Infant Warming and Phototherapy

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Medicines and Healthcare products regulatory Agency logoEvaluation report

Report 05103Market survey: infant

warming and

phototherapy

January 2005

Health and social care working together

EVA

LU

ATION

www.pasa.nhs.uk/cep


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About evaluation reports

The Centre for Evidence-based Purchasing provides independent and objectiveevaluations of medical devices available on the UK market. Specialist centres,mainly in NHS Trusts, do the evaluations under contract to the NHS Purchasing andSupply Agency (NHS PASA). Results are available on our website(www.pasa.nhs.uk/cep).

Our evaluations are usually of products supplied by the manufacturer. We expectthese products to be representative of those on the market but cannot guaranteethis. Prospective purchasers should satisfy themselves about any modifications thatmight have been made after our evaluation.

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S C Peirce, A J Hedges, D C Crawford

CEDAR

Cardiff Medicentre

University Hospital of WalesHeath ParkCardiff

CF14 4UJ

Tel: 029 2068 2120Fax: 029 2075 0239

E-mail:[email protected]

For more information on CEDAR visitwww.cedar.wales.nhs.uk

Market survey: infant

warming and phototherapy

Crown Copyright 2006

Apart from any fair dealing for the purposes of research or private study, or criticism, or review, aspermitted under the Copyright, Designs & Patents Act, 1998, this publication may only be reproduced,stored, or transmitted in any form or by any means with the prior permission, in writing, of theController of Her Majestys Stationery Office (HMSO).

Information on reproduction outside these terms can be found on the HMSO website(www.hmso.gov.uk)or e-mail: [email protected].
mailto:[email protected]:[email protected]:[email protected]://www.cedar.wales.nhs.uk/http://www.cedar.wales.nhs.uk/http://www.hmso.gov.uk/http://www.hmso.gov.uk/mailto:[email protected]:[email protected]:[email protected]://www.cedar.wales.nhs.uk/http://www.hmso.gov.uk/mailto:[email protected]


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Summary 1

Introduction 2Infant Warming and phototherapy Framework (IWpF)Purpose of this reportCreating the optimal thermal environment for infantsNeonatal phototherapyStandardsContract detailsEvaluation reportsProcurement issuesOrganisation of this reportDisclaimer

Nursing incubators 5How incubators work

BeaverMP5 ISIS A & SI/REA (Mediprema) 10SATIS (Mediprema) 12

DrgerCaleo (Drger) 14Isolette C2000 (Air-Shields) 16

GE HealthcareGiraffe & Omnibed (Ohmeda) 18

InspirationV 2100G A / B / C (ATOM) 20

Medical Imaging SystemsC186-TS (Fanem) 22Vision 2186 (Fanem) 24

Transport incubators 26How transport incubators work

BeaverNITE (Mediprema) 28

Medical Information SystemsIT158-TS (Fanem) 30

Warming therapy 32How warming therapy devices workGrouping of devices in this reportThermal controlResuscitation cabinets

Fisher & PaykelCosyCabinet (Fisher & Paykel) 38

Viamed

Infant Resuscitation Cabinet (Various) 39

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Complex care mobile unitsBeaver

ISIS Ambiance (Mediprema) 40ISIS Radiant (Mediprema) 42

Central Medical SystemsInfant Warming System - Kanmed AB 44Thermocare 2000 K (Weyer) 46Thermocare / Variotherm 2000 (Weyer) 48

DrgerResuscitaire (Air-Shields) 50BabyTherm 8000 (CosiTherm) (Drger) 52BabyTherm 8004 / 8010 (Drger) 54

Fisher & PaykelCosyCot (Fisher & Paykel) 56

GE HealthcareGiraffe Omnibed (Ohmeda) 58Ohio 3400 3400 (Ohmeda) 60

Medical Imaging SystemsMultisystem 2051 (Fanem) 62

Mobile lamps with baby surfacesCentral Medical Supplies

Variotherm Easy Care (Weyer) 64Viamed

Ceratherm 600-2 with DINO Mobil (Nufer) 65

Mobile lampsBeaverISIS Ambiance (Mediprema) 66

Central Medical SuppliesCeramotherm (Weyer) 67

Fisher & PaykelMobile Infant Warmer (Fisher & Paykel) 68

NatusIrradiator 300N (Hydrosun) 69

ViamedCeratherm 600-2 (Nufer) 70

Warming mattressesCentral Medical Supplies

Baby Warmer Complete (Kanmed AB) 71Thermocare Convenience (Weyer) 72

ViamedAmecosy NC1, NC2, NC3 (ARDO) 73

Phototherapy 74How neonatal phototherapy worksIrradiance/light sources

HeatingTreatment

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BeaverAmpliflux 1 or 2 Hoods (Mediprema) 77Cradle 360 (Mediprema) 78

Central Medical SuppliesBili-Compact (Weyer) 79

DrgerMicro-Lite (Air-Shields) 80Photo-Therapy 4000 (Drger) 81

GE HealthcareBiliBlanket Plus (Ohmeda) 82Giraffe Spot PT Lite (Ohmeda) 83

Medical Imaging SystemsBiliberco 006FB (Fanem) 84Bilispot 006BP or 006BB (Fanem) 85

Bilitron 3006 (Fanem) 86Octofoto (Fanem) 87

NatusneoBLUE (Natus) 88

Natus, Fisher & PaykelneoBLUEmini (Natus) 89

ViamedAmelux (ARDO) 90BiliCrystal Bulle 2 (Medestime) 92BiliCrystal Mono/Duo 2 (Medestime) 92

BiliCrystal Trans (Medestime) 93BiliCrystal IV 2 (Medestime) 93

Appendix 94Suppliers contact detailsManufacturing standards for medical devicesA brief guide to the Medical Devices DirectiveGlossaryAcknowledgementsReferences

TablesTable 1: Comparison of nursing incubators features 7Table 2: Comparison of nursing incubatorsspecifications 8Table 3: Warming therapy device types 34Table 4: Mobile complex care warming units - features andspecifications 36Table 5: Phototherapy lamps - features and specifications

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A new NHS purchasing framework agreement for infant warming and phototherapyequipment* (IWpF) was established by NHS Purchasing and Supplies Agency (NHS

PASA) in March 2005. This makes it easier, quicker and cheaper for NHSorganisations to purchase a range of neonatal care products. Constraints imposedby European legislation and standing financial instructions are removed as thesewere taken into consideration when drawing up the framework, which covers all NHSTrusts in England, Northern Ireland, Scotland and Wales.

This comparative report provides an extensive independent information resource tohelp purchasers identify the full range of products and issues that can influencesuitability. An assessment of each departments technical and clinical needs can becompared to the products on the NHS PASA IWpF website [1] to select the bestvalue product.

Approximately 45 IWpF products have been grouped as: nursing incubators (8product listings), transport incubators (2), warming therapy (24, including 2resuscitation cabinets, 12 complex care units, 7 mobile devices and 3 warmingmattresses) and phototherapy lamps (18). An overview of relevant clinical andprocurement issues is provided for each section.

The information presented here comprises comparative tables of key dimensionsand features, and a product summary page for each model. This market surveycontains data provided by the nine UK suppliers and the NHS PASA IWpF website.

In some cases, further evaluation information is available in previously publishedreports. These are noted on the relevant product pages.

Prices quoted are the suppliers list prices from the PASA website. NHSorganisations can obtain discounted prices via the NHS PASA IWpF website [1].

Suppliers may have other, similar products not included in the IWpF contract. AnyNHS organisation interested in purchasing items not listed on the IWpF mustconduct the relevant competitive tender exercise, depending on the value of theorder. The contract is subject to ongoing review to encompass new suppliers and

new technologies. For further information about the contract please contact NHSPASA ([email protected]).

* Following acquisition of Air-Shields by Drger Medical, the UK CompetitionCommission recommended that price stabilisation and increased market competitionshould be encouraged[2].The IWpF project fulfilled these recommendations.

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Infant Warming and phototherapy Framework (IWpF)

The NHS Purchasing and Supply Agency (NHS PASA) has developed a nationalcontract for infant warming and neonatal phototherapy equipment (IWpF). Thisframework agreement was designed to stabilise prices and encourage moremanufacturers to supply quality products to the UK and circumvents the need forpurchasing departments to tender for larger purchases of neonatal care equipment[3].This reduces the time involved and may also provide lower prices than areavailable to individual organisations. The equipment covered by this contractincludes:

nursing incubators

transport incubators warming devices (radiant warmers and heated mattresses) phototherapy lamps (for hyperbilirubinaemia)

Not every device in the IWpF contract is listed in this report. Items which might beconsidered as accessories do not have separate product pages but may be listed onthe main item product pages.

Purpose of this report

The information in the comparative tables and product pages has been compiledfrom documents supplied by the manufacturing/supplying companies, from theirwebsites and from the NHS PASA IWpF website [1].It is designed as a first stopbrochure to allow quick and simple comparisons between similar devices so thatpurchasers can identify which products are most likely to suit their individualrequirements. The report provides information of interest to neonatal clinicians,nurses and managers, technologists and equipment managers and procurementstaff. Inclusion in this report does not constitute an endorsement of any of thedevices or companies, nor does it replace the need for departments to carry out theirown evaluations prior to purchase.

Creating the optimal thermal environment for infants

The use of warming therapy has been shown to reduce mortality in low birth-weightbabies. Premature babies have greater difficulty maintaining their body temperaturethan full-term babies and adults because they have a larger surface area relative totheir volume. Heat is lost through the skin by radiation (infra-red), convection(warming the air), conduction (contact with surfaces) and evaporation of moisturefrom the skin. The latter is highly effective for cooling the body, and is particularly aproblem if the skin is uncovered and the air has low humidity.

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Three different types of devices have been developed to actively warm neonatesand infants:

Incubators use warm air circulating in a closed environment to transferheat through the skin. Humidification is frequently added to minimisecooling and dehydration

Radiant warmers provide infra-red radiation which penetrates andtransfers heat to the upper skin layers

Heated mattresses warm the babys skin surface by conduction.

Monitoring of the infants temperature and adjustment of the devices thermal outputlevels is required to maintain an optimal environment as the infants physicalcondition changes.

Neonatal phototherapy

Phototherapy lamps transfer radiant energy into the skin specifically to achieve atherapeutic reduction in the bilirubin concentration in the blood. Blue or blue-greenlight interacts with the bilirubin molecules in the superficial blood vessels. Thesedevices may be used in combination with incubators or other warming therapies.

Standards

All equipment in the IWpF contract is CE marked. This means that the manufacturerclaims that the device meets the Essential Requirements of the European MedicalDevices Directive[4].CEDAR have requestedevidence from each supplier whichdemonstrates this conformity. A list of relevant standards and an explanation of howcompliance is demonstrated is contained in the Appendix. Each product pageincludes information about the standards with which the manufacturer claimscompliance and the Notified Body (NB) that has certified the process.

Contract details

Prices included in the product pages are the list prices from the NHS PASA IWpFwebsite which was published in March 2005. In order to obtain up-to-date details ofprices and products, users should consult the website[1] from a computer linked toNHSnet. Some user training is included in the purchase price

Evaluation reports

Several products in this report have been the subject of previous evaluation reports

which may contain detailed descriptions, technical and user evaluations. These arelisted in the product pages. Where these reports refer to previous models, this has

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been made clear. These reports areavailable from the NHS PASA Centre forEvidence-based Purchasing (CEP) [5].

Procurement issues

It is good practice to compare the total cost of devices over their expected lifetime,for example ten years. Where initial capital cost is low, the costs of consumablesand maintenance may be relatively high, and vice versa.

Additional features can add to the total cost and complexity of a device and may beunnecessary in some cases. Storage facilities for accessories and baby clothes,shelves for placing equipment during interventions and poles for affixing accessoriescan be important considerations.

The installation of equipment, including electrical and gas supplies, and relatedlabour costs for fitting wall, ceiling and cabinet mounted warmers should be includedin the total cost. Some user training is included in the purchase pricebyallsuppliers, further details of which can be found on the IWpF website[1].The cost oftechnical manuals and service training for technical support staff is given in theproduct pages, where available. Also on the product pages are costs for commonconsumables (i.e. component items or accessories which are replaced at setintervals or which have an estimated lifetime of a year or less).

Organisation of this report

Products are grouped into sections according to the four categories listed onpage 2.Each section has an introduction that provides general information to consider whenchoosing a device, and guidance on interpreting the product pages and comparativetables. Product pages provide an overview of the key features of each product. AGlossary explaining the terms used in the comparative tables and product pages isincluded in the Appendix. The Appendix also contains a table with the contact detailsof thesuppliers.

Disclaimer

Every effort has been made to ensure that the information in this report is correct.However, the large number and variety of products and the continuousimprovements that suppliers and manufacturers make to their ranges andspecifications means that prospective purchasers should seek up-to-date detailsfrom the suppliers before making a final decision. Blank rows on the product pagesindicate that specific information was not provided by the supplier.

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How incubators work

Nursing incubators provide a warm, stable microenvironment for small and sickbabies so that the energy they would use to keep warm can instead be used forgrowth, recovery and development. The environment can be controlled either bymaintaining the air temperature or the babys core skin temperature (measured atthe abdomen) at a pre-set value. All the incubators in this document include

air temperature control mode skin temperature control mode tilting mattress a minimum of 4 hand ports (2 in each long side), to allow nursing care

without compromising the regulated environment in the enclosure

Other facilities may be included as standard or charged as optional extras (Table 1).Warm internal canopy surfaces reduce radiant heat loss (double walls can improvethis function) and low air velocity over the babys skin reduces convective heat loss.Humidified air also reduces heat lost dueto evaporation of moisture from the skinand is beneficial for the respiratory tract.Controlled humidification is particularlyused for the most premature babies, but should be designed to discourage infection.

Babies may require oxygen-enriched air, which can be delivered using nasal prongs,headboxes, or by increasing oxygen levels within the whole canopy. This can be

accomplished using externally-fixed flowmeters to maintain a set gas flow rate(manufacturers will provide tables of approximate concentrations that will beachieved at different flows), or by monitoring the concentration in the enclosure(servo-controlled oxygen).

Increasing use is being made of simultaneous monitoring of the skin temperature atthe abdomen (close to core temperature) and at a peripheral site (usually the foot).Products with peripheral temperature measurement as a standard or optional featureare capable of dual temperature monitoring.

Kangaroo nursing, using skin-to-skin contact with a parent for warming sick andpremature neonates, is becoming increasingly popular as it also encourages parent-child bonding. Some incubators provide a specialkangaroo mode, whereby theinfants temperature is monitored whilst the incubator temperature is maintainedseparately. Other incubators may allow kangaroo nursing care, but do notspecifically label this as a feature.

The frequency and level of access to the baby that nurses and medical staff requirevaries depending on the typical size and medical condition of babies on each unit.This will influence the ideal physical dimensions of canopy and mattress, range of

vertical height adjustment and mattress tilt and optimum access features (ports,doors, tubing ports, removable canopy). Comparing the trolleywheelbase height of

Nursing incubators

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other mobile equipment and the incubatorsground clearance will indicate whetherthey can be used together. Key incubator dimensions and characteristics arecompared inTable 2.

Nursing incubators

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Nursing incubators

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S

upplier

Beav

er

Drger

GEHealthcare

In

spiration

MIS

M

odel

MP5

ISIS-A

MP5ISIS

SI/RE

A

SATIS

Caleo

Isolette

Giraffe

Omnibed

V-2100G

A

V-2100G

B

V-2100G

C

C186

Vision

2

186

P

eripheral

temperature

C

ontrolled

h

umidificaton

O

O

#

X

-raytray

W

eighing

s

cales

O

O

O

O

O

O

O

O

K

angaroo

m

ode

O

xygen

m

onitoring

O

O

O

O

O

S

ervo-

c

ontrolledO2

O

O

O

O

O

D

oublewalls

O

O

O

O

O

M

attress

e

levation

P

oweredVHA

O

O

O

O

O

O

O

O

O

O

A

ccessdoors

b

othsides

O

O

O

O

H

andports

4

6

6

6

4-6

4-6

4-6

6

6

6

6

6

T

rending/

h

istory

O

O

C

omputer/

n

etwork

O

O

O

O

O

C

ontrolpanel

lock/cover

-includedasstandard

O

-availableasanoptionalextra

#-noX-raytray,

butincludesa

gapbeneaththemattressforplates

-airishumidified,

butnotmonitoredorcontrolled

Table1:Comparisonof

nursingincubatorsfeatures


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Nursing incubators

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Su

pplier

Beaver

Drger

GEHealthcare

Inspiration

MIS

Mo

del

MP5ISIS-

A

M

P5ISIS

SI/REA

SATIS

Caleo

Isolette

Giraffe

Omnibed

V-2100G

A/B/C

C186

Vision

DimensionsLW

(cm)

104x53

104x60

102x58

117x69

99x67

114x66

114x66

100x63

107x56

105x56

He

ight(cm)

130-153

1

30-153

159-182

122-152

133-152

147-177

147-2

38

135-152

134-154

130

-150

Ma

ttressLW

(cm)

61x39

61x39

61x38

65x50

81x41

66x48

66x4

8

74x36

63

x

34

63

x34

VH

A(mattress

he

ight)(cm)

93-116

93-116

94-117

80-110

90-111

81-111

81-11

1

92-113

94-114

93

-113

Ma

ttresstilt

10

+

20-10

+20-10

13

12

12

12

12

12

12

WeightinclVHA

(kg)

90

90

90

130

90

131

131

88

68

93

Ca

nopyLW

H(cm)

89x45x

34

8

9x45x

50

89x45x

50

100x59x

42

86x41x

47

86

x41x

47

Gr

oundclearance

(cm)

16

16

16

13

11.5

9.5

9.5

12

13.5

1

3.5

Tu

bingports

3

10

10

10

10

8

8

10

4

4

Warm-uptime

(m

ins)

20(25-

37C

20(25-

37C)

20(25-

37C)

20(20-

31C)

Documents

Infant Warming and Phototherapy