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Design Review of Giraffe
Design Review of Giraffe
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
• Air temperature control
• Baby temperature control
• Integral humidification
• Access doors two
• Access ports up to five
Radiant Warmer Mode
• Maximum power 450W
Price ex VAT £ 27,000 (basic unit) • Manual control
£ 29,000 (with servo O2) • Baby temperature control
Supplier Datex Ohmeda Ltd General
(see product support • Vertical height adjustment - foot-switch
for contact information) • Canopy control Foot-switch (raise only)
CE marking? Yes Finger-switch (raise and lower)
Notified Body BSI (0086) • Mattress rotates - 360°
Type tested by CSA • Electroluminescent control screen
Manufactured to
International to • Four wheel locks
Standard?
IEC 60601-1, • X-ray tray
IEC 601-2-19 & • Sliding storage draw
IEC 601-2-21 • Integral scales
Description
CONTENTS Page
Description 2
User Assessment 7
Technical Assessment 13
Manufacturer's comments 19
Manufacturer's data 20
Appendix
Questionnaire Data 21
Acknowledgements & 24
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 Photo 1: Giraffe OmniBed in incubator mode
visual alarms include a large bank of red light radiant heater switches off and the heater cover
emitting diodes (LEDs) above the control panel. doors close.
FACILITIES Raising the canopy when the incubator is in servo-
Canopy: The transformation from incubator to controlled baby mode automatically activates the
radiant warmer mode is activated by the touch of a radiant heater in servo-controlled baby mode using
foot-switch, see Photo 2 and Photo 1, located on the same set temperature. Similarly if the canopy
the wheel base parallel to the vertical height is lowered and the radiant heater was in baby
adjustment (VHA) pedals. There are VHA and mode the incubator will activate and continue to
canopy foot-switches located on each side of the operate in baby mode.
wheel base frame. The canopy can also be
activated by a finger-switch, located each side
beside 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
Photo 2: Special foot pedal for raising canopy
opening. When the canopy reaches its maximum
height, the heater doors are fully open and the If the Giraffe OmniBed is in air controlled mode
radiant heater automatically switches on. when the canopy is raised then the radiant heater,
when the canopy reaches the end of its travel, will
To switch back to incubator mode the down activate in pre-warm mode and prompt the user for
finger-switch, marked "∨∨ ", must be pressed and a manual heater power setting. When lowered in
held to activate the lowering mechanism. If it is manual heater mode it will operate in air
released the canopy will stop in mid travel. temperature mode as an incubator at the last set air
Immediately the canopy starts its descent the temperature or at 33°C, the programmed pre-warm
M o b ility 1
Wheel locks 2
Stability 3
VHA of stand 4
VHA mechanism 5
Cupboard/drawer space 6
Fixing ancillary eq 7
Aesthetic appeal 8
Unacceptable
Canopy foot pedals 9
Poor
Canopy finger switches 10
Satisfactory
Canopy rise speed 11 Good
Height of device 12 Excellent
Number of Respondents
0 5 10 15 20 25 30 35 40
Accessibilty of controls 13
Clarity of controls 15
Visibility of controls 16
Number of Respondents
0 5 10 15 20 25 30 35 40
Length of lead 29
Satisfactory
Ease of use of relative humidity 52
Good
Ease of filling the water reservoir 53 Excellent
Auditory warnings 54
Visual warnings 55
radiant warmer mode. The unacceptable response the water in the water reservoir increasing the
was accompanied by a comment that it was likelihood of bacterial growth. See
difficult to see the display when the patient needed Manufacturer's Comments.
phototherapy. One of the users who rated the The response to the auditory and visual warnings
display as poor commented that they could be were split very similarly with the majority of users
"larger/brighter". rating these as satisfactory or good. Those who
Figure 3 considers the skin sensor, the relative rated the auditory alarms as poor found it too
humidity system and the alarms. Both reusable and noisy, but stated that they later found that the
disposable skin sensors were used. Users indicated volume could be turned down. The visual captions
that they thought they were satisfactory or good - on the alarm conditions were thought to be a little
but neither type elicited a specific comment. The small.
lead was thought to be a little too long and the Figure 4 is a little different from the other charts.
sensor head a little large for very small babies. Here, in addition to displaying the user ratings for
More nurses commented that connecting the lead these features we also indicate whether the
to the Giraffe socket was awkward. The relative respondents have used a feature of the Giraffe or
humidity feature was well liked by all the users, not. Those who had used a feature were asked, in
some thought that this was the best feature. It was the next question, to rate it. The ratings are shown
considered easy to use but many nurses in the section along the bar after the block
commented that it was not easy to open the water indicating those who hadn't used it.
reservoir to refill it. One user reported that there
had been "some hot water spills". A technician The fan boost was a feature, that many nurses had
commented that one of the water reservoirs on not used. One technical comment received queried
their Giraffes was cracked, possibly due to the why the fan boost was not automatic on closing
force applied to remove it. the incubator canopy in the transition from radiant
warmer mode to incubator mode. It was very easy
One consultant who saw the Giraffe OmniBed but to forget to switch the fan boost on to enhance the
had not used it commented that he was concerned speed at which the incubator attained the set
that the heater within the water would warm all of temperature.
Number of Respondents
0 5 10 15 20 25 30 35 40
Not used
Fan boost 26
Poor
Timer 36 & 37 Not used
Not used
Humidity 49 & 50
A few users rated the Electroluminescent (EL) The mattress area was large and this was
screen poor, but most said that they found it easy considered good by many nurses, although some
to use. The help screens were found to be helpful felt that the baby looked very small in the middle.
especially when the nurses were new to using the The mattress tilt was considered good and two
Giraffe. None of the nurses used the Apgar timer, users commented that they would like more tilt
this feature is more appropriate for delivery suite. since some babies require it. The tubing ports were
Neither did they use the other timing facility. Only a problem for some nurses. They complained that
three nurses used the trending facility and they all the grommets that fitted in the tubing port holes
considered it satisfactory or good, one commented fell off after a while and also that they clasped
that they liked the trending facility but found that ventilator tubing too tightly. They preferred to use
they were liable to lose the trend information "iris" ports to route and support ventilator tubing
between shifts when other users used the Giraffe. but these were not available on their Giraffes
The in-bed scales were well liked and a high
The use of tubing ports was also a problem in one
proportion of users rated them as excellent but two
unit where they administered oxygen directly into
users commented that they had obtained three
the canopy to provide a higher ambient level. No
different readings when taking measurements
oxygen port was available on their Giraffes so they
consecutively. It was not clear whether this was
had to use one of the port-holes.
user unfamiliarity or a problem with the scales.
Care must be taken to follow the weighing Mattress rotation was well liked and one user
procedure prompted by the EL display screen. All thought that this was the best feature. However,
the users who had used the humidity facility rated another nurse stated that mattress rotation was
it satisfactory or better. "easy when the bed empty. V difficult with wires,
drips, ventilator tubing etc." [attached to the baby].
None of the features considered in Figure 4 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.
Number of Respondents
0 5 10 15 20 25 30 35 40
Mattress size 59
Number of Respondents
0 5 10 15 20 25 30 35 40
Poor
IRW mode : ease to feed infant 71
Satisfactory
IRW mode : ease of access for nursing 72 Good
Excellent
IRW mode : ease of medical examination 73
Operator comfort 78
Figure 7 Effect of opening hand ports and access door on air temperature
40
39
38
37
Temperature (°C)
33
32
Four ports open One access door open
31
30
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 Opening the access door caused a larger
temperature drop of 3.6°C but the set air
Neonatal Incubator Mode temperature, 38°C, was regained in only 6
Section (a) Warm up time using minutes. However, once again, there was a
temperature overshoot of 1.1°C after the door has
Air control temperature set to 34°C 32.5
and RH set to 50% minutes been closed, as shown in Figure 7 and Table 1
section (c). This result can be compared to the
Air control temperature set to 38°C 50 response of other incubators to this test shown in
and RH set at 95% (max value) minutes the earlier evaluation report Evaluation 375; the
Section (b) Temperature Uniformity (air overshoot is well within the limits set by the
control temperature of 38°C and RH 95%) standard, ± 2°C.
Mattress horizontal ± 0.3°C Relative Humidity: Measurements of RH were
made during the above tests. When the access door
Mattress tilted towards controls ± 0.1°C
or four ports were opened for 5 minutes the RH
Mattress tilted away from controls. ± 0.4°C dropped from its set value of 95% to around
Section (c) Opening ports and doors (air ambient RH, in this case 50%. The set RH level
control temperature of 38°C and RH 95%) was quickly regained in 2 minutes once the door or
ports were closed again, performing as well as
Time to regain 38°C after opening 3 minutes other incubators evaluated in Evaluation 375.
4 ports for 5 minutes
Temperature overshoot above 0.5°C Transition from Incubator Mode to Radiant
previous average temperture Warmer Mode, Raising the canopy:
The Giraffe OmniBed is designed to provide good
Time to regain 38°C after opening 6 minutes
emergency access to a sick neonate being nursed
one access door for 5 minutes
in an incubator by changing swiftly from incubator
Temperature overshoot above 1.1°C mode to radiant warmer mode. Its ability to
previous average temperature 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
Temperature (°C)
34
32 100% IRW
25% IRW
30
28
26
Raise canopy Close canopy
24
70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220
Time (minutes)
Warm up time: Using the Giraffe's automatic pre- Temperature Stability: From a steady state the
warm mode, 100% power for 10 minutes then 25% variation in temperature across the mattress, when
heater power, raised the temperature of the central horizontal, and when in each of its two extreme
disc on the mattress by 4.7°C after 30 minutes, as tilted positions were measured, and are shown in
Table 4. In the horizontal position the temperature
shown in Table 4. The temperature continued to
rise slowly at a rate of 0.5°C per hour over and variation should be less than 2°C to comply with
above the ambient temperature. the standard. There are no specification for when
the mattress is tilted but as shown in Table 4 a
Table 4 2.2°C variation was measured when the mattress
Radiant Warmer Mode was tilted away from the controls.
(a) Temperature rise using Simulation of an internal transfer: To assess the
Manufacturer's pre-warm performance of the Giraffe OmniBed when used in
after 30 minutes 4.7°C radiant warmer mode but needed for an internal
Maximum heat transfer between departments in a hospital the
after 15 minutes 5.9°C
following test was devised.
(b) Time to warm disc to 36.5°C
Max heat from ambient (23°C) 38 mins The Giraffe OmniBed was set in skin control
Max heat from pre-warm temp 24 mins mode at 36.5°C and stabilised. The canopy was
(28.3°C) then closed and the Giraffe OmniBed prompted
Temperature variation when 1.3°C the user for a temperature setting for incubator
horizontal at 36.5 baby temperature mode. The device was then switched off for 15
Temperature variation when tilted 0.6°C minutes to simulate its condition during an internal
towards controls transfer, since it has no backup battery to maintain
power during a power failure. When switched on
Temperature variation when tilted 2.2°C again the canopy was raised to its full extent, the
away from controls
Figure 10 Surface temperature of the mattress at 50% radiant heater power (max temperature = 34°C)
0 to 1°C below
1 to 2°C below
Controls
2 to 3°C below
3 to 4 °C below
4 to 5 °C below
35
34
difference from the maximum, 34°C, at the centre
33
of the mattress. It is seen to be slightly skewed to
32 Canopy closed
the left and the contours are tighter towards the
31
and Giraffe
switched off
controls end of the mattress, which could be
attributed to the shape of the reflector behind the
30
100 120 140 160 180 200 220 240 radiant heater element directing the heat onto the
Time (minutes)
oval shaped mattress. The black oval shape on
Figure 9. Simulation of an internal transfer - the Figure 10 represents the approximate dimensions
effect on temperature of the mattress.
Giraffe automatically entered skin control mode The temperature variation in the central area of the
and the 36.5°C temperature setting was confirmed. mattress, 20cm by 30cm, as shown by the white
Changes in temperature during this test are shown box, is mostly within 1°C of the maximum
in Figure 9. The temperature dropped by 1.8°C temperature. This is a good result as it shows that
and recovered to an average temperature of the centre of the mattress provides a uniform
36.8°C, while set at 36.5°C, in 8.5 minutes. It must thermal environment, but it also shows how
be noted that this figure shows how the important it is to place the baby in the centre of the
temperature as measured within the disc fluctuated mattress to reduce thermal stress.
between 36.5°C and 37°C. The periodicity was
approximately 17 minutes. CEDAR Note: There The skin temperature sensor was placed at the
are no specific limits on fluctuations of centre of the mattress during the measurements
temperature. This data is provided for comparison and covered with a reflecting pad, as it would be
with other Evaluation reports. when used on a baby. The temperature of the skin
sensor displayed on the Giraffe OmniBed control
Surface Temperature: The uniformity of heating panel agreed with the temperatures measured at
across the mattress is important to clinical users of the centre of the mattress.
radiant warmers. To assess this the Giraffe
OmniBed was set at 50% manual power output Irradiance Contour Mapping: The temperature
and the mattress was covered with a black felt measured is dependent on the time the radiant
heater has been operating. Measurement of the
0 to 1 mW.cm-2
-2
1 to 2 mW.cm
-2
2 to 3 mW.cm
Controls
3 to 4 mW.cm-2
PRODUCT SUPPORT
Supplier Datex-Ohmeda Tel : 01707 263570
71 Great North Road Fax 01707 260065
Hatfield
Web : www.ohmedamedical.com
Hertfordshire AL9 5EN
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 (includes 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)
Unacceptable
Satisfactory
Question
Number
Excellent
Good
Poor
Part 1 General
Unacceptable
Satisfactory
Question
Number
Excellent
Good
Poor
29 What do you think of the length of lead? 1 15 17
30 How easy do you find it to fix the sensor to the patient ? 1 14 16 1
31 What is you opinion of the patient lead connection to the socket on the Giraffe? 3 14 12
PART 4 Electroluminescent (EL) Graphic Control and Display Screen
Please give your opinion of the EL graphic control/display screen on the right
32 3 10 12 2
hand side of the control panel
33 Do you find it easy to use and move between options? Yes = 32
34 Have you used the "?" icon which accesses the help screen ? Yes = 24
35 What is your opinion of the help screens available from this menu? 13 9 2
36 Have you used the timer option, accessed by selecting the clock icon? Yes = 0
37 If so, what is your opinion of the timer options?
38 An Apgar timer with tones can be activated from this menu, have you used it? Yes = 0
39 If so, what is your opinion of it?
An information trending screen can be accessed by selecting the stylised graph
40 Yes = 3
icon, have you used it?
If you have used the trending screen please tick which trending lines have been
41
useful to you
Patient temperature Yes = 2
Air temperature Yes = 3
Set temperature
Relative humidity Yes = 2
Heater power
42 What is your overall opinion of the trending screen and information? 1 4
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 Yes = 13
babies. Have you used it?
44 If you have used it, what is your opinion of this feature? 5 7 1
The spanner symbol accesses the settings menu for changing alarm volume,
45 Yes = 17
patient alarm settings and other user settings. Have you used this?
46 If so, what is your opinion of the settings menu? 7 9 1
If your Giraffe has in-bed scales the scales symbol accesses the in-bed scales
47 Yes = 25
menu. Have you used this?
48 If so, what is your opinion of this feature? 1 5 10 9
The three drops icon accesses the integral relative humidity control and display
49 Yes = 25
menu. Have you used this feature?
50 If so what is you opinion of this feature? 8 12 5
PART 5 Relative Humidity
51 What is your opinion of the range of relative humidity values (30% to 95%)? 7 17 5
52 What is your opinion of its ease of use? 8 18 3
53 What is your opinion of the ease of filling the water reservoir? 2 10 10 8
PART 6 Alarm Systems
54 How do you find the auditory warnings ? 4 15 14 2
55 How do you find the visual warnings ? 2 15 17 1
56 How clearly do you understand the alarm caption? 1 16 17
57 How visible is the alarm caption ? 2 14 16
Unacceptable
Satisfactory
Question
Number
Excellent
Good
Poor
PART 7 Patient Area
58 How easy do you find it to access the patient ? 2 2 11 11 5
What is your opinion of the :
59 3 9 17 5
mattress size ?
60 mattress tilt mechanism ? 1 10 16 7
61 range of tilt of the mattress? 1 11 17 5
62 mattress tray withdrawal? 3 12 11 8
63 mattress rotation 1 12 11 9