NUMBER

01160

Neonatal Phototherapy
Mediprema Cradle 360

MAIN FEATURES
• 16 blue fluorescent lamps
• Treatment timer
• Lamp life timer
• Gauze hammock for patient
• Thermometer (indication only)
• Mobile stand
• Stand alone device

Replacement Items
Tubes (each) £31
Life span of tubes - Manufacturer recommends
changing them after 2000 hours.

SUMMARY Price ex VAT £6,759

Advantages: 360° whole body illumination, Manufacturer Mediprema,
high irradiance, treatment timer, lamp life 4, Avenue Marcel
timer. Merieux, B P 634-37206
Tours Cedex 3 France.
Disadvantages: Cannot be used with an
incubator. No thermal control mechanisms, Supplier Rhesus Medical,
unsuitable for babies needing a stable Hall Farm,
thermal environment. Church Road, Hixon,
Staffordshire ST18 0PB.
CE marking? Yes (Annex II, QA route)
Notified Body GMED (0459)
BRIEF DESCRIPTION
Manufactured to Manufacturer states
The Cradle 360 is a novel phototherapy device Standard? conformity to
designed to provide high intensity neonatal
phototherapy treatment. It consists of a IEC 601-1 (1988),
chamber containing 16 blue fluorescent tubes IEC 601-1 (amendment
arranged cylindrically. The baby is laid on a 1 1991)
gauze hammock suspended along the centre IEC 601-1 amendment 2
of the chamber and is illuminated from all (1995)
sides. NF EN 60601-1-2
(1993)
Description
DESCRIPTION tube lifetime counter must be reset by a trained
The Mediprema Cradle 360 is a novel neonatal technician. Access to the reset button requires a
phototherapy device designed to provide blue light special tool.
illumination to the whole of a baby's skin surface. Treatment time is set by pressing the
Neonatal phototherapy is most effective at high DEFILEMENT RAPIDE/FAST COUNTER and
irradiance and high treatment area coverage; the DEFILEMENT LENT/LOW COUNTER buttons,
Cradle 360 is designed to maximise both factors. in the lower pink section of the control panel.
This standalone device is mounted on a mobile These increment the time in the lower display in
stand with four wheels each with a brake. The one minute intervals, up to a maximum of 39
therapy chamber is a horizontal cylinder hours and 59 minutes. The fast and slow counters
containing 16 blue TL 20W/52 fluorescent tubes, enable the user to set the time quickly and
see Cover photo. A gauze hammock is suspended accurately. Once the time for treatment has been
along the horizontal axis from two rods within a set the MARCHE/ON button, in the blue section
rectangular frame. The frame is positioned on may be pushed to activate the fluorescent tubes.
runners and can be partially withdrawn from the Treatment can be stopped at any time by pressing
cylinder to a stop point to allow the baby to be the ARRET TEMPORAIRE/TEMPORARY OFF
placed on the gauze hammock. The frame may be button or drawing out the frame, which releases a
completely removed by releasing two spring- spring-loaded switch. To stop the phototherapy
loaded catches. completely the REMISE A ZERO/RESET button,
at the bottom of the pink section can be pushed
For therapy the baby is placed on the hammock and the tubes and all the displays will go out.
and must wear eye protection. The hammock
weight limit is 5kg. They may wear a small nappy The user is warned on the front of the control
but if they can be treated without one a greater part panel that eye protection is mandatory. Mediprema
of their skin will be exposed to the light and their can supply eye protection in the form of goggles,
treatment should be more effective. The frame is which can be cut to fit the face of the neonate.
then pushed back into the cylinder and only when
it clicks into place can the device be switched on.

Photo 1 Control Panel showing on/off switch

and timers.
The control panel, mounted above and to the back
of the cylinder, is labelled in French and English,
see Photo 1. The Cradle 360 is switched on by
pressing the green (MARCHE) ON/ (ARRET)
OFF switch; the top display then shows the
number of hours the tubes have been in use. If this
time is greater than 2000 hours it will flash
intermittently indicating that all the tubes must be Photo 2 Cradle 360 open and displaying gauze
changed. When the tubes have been changed the hammock.

MDA evaluation 01160, December 2001 2

 Description and Technical Assessment
The baby can be observed through three side drainage hole located in the lower darkened
windows in the cylinder and the front panel, all of perspex cover. Mediprema can supply an optional
which have darkened perspex to prevent glare to urine bag to attach to this hole.
the observer. There is no cover or darkened USER ASSESSMENT
perspex at the back of the device as it is intended
to be used against a wall. This report does not contain a user assessment
since there are only a few units in clinical use in
A small tray for holding light items is fitted above the UK at present.
the cylinder. At the front of the small tray a
thermometer display indicates the temperature TECHNICAL ASSESSMENT
inside the cylinder. The temperature detector is Our tests were designed to assess criteria we
suspended from the centre of the upper section; considered important for clinical effectiveness and
this thermometer is intended for indication only. safety. For phototherapy devices clinical
A fan provides enhanced ventilation to the tubes effectiveness is dependent on light being in the
which warm up during operation and are more effective waveband, 400-550nm, being of
efficient at lower temperatures. The treatment sufficient irradiance and covering as large an area
chamber also warms up and if the baby becomes of the baby's skin as possible.
too hot the top section can be manually raised In addition heat production by the phototherapy
while therapy continues, see Photo 2. To raise the lamps is also considered. Any heat production may
top section it must first be released by unscrewing be a disadvantage or may be used in a controlled
a black bakelite knob. The upper section can then way to keep the baby warm.
be lifted using the side handle while also placing a
foot on the base. When in the desired position it is Irradiance: We measured the spectral irradiance
secured in place again by tightening the knob. The of the Cradle 360 using a Bentham double
manual suggests the use of stand side screens if the monochromator spectroradiometer incorporating a
baby needs to be kept warmer. Teflon cosine diffuser. Scanning at 1nm intervals
in the 300nm to 700nm waveband at the centre of
The baby is most effectively treated naked, except the cylinder we measured the spectrum shown in
for eye protection. The cylinder is designed so that Figure 1.
any urine or faecal material from the baby that
passes through the gauze will be channelled
towards the front of the cylinder and a small
0.16
Ultraviolet Blue Green Yellow Orange Red

0.14
Spectral Irradiance (mW.cm -2.nm-1 )

0.12

0.10

0.08

0.06

0.04

0.02

0.00
300 350 400 450 500 550 600 650 700
W a v e length (nm)

Figure 1: Spectral irradiance of upper cylinder Cradle 360 lamps at 20cm.

3 MDA evaluation 01160, December 2001

Technical Assessment
Figure 3: Variation of irradiance along length of cylinder

100%

90%
Percentage of maximum irradiance

80%

70%

60%

50%

40% 0°

30% 0° 90°
20%
180° 180° 270°
10%

0%
0 10 20 30 40 50
Distance along central axis (cm)

Figure 4 Variation in irradiance around the centre of the cylinder

6
Irradiance (mW.cm -2) (IL meter reading
corrected for 400-550nm waveband)

0
0 30 60 90 120 150 180 210 240 270 300 330
Degrees around clockwise from vertical

MDA evaluation 01160, December 2001 4

 Technical Assessment
The spectroradiometer was sited on a board across position for measurement was secured with a
the centre of the opened cylinder with its detector screw attached to the black knob. The aluminium
20cm from the overhead tubes. rod was marked in 1cm intervals for reference.
When in position the detector was 17.5cm from
The spectrum shown in Figure 1 is typical for blue
the upper perspex surface. A plastic circular
light fluorescent tubes. Most of the light energy is
protractor was also threaded onto the rod in order
in the blue-green region. The total irradiance
that measurements at different orientations to the
calculated for our two chosen wavebands, shown
vertical could be made and a reference pin on the
in Table 1, allows direct comparison with the
carrier allowed the radiometer to be lined up to
irradiance from other phototherapy devices we
within 2° of the required angle.
have evaluated.
Table 1 Irradiance With the gauze removed, to allow free movement
of the radiometer, the irradiance was measured
Bandwidth (nm) Irradiance at 20cm along the central axis at 1cm intervals. The
variation of irradiance along the axis and at 0°, (on
320 - 400 (UV) 0.005 mW.cm-2
the front of the baby's chest when supine) 90°,
400 - 550 5.25 mW.cm-2 180° and 270° from the upwards vertical are
shown in Figure 3. The maximum irradiance for
360°, whole of baby's
Effective surface area each orientation measured in the central region
skin.
varied by up to 30% with the lowest irradiance
The high blue waveband irradiance (>5mW.cm-2) measured at 270°, (from the side), and the highest
should, from the current understanding of at 180° (directly beneath the baby). Additional
phototherapy, be very effective. The UVA is low measurement of irradiance in a circle about the
and is below published safety levels for adults. centre, at 30° intervals confirmed a higher
International bodies have not yet agreed separate irradiance level in the lower half of the cylinder,
levels for infants. see Figure 4. Measurements resulted in showing a
variation between 5.47 mW.cm-2 at the 180°
The irradiance distribution along the axis of the
position and 3.89 mW.cm-2 at the 90° position.
cylinder and circularly around the cylinder was
also measured. A specially designed jig (see The lowest levels of irradiance measured
Photo 3) was constructed to hold the small blue circularly were at 90° and 300° to the vertical.
light detector head of an International Light These correspond approximately, to the largest
IL400A radiometer. gaps between the fluorescent tubes and where the
two sections of the cylinder can be separated.
When a baby lies face up on the gauze his/her
arms and sides would be towards this lower
irradiance region but most of the skin area would
be illuminated by the higher levels, above and
below. Some of the variation in irradiance
demonstrated in Figure 4 is a result of the small
variation in proximity of the radiometer to the
lights. The radiometer was used to measure
irradiance in a circle about the centre of the frame
and its distance from the perspex covering the
tubes varied from 16.5cm to 17.5cm. All
Photo 3: Jig used for irradiance measurements
irradiance levels measured around the inside of the
The jig consisted of a hollow aluminium rod, cylinder exceed the currently acceptable minimum
which could be fixed along the central axis of the level of 1mW.cm-2.
Cradle 360 frame. A white plastic carrier was Technical CEDAR Note: The IL meter used to
threaded onto the rod to hold the blue light measure the irradiance plotted in Figures 3 and 4
detector and the carrier was such that it could
was only responsive in the 400-490nm waveband.
rotate through 360° and slide along the rod
In order to allow direct comparison with the
allowing two-dimensional measurement. The irradiance measured in the 400-550nm waveband
radiometer fitted snugly into the carrier and was selected for the comparative assessment of
also secured with a plastic screw. The carrier's

5 MDA evaluation 01160, December 2001

Technical Assessment
neonatal phototherapy devices, a correction factor The thermometer suspended from the upper
was calculated using calibration data and the section registered a temperature 4°C lower than
spectral irradiance of the lamps. measured by our central PRT embedded in the
black aluminium disc.
Heating Effect: The 16 fluorescent tubes produce
a heating effect, and the Cradle 360 incorporates a During phototherapy it is essential to
thermometer whose detector is suspended from the independently monitor the baby's temperature.
centre of the top surface of the cylinder. This When using this device it is especially
thermometer is provided to give the users an important since there is no other thermal
indication of the temperature of the air above the support for the baby.
hammock, within the chamber. We measured the
The speed of warm up can be seen in Figure 5, the
warming effect of this phototherapy device using
Cradle warmed our centrally-placed PRT to 30°C
three platinum resistance thermometers (PRTs)
in 52.5 minutes. The aluminium discs used are not
embedded in three matt black aluminium discs
intended to simulate a baby but to provide a simple
arranged at equal intervals along the gauze
means of comparing devices. The discs are used
hammock. The temperature was monitored over a
primarily for testing infant radiant warmers, but
period of 8 hours and rose by 15.4°C to 34°C over
have been used by CEDAR and others to test the
4 hours, see Figure 5. This is warm enough to
heating effect of phototherapy devices. Obviously
thermally support a baby but it is not a controlled
the speed at which the PRT within the disc is
temperature such as would be found within an
warmed will be dependent on the aluminium disc.
incubator or radiant warmer. As stated in the
However, it must be noted that the warm up speed
manual "the Cradle 360 is not an incubator, so the
is slow when compared to some infant radiant
air around the child is not regulated." The heating
warmers. If a warm baby requires urgent
effect is a by-product of the lamps being
phototherapy it may be necessary to run the Cradle
illuminated. If the baby becomes too hot then the
360 for up to an hour before placing the baby on
upper section of the cylinder can be raised,
the hammock so that he/she does not become
allowing more ventilation, as shown in Photo 2.
unnecessarily cool.
CEDAR Note: This device cannot be used as an
alternative to an incubator for babies needing a User Manual: The instructions for use are clear
thermo-regulated environment and phototherapy. but the layout within the manual does not make
them easy to find.
Figure 5: Warming effect of the Cradle 360

38

36
Average temperature rise
34 after 1 hour = 10.7°C

32 Average temperature rise

Temperature (°C)

after 4 hours = 15.4°C

30

28

26

24

22 L a m p s w itched on

20
0 60 120 180 240 300 360 420 480
T ime (Minutes)

MDA evaluation 01160, December 2001 6

 Manufacturer's Data
CERTIFICATION AND STANDARDS
The Mediprema Cradle 360 carries CE marking in respect of the Medical Devices Directive (MDD).
Mediprema declare their sole responsibility for the Cradle 360 to which the declaration relates is in
conformity with the following standards or other normative documents: IEC 601-1(1988), IEC601-
1Amendment 1(1991-11), IEC 601-1 Amendment 2(1995-03) and NF EN 60601-1-2 (November 1993)
Following the provision of the Directives 93/42/CEE dated June 14th 1993 and Directive 89/366/CEE dated
May 3rd 1989 relative to the electromagnetic compatibility. The assessment route was a quality audit certified
to EN46002/ISO 9002. The Notified body was GMED France (0459).

MANUFACTURER'S COMMENTS
Thank you very much for this excellent report on our Neonatal Phototherapy Cradle 360.
The Mediprema 360° is not really a novel equipment, clinical trials have demonstrated its effectiveness and
since 1992 more than 500 units have been purchased and are used in France and abroad.
Thanks to the Mediprema Cradle, thousands of blood exchange transfusions have been avoided for babies. A
doctor recently claimed during a congress "intensive phototherapy has changed our lives".
We hope that this report will contribute to making this phototherapy technique available in the UK.

PRODUCT DATA
Procurement data
Manufacturer Mediprema, 4, Avenue Marcel Merieux, B P 634-37206 Tours Cedex 3 France.
www.mediprema.com
Country of Origin France
Prices (ex VAT) Cradle 360 £ 6,739
Eye goggles(24) £ 292
Blue Hammock Tube £ 31
Hammocks (10) £ 163

Physical Data
Size (H x W x D) 152 to 184 cm (when opened) x 64cm x 90cm
Weight 65kg
Castors 4 locking
Fluorescent tubes TL 20W/52 x 16

PRODUCT SUPPORT
Supplier Rhesus Medical, Hall Farm, Church Road, Hixon, Tel : 01889 271472
Staffordshire, ST18 0PB Fax : 01889 271948
Web :www.rhesusmedical.co.uk
Guarantee 1 year
Servicing Planned Preventative Maintenance one or two visits per annum. £ 250
Includes travelling and labour ex
Excludes spare parts VAT

7 MDA evaluation 01160, December 2001

Appendix
ACKNOWLEDGEMENTS
This report was prepared by Dr Stephanie Wentworth and Dr Diane Crawford of CEDAR, (Clinical
Engineering Device Assessment and Reporting), Medical Physics and Clinical Engineering Directorate,
Cardiff and Vale NHS Trust, under contract to the Medical Device Agency.
• Enquires to Dr Stephanie Wentworth, CEDAR, Cardiff Medicentre, University Hospital of Wales,
Heath Park, Cardiff, CF14 4UJ. [email protected]
Tel 029 2068 2120 Fax : 029 2075 0239 INTERNET:
www.imaging.uwcm.ac.uk/mpce/sctns/cedar/index.htm
• Or Mr Robert Allen, Programme Manager, Medical Devices Agency, Hannibal House, Elephant and
Castle, London SE1 6TQ. Tel 0207 972 8226 Fax : 0207 972 8105
[email protected] INTERNET : www:medical-devices.gov.uk
We would like to thank Mrs Grace Carolan-Rees, Medical Physics, Cardiff for her help with the technical
work, Mr Brian Weston for construction of the jig used for measurement and Gloucestershire Medical
Physics Service for the loan of the spectroradiometer, especially, Mr David Taylor, and finally Media
Resources at UWCM for their assistance with photographs in this report.
Finally we would like to thank Rhesus Medical and Mediprema for supplying a sample of the Cradle 360
free of charge for the period of the evaluation.

OTHER RECENT MDA REPORTS ON NEONATAL EQUIPMENT

01162 Draeger Photo-Therapy 4000 coming soon
01161 Medela Phototherapy Lamp Dec 2001
01044 Fisher and Paykel CosyCot Infant Radiant Warmer Sept 2001
01043 Hill-Rom Air-Shields Resuscitaire RW82 VHA-1C Infant Radiant Warmer Sept 2001
00092 Ohmeda Spot Phototherapy Lamp May 2001
00091 Hill-Rom Micro-Lite Phototherapy System Jan 2001
391 Neonatal Phototherapy - A review including evaluations of Ohmeda Apr 2000
BiliBlanket & Medela BiliBed
380 Ohmeda IWS 3400 Infant Radiant Warmer Feb 2000
375 Comparative Review of Three Nursing Incubators : Hill-Rom Isolette, Feb 1999
Ohmeda Care Plus 4000, Draeger 8000 IC

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 Mr J Lewis Mr D Calfolla
Room 1207,Hannibal House Health Planning & Quality National Assembly for Health Estates,
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SE1 6TQ Health Department, Cathays Park Dundonald, Belfast,
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Tel: 0131 244 6913
Copies may be obtained from the NHS Intranet site http://cymruweb.wales.nhs.uk/cedar/index.htm

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.

© 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 Majesty’s Stationery Office (HMSO).
Enquiries about reproduction should be made to the MDA at the above address.

MDA evaluation 01160, December 2001 8