Neonatal Phototherapy

Hill-Rom Micro-Lite
Phototherapy System

MAIN FEATURES
• 3 x 50W halogen bulbs
SUMMARY
• Treatment timer
Advantages: Easy to use, compact and
• Lamp life timer
lightweight phototherapy unit. It can be
mounted on a stand or placed directly onto an • Wide waveband
incubator canopy. Has a treatment timer. • Fan to cool bulbs
• Stands on incubator canopy
Disadvantages: Noticeable heating effect
due to halogen bulbs. Options
Unit may be mounted on a mobile stand.
BRIEF DESCRIPTION The mobile stand costs £595
The Hill-Rom Micro-Lite Phototherapy Unit is a
compact unit housing three 50W halogen bulbs Replacement Items
and a fan. The fan runs while the lamps are lit Bulb £19.30 each
and continues for a further three minutes after
the unit has been switched off. The Micro-Lite Life span of bulb - manufacturer states
may be placed on an incubator canopy. A mobile "nominal lamp life" is 1000 hours.
stand is also available which allows vertical and
tilt movement of the lamp once it is safely
secured to the stand. The unit displays an LCD
timer which can be reset between patients.

Price ex VAT £1,795

Manufacturer Hill-Rom Air-Shields Inc
330 Jacksonville Road,
Hatboro, PA USA 19040
Supplier Hill-Rom
Clinitron House, Ashby
Park, Ashby de la Zouch,
Leicestershire LE65 1JG
Tel : 01530 411000
Fax : 01530 411555
www.hill-rom.com
CE marking Yes, MD Directive
Notified Body KEMA (Netherlands)
Manufactured Manufactured under an
to Standard ISO9001/EN46001 quality
assurance system, audited
by KEMA,
HILL-ROM MICRO-LITE
DESCRIPTION
The Hill-Rom Air-Shields Phototherapy System is
a compact phototherapy device using halogen
bulbs as the light source. The unit is designed to
stand directly on the hood of a neonatal incubator
or be mounted on a mobile stand (see Front
Cover photo). Three 50W quartz halogen bulbs,
producing white light, are arranged in a row. The
lamp housing contains ultraviolet (UV) and
infrared (IR) filters. A fan provides cooling for the
bulbs and continues to run for 3 minutes after the
bulbs have been switched off. The main unit
housing the bulbs has easy grip handles and
moulded, padded feet to prevent scratching the
incubator canopy.
When the unit is switched on, by briefly
depressing the on/standby switch, it goes through a
self-test process. The segments of the display are
checked, the software version is displayed and
then a time is shown. During this start up
sequence, the three halogen lamps are lit in turn.
After the start-up procedure described above, the
timer display shows the length of time since it was
last reset and is designed to be used as a treatment
timer. Pressing and holding the on/standby switch
while the lights are on resets this timer. If the
Figure 1 User Response
on/standby switch is held in during the start up
procedure, the Bulb Life Timer is displayed.
Releasing and then holding in the on/standby
switch again resets the Bulb Life Timer; the
treatment timer is unaffected.
USER ASSESSMENT
17 users in three hospitals participated. Two
hospitals had bought the Micro-Lite and 11 users,
with at least three months experience, completed
questionnaires. Six users from another hospital had
used the Micro-Lite on trial for a month.
The nurses completing the questionnaire rated the
facilities and attributes as unacceptable, poor,
satisfactory, good or excellent. To clarify issues
raised by users' responses two neonatal units were
visited by an evaluator and the third unit was
contacted by telephone. The averaged response of
the nurses sampled is shown in Figure 1.
Lamp All the respondents considered the Hill-
Rom Micro-Lite to be an effective phototherapy
unit, most scored its effectiveness as good or
excellent. The white light from the three halogen
lamps was generally liked and one nurse noted that
even though she suffered migraine headaches
when nursing babies undergoing phototherapy, the
therapeutic light from the Micro-Lite was not a

Excellent

Good

Satisfactory

Poor

Unacceptable

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MDA Evaluation 00091, January 2001 2


Figure 2 Irradiance Spectrum
0.04
Ultraviolet
Spectral Irradiance (mW.cm .nm )
-1
0.03
-2
0.02
0.01
0.00
300 350 400
problem for her. Nurses covered babies' eyes with
bandages or used amber protective head shields.
CEDAR note: The baby's eyes should be shielded
to prevent retinal damage from exposure to bright
light, as the eye is more prone to damage from
blue light than from other wavelengths.
Most users commented that the babies temperature
increased when using the Micro-Lite. This was
considered a disadvantage as it required extra
vigilance in monitoring. The Micro-Lite uses
halogen bulbs which have a greater heating effect
than some other light sources used in
phototherapy. CEDAR Note: neonates undergoing
phototherapy should always have their temperature
monitored.
Mounting Nurses placing the Micro-Lite on the
canopy of an incubator found the device light and
easy to manoeuvre. Those using the device
mounted on a mobile stand rated this either
satisfactory or good.
TECHNICAL ASSESSMENT
Our technical testing is designed to test criteria we
consider important to clinical effectiveness and
safety; and takes into account the information in
the forthcoming neonatal phototherapy standard
BS EN 60601-2-50.
Light output power measurements were made
using a Bentham double monochromator
HILL-ROM MICRO-LITE
Blue Green Yellow Orange Red
450 500 550 600 650 700
Wavelength (nm)
spectroradiometer. The irradiance was measured at
each wavelength in a band from 300nm to 700nm
(see Figure 2) at the minimum treatment distance
specified by Hill-Rom, 43cm (17 inches). Total
irradiance from 400nm to 550nm (blue-green) and
from 300nm to 400nm (UV) are shown in Table 1
for the treatment distance 43cm. The irradiance in
the therapeutic blue-green waveband is average
compared to current phototherapy devices.
Measured UV levels are below published safety
levels for adults; separate limits for infants have
not yet been agreed by international bodies.
Table 1 Irradiance through air
Bandwidth (nm) Irradiance at 43cm
2
320 - 400 (UV) 0.0024 mW/cm
400 - 550 2.50 mW/cm2
Effective surface area ~1,000 cm2
This device has higher levels of red and yellow
light output (above 550nm in Figure 2) compared
with some other phototherapy devices and this
prompted our assessment of the lamp's skin
heating effect. To simulate phototherapy of a
neonate in an incubator we monitored the
temperature of five matt black aluminium blocks
(as described in BS EN 60601-2-21 1997) placed
in an incubator at a stable temperature. The Hill-
Rom Micro-Lite was positioned 43cm directly
3 MDA Evaluation 00091, January 2001
HILL-ROM MICRO-LITE
over the central disc and the lamp switched on.
The temperature rise recorded over four hours was
5.5°C. Without the incubator canopy in place and
with no additional heat source, simulating
phototherapy with an unheated cot, the
temperature rise was 6.5°C above room
temperature. These are significant temperature
rises and the users were found to be aware that the
Micro-Lite causes an inadvertent heating effect
(see User Assessment).
MANUFACTURER'S COMMENTS
Thank you for the opportunity to comment on the
draft report.
Hill-Rom Air Shields favour halogen lamps as they
have a longer life and do not degrade as quickly
as tubes. Phototherapy units using halogen lamps
may cause inadvertent heating. Verification testing
of the Microlite phototherapy system in
conjunction with the C2000 incubator, using a
500g simulated anatomical model showed the
temperature increase was 3-4 °C in air mode and
less than 1°C in skin mode.
The Microlite user manual recommends that users
be aware of the radiant heating effect and
recommends the incubator be used in skin mode to
control temperature changes. When skin mode is
not an option it may be necessary to select a lower
air temperature. In all cases independent
temperature monitoring should be performed, this
would also be the case for other types of
phototherapy lights.
Hill-Rom Air Shields will continue to use white
light phototherapy as it is effective, allows
assessment of the baby's colour and is more
acceptable to staff, who do not suffer the side
effects of blue light phototherapy, such as
headaches, nausea or dizziness.
ACKNOWLEDGEMENTS
This report was prepared by Dr S D P Wentworth,
Dr D C Crawford and Dr N J Cook of CEDAR,
Medical Physics and Clinical Engineering
Directorate, Cardiff & Vale NHS Trust, under
contract to the Medical Devices Agency.
• Enquiries to : S Wentworth at CEDAR, Cardiff
Medicentre, Heath Park, Cardiff, CF14 4UJ.
Email : cedar@cardiffandvale.wales.nhs.uk
Tel: 029 2068 2120 Fax : 029 2075 0239
• Or : Arthur Goodman at the MDA, Hannibal
House, Elephant & Castle, London SE1 6TQ.
Email:. arthur.goodman@doh.gsi.gov.uk Tel :
0207 972 8156 Fax : 0207 972 8105
MDA Evaluation 00091, January 2001
We thank all the medical and nursing staff in
Northern General Hospital in Sheffield, South
Cleveland Hospital in Middlesbrough, Darlington
Memorial Hospital and Newham Hospital London,
who helped in the evaluation.
Thanks also to Hill-Rom for loaning this device
for evaluation free of charge.
OTHER MDA REPORTS ON NEONATAL
PHOTOTHERAPY DEVICES
The irradiance of this phototherapy device may be
compared with other phototherapy devices, see
Evaluation Reports listed below and available on
http://cymruweb.wales.nhs.uk/cedar/index.htm
391 A review including evaluations of the
Ohmeda BiliBlanket Plus and the
Medela BiliBed.
00092 Ohmeda Spot Phototherapy Lamp
DISTRIBUTION
This report should be distributed to the following
departments:
• Clinical • Neonatal Units/
Engineering SCBU
• Health Authority • Maternity
Libraries
• EBME • Hospital Libraries
• Medical Physics • Supplies
How to obtain copies
"Evaluation" is free to NHS staff and is issued by
the Medical Devices Agency, (020 7972 8181)
Scottish Health Care Supplies (0131 244 3077),
The National Assembly for Wales (029 2082
3536), and Health Estates (Northern Ireland) (028
905 20025) For further information contact:
Orders Department, Medical Devices Agency.
© CROWN COPYRIGHT 2001
Apart from any fair dealing for the purpose of
research or private study, or criticism or review,
as permitted under the Copyright, Design &
patents Act, 1988, this publication may only be
reproduced, stored or transmitted in any form or
by any means with prior permission, in writing, of
the Controller of Her Majesty's Stationery Office
(HMSO). Enquires concerning reproduction
outside these terms should be made to the
Medical Devices Agency at the above address.
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