Design Review of Giraffe
Design Review of Giraffe
Design Review of Giraffe
C
)
Four ports open One access door open
Air control temperature = 38C
RH setting = 95%
Ambient temperature = 23C
Ambient RH = 39%
Technical Assessment
MDA evaluation 02090, July 2002 14
Table 1
Neonatal Incubator Mode
Section (a) Warm up time using
Air control temperature set to 34C
and RH set to 50%
32.5
minutes
Air control temperature set to 38C
and RH set at 95% (max value)
50
minutes
Section (b) Temperature Uniformity (air
control temperature of 38C and RH 95%)
Mattress horizontal 0.3C
Mattress tilted towards controls 0.1C
Mattress tilted away from controls. 0.4C
Section (c) Opening ports and doors (air
control temperature of 38C and RH 95%)
Time to regain 38C after opening
4 ports for 5 minutes
3 minutes
Temperature overshoot above
previous average temperture
0.5C
Time to regain 38C after opening
one access door for 5 minutes
6 minutes
Temperature overshoot above
previous average temperature
1.1C
Opening the access door caused a larger
temperature drop of 3.6C but the set air
temperature, 38C, was regained in only 6
minutes. However, once again, there was a
temperature overshoot of 1.1C 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, 2C.
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 to 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.
24
26
28
30
32
34
36
38
40
70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220
Time (minutes)
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100% IRW
25% IRW
Raise canopy Close canopy
Technical Assessment
MDA evaluation 02090, July 2002 15
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 38C, 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 13.6C to 25C, a little above the ambient
temperature of 22.9C, as can be seen in Figure 8.
On closing the canopy the air control temperature,
38C, was regained in 12.5 minutes.
The Giraffe temperature was re-stabilised in air
controlled incubator 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 9.8C
but then rose to settle around 32C. On closing the
canopy the temperature dipped again briefly to
30.6 before rising to regain the set temperature of
38C in 14 minutes. Recovery time was prolonged
by a "saddle point" at 36C. It appeared that the
Giraffe tried to use 36C as the set temperature
before continuing to warm up to 38C. 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 38C in incubator
mode after 25% heater power.
12.5
minutes
Time to regain 38C in incubator
mode after 100% heater power.
14
minutes
Time to regain 36.5C in radiant
warmer mode after lowering the
canopy and switching off
8.5
minutes
Using 25% heater power provides very little
heating effect to the mattress and the temperature
drops to just 2C above ambient room
temperature. 100% radiant heater power on raising
the canopy can be seen to have an appreciable
effect, the temperature drops and then stabilises at
32C. When the canopy is closed the temperature
drops again briefly before rising to regain the set
temperature of 38C. 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 38C. On closing the canopy
after using 100% heater power the Giraffe
OmniBed appears to try to reach a temperature of
36C as the shallow "saddle point" on the graph
shows, before moving up to 38C. 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
at 38C and 95% RH
Temperature
drop
Open 4 ports for 5 minutes 1.9C
Open 1 access door for 5
minutes
3.6C
Raise the canopy for 15
minutes, use 25% power
13.6C
Raise the canopy for 15
minutes use 100% radiant
heater power.
9.8C
Technical Assessment
MDA evaluation 02090, July 2002 16
RADIANT 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 4.7C after 30 minutes, as
shown in Table 4. The temperature continued to
rise slowly at a rate of 0.5C per hour over and
above the ambient temperature.
Table 4
Radiant Warmer Mode
(a) Temperature rise using
Manufacturer's pre-warm
after 30 minutes
Maximum heat
after 15 minutes
4.7C
5.9C
(b) Time to warm disc to 36.5C
Max heat from ambient (23C)
Max heat from pre-warm temp
(28.3C)
38 mins
24 mins
Temperature variation when
horizontal at 36.5 baby temperature
1.3C
Temperature variation when tilted
towards controls
0.6C
Temperature variation when tilted
away from controls
2.2C
The time to achieve 36.5C 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 the temperature
variation should be less than 2C to comply with
the standard. There are no specification for when
the mattress is tilted but as shown in Table 4 a
2.2C 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 36.5C 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
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Figure 10 Surface temperature of the mattress at 50% radiant heater power (max temperature = 34C)
0 to 1C below
1 to 2C below
2 to 3C below
3 to 4 C below
4 to 5 C below
Technical Assessment
MDA evaluation 02090, July 2002 17
Figure 9. Simulation of an internal transfer - the
effect on temperature
Giraffe automatically entered skin control mode
and the 36.5C temperature setting was confirmed.
Changes in temperature during this test are shown
in Figure 9. The temperature dropped by 1.8C
and recovered to an average temperature of
36.8C, while set at 36.5C, in 8.5 minutes. It must
be noted that this figure shows how the
temperature as measured within the disc fluctuated
between 36.5C and 37C. 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
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, 34C, 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 variation in the central area of the
mattress, 20cm by 30cm, as shown by the white
box, is mostly within 1C 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
30
31
32
33
34
35
36
37
38
100 120 140 160 180 200 220 240
Time (minutes)
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(
C
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Canopy closed
and Giraffe
switched off
0 to 1 mW.cm
-2
1 to 2 mW.cm
-2
2 to 3 mW.cm
-2
3 to 4 mW.cm
-2
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Technical Assessment
MDA evaluation 02090, July 2002 18
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 focus 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
-2
. At 100% power the maximum
irradiance measured was 13.45mW.cm
-2
.
Irradiance in the central region was greater than
the 10mW.cm
-2
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 33C to 53C
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 temperatures.
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
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, and 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.
Technical Assessment
MDA evaluation 02090, July 2002 19
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 quality assurance, Annex
II of MDD. The Notified Body was BSI, UK,
(0086), device classification IIb. 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
general safety standard) edition 2:1988, including
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
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 the 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 58C, 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 & 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 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.
Manufacturer's Data
MDA evaluation 02090, July 2002 20
PRODUCT DATA
Manufacturer Ohmeda Medical, 8880 Gorman Road, Laurel MD 20723, USA
Country of Origin United States of America
Prices (ex VAT) Giraffe OmniBed (standard) including elevating base, in-
bed scales and servo relative humidity
27,000
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
71 Great North Road
Hatfield
Hertfordshire AL9 5EN
Tel : 01707 263570
Fax 01707 260065
Web : www.ohmedamedical.com
Guarantee 1 year
Servicing Warranty Extension with Planned Preventative Maintenance
Fully comprehensive for a 3 or 5 year period (Includes year 1 maintenance)
Only available at time of sale
1153.17
per year
Planned Preventative Maintenance (includes routine labour and parts) 960.93
Comprehensive (includes routine labour and parts and corrective
maintenance labour and parts)
1537.45
Biomed partnership with corrective maintenance (includes second level
training, routine parts and corrective maintenance labour and parts)
1153.17
Appendix
MDA evaluation 02090, July 2002 21
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.
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Part 1 General
1 What is your opinion of the general mobility of this device? 2 9 17 6
2 What is your opinion of wheel locks? 8 23 4
3 What is your opinion of the stability of this device? 9 20 6
4 What is your opinion of the vertical height adjustment of the device? 2 7 18 6
5 What is your opinion of the VHA mechanism of the device? 1 12 16 6
6 What is your opinion of the cupboard/drawer space on the unit? 3 9 16 6
7 What is your opinion of the fixing of ancillary equipment to this device? 3 9 10 3
8 What do you think about the aesthetic appeal of the unit? 2 2 10 17 4
Part 2 Conversion from Incubator to Radiant Warmer and vice versa
9
What is your opinion of the foot-switches for raising the canopy to radiant warmer
mode?
2 12 16 2
10 What is your opinion of the finger-switches for raising and lowering the canopy? 1 14 14 4
11 Please indicate your opinion of the speed of raising and lowering the canopy 9 18 3
12
Please indicate your opinion of the height of the device when in radiant warmer
mode
1 11 17 2
PART 3 Temperature Controls and Sensor
13
Please indicate your opinion of the accessibility of the Giraffe temperature and
accessory controls
3 15 13 3
14
What is your opinion of the general ease of use of all Giraffe temperature
controls
2 14 15 3
15 How clear do you find the controls? 2 19 13 1
16 How visible are the Giraffe temperature controls? 1 2 9 22 1
Radiant warmer mode
17
What is your opinion of the range of heater control in manual mode? (0% to
100%)
9 17 3
18 How do you find the visibility of the heater power level? 1 9 18 2
19
How easy do you find it to change the Giraffe temperature in radiant warmer
mode between manual and baby?
12 15 1
20 How easy do you find it to use the radiant warmer controls in manual mode? 16 12 1
21 How easy do you find it to use the radiant warmer controls in baby mode 16 13 1
22 How do you find the visibility of the set and measured baby temperature? 1 13 14 2
Incubator mode
23
How easy do you find it to use the incubator temperature controls in air
temperature mode?
1 12 19 1
24
How easy do you find it to use the incubator temperature controls in baby
temperature mode?
2 12 18 2
25 What is your opinion of the display of the set and measured baby temperature? 1 11 20 3
26 Do you often use the boost air curtain auxiliary fan? Yes = 8
27 Please circle the type of skin sensor you use: disposable OR reusable
Disposable = 7
Reusable = 18
28 What is your opinion of the skin sensors size and shape? 12 20
Appendix
MDA evaluation 02090, July 2002 22
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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
32
Please give your opinion of the EL graphic control/display screen on the right
hand side of the control panel
3 10 12 2
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?
40
An information trending screen can be accessed by selecting the stylised graph
icon, have you used it?
Yes = 3
41
If you have used the trending screen please tick which trending lines have been
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
43
The next icon, a smiling face and thermometer, accesses a menu which gives
information on possible temperature settings for different age and birth-weight
babies. Have you used it?
Yes = 13
44 If you have used it, what is your opinion of this feature? 5 7 1
45
The spanner symbol accesses the settings menu for changing alarm volume,
patient alarm settings and other user settings. Have you used this?
Yes = 17
46 If so, what is your opinion of the settings menu? 7 9 1
47
If your Giraffe has in-bed scales the scales symbol accesses the in-bed scales
menu. Have you used this?
Yes = 25
48 If so, what is your opinion of this feature? 1 5 10 9
49
The three drops icon accesses the integral relative humidity control and display
menu. Have you used this feature?
Yes = 25
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
Appendix
MDA evaluation 02090, July 2002 23
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PART 7 Patient Area
58 How easy do you find it to access the patient ? 2 2 11 11 5
59
What is your opinion of the :
mattress size ?
3 9 17 5
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
64 security of the side panels? 1 15 14 5
65 suitability of the tubing ports? 3 5 12 12 2
66 suitability of hand ports? 1 2 10 17 4
67 security of canopy access doors when in incubator mode? 1 14 17 3
68 ease of performing X-rays? 1 2 13 6 6
69 Do you use the X-ray tray? Yes = 11
PART 8 Nursing and Medical Procedures
In Radiant Warmer mode
70 How easy do you find it to handle the infant and provide general patient care? 1 2 7 17 7
71 How easy do you find it to feed the infant? 1 6 11 10 4
72 What is your opinion of the ease of access to the infant for nursing procedures? 1 2 11 14 6
73 How easy is it to perform a medical examination while the infant is in this unit? 1 2 7 17 5
In Incubator mode
74 How easy do you find it to handle the infant and provide general patient care? 1 4 12 14 5
75 How easy do you find it to feed the infant? 1 10 13 7 2
76 What is your opinion of the ease of access to the infant for nursing procedures? 1 5 10 16 4
77 How easy is it to perform a medical examination while the infant is in this unit? 1 2 11 12 6
In either mode
78
What is your opinion of the operator comfort when you are providing nursing and
general care using this device ?
2 3 10 16 4
79 Please indicate your experience of cleaning and disinfection of the unit? 8 6 2
Appendix
MDA evaluation 02090, July 2002 24
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 & Vale NHS Trust, under contract to the
Medical Devices Agency (MDA).
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
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 for loaning this device for evaluation free of charge.
HOW TO OBTAIN MDA EVALUATION REPORTS
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Tel: 029 2082 3373
In Northern Ireland
Mr D Cafolla
Health Estates,
Stoney Road,
Dundonald,
Belfast, BT16 1US
Tel: 028 9052 3745
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 & 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 Majestys Stationery Office (HMSO). Enquiries about reproduction should be
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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 &
Gynaecology, Paediatrics, Procurement and Supplies.
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OTHER RECENT MDA REPORTS ON NEONATAL DEVICES
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http://cymruweb.wales.nhs.uk/cedar/index.htm
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