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Incubators PDF
Incubators PDF
Price ex VAT
Supplier
CE marking?
Notified Body
Manufactured to
Standard?
Incubator Mode
Air temperature control
Baby temperature control
Integral humidification
Access doors
two
Access ports
up to five
Radiant Warmer Mode
Maximum power
450W
Manual control
Baby temperature control
General
Vertical height adjustment - foot-switch
Canopy control
Foot-switch (raise only)
Finger-switch (raise and lower)
Mattress rotates - 360
Electroluminescent control screen
Four wheel locks
X-ray tray
Sliding storage draw
Integral scales
Description
CONTENTS
Page
Description
User Assessment
Technical Assessment
Manufacturer's comments
Manufacturer's data
Appendix
Questionnaire Data
Acknowledgements &
MDA information
2
7
13
19
20
21
24
DESCRIPTION
FACILITIES
Raising the canopy when the incubator is in servocontrolled 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.
Description
temperature, and then prompt the user for a
manual air temperature.
Height
Adjustment
(VHA):
Manufacturer's Data.
Photo 3: Access door open and mattress tilted.
Inset - canopy finger switches
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
, symbols
respectively, and overriding the 37C setting.
Description
Neonatal Incubator Mode
Description
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-2. 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 35C and 37.5C can be set,
in the same way as in incubator mode.
User Assessment
USER ASSESSMENT
10
15
20
25
30
35
40
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
Poor
Canopy finger switches 10
Satisfactory
Good
Excellent
Height of device 12
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
10
Number of Respondents
15
20
25
30
35
40
Accessibilty of controls 13
Ease of use, temperature controls 14
Clarity of controls 15
Visibility of controls 16
Heater power range 17
Heater power visibility 18
Unacceptable
Poor
Satisfactory
Good
Ease of use (IRW mode) in baby mode 21
Excellent
User Assessment
Figure 3 User Response, Questions 28 to 31 and 51 to 57
0
10
Number of Respondents
15
20
25
30
35
40
Unacceptable
Poor
Satisfactory
Good
Ease of filling the water reservoir 53
Excellent
Auditory warnings 54
Visual warnings 55
Understanding the alarm caption 56
Visiblility of the alarm caption 57
User Assessment
Figure 4 User response, Question 26, 27, 32 to 50
Number of Respondents
0
Fan boost 26
Not used
Disposable
10
15
30
35
40
Not used
No
Used/Yes
Not used
Timer 36 & 37
Not used
Not used
Trending 40 & 41
Not used
Not used
Not used
Not used
Humidity 49 & 50
Not used
Poor
Satisfactory
Good
Excellent
25
Reusable
20
10
User Assessment
Figure 5 User Response, Questions 58 to 68
10
Number of Respondents
15
20
25
30
35
40
10
15
20
25
30
35
40
Unacceptable
Poor
Good
Excellent
11
User Assessment
X-rays were taken by radiographers and most of
the nurses thought that it was fairly easy to do.
12
Technical Assessment
TECHNICAL ASSESSMENT
INCUBATOR MODE
Warm up time: We tested the speed at which the
Figure 7 Effect of opening hand ports and access door on air temperature
40
39
Temperature (C)
38
37
Air control temperature = 38C
RH setting = 95%
Ambient temperature = 23C
Ambient RH = 39%
36
35
34
33
32
31
30
40
50
60
70
80
90
100
110
120
130
140
150
160 170
180
190
200
Time (minutes)
13
Technical Assessment
Table 1
Opening
32.5
minutes
50
minutes
0.3C
0.1C
0.4C
3 minutes
0.5C
6 minutes
1.1C
Figure 8 Effect of raising the canopy and setting the radiant heater at 25% and 100% power.
40
38
Temperature (C)
36
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)
14
Technical Assessment
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.
12.5
minutes
14
minutes
8.5
minutes
15
Temperature
drop
1.9C
3.6C
13.6C
9.8C
Technical Assessment
RADIANT WARMER MODE
4.7C
5.9C
38 mins
24 mins
1.3C
0.6C
2.2C
Figure 10 Surface temperature of the mattress at 50% radiant heater power (max temperature = 34C)
0 to 1C below
Controls
1 to 2C below
2 to 3C below
3 to 4 C below
4 to 5 C below
16
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, 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.
38
37
Temperature (C)
36
35
34
33
Canopy closed
and Giraffe
switched off
32
31
30
100
120
140
160
180
200
220
240
Time (minutes)
1 to 2 mW.cm
-2
Controls
2 to 3 mW.cm
3 to 4 mW.cm-2
17
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.
55 dB(A) 2dB(A)
68 dB(A) 2dB(A)
Alarms (level 1 to 4)
48 to 66 dB(A) 2dB(A)
Incubator mode
18
Technical Assessment
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
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.
19
Manufacturer's Data
Manufacturer
Country of Origin
Prices (ex VAT)
PRODUCT DATA
Ohmeda Medical, 8880 Gorman Road, Laurel MD 20723, USA
United States of America
Giraffe OmniBed (standard) including elevating base, inbed scales and servo relative humidity
Giraffe OmniBed (as above) with servo oxygen
Monitor shelf
Instrument shelf
IV mounting pole
Ventilator mounting pole
Utility post
IV dual hook 12"
IV pole dual hook 24"
Porthole wristlets (box of 8)
Hood cover
Filter (pack of 10)
Tubing management arm
Fitted mattress cover
High Frequency Oscillatory Ventillation (HF OV) porthole
Disposable patient probe (box of 10)
Disposable patient probe (box of 50)
Reusable patient probe
Heat reflecting patch (box of 50)
Examination lamp (specify Giraffe plug or wall outlet plug)
Phototherapy lamp (Spot light) (specify IEC or UK plug)
27,000
29,000
700
425
200.72
234
99.84
122.72
155
25
150
50
250
50
135
150
650
150
13
850
TBC
Physical Data
Size (H x W x D)
Weight
Mattress size
Bed tilt
Heater movement
Castors
Heater power
Supplier
Guarantee
Servicing
PRODUCT SUPPORT
Datex-Ohmeda
Tel : 01707 263570
71 Great North Road
Fax 01707 260065
Hatfield
Web : www.ohmedamedical.com
Hertfordshire AL9 5EN
1 year
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)
1153.17
Biomed partnership with corrective maintenance (includes second level
training, routine parts and corrective maintenance labour and parts)
20
Appendix
Poor
Satisfactory
Good
Excellent
Unacceptable
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.
17
23
20
Number
Question
Part 1 General
18
12
16
16
10
10
17
12
16
14
9
14
18
4
3
11
17
15
13
14
15
19
13
22
17
18
12
15
16
12
21 How easy do you find it to use the radiant warmer controls in baby mode
22 How do you find the visibility of the set and measured baby temperature?
16
13
13
14
12
19
12
18
11
20
Incubator mode
How easy do you find it to use the incubator temperature controls in air
23
temperature mode?
How easy do you find it to use the incubator temperature controls in baby
24
temperature mode?
25 What is your opinion of the display of the set and measured baby temperature?
26 Do you often use the boost air curtain auxiliary fan?
27 Please circle the type of skin sensor you use: disposable OR reusable
28 What is your opinion of the skin sensors size and shape?
21
Yes = 8
Disposable = 7
Reusable = 18
12 20
15
17
14
16
31 What is you opinion of the patient lead connection to the socket on the Giraffe?
14
12
10
12
Excellent
Good
Satisfactory
Number
Question
Poor
Unacceptable
Appendix
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
36 Have you used the timer option, accessed by selecting the clock icon?
Yes = 0
Yes = 0
Yes = 3
Yes = 2
Air temperature
Set temperature
Yes = 3
Relative humidity
Yes = 2
Heater power
42 What is your overall opinion of the trending screen and information?
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?
The spanner symbol accesses the settings menu for changing alarm volume,
45
patient alarm settings and other user settings. Have you used this?
46 If so, what is your opinion of the settings menu?
If your Giraffe has in-bed scales the scales symbol accesses the in-bed scales
47
menu. Have you used this?
48 If so, what is your opinion of this feature?
The three drops icon accesses the integral relative humidity control and display
49
menu. Have you used this feature?
50 If so what is you opinion of this feature?
Yes = 13
5
10
Yes = 17
7
Yes = 25
1
Yes = 25
8
12
51 What is your opinion of the range of relative humidity values (30% to 95%)?
17
18
10
10
15
14
15
17
16
17
14
16
22
Unacceptable
Poor
Satisfactory
Good
Excellent
Appendix
11
11
17
10
16
1
3
11
12
17
11
5
8
63 mattress rotation
12
11
15
14
Number
Question
PART 7 Patient Area
12
12
10
17
14
17
13
6
Yes = 11
70 How easy do you find it to handle the infant and provide general patient care?
17
11
10
72 What is your opinion of the ease of access to the infant for nursing procedures?
11
14
73 How easy is it to perform a medical examination while the infant is in this unit?
17
74 How easy do you find it to handle the infant and provide general patient care?
75 How easy do you find it to feed the infant?
1
1
4
10
12
13
14
7
5
2
76 What is your opinion of the ease of access to the infant for nursing procedures?
10
16
77 How easy is it to perform a medical examination while the infant is in this unit?
11
12
10
16
In Incubator mode
In either mode
What is your opinion of the operator comfort when you are providing nursing and
78
general care using this device ?
79 Please indicate your experience of cleaning and disinfection of the unit?
23
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 & 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
MDA Evaluation Reports are free of charge to NHS Trusts and Clinics
In England
Medical Devices Agency
Room 1207,
Hannibal House
Elephant & Castle,
London SE1 6TQ
Tel : 020 7972 8181
In Scotland
Mr R Stock
Health Planning & Quality
Division, Scottish Executive,
Health Department,
St Andrew's House,
Edinburgh, EH1 3DG
Tel: 0131 244 6913
In Wales
Ms S Woolhouse
National Assembly for
Wales, HIMTE 3,
Cathays Park,
Cardiff, CF10 3NQ
In Northern Ireland
Mr D Cafolla
Health Estates,
Stoney Road,
Dundonald,
Belfast, BT16 1US
Dec 2001
Dec 2001
Dec 2001
Sept 2001
Sept 2001
24