Neonatal Incubator / Infant Radiant Warmer Ohmeda Giraffe OmniBed
Contents
1. has staight sides but is curved at the ends giving an overall oval shape Photo 3 It has a sliding mechanism and can be withdrawn when horizontal from either side When withdrawn it may also be rotated about its centre 360 rotation available to allow better access to the neonate The mattress can be freely tilted to any angle up to 12 in either the feet up or head up direction when inside the baby compartment Photo 3 To activate the tilt a small slider at the controls end of the mattress is squeezed to release the tilting mechanism The mattress is locked into position on release Tilting the mattress with the Giraffe Omnibed in incubator mode requires the user to open a port or access door Vertical Height Adjustment VHA Foot switches marked and located on the wheel base frame Photo 1 activate the powered height adjustment mechanism and allow adjustment of the bassinet for user comfort or for more comfortable access by parents sitting beside the Giraffe for example when confined to a wheelchair The range of travel is stated in the Manufacturer s Data Controls and Information Screen Controls for all facilities except the VHA and the canopy operation are located above and to the back of the bassinet in a module attached to the two upright rails see Photo 4 The control panel is divided into two areas the left hand side consisting of buttons and indicators for temperature adjustment and display and the2. if fitted can be activated and used by selecting the scales icon Servo controlled relative humidity can be selected if this option is fitted using the three drops icon Storage A sliding storage drawer is fitted beneath the bassinet and may be accessed from either side Additional shelves and poles may be added Weighing scales Optional integral scales can be fitted beneath the mattress The scales are operated from the EL display screen on the right hand side of the control panel and selecting the scales icon accesses the in bed scales menu The menu software leads the user through a procedure to weigh the infant within the warming environment The scales should be calibrated annually using the procedure described in the service manual The patient weight data can be trended Photo 5 X ray tray withdrawn X ray tray An X ray tray may be fitted beneath the bassinet to enable X rays to be taken without disturbing the infant This may be done with the canopy up or down The tray is shown withdrawn in Photo 5 The scales if installed fit below the mattress and above the X ray tray and have an open clear space where they coincide with the X ray tray area CEDAR Note X rays taken using the tray may result in a higher dose to the patient because of the bedding the mattress and other plastics In a previous user assessment of incubators incorporating X ray trays or slots MDA Evaluation 375 it was discovered that users
3. opinion of the range of relative humidity values 30 to 95 BEARS 52 What is your opinion of its ease of use 8 18 What is your opinion of the ease of filling the water reservoir 2 10 10 8 54 How do you find the auditory warnings 4 15 14 How do you find the visual warnings 2 15 17 How clearly do you understand the alarm caption fife 57 How visible is the alarm caption MDA evaluation 02090 July 2002 22 Appendix Unacceptable atisfactory How easy do you find it to access the patient What is your opinion of the mattress size SE Mi mecan 4 61 range of tilt of the mattress 2 range of tilt of the mattress 2 tilt of the matress 62 rat wen EAA 63 mattress rotation mee a a a 65 suitability ofthe tubing pons jse 66 G7 security of canopy access doors when in incubator mode a aior ease oipertorming xrays O o heee Do you use the X ray tray 71 How easy do you find tto teed the intan Njeni 72 What is your opinion of he ease of access to the infant for nursing procedures 1 2 11 141 73 74 How easy do you find itto handle the infant and provide general patient care 1 4 12 14 How easy do you fnd itto teed theinfant it WO 13 7 76 Whats your opinion of the ease of access fo the infant for nursing procedures 1 5 10 16 77 How easy is it to perform a medical examination
4. the vertical rails inset Photo 3 Once the pedal or canopy up finger switch has been pressed the canopy rises in one uninterrupted movement On activation using either switch the canopy immediately rises and small doors enclosing the radiant heater at the control end of the canopy start opening When the canopy reaches its maximum height the heater doors are fully open and the radiant heater automatically switches on To switch back to incubator mode the down finger switch marked v must be pressed and held to activate the lowering mechanism If it is released the canopy will stop in mid travel Immediately the canopy starts its descent the MDA evaluation 02090 July 2002 Photo 1 Giraffe OmniBed in incubator mode radiant heater switches off and the heater cover doors close Raising the canopy when the incubator is in servo controlled baby mode automatically activates the radiant heater in servo controlled baby mode using the same set temperature Similarly if the canopy is lowered and the radiant heater was in baby mode the incubator will activate and continue to operate in baby mode Photo 2 Special foot pedal for raising canopy If the Giraffe OmniBed is in air controlled mode when the canopy is raised then the radiant heater when the canopy reaches the end of its travel will activate in pre warm mode and prompt the user for a manual heater power setting When lowered in manual heater mode it will operate in ai
5. warm air to achieve this temperature The fan speed may be increased to enhance the air flow through the double walled side panels of the Giraffe OmniBed by pressing the Boost Air Curtain button This extra flow of warm air is designed to help reduce heat loss and increase the rate at which the incubator achieves the set temperaure This feature is also designed to help reduce heat loss when the access door is open as demonstrated by the icon for activation Once activated the fan operates at high speed for 20 minutes and then automatically switches back to normal speed it may be manually switched back Description by pressing the open incubator icon again CEDAR Note For conditions under which the high speed fan is activated see Manufacturer s Comments Photo 7 The water reservoir Humidification The Ohmeda Giraffe OmniBed has an integral humidification system option The water reservoir is built into the end of the bassinet furthest from the controls and contains a heater column see Photo 7 The heater column in the humidity system is designed to heat the water to boiling point and then release water vapour into the warm air stream conveying it into the patient chamber The water boiling mechanism is designed to prevent infection reaching the patient from the humidity system The water in the reservoir itself does not boil The reservoir and heater column are marked with minimum and maximum water levels When the reservoi
6. 2002 User Assessment Figure 3 User Response Questions 28 to 31 and 51 to 57 Number of Respondents 0 5 10 15 20 25 30 35 40 Skin sensor s size and shape 28 Length of lead 29 jj Ease to fix the sensor to the patient 30 I Patient lead connection to the socket on the Giraffe 31 E Unacceptable Range of relative humidity values 30 to 95 51 EE Poor Satisfactor Ease of use of relative humidity 52 J Good Ease of filling the water reservoir 53 i E Excellent Auditory warnings 54 _ Visual warnings 55 Understanding the alarm caption 56 E Visiblility of the alarm caption 57 J radiant warmer mode The unacceptable response was accompanied by a comment that it was difficult to see the display when the patient needed phototherapy One of the users who rated the display as poor commented that they could be larger brighter Figure 3 considers the skin sensor the relative humidity system and the alarms Both reusable and disposable skin sensors were used Users indicated that they thought they were satisfactory or good but neither type elicited a specific comment The lead was thought to be a little too long and the sensor head a little large for very small babies More nurses commented that connecting the lead to the Giraffe socket
7. DA evaluation 02090 July 2002 Appendix Unacceptable atisfactory What do you think of the length of lead a 15 17 How easy do you find it to fix the sensor to the patient 1 14 16 What is you opinion of the patient lead connection to the socket on the Giraffe What is you opinion of the patient lead connection to the socket on the Giraffe 3 14 12 Please give your opinion of the EL graphic control display screen on the right hand side of the control panel Do you find it easy to use and move between options 42 What is your overall opinion of the trending screen and information O Jila The next icon a smiling face and thermometer accesses a menu which gives 43 information on possible temperature settings for different age and birth weight babies Have you used it 44 If you have used it what is your opinion of this feature 5 17 The spanner symbol accesses the settings menu for changing alarm volume patient alarm settings and other user settings Have you used this If so what is your opinion of the settings menu z7 9 If your Giraffe has in bed scales the scales symbol accesses the in bed scales menu Have you used this If so what is your opinion of this feature 1 5 10 The three drops icon accesses the integral relative humidity control and display menu Have you used this feature 50 If so what is you opinion of this feature 8 12 What is your
8. NT WARMER MODE Temperature was measured using five matt black aluminium discs constructed and positioned on the mattress as described in BS EN 60601 2 21 the standard for infant radiant warmers Warm up time Using the Giraffe s automatic pre warm mode 100 power for 10 minutes then 25 heater power raised the temperature of the central disc on the mattress by 4 7 C after 30 minutes as shown in Table 4 The temperature continued to rise slowly at a rate of 0 5 C per hour over and above the ambient temperature Table 4 Radiant Warmer Mode a Temperature rise using Manufacturer s pre warm after 30 minutes 4 7T Maximum heat after 15 minutes 5 9 C b Time to warm disc to 36 5 C Max heat from ambient 23 C 38 mins Max heat from pre warm temp 24 mins 28 3 C Temperature variation when 1 3 C horizontal at 36 5 baby temperature Temperature variation when tilted 0 6 C towards controls Temperature variation when tilted 2 2 away from controls The time to achieve 36 5 C skin control temperature from the pre warm state and from ambient cold start were also measured as it was considered that these would be conditions under which the Giraffe OmniBed may be used Temperature Stability From a steady state the variation in temperature across the mattress when horizontal and when in each of its two extreme tilted positions were measured and are shown in Table 4 In the horizontal position th
9. Price ex VAT 27 000 basic unit 29 000 with servo Oz Supplier Datex Ohmeda Ltd see product support for contact information CE marking Yes Notified Body Manufactured to Standard BSI 0086 Type tested by CSA International to IEC 60601 1 IEC 601 2 19 amp IEC 601 2 21 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 Care needed on raising canopy to avoid collisions with other equipment close by Expensive Water reservoir difficult to open BRIEF DESCRIPTION A novel device combining an incubator and a radiant warmer in one unit The transformation from an incubator to a radiant warmer is activated by the touch of a switch All the usual features of an incubator and radiant warmer are included In addition the mattress swivels MAIN FEATURES Incubator Mode e Air temperature control Baby temperature control Integral humidification Access doors two Access ports up to five Radiant Warmer Mode e Maximum power 450W e Manual control e Baby temperature control General e Vertical height adjustment foot switch e Canopy control Foot switch raise only Finger switch raise and lower Mattress rotates 360 Electroluminescent control screen Four whee
10. T YOU CAN EXPECT FROM MDA EVALUATION REPORTS DISCLAIMER The Device Evaluation Service DES aims to provide independent and objective evaluations of medical devices available on the UK market Specialist centres mainly in NHS Trusts do the evaluations under long term contract to and in accordance with protocols approved by the MDA The evaluations are usually of a unit supplied by the manufacturer We would expect this unit to be representative of the product on the market but cannot guarantee this Prospective purchasers should satisfy themselves with respect to any modifications that might be made to the product type after MDA s evaluation The reports are intended to supplement not replace information already available to prospective purchasers CROWN COPYRIGHT 2002 Apart from any fair dealing for the purpose of research or private study or criticism or review as permitted under the Copyright Designs amp Patents Act 1988 this publication may only be reproduced stored or transmitted in any form or by 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 MDA evaluation 02090 July 2002 24
11. accessing the baby in an emergency The height of the device maximum 2 36m was not a problem for most users and one nurse noted that it was high and out of head hitting height Figure 2 shows the response to questions 13 to 25 concerning the temperature controls and the ease of use The temperature controls were considered good by most users some of whom commented that they found them easier to use when they were more familiar with them However some considered the controls hard to reach because they were behind the canopy Most users were at least satisfied with the temperature displays both in incubator mode and Number of Respondents 10 15 20 25 30 35 40 Accessibilty of controls 13 Ease of use temperature controls 14 Clarity of controls 15 Visibility of controls 16 BP Heater power range 17 Heater power visibility 18 F IRW mode changing modes 19 Ease of use IRW mode in manual mode 20 Ease of use IRW mode in baby mode 21 Unacceptable E Poor E Satisfactory Good E E Excellent Visibility of set and measured baby temperature 22 Ease of use NI mode air temperature mode 23 Ease of use NI mode baby temperature mode 24 Displayed set and measured baby temperature 25 M MDA evaluation 02090 July
12. aising the canopy can be seen to have an appreciable effect the temperature drops and then stabilises at 32 C When the canopy is closed the temperature drops again briefly before rising to regain the set temperature of 38 C This demonstrates that if the canopy is raised then setting the heater at 100 power provides a warmer environment than using the pre warm value of 25 heater power At the lower heater power the Giraffe takes a shorter time to regain 38 C On closing the canopy after using 100 heater power the Giraffe OmniBed appears to try to reach a temperature of 36 C as the shallow saddle point on the graph shows before moving up to 38 C These results are shown in Table 2 The average time to raise and lower the canopy is discussed later in this Technical Assessment For a comparison of the temperature fall measured during opening the incubator canopy opening four port holes and opening the access door see Table 3 As expected opening the port holes results in the smallest temperature disturbance to the baby whilst raising the canopy produces the largest Table 3 Test with the Giraffe set Temperature at 38 C and 95 RH drop Open 4 ports for 5 minutes 1 9 C Open 1 access door for 5 3 6 minutes Raise the canopy for 15 13 6 minutes use 25 power Raise the canopy for 15 9 8 minutes use 100 radiant heater power MDA evaluation 02090 July 2002 Technical Assessment RADIA
13. aising and lowering the canopy indicate your opinion of the height of the device when in radiant py_ 3 15 13 What is your opinion of the general ease of use of all Giraffe temperature 2 4141415 controls How clear do you find the controls 2 19 13 How visible are the Giraffe temperature controls 1 2 9 22 What is your opinion of the range of heater control in manual mode 0 to Ff fg faz 100 How do you find the visibility of the heater power level 1 9 18 How easy do you find it to change the Giraffe temperature in radiant warmer 12 mode between manual and baby How easy do you find it to use the radiant warmer controls in manual mode 16 12 How easy do you find it to use the radiant warmer controls in baby mode 16 13 22 How do you find the visibility of the set and measured baby temperature 1 13 14 How easy do you find it to use the incubator temperature controls in air f Jo 19 temperature mode How easy do you find it to use the incubator temperature controls in baby 2 12 temperature mode What is your opinion of the display of the set and measured baby temperature a 11 20 Do you often use the boost air curtain auxiliary fan Disposable 7 27 Please circle the type of skin sensor you use disposable OR reusable Reusable 18 28 What is your opinion of the skin sensor s size and shape 21 M
14. and they all considered it satisfactory or good one commented that they liked the trending facility but found that they were liable to lose the trend information between shifts when other users used the Giraffe The in bed scales were well liked and a high proportion of users rated them as excellent but two users commented that they had obtained three different readings when taking measurements consecutively It was not clear whether this was user unfamiliarity or a problem with the scales Care must be taken to follow the weighing procedure prompted by the EL display screen All the users who had used the humidity facility rated it satisfactory or better None of the features considered in Figure 4 were rated as unacceptable Figure 5 shows the responses to questions about the patient area the mattress and the tubing ports Again generally these features were well liked MDA evaluation 02090 July 2002 10 The mattress area was large and this was considered good by many nurses although some felt that the baby looked very small in the middle The mattress tilt was considered good and two users commented that they would like more tilt since some babies require it The tubing ports were a problem for some nurses They complained that the grommets that fitted in the tubing port holes fell off after a while and also that they clasped ventilator tubing too tightly They preferred to use iris ports to route and support ventilator tubin
15. bator mode and the procedure above repeated using 100 radiant warmer power whilst the canopy was raised see Figure 8 This time the temperature dropped initially by 9 8 C but then rose to settle around 32 C On closing the canopy the temperature dipped again briefly to 30 6 before rising to regain the set temperature of 38 C in 14 minutes Recovery time was prolonged by a saddle point at 36 C It appeared that the Giraffe tried to use 36 C as the set temperature before continuing to warm up to 38 C No change on the display was noticed For ease of comparison only the temperature of the central thermometer is shown and graphs of the two tests have been superimposed in Figure 8 In both procedures the boost air curtain option was activated after closing the canopy to enable optimum re warming of the incubator CEDAR note It is easy to forget to manually activate the auxiliary fan which is not automatic on closure of the canopy Table 2 Transition Time to regain 38 C in incubator 12 5 mode after 25 heater power minutes Time to regain 38 C in incubator 14 mode after 100 heater power minutes Time to regain 36 5 C in radiant 8 5 warmer mode after lowering the minutes canopy and switching off Technical Assessment 15 Using 25 heater power provides very little heating effect to the mattress and the temperature drops to just 2 C above ambient room temperature 100 radiant heater power on r
16. c Opening ports and doors air control temperature of 38 C and RH 95 Time to regain 38 C after opening 3 minutes 4 ports for 5 minutes Temperature overshoot above 0 5 C previous average temperture Time to regain 38 C after opening 6 minutes one access door for 5 minutes Temperature overshoot above 1 1 C previous average temperature Opening the access door caused a larger temperature drop of 3 6 C but the set air temperature 38 C was regained in only 6 minutes However once again there was a temperature overshoot of 1 1 C after the door has been closed as shown in Figure 7 and Table 1 section c This result can be compared to the response of other incubators to this test shown in the earlier evaluation report Evaluation 375 the overshoot is well within the limits set by the standard 2 C Relative Humidity Measurements of RH were made during the above tests When the access door or four ports were opened for 5 minutes the RH dropped from its set value of 95 to around ambient RH in this case 50 The set RH level was quickly regained in 2 minutes once the door or ports were closed again performing as well as other incubators evaluated in Evaluation 375 Transition from Incubator Mode to Radiant Warmer Mode Raising the canopy The Giraffe OmniBed is designed to provide good emergency access to a sick neonate being nursed in an incubator by changing swiftly from incubator mode t
17. d rose to the top of its travel in approximately six seconds It could be stopped in its ascent by pressing the finger switch or foot switch again Descending the canopy was slower and took approximately 14 seconds however if an object for example a hand was in the path of the descending canopy the canopy would not stop and pressure would be applied to the object A safeguard built into the design was that the canopy could only be lowered by pressing and holding the down finger switch Once released the downward travel would stop Height The height of the device in its various configurations is given in the Manufacturer s Data section As the maximum height of the overhead heater exceeds two meters care must be taken to ensure that there is enough headroom to raise the canopy of the Giraffe OmniBed to radiant warmer mode CERTIFICATION AND STANDARDS Medical devices placed on the market in the European Union are required to comply with the relevant European Union Medical Devices Directive Manufacturers must display the CE mark on the device as a declaration that it meets the appropriate provisions of the relevant legislation including those relating to safety and where required has been assessed in accordance with these The Giraffe OmniBed carries CE marking in respect of the Medical Devices Directive MDD Datex Ohmeda submitted a certificate confirming compliance with European Council Directive 93 42 EEC based on full qua
18. dard including elevating base in 27 000 bed scales and servo relative humidity Giraffe OmniBed as above with servo oxygen 29 000 Monitor shelf 700 Instrument shelf 425 IV mounting pole 200 72 Ventilator mounting pole 234 Utility post 99 84 IV dual hook 12 122 72 IV pole dual hook 24 155 Porthole wristlets box of 8 25 Hood cover 150 Filter pack of 10 50 Tubing management arm 250 Fitted mattress cover 50 High Frequency Oscillatory Ventillation HF OV porthole 135 Disposable patient probe box of 10 150 Disposable patient probe box of 50 650 Reusable patient probe 150 Heat reflecting patch box of 50 13 Examination lamp specify Giraffe plug or wall outlet plug 850 Phototherapy lamp Spot light specify IEC or UK plug TBC Physical Data Size H x W x D 147cm to 236cm with VHA and canopy raised x 69cm x 112cm Weight 129kg Mattress size 65cm x 50cm Bed tilt 12 continuously adjustable Heater movement Does not rotate Castors 4 locking Heater power 450W PRODUCT SUPPORT Supplier Datex Ohmeda Tel 01707 263570 71 Great North Road Fax 01707 260065 Hatfield Hertfordshire AL9 5EN Web www ohmedamedical com Guarantee 1 year Servicing Warranty Extension with Planned Preventative Maintenance 1153 17 Fully comprehensive for a 3 or 5 year period Includes year 1 maintenance per year Only available at time of sale Planned Preventative Maintenance inc
19. e ease to feed infant 71 Satisfactory IRW mode ease of access for nursing 72 Good NI mode ease to provide general patient care 74 NI mode ease to feed the infant 75 NI mode ease of access for nursing 76 IRW mode ease of medical examination 73 J OC E Excellent Operator comfort 78 NI mode ease of a medical examination 77 Cleaning and disinfection of the unit 79 11 MDA evaluation 02090 July 2002 User Assessment X rays were taken by radiographers and most of the nurses thought that it was fairly easy to do Two neonatal units were not using the X ray tray At one of these a nurse stated that due to the increased radiation required we are not using the X ray tray CEDAR Note Local measurements of radiation dose when using the tray had led radiation protection professionals at that hospital to advise radiographers against its use When the tray is not used babies requiring X rays are lifted and the X ray film placed underneath them Figure 6 shows the response to the questions concerning nursing and medical procedures carried out whilst the infant is in the Giraffe One nurse rated all of the questions here as unacceptable because difficulty was encountered during procedures The Giraffe was considered wide and this made it di
20. e that many nurses had not used One technical comment received queried why the fan boost was not automatic on closing the incubator canopy in the transition from radiant warmer mode to incubator mode It was very easy to forget to switch the fan boost on to enhance the speed at which the incubator attained the set temperature MDA evaluation 02090 July 2002 User Assessment Figure 4 User response Question 26 27 32 to 50 Number of Respondents Timer 36 amp 37 0 5 10 15 20 25 30 35 40 Fan boost 26 Reusable or disposable skin sensor 27 EL screen ease of use 32 Not used Moving between options easy 33 No J Z Used Yes Help screens 34 amp 35 E Poor Apgar timer 38 amp 39 Satisfactory Trending 40 amp 41 Good Temperature settings 43 amp 44 E Excellent User settings 45 amp 46 In bed scales 47 amp 48 Humidity 49 amp 50 t A few users rated the Electroluminescent EL screen poor but most said that they found it easy to use The help screens were found to be helpful especially when the nurses were new to using the Giraffe None of the nurses used the Apgar timer this feature is more appropriate for delivery suite Neither did they use the other timing facility Only three nurses used the trending facility
21. e temperature variation should be less than 2 C to comply with the standard There are no specification for when the mattress is tilted but as shown in Table 4 a 2 2 C variation was measured when the mattress was tilted away from the controls Simulation of an internal transfer To assess the performance of the Giraffe OmniBed when used in radiant warmer mode but needed for an internal transfer between departments in a hospital the following test was devised The Giraffe OmniBed was set in skin control mode at 36 5 C and stabilised The canopy was then closed and the Giraffe OmniBed prompted the user for a temperature setting for incubator mode The device was then switched off for 15 minutes to simulate its condition during an internal transfer since it has no backup battery to maintain power during a power failure When switched on again the canopy was raised to its full extent the Figure 10 Surface temperature of the mattress at 50 radiant heater power max temperature 34 C Controls MDA evaluation 02090 July 2002 16 E 0 to 1 C below 1 to 2 C below 2 to 3 C below n 3 to 4 C below m 4 to 5 C below 36 cy 35 Temperature C g 33 ft 32 _____ Canopy closed and Giraffe 31 __ __ switched off T T T T T T T 100 120 140 160 180 200 220 240 Time minutes Figure 9 Simulation of an internal transfer the effect on temperature Giraffe automatica
22. er had been replaced in another the mattresses had all split down the seams and had had to be replaced The third neonatal unit encountered problems with the transformer but the Giraffe was still under warranty and Ohmeda responded the same day Two technicians experienced in working with incubators and radiant warmers commented that they would have liked to have been able to purchase the Service Manual from Ohmeda without attending the specific Giraffe technical training course They also noted that when authorising purchases of expensive medical equipment allowing a budget for technical training of in house staff expected to cover first line maintenance should be a priority TECHNICAL ASSESSMENT The Ohmeda Giraffe OmniBed is a very new type of device Ohmeda claims compliance with the general medical devices international standard BS EN 60601 1 and the standards for both neonatal incubators BS EN 60601 2 19 and infant radiant warmers BS EN 60601 2 20 Our technical assessment is based on these standards and performance tests developed at CEDAR in consultation with experienced clinical users of radiant warmers and incubators Results of these tests may be compared with those of other recent evaluations of infant radiant warmers INCUBATOR MODE Warm up time We tested the speed at which the Giraffe OmniBed warmed up to temperatures commonly required for nursing sick neonates An air control temperature of 34 C and relative humidit
23. fficult for a nurse assisting from the other side of the mattress during a procedure Many nurses stated that it was difficult to feed the baby using a gravity feed system since this is normally administered via a tube which is fed through a hole in the canopy of the incubator The Giraffe OmniBed does not have a hole in the canopy CEDAR Note The Giraffe Incubator as opposed to the Giraffe OmniBed does have a hole in the canopy It was also noted that changing linens was difficult One other problem highlighted was that during care for example changing a nappy it was not possible to put items safely on the canopy because it sloped Cleaning the Giraffe OmniBed was rated as Satisfactory or better by most nurses although one nurse commented that it took a long time and was fiddly Overall the Giraffe was a well liked device Users had become aware that special precautions were needed such as positioning it away from the wall where the rising canopy could cause an accident Many users commented that the humidity function the rotating mattress and the fact that it could function as both an incubator and a radiant warmer were advantages Considering the user responses of the separate neonatal units one neonatal unit scored the Giraffe lower than the other two This was linked to the location of the Giraffe within their unit and an increased need for training The use of existing phototherapy equipment with the Giraffe led to many ad
24. g but these were not available on their Giraffes The use of tubing ports was also a problem in one unit where they administered oxygen directly into the canopy to provide a higher ambient level No oxygen port was available on their Giraffes so they had to use one of the port holes Mattress rotation was well liked and one user thought 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 User Assessment Figure 5 User Response Questions 58 to 68 Number of Respondents 0 5 10 15 20 25 30 35 40 Ease to access the patient 58 C Mattress size 59 Mattress tilt mechanism 60 E Unacceptable Range of mattress tilt 61 Poor Mattress tray withdrawal 62 Satisfactory Mattress rotation 63 Good Security of the side panels 64 Suitability of the tubing ports 65 I Suitability of hand ports 66 fj E Excellent Security of access doors in incubator mode 67 Ease of performing X rays 68 Figure 6 User Response Questions 70 to 79 Number of Respondents 0 5 10 15 20 25 30 35 40 IRW mode ease to provide general patient care 70 E Unacceptable E Poor IRW mod
25. he top of the reservoir has greatly improved accessibility This new design was incorporated into new Giraffe products from 17 6 2002 New lids will be shipped free of charge to all existing Giraffe customers during summer 2002 The temperature of the reservoir water has been measured to be 52 to 58 C this is considered bactericidal to most mesophilic micro organisms that may thrive in the human body or act as pathogens Tubing Grommets have undergone a design change to improve retention Changed parts were provided free of charge to all customers who had purchased a Giraffe OmniBed The air circulation fan operates at 1000 amp 1500 rpm High fan speed is activated under 4 conditions 1 for 90 minutes after unit start up as an incubator 2 for 45 minutes after transition from warmer to incubator 3 whenever the Boost Air button is activated and 4 if the heater temperature exceeds a pre set temperature Sloping canopy This and the omission of a hole are intentionally part of the design for safety reasons It is not prudent to suspend or place equipment on a device with a rising canopy Developmental care principles identify that placing items on top of a canopy raises sound levels within the hood and carries a risk of marking or damaging the surface of the hood particularly where liquids are used Ancillary equipment may be requested when purchasing the OmniBed to allow users to customise the OmniBed to their requirements Most users do not
26. ir temperature control mode and maximum RH 95 When a steady state had been achieved four hand ports were opened for five minutes After the ports had been closed and a steady temperature state was re established one of the two access doors was opened for five minutes Opening the four ports causes the temperature to drop by 1 9 C it quickly recovers but an overshoot of 0 5 C was observed see Figure 7 and Table 1 section c Figure 7 Effect of opening hand ports and access door on air temperature 40 39 38 37 2 36 Air control temperature 38 C RH setting 95 35 Ambient temperature 23 C D Ambient RH 39 E 34 H o ml 33 32 Four ports open One access door open H H 30 i 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 Time minutes 13 MDA evaluation 02090 July 2002 Technical Assessment Table 1 Neonatal Incubator Mode Section a Warm up time using Air control temperature set to 34 C 32 5 and RH set to 50 minutes Air control temperature set to 38 C 50 and RH set at 95 max value minutes Section b Temperature Uniformity air control temperature of 38 C and RH 95 Mattress horizontal 0 3 C Mattress tilted towards controls 0 1 C Mattress tilted away from controls 0 4 T Section
27. l locks X ray tray Sliding storage draw Integral scales Description CONTENTS Description User Assessment Technical Assessment Manufacturer s comments Manufacturer s data Appendix Questionnaire Data Acknowledgements amp MDA information DESCRIPTION The Ohmeda Giraffe OmniBed is a novel device designed to operate as both an incubator and a radiant warmer so reducing the necessity of transferring the patient This mobile device incorporates all the usual features of modern incubators and radiant warmers In incubator mode Photo 1 it has air temperature and baby skin temperature control and integral humidification In radiant warmer mode Front Cover Photo it has baby skin temperature control and manual heater control where the user selects the percentage of power output from the radiant heater The Giraffe operates either as an incubator or a radiant warmer never as both simultaneously Auditory alarms have adjustable volume and visual alarms include a large bank of red light emitting diodes LEDs above the control panel FACILITIES Canopy The transformation from incubator to radiant warmer mode is activated by the touch of a foot switch see Photo 2 and Photo 1 located on the wheel base parallel to the vertical height adjustment VHA pedals There are VHA and canopy foot switches located on each side of the wheel base frame The canopy can also be activated by a finger switch located each side beside
28. lity assurance Annex II of MDD The Notified Body was BSI UK 0086 device classification Ib Datex Ohmeda also supplied a certificate from Ohmeda Medical Laurel MD USA stating that the Giraffe OmniBed System is a Class 1 device with Type B applied parts and that it had been type tested by Canadian Standards Authority CSA International They had issued a CB Test Certificate stating that it was found to be in conformity with International Electrotechnical Commission IEC 60601 1 the Technical Assessment amendments 1 1991 and 2 1995 IEC 601 2 19 particular standard for incubators and IEC 601 2 21 particular standard for radiant warmers Procurement issues All prices in this report exclude VAT and are correct at time of going to print however you are encouraged to contact Datex Ohmeda at the address given for current prices and configurations Training User knowledge and skills have major implications for safety Procurement of a new medical device should include a_ resource allocation for user training and also any technical training for the Clinical Engineering EBME technical staff should they be required to maintain general safety standard edition 2 1988 including it MANUFACTURER S COMMENTS Generally we consider this a very favourable review of the Giraffe OmniBed both technically and from a user assessment We have addressed some of the points raised below Water Reservoir A design modification to t
29. lly entered skin control mode and the 36 5 C temperature setting was confirmed Changes in temperature during this test are shown in Figure 9 The temperature dropped by 1 8 C and recovered to an average temperature of 36 8 C while set at 36 5 C in 8 5 minutes It must be noted that this figure shows how the temperature as measured within the disc fluctuated between 36 5 C and 37 C The periodicity was approximately 17 minutes CEDAR Note There are no specific limits on fluctuations of temperature This data is provided for comparison with other Evaluation reports Surface Temperature The uniformity of heating across the mattress is important to clinical users of radiant warmers To assess this the Giraffe OmniBed was set at 50 manual power output and the mattress was covered with a black felt Technical Assessment sheet marked at 5cm intervals After one hour a surface temperature probe was used to measure the temperature at each of the marked points The contours in Figure 10 display the temperature difference from the maximum 34 C at the centre of the mattress It is seen to be slightly skewed to the left and the contours are tighter towards the controls end of the mattress which could be attributed to the shape of the reflector behind the radiant heater element directing the heat onto the oval shaped mattress The black oval shape on Figure 10 represents the approximate dimensions of the mattress The temperature varia
30. ludes routine labour and parts 960 93 Comprehensive includes routine labour and parts and corrective 1537 45 maintenance labour and parts Biomed partnership with corrective maintenance includes second level 1153 17 training routine parts and corrective maintenance labour and parts MDA evaluation 02090 July 2002 20 Appendix Table A1 User assessment data from questionnaire The number of users sharing the same opinion about a feature is recorded eg 17 users thought general mobility was good The most common response is marked in BOLD For some features only a few users scored their opinion on their questionnaire Unacceptable Satisfactory 1 What is your opinion of the general mobility ofthis devie 2fe 7 2 What is your opinion ofwheel locks ele What is your opinion ofthe stability ofthis device Jeta 4 What is your opinion ofthe vertical height adjustment ofthe device 2 7 me What is your opinion of the VHA mechanism ofthe device i 0 8 What is your opinion ofthe eupboardidrawer space on the ui a e fre 7 what is your opinion ofthe fixing of ancillary equipment to this device 3 o no 3 What is your opinion of the foot switches for raising the canopy to radiant warmer 2 faz 16 mode 10 What is your opinion of the finger switches for raising and lowering the canopy ras yeu oenar oe nger setetes o raising and tonerna teret L ae e your opinion of he speed of r
31. n 02090 July 2002 User Assessment items they considered essential for example shelves and poles were not included in the price of the Giraffe CEDAR Note see Manufacturer s Comments In a later question one user commented that battery powered syringe drivers had to be secured to the Giraffe by tape The general appeal of the unit was well spread with the majority rating it as satisfactory or good but a few users rated it as unacceptable or poor The foot pedals for raising the canopy were generally rated well although in all three units they were disabled either permanently or using the user settings menu The main reason was that accidents had occurred where the canopy had been raised and had collided with other equipment attached to the wall damaging both One Giraffe had a cracked canopy as a result of such an accident Nurses were also concerned that small children could step on the pedal Disabling the foot pedals reduced the risk of their inadvertent activation CEDAR Note Once the pedal has been pressed the canopy rises in one uninterrupted movement the pedal does not have to be held down in the same Figure 2 User Response Questions 13 to 25 way as the VHA pedals see Description More users scored the canopy finger switches as excellent but one user commented that they were small and difficult to access if lots of equipment around The speed at which the canopy rose was well liked and considered good for
32. o radiant warmer mode Its ability to maintain a steady thermal environment for the Figure 8 Effect of raising the canopy and setting the radiant heater at 25 and 100 power 40 38 36 a 34 32 _ ie el 25 IRW 30 Temperature C ye 100 IRW 28 J 26 Raise canopy Pa Close canopy 24 70 80 90 MDA evaluation 02090 July 2002 100 110 120 130 140 150 160 170 180 190 200 210 220 Time minutes 14 baby is also important To simulate the impact on a neonate of the change from incubator mode to radiant warmer mode we monitored the change in temperature 10cm above the mattress using the same experimental set up as for testing the Giraffe in incubator mode The Giraffe was stabilised at 38 C air control temperature and 95 RH maximum level The canopy was then raised and the radiant heater set to its default value of 25 After 15 minutes the canopy was lowered and the Giraffe OmniBed reset to the original settings the high fan speed option was activated once the canopy had been lowered to allow the Giraffe OmniBed its optimum warm up rate The temperature dropped by 13 6 C to 25 C a little above the ambient temperature of 22 9 C as can be seen in Figure 8 On closing the canopy the air control temperature 38 C was regained in 12 5 minutes The Giraffe temperature was re stabilised in air controlled incu
33. ollowed by 25 power pre warm heater setting The factory setting of 25 pre warm mode up to which no alarms will be activated can be adjusted up to 50 using the procedure in the service manual however the user is warned that in doing MDA evaluation 02090 July 2002 so the device no longer complies with the safety Standard for infant radiant warmers BS EN 60601 2 21 CEDAR Note On contacting the manufacturer they confirmed that this refers to section 46 104 and Appendix AA General Guidance and Rationale of BS EN 60601 2 21 A radiant warmer is required to activate an alarm every 15 minutes if it is in manual mode unless the infra red IR irradiance as measured at the mattress is less than 10mW cm Datex Ohmeda state that at 25 power this criteria is fulfilled It must be noted that the heater is rated as 450W When a skin sensor is connected the baby s skin temperature is displayed on the temperature panel on the left of the control panel On switching to baby control mode by pressing the baby icon a temperature between 35 C and 37 5 C can be set in the same way as in incubator mode Two skin sensors may be connected simultaneously for example to measure the temperature at two sites on the baby s skin or if twin babies are co bedded The Giraffe OmniBed will not then operate in baby mode but will display the second skin temperature at the top right hand corner of the EL control and display panel Alarms The ala
34. or loaning this device for evaluation free of charge HOW TO OBTAIN MDA EVALUATION REPORTS MDA Evaluation Reports are free of charge to NHS Trusts and Clinics In England In Scotland In Wales In Northern Ireland Medical Devices Agency Mr R Stock Ms S Woolhouse Mr D Cafolla Room 1207 Health Planning amp Quality National Assembly for Health Estates Hannibal House Division Scottish Executive Wales HIMTE 3 Stoney Road Elephant amp Castle Health Department Cathays Park Dundonald London SE1 6TQ St Andrew s House Cardiff CF10 3NQ Belfast BT16 1US Edinburgh EH1 3DG Tel 020 7972 8181 Tel 0131 244 6913 Tel 029 2082 3373 Tel 028 9052 3745 OTHER RECENT MDA REPORTS ON NEONATAL DEVICES Evaluation Reports are available from the above addresses or in full on the NHS INTRANET http cymruweb wales nhs uk cedar index htm 01162 Draeger 4000 Photo Therapy Unit Dec 2001 01161 Medela Phototherapy Lamp Dec 2001 01160 Mediprema Cradle 360 Dec 2001 01044 Fisher and Paykel CosyCot Infant Radiant Warmer and Resuscitation Unit Sept 2001 01043 Hill Rom Air Shields Resuscitaire Infant Radiant Warmer amp Resuscitation Unit Sept 2001 DISTRIBUTION OF THIS REPORT This report should be distributed to the following departments Clinical Engineering EBME Labour and Delivery Libraries Maternity Medical Physics Neonatal Units and Special Care Baby Units Obstetrics amp Gynaecology Paediatrics Procurement and Supplies WHA
35. r temperature mode as an incubator at the last set air temperature or at 33 C the programmed pre warm temperature and then prompt the user for a manual air temperature Photo 3 Access door open and mattress tilted Inset canopy finger switches Patient area amp bassinet The bassinet baby compartment has four sides that can be removed individually for cleaning Three sides can be folded down to increase patient access the back panel below the control panel does not fold down This panel on the samples we saw had a long tubing port the two longer sides or access doors have two ports each The access doors sides are hinged at the base and are weighted so that if they are left unlocked and fractionally open they move towards the closed position Their being unlocked is evident from the orange flashes visible on the catches The end panel above the humidifier may optionally have a hand port a long tubing port or no ports We saw one model with a hand port Photo 1 and one with no port Front Cover photo In incubator mode the canopy fits snugly onto the four sides allowing only the two side access doors to be folded down The panel furthest from the controls cannot be folded down with the canopy in place The side access doors have double walls to reduce radiant heat loss and provide a channel for the warm airflow into the incubator These double Description walls may be removed for cleaning The mattress
36. r is tilted open the heater column marker corresponds to the maximum level on the plastic reservoir when it is closed To activate the servo controlled relative humidity option the three drops icon is selected on the EL controls and information screen and the knob pressed see Photo 8 The level of relative humidity 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 a choice the knob must be pressed again MDA evaluation 02090 July 2002 Description EE Photo 8 Activating the relative humidity option To leave the EL control and display screen EXIT must be selected by turning the knob which should then be pressed to confirm the choice However it will default to the EXIT position after a short time Radiant Warmer Mode The radiant heater is only activated and powered when the canopy is at its topmost position and the heater doors are fully open The heater is a coiled metal element located behind a guard see Photo 9 A hemispherical reflector behind the heater is designed to focus the heat onto the mattress Photo 9 Radiant heater Temperature Control On switching into radiant warmer mode the control panel will prompt for a temperature setting The heater can be set manually in 5 increments If no temperature or power level is selected the Giraffe OmniBed will default into an automatic warm up mode of 100 power for 10 minutes f
37. request this level of information Exam lights and phototherapy spot lights are available for the Giraffe they may be ordered with connectors for wall sockets or accessory power outlets and mount on the rail system Ventilator tubing support is also now available Sound levels of 55 2dB A correspond to the Giraffe OmniBed in incubator mode in Boost Air Mode The conditions under which the Giraffe normally operates expose the patient to a noise level of 46 3 dB A The control panel location at the head of the device is designed to be accessible from both sides allowing wider visibility of the information and it is also better protected from knocks The temperature sensor connector is deliberately placed to prevent accidental removal and damage to the sensor from frequent removal Their interfaces are not generally required to be manipulated frequently Mattress rotation allows improved access to the baby and it can be positioned far more appropriately Cost The product can be thought of as two separate devices incubator and warmer adding in the cost of the extra built in features scales trending tilt etc and coupled with not having to transfer the baby between devices you have a very competitively priced product 19 MDA evaluation 02090 July 2002 Manufacturer s Data PRODUCT DATA Manufacturer Ohmeda Medical 8880 Gorman Road Laurel MD 20723 USA Country of Origin United States of America Prices ex VAT Giraffe OmniBed stan
38. res Measurements of the relative humidity showed agreement within the limits set by the standard 10 of the indicated relative humidity value at values below 70 Above 70 the discrepancy between the displayed relative humidity level and the measured level exceeded 20 Sound levels The noise level within the baby compartment was measured during normal operation as an incubator with the alarm sounding at its four noise levels and whilst raising the canopy see Table 5 The noise level during normal MDA evaluation 02090 July 2002 18 operation is below the 60dB A limit set by the standard Neither the alarm levels nor raising the canopy are considered to be part of normal operation and so these levels may exceed the 60dB A limit The alarm noise level limit is 80dB A and even at Level 4 the Giraffe alarms are well below this The decibel A dB A scale is weighted to correspond to the response of the human ear Although the general noise level measured here is low the general overall neonatal noise exposure must be kept to a minimum Table 5 Sound levels on the mattress Noise level Incubator mode 55 dB A 2dB A Raising the canopy 68 dB A 2dB A Alarms level 1 to 4 48 to 66 dB A 2dB A Canopy Travel The time taken to raise and lower the canopy was measured because it would influence the clinical use of the Giraffe OmniBed The canopy ascended quickly once it was activated an
39. right hand side containing an electroluminescent EL control information screen which displays and controls all the accessory options on the Giraffe OmniBed Photo 4 Control and information panel Seven buttons covered with a tactile membrane on the left side allow selection of the available MDA evaluation 02090 July 2002 Description temperature control modes Clockwise starting from the top right are buttons for baby temperature control mode baby icon manual heater power mode available when operating as a radiant warmer heater icon air temperature control mode available when operating as an incubator fan icon increased fan activation available when operating as an incubator open incubator and air flow icon decrease and increase temperature setting and O symbols respectively and overriding the 37 C setting A small indicator beside each button illuminates to display which options are selected In Photo 4 the Giraffe is in incubator mode with air temperature control set at 34 C The incubator indicates that the air temperature is 31 9 C and the baby s skin temperature sensor indicates a temperature of 31 4 C The increase fan speed button has also been selected The EL control and information screen is activated by pressing the knob in the top right hand corner and rotating it to highlight the various options To select an option the icon must be highlighted and then the knob pressed Fu
40. rm tone volume may be set at one of four levels and a bank of LEDs provides a bright visual display All alarms usually found on an incubator or radiant warmer are present on the Giraffe OmniBed In addition an alarm activates if the canopy is stopped in its path for more than 30 seconds while opening or closing This is to alert the user that no heat is being generated Cleaning The Giraffe dismantles down to the heater level for cleaning Manuals An Operator s Manual and a Service Manual are available Both appear quite comprehensive and the Service Manual contains useful exploded diagrams However one important omission noted was that the service schedule indicated that the air filter should be changed quarterly or more frequently if used with an infectious patient but neither the Service Manual nor the Operator s Manual explains where to find the air filter or how to change it On closer examination of exploded diagrams in the Service Manual the air filter was found to be located behind the humidity system s water reservoir and could only be accessed when this was removed USER ASSESSMENT One Senior House Officer SHO and 35 neonatal nurses in three hospitals and participated in our user assessment Five Medical Technical Officers MTOs who had worked with the Giraffe OmniBed were also invited to comment All three hospitals had owned at least one Giraffe OmniBed for a minimum of six months 32 users stated that they had
41. rses rated the mobility as poor and another commented that it was ungainly to manoeuvre The vertical height adjustment VHA was considered good or excellent by most users although some users were concerned that it was easy to confuse the two sets of foot pedals The range of VHA was commented on favourably the nurses found that the VHA lowered the bassinet enough for mothers seated beside the Giraffe or in a wheelchair to be able to see their child Some nurses found the drawer difficult to use and another noted that it could not be opened when the access doors sides of the bassinet were down Fixing ancillary equipment was also a problem although it was only rated by 25 respondents out of a possible 36 Many were dissatisfied with the space available and some interpreted this question as relating to the availability of ancillary equipment They were disappointed that many Number of Respondents 0 5 10 15 20 25 30 35 40 Mobility 1 al Wheel locks 2 Stability 3 VHA of stand 4 il od VHA mechanism 5 Oooo Cupboard drawer space 6 o Fixing ancillary eq 7 f Aesthetic appeal 8 E ae Canopy foot pedals 9 m mUnacceptable 4 m Poor Canopy finger switches 10 E Satisfactory Canopy rise speed 11 Good Height of device 12 L m Excellent 7 MDA evaluatio
42. rther pressing and rotation of the knob will enable selections from the menu within that option A help screen indicated by gives more details on alarm conditions Next to this a clock icon can be selected to activate a general timer which could be used for clinical procedures An Apgar timer with associated tones is also available The chart icon accesses a menu of patient and machine monitoring information Displays include monitoring the change in air temperature baby temperature heater power if in radiant warmer mode and relative humidity over periods of 2 8 24 or 96 hours Each graphical display line can be toggled on or off using the display screen The screen returns automatically to normal after displaying the trending information The smiling face and thermometer motif activates a procedure which on entry of patient weight gestational age and post natal age suggests a possible air temperature range for that patient This information is based on research published in Archives of Disease in Childhood by Sauer et al 1984 59 p18 22 The spanner symbol accesses the setup screen allowing the user to change some basic parameters including the unit of temperature measurements C or F the volume of the alarm tones enabling MDA evaluation 02090 July 2002 or disabling the canopy foot switch enabling or disabling the VHA foot switches and the limits for manual and patient controlled alarms In bed scales
43. s of the radiant heater reflector It can be seen that the warmest part of the mattress extends from the centre towards the control panel The areas around the edge showing a zero value of irradiance are positions outside the edge of the mattress where the irradiance was not measured These have a default value of zero The maximum irradiance measured at 50 power was 3 2mW cm At 100 power the maximum irradiance measured was 13 45mW cm Irradiance in the central region was greater than the 10mW cm maximum limit in the radiant warmer standard BS EN 60601 1 21 and covered over 50 of the mattress area Irradiance levels greater than this limit are permissible for short periods as no harmful incidents had been reported at the time of the standards publication CEDAR Note These levels of irradiance may be compared to recent measurements on other infant radiant warmers Evaluations 01043 and 01044 Humidification system The heater in the water reservoir heats the water to boiling point and the water vapour is released into the warm air stream The water heater however is immersed in the reservoir and warms all of the water The temperature of the outside of the reservoir and above the reservoir varies from 33 C to 53 C indicating that all of the water in the reservoir becomes hot The surfaces around the reservoir become warm but their temperature does not exceed the limits set by the standard BS EN 60601 1 for excessive temperatu
44. tended to prefer to place the baby directly onto the X ray plate From experience they had found that this resulted in clearer images and helped the radiographer to minimise the dose to the baby Neonatal Incubator Mode Temperature Control The Giraffe OmniBed temperature controls are on the left hand side of the main control panel see Photo 4 and Photo 6 Air temperature control mode is selected by pressing the air temperature control button When switched on in incubator mode the Giraffe prompts for a set temperature This can be set at any value in the range 20 C to 39 C using the overide 37 C button in increments of 0 1 C by pressing the arrow keys as shown in Photo 6 here the set temperature is being increased by pressing the A button The measured air temperature and the set air temperature 23 7 C and 33 3 C respectively in Photo 6 are displayed at the bottom right of the temperature control panel the measured temperature is a larger display a IC s 4 Photo 6 Control Panel setting air temperature in incubator mode Baby skin temperature may also be used to control the incubator The patient sensor should be attached to the baby as described in the manufacturer s instructions and the device switched into baby mode by pressing the baby icon When baby mode has been selected a temperature range of 35 C to 37 5 C in 0 1 C increments is available the incubator will adjust the level of
45. tion in the central area of the mattress 20cm by 30cm as shown by the white box is mostly within 1 C of the maximum temperature This is a good result as it shows that the centre of the mattress provides a uniform thermal environment but it also shows how important it is to place the baby in the centre of the mattress to reduce thermal stress The skin temperature sensor was placed at the centre of the mattress during the measurements and covered with a reflecting pad as it would be when used on a baby The temperature of the skin sensor displayed on the Giraffe OmniBed control panel agreed with the temperatures measured at the centre of the mattress irradiance Contour Mapping The temperature measured is dependent on the time the radiant heater has been operating Measurement of the Figure 11 IR irradiance at 50 radiant heater power Controls 17 o 0 to 1 mW cm o 1 to 2 mW cm o 2 to 3 mW cm o 3 to 4 mW cm MDA evaluation 02090 July 2002 Technical Assessment infrared IR irradiance produced provides a more objective assessment of the effectiveness of the radiant heater because it is not affected by air flow variations across the mattress The IR irradiance on the mattress was measured at the same positions as the previous set of temperature measurements using an IL1400A radiometer calibrated for 780nm Figure 11 This plot of irradiance in the IR region clearly demonstrates the focu
46. used the device for at least several months Three users completed the questionnaire after using the device for the first time and only one user gave no indication of how long they had been using the device Our questionnaire asked users to rate features of the Giraffe OmniBed as unacceptable poor satisfactory good or excellent and written comments were invited in a space beside each question The questionnaire contained over 80 questions relating to the use of the Giraffe in both modes of operation and included general questions to ascertain the users training and experience of the Giraffe OmniBed Users were also asked which other incubators and radiant warmer devices they had used and then what they considered to be the advantages and disadvantages of this device To clarify issues raised by the questionnaire an evaluator visited each neonatal unit The numerical data response from the questionnaire is reproduced in the Appendix for interested readers Figure 1 User response Questions 1 to 12 User Assessment The data has been displayed graphically below to give the reader an overview of the users response Points of particular interest are discussed especially where users made comments about specific features Figure 1 below shows the user response to questions 1 to 12 which concerned general features of the Giraffe Most users considered the mobility wheel locks and stability to be Satisfactory or better however two nu
47. verse comments A new Ohmeda phototherapy unit designed for use with MDA evaluation 02090 July 2002 12 the Giraffe is not yet available in the UK Existing stand based phototherapy units were found to be difficult to position because of the sloping canopy and aligning the stands legs beneath the Giraffe There is also a danger of raising the canopy whilst the phototherapy was in place The control panel mounted between the two rails also blocked the users view and made it difficult for them to access devices placed on shelves behind the Giraffe Several users also commented on the cost of the Giraffe They considered it expensive and were not happy that the price did not include shelves and poles that they considered an essential part of the device The nurses would also have liked the Giraffe to have an examination light Indeed in one unit the nurses found it necessary to transfer the baby to a radiant warmer with an examination light in order to insert drips and cannula CEDAR Note Examination lamps are now available All users except the SHO stated that they had been trained by the manufacturer read the manual or been trained by their colleagues In discussion with the MTOs working with the Giraffe they considered it to be a well behaved device and they had had few call outs Only a few problems had been encountered and the support and response from Ohmeda had been good In one unit a backup battery and transform
48. was awkward The relative humidity feature was well liked by all the users some thought that this was the best feature It was considered easy to use but many nurses commented that it was not easy to open the water reservoir to refill it One user reported that there had been some hot water spills A technician commented that one of the water reservoirs on their Giraffes was cracked possibly due to the force applied to remove it One consultant who saw the Giraffe OmniBed but had not used it commented that he was concerned that the heater within the water would warm all of the water in the water reservoir increasing the likelihood of bacterial growth See Manufacturer s Comments The response to the auditory and visual warnings were split very similarly with the majority of users rating these as satisfactory or good Those who rated the auditory alarms as poor found it too noisy but stated that they later found that the volume could be turned down The visual captions on the alarm conditions were thought to be a little small Figure 4 is a little different from the other charts Here in addition to displaying the user ratings for these features we also indicate whether the respondents have used a feature of the Giraffe or not Those who had used a feature were asked in the next question to rate it The ratings are shown in the section along the bar after the block indicating those who hadn t used it The fan boost was a featur
49. while the infantis inthis nt 1 2 11 12 What is your opinion of the operator comfort when you are providing nursing and general care using this device 79 Please indicate your experience of cleaning and disinfection of the unit 8 6 2 23 MDA evaluation 02090 July 2002 Appendix ACKNOWLEDGEMENTS This report was prepared by Dr SDP Wentworth Dr DC Crawford and Mr SD Edwards of CEDAR Medical Physics and Clinical Engineering Directorate Cardiff amp Vale NHS Trust under contract to the Medical Devices Agency MDA e Enquiries to Dr Stephanie Wentworth at CEDAR Cardiff Medicentre Heath Park Cardiff CF14 4UJ stephanie wentworth uhw tr wales nhs uk Tel 029 2068 2120 Fax 029 2075 0239 INTERNET www imaging uwcm ac uk mpce sctns cedar index htm e Or Mr Robert Allen at MDA Hannibal House Elephant and Castle London SE1 6TQ robert allen doh gsi gov uk Tel 0207 972 8226 Fax 0207 972 8105 INTERNET www medical devices gov uk We thank all the nursing and technical staff of the Neonatal Units of Liverpool Women s Hospital Milton Keynes General Hospital and The John Radcliffe Hospital Oxford for their help in carrying out the user assessment We would also like to thank Mrs SM Hancock for her administrative help and Belinda Colton for her help with the photographs Thanks too to Dr N Cook for his work on this report prior to taking up a new appointment in New Zealand Finally we would like to thank Datex Ohmeda f
50. y RH of 50 were chosen to simulate the conditions often used for a medium pre term baby 34 weeks old Air control temperature of 38 C and maximum RH in this case 95 settings were chosen to simulate the conditions often used for a very pre term baby 24 weeks old in their first week The Giraffe OmniBed warmed up from ambient room temperature to both settings smoothly with little overshoot The times taken to achieve the temperature set are shown in Table 1 section a Technical Assessment Temperature Uniformity Uniform warming in the baby compartment is very important because the neonate needs a stable isothermal environment in which to thrive Trying to maintain his her temperature reduces the energy a neonate has available for growth and maturity The temperature across the mattress was measured at 10cm above the mattress as described in the harmonised standard BS EN 60601 2 19 for incubators The variation of temperature across the mattress while horizontal and while in its extreme tilted positions of 12 towards or away from the control panel are shown in Table 1 section b To access the tilt mechanism an access door or a port must be opened briefly this results in a small temperature drop of approximately 1 3 C Opening ports or access doors to gain access to the neonate for medical or nursing procedures lowers the incubator temperature To assess this temperature drop the Giraffe OmniBed was set at 38 C in a
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