer's data


PRODUCT DATAProcurement dataManufacturer Fisher and Paykel Healthcare, 25 Carbine Road, PO Box 14-348, Panmure,

Auckland, New Zealand.Country of Origin New Zealand

Prices (ex VAT) Cosycot IW930 (has baby control) Standard or large bassinet, skinsensor, heat reflecting patches

£ 4,950

VHA stand £ 1,100

Neopuff infant resuscitator £ 495Cosy pack £ 52Disposable neopuff circuit pack (30) £ 90

Gas supply Rear oxgen only or oxygen/airFlowmeters oxy/oxy or oxy/air

£ 1,450

Suction Injector suction - reusable or single useSuction catheter basket

£ 570£ 75

Side shelf £ 176

Large & small storage bins £ 425Bin cover £ 20

Short mounting pole £ 48Long mounting pole £ 96

Accessory hook £ 24X-ray tray £ 338Blender (Bird Micro-blender) £ 1,750

Phototherapy lamp (Medela) £ 1,700Physical Data

Size (H x W x D) 174 to 189 cm (with VHA) x 77cm x 120cm

Weight 60kg (excluding accessories)Mattress size 65cm x 65cm (optional larger mattress 75cm x 65cm)

Bed tilt +10° to -10°Heater movement 90° to 130° either sideCastors 4 locking

PRODUCT SUPPORTSupplier Fisher & Paykel Healthcare

Unit 16, Cordwallis Park, Clivemont Road, Maidenhead,Berkshire, SL6 7BU

Tel : 01628 626 136Fax : 01628 626 146Web :www.fisherpaykel.com

Guarantee 1 yearServicing First line/in house One visit per annum

Spare parts at list price minus 5%. Hospital technical staff supported by phone.Advisable for technical staff to undertake the technical training course for IW900series

£ 300

Planned Preventative Maintenance Two visits per annum.Spare parts list price minus 5%

£ 550

Comprehensive Two visits per annum and breakdowns.Spare parts supplied and fitted free

£ 895

Minimum onsite contract charge (2 units or more 10% discount) £ 300

Appendix 1

MDA evaluation, 01044, September 200113

User assessment data from questionnaire The number of users sharing the same opinion about a featureis recorded, eg 12 midwives thought general mobility was good. The most common response is marked inBOLD. For some features only a few users scored their opinion on their questionnaire.

NeonatalNurses

Midwives

Num

ber Question

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Part 1 General

1 What is your opinion of the general mobility of this device? 1 10 7 2 1 10 12

2 What is your opinion of wheel locks? 6 12 3 4 17 2

3 What is your opinion of the stability of this device? 6 13 3 3 16 4

4 What is your opinion of the vertical height adjustment of the device? 8 9 2 1 16 5

5 What is your opinion of the VHA mechanism of the device? 1 8 6 4 3 13 5

6 What is your opinion of the cupboard/drawer space on the unit? 6 7 6 2 1 2 8 10 1

7 What is your opinion of the fixing of ancillary equipment to thisdevice?

5 10 5 1 2 8 11

8 What do you think about the aesthetic appeal of the unit? 1 10 9 2 9 10 4

Part 2 Controls For The Warmer Unit

9 Please indicate your opinion of the accessibility of controls 1 6 9 5 1 6 13 3

10 What is your opinion of the general ease of use of all the warmercontrols?

1 4 10 6 4 15 4

11 How clear do you find the controls? 2 2 15 3 1 4 15 3

12 How visible are the controls? 1 2 15 4 1 3 14 4

13 How easy do you find it to change the warmer mode between 'pre-warm', 'manual' and 'baby'?

1 2 12 6 1 4 14 4

14 How easy do you find it to use the warmer controls in 'pre-warm'mode?

1 3 13 4 4 16 3

15 How easy do you find it to use the warmer controls in 'manual' mode? 1 3 13 4 4 16 3

16 How easy do you find it to use the warmer controls in 'baby' mode 1 4 13 3 6 10 2

17 What is your opinion of the range of heater control in manual mode?(0% to 100%)?

10 8 2 4 17 2

18 What is your opinion of the examination light control? 5 12 4 3 17 3

19 What is your opinion of the keypad lock control? Not applicable to this device

20 Consider the Apgar timer - what is your opinion of its controls? 1 4 4 2 1 5 14 3

21 What is your opinion of the ease of use of the Apgar timer? 1 4 4 2 1 6 12 2

PART 3 Skin Temperature Control and Sensor

22 What is your opinion of the skin temperature control range? 6 11 3

23 What is your opinion of the display of skin temperature? 6 10 5 4 9

24 What type of skin sensor do you use - disposable or reusable? All users used reusable skin sensors

25 What is your opinion of skin sensor's size & shape? 10 7 2 5 6

Appendix 1


NeonatalNurses

Midwives

Num

ber Question

Una

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Una

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26 What do you think of the length of the lead? 11 9 4 7

27 How easy do you find it to fix the sensor to patient? 4 7 7 2 5 5

Part 4 Warmer Alarm System

28 How do you find the auditory warnings? 8 9 3 1 7 8 4

29 How do you find the visual warnings? 10 10 1 2 5 6 2

30 How clearly do you understand the alarm caption? 9 10 2 2 12 5 1

31 How visible is the alarm caption? 8 10 1 9 6 1

Part 5 Patient Area

32 How easy do you find it to access the patient? 1 7 8 5 2 15 6

33 What is your opinion of the mattress size? 2 4 14 1 13 10

34 What is your opinion of the mattress tilt? 6 10 2 3 12 6

35 What is your opinion of the range of tilt of the mattress? 2 5 11 1 6 12 5

36 What is your opinion of the security of side panels? 1 7 11 1 3 3 12 4

37 What is your opinion of suitability of tubing ports? 2 5 12 1 2 6 12 1

38 What is your opinion of the ease of performing X-rays? 4 10 3 2 5

Part 6 Nursing Procedures

39 How easy do you find it to handle the infant and provide generalpatient care?

7 8 6 4 13 5

40 How easy do you find it to feed the baby? 7 10 1 1 1 2 1

41 What is your opinion of the ease of access to the infant for nursingprocedures?

7 9 5 1 12 3

42 How easy do you find it to use the suction facility on the device? 2 8 7 7 13 2

43 What is your opinion of the operator comfort when you are providingnursing and general care using this device?

3 6 9 2 5 12 3

44 Please indicate your experience of cleaning & disinfection of the unit 7 8 3 9 9

Part 7 Medical Procedures

45 How easy is it to perform a medical examination while the infant is inthis unit?

5 8 3 3 12 3

46 How easy is it to resuscitate an infant? 4 8 1 2 14 4

47 How easy is it to intubate an infant whilst using this unit? 3 8 1 2 8 4

Part 8 Phototherapy

48 How do you rate the vertical height adjustment of the phototherapyunit?

5 3 1

49 How do you rate the tilt adjustment of the phototherapy unit? 5 4 1

50 How do you rate the light output from the lamp? 5 2 2

Appendix 1

MDA evaluation, 01044, September 200115

NeonatalNurses

Midwives

Num

ber Question

Una

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51 How do you rate the glare from the lamps? 5 4 1

52 The phototherapy unit has two on/off switches, switching on two orfour bulbs. What is your opinion of this facility?

6 3

53 How effective do you consider the phototherapy is from this device? 1 4 3

Part 9 Ventilation and Oxygen Supply

54 How do you rate the control of flow of auxiliary oxygen? 8 8 1 7 14 2

55 How do you rate the range of flow of auxiliary oxygen? 8 8 1 5 14 2

56 How do you rate the tubing connection from the auxiliary oxygensupply?

1 8 7 1 6 13 2

57 How do you rate the labelling of the auxiliary oxygen supply? 8 6 0 1 9 11 2

58 Did you use the blender control system? Yes = 2 Yes = 2

59 How do you rate the ease of use of blender control? 1 2 2

60 How do you rate the range of operation of the blender? 1 2 2

61 How do you rate the range of flow of blended gas? 1 2 2

62 How do you rate the labelling on the blender? 1 2 2

63 Did you use pressure control system? Yes = 7 Yes = 2

64 How do you rate the range of operation of pressure control? 7 2 2 4

65 How do you rate the display of pressure generated? 1 6 2 2 4

66 How do you rate the ease of use of the control? 3 3 3 2 4

67 How do you rate the ease of connection to the breathing system? 7 2 2 4

68 How do you rate the breathing system supplied? 7 2 2 4

69 How do you rate the labelling of pressure control system? 7 2 2 4

70 Did you use the suction facility? Yes = 10 Yes = 13

71 How do you rate the range of vacuum of the suction system? 3 5 4 1 10 9 2

72 How do you rate the flow capability of the suction system? 3 6 3 9 10 2

73 How do you rate the size of the reservoir of the suction system? 2 6 4 9 10 2

74 How do you rate the ease of setting up the suction system? 2 6 4 10 9 2

75 How do you rate the ease of emptying the suction system? 1 7 3 1 10 9 2

Part 10 Training and Use of the Device

76 Did you receive training from the company? Yes = 7 Yes = 16

77 What was your opinion of that training? 1 3 2 1 1 4 3 4

78 Have you read the user manual? Yes = 12 Yes = 7

79 What is your opinion of the user manual? 7 3 5 2

80 Did you receive training from colleagues in your hospital? Yes = 11 Yes = 11

Appendix 2


HOW TO OBTAIN MDA EVALUATION REPORTSMDA Evaluation Reports are free of charge to NHS Trusts and Clinics

In EnglandMedical Devices AgencyRoom 1207,Hannibal HouseElephant & Castle, LondonSE1 6TQTel : 020 7972 8181

In ScotlandMr S EalesHealth Care Policy DivisionScottish Executive, HealthDepartment, St Andrew'sHouse, Edinburgh, EH1 3DGTel: 0131 244 3077

In WalesMr Richard RoweNational Assembly forWales, Health Services 3Division, Cathays ParkCardiff, CF10 3NQTel: 029 2082 3536

In Northern IrelandMr D CalfollaHealth Estates,Stoney Road,Dundonald, Belfast,BT16 OUSTel: 028 9052 0025

Copies may be obtained from the NHS Intranet site http://cymruweb.wales.nhs.uk/cedar/index.htm

ACKNOWLEDGEMENTSThis report was prepared by Dr Stephanie Wentworth, Dr Diane Crawford and Dr Nicholas Cook ofCEDAR, (Clinical Engineering Device Assessment and Reporting), Medical Physics and ClinicalEngineering Directorate, Cardiff and Vale NHS Trust, Cardiff and Dr John Mecklenburgh and Mr MarkHampson of the Department of Anaesthetics and Intensive Care Medicine, University of Wales College ofMedicine. All authors are under contract to the Medical Device Agency.

• Enquires to Dr Stephanie Wentworth, CEDAR, Cardiff Medicentre, University Hospital of Wales,Heath Park, Cardiff, CF14 4UJ. email [email protected] Tel 029 2068 2120 Fax : 029 2075 0239,INTERNET : www.imaging.uwcm.ac.uk/mpce/sctns/cedar/index

• Or Mr Arthur Goodman, Programme Manager, Medical Devices Agency, Hannibal House, Elephantand Castle, London SE1 6TQ. Tel 0207 972 8156 Fax : 0207 972 8105Email : [email protected] INTERNET : www:medical-devices.gov.uk

We thank Dr Mark Drayton, the Neonatal Intensive Care Unit at UHW, the special care baby units andneonatal units in Staffordshire General Hospital, Royal Oldham Hospital, and Tameside General Hospital;and the delivery suites in Taunton and Somerset District Hospital, Tameside General Hospital andLlandough Hospital for their help and co-operation in carrying out the user assessment. We would alsolike to thank Mrs SM Hancock of CEDAR for her administrative help with the technical work and MediaResources at UWCM for their assistance with photographs in this report.

Finally we would like to thank Fisher and Paykel Healthcare for supplying a sample of the CosyCotIW930 free of charge for the period of the evaluation.

DISTRIBUTION OF THIS REPORT

This report should be distributed to the following departments: Anaesthetics, Clinical Engineering, EBME,Labour and Delivery, Libraries, Maternity, Medical Physics, Neonatal Units and Special Care Baby Units,Obstetrics & Gynaecology, Paediatrics, Procurement and Supplies.

© CROWN COPYRIGHT 2001Apart from any fair dealing for the purpose of research or private study, or criticism or review, as permitted under theCopyright, Designs & Patents Act, 1988, this publication may only be reproduced, stored or transmitted in any form orby any means with the prior permission, in writing, of the Controller of Her Majesty’s Stationery Office (HMSO).Enquiries about reproduction should be made to the MDA at the above address.

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380 Ohmeda IWS 3400 Infant Radiant Warmer391 Neonatal Phototherapy - A review including evaluations of Ohmeda BiliBlanket & Medela

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