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UK Market survey infant warming

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1. Other temperature No a heater 750 W Heater swing away Yes Examination light Yes APGAR timer Yes Oxygen control Optional Trending history No Computer network Yes RS232 Alarms Increasing volume with duration Maintenance Consumables Auto breath breathing circuit amp valves breathing circuit diphragms suction bottle various sizes amp tubing suction filters skin temperature probes covers Service training Service manual 1st copy FOC then 45 training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb compliance method not supplied ISO9001 EN46001 EN13485 Kema Medical Quality 0344 certificate not seen Supplier s Quality System ISO9001 T V Gmbh 0123 certificate not seen Device complies with Financial Consumables Evaluation report MDA 01043 Sept 2001 MRRP 9 250 00 11 680 00 depending on blender amp ventilator options 31 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Drager BabyTherm 8000 CosiTherm Drager ID Number 3208055 Available since General Dimensions H W D 95 x 62 x 123 152 cm Lockable wheels 2 out of 4 VHA mattress height 89 118 cm Mattress tilt 202 15 Ground clearance 13 cm Weight incl VHA 83 kg
2. Dimensions L W H 65 x 20 x 11 cm Mono hood Duo 68 x 62 x 105 140 cm 68 x 77 x 105 140 cm Lockable wheels 2 out of 4 Head tilt Yes 360 Wheelbase height 9 5cm Weight Mono 13 kg Duo 18 kg Source 4 tubes each hood Treatment distance 18 25 cm irradiance Mono 4 mW cm2 Duo 4 3 mW cm2 Illumination area MRRP Mono 3400 00 Duo 3230 00 or 3350 00 BiliCrystal Bulle 2 Medestime ID Number 2110104 Available since Description Light box with cradles for use on tabletops in incubators warmers and with Medestime trolleys Neonate lies on a mesh hammock or clear gel mattress Requires a standard IV cradle 15cm high or shorter incubator cradle If used in an incubator the Bulle must be equipped with silicone pipes that extend outside the enclosure to facilitate cooling of the device Dimensions L W H 67 x 39 x 12 cm Lockable wheels NA Head tilt NA Wheelbase height NA Weight 3 kg Source 6 tubes Treatment distance NA irradiance 8 9 mW cm2 Illumination area NA MRRP Bulle 2 2 735 00 IV cradle 350 Incubator cradle 280 Silicone pipes 75 91 Report 05103 Market survey infant warming and phototherapy Phototherapy BiliCrystal IV 2 Medestime ID Number 2110100 Available since Description System comprising Bulle 2 and Mono sources with high walled IV cradle mounted on troll
3. Lockable wheels NA VHA mattress height NA Head tilt Yes Wheelbase height NA Photo courtesty of Natus Medical Incorporated Weight 2 7 kg lamp amp arm Description Small LED lamp on flexible arm for pole mounting Light Light source Blue and yellow LEDs with diffuser Peak spectrum 450 475 nm Treatment distance 30 5 cm minimum irradiance 30 35 uW m2 nm Illumination area 20 x 13 cm Nursing amp medical Power control No Treatment timer No Alarms No Maintenance Lamp hours meter No Check output every 3000hrs can be adjusted by technician Consumables Blue diodes replaced in groups of 6 Device can continue in use with a few non working diodes Service training Service manual fault finding and PPM FOC available on disk Training is not required for 1st line maintenance PPM calibration or repair Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance _ EN46001 ISO9001 15013485 TUV Rheinland 0197 Supplier s Quality System Fisher amp Paykel ISO9001 TUV Product Services 0123 Genesys Medical Working towards ISO9001 Device complies with EN60601 1 EN60601 1 2 EN60601 1 2 50 Financial Consumables Evaluation report neoBLUE MHRA 041483 Dec 2004 MRRP 1 500 00 88 Report 05103 Market survey infant warming and phot
4. BabyTherm 8004 8010 Drager Nursing amp medical Control panel location 8004 radiant warmer controls on stand below heater 8010 radiant and mattress controls on stand below heater Manual control Levels 1 10 overhead radiant Skin temperature Min 352C Max 37 52C Other temperature Min 30 C Max 938 5 C surface temperature of mattress irradiance heater power lt 30 mW cm2 Heater swing away Yes remains directed at baby Examination light Yes two brightness levels APGAR timer Optional Oxygen control Optional flowmeters distributor hood amp monitor Trending history No Computer network Optional RS232 Alarms Red for alarm and yellow for caution LEDs and message on control panel red light at end of overhead heater Maintenance Consumables Core and peripheral skin probes lamps Service training Service manual 50 training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class IIb compliance method not supplied ISO9001 TUV Product Services 0123 certificate not seen Supplier s Quality System ISO9001 T V Product Services 0123 certificate not seen Device complies with EN60601 1 EN60601 1 2 EN60601 2 35 8010 EN60601 1 21 Financial Consumables Evaluation report Evaluation 324 BabyTh
5. Walls have 17cm walls as standard Thermocare 25cm Tubing ports 2 Treatment distance 80 cm 48 Report 05103 Market survey infant warming and phototherapy Warming therapy Thermocare Variotherm 2000 Weyer Nursing amp medical Control panel location On front of heater unit for radiant heater On front of baby compartment for conductive mattress heater Manual control Continuously variable output not displayed on Ceramotherm 1200 Skin temperature No Other temperature Min 35 C Max 37 C Override 30 35 C and 37 382C not Variotherm 2000 REA C irradiance heater power 0 30 mW cm2 Heater swing away 2041 No 2032 2043 Yes swivel action means the heater remains aimed at the mattress surface Examination light Yes APGAR timer Optional Oxygen control Optional Trending history No Computer network No Alarms Yes Maintenance Consumables None Service training Service manual FOC training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Variotherm REA C Class lla Variotherm REA KCE Thermocare KCE Class IIb Full Quality Assurance ISO9001 15013485 TUV Rheinland 0197 Supplier s Quality System ISO9001 ISOQAR Device complies with EN60601 1 EN60601 2 21 EN60601 2 35 Financial Consumables None Evaluation report NA
6. 202 10 132 12 Weight incl VHA 90 90 90 130 90 kg 89 x45x 89x45x 89x45x Canopy L W H cm 3A 50 50 Ground clearance 16 16 16 13 115 cm Tubing ports 3 10 10 10 10 Warm up time 20 25 20 25 20 25 20 20 o mins 372C 37 C 37 C 31 C ambient Water tank 25 25 i 28 capacity L GE Healthcare Giraffe 114 x 66 147 177 66 x 48 81 111 95 8 lt 50 25 392C Omnibed 114 x 66 147 238 66 x 48 20 11 g3 8 lt 50 25 392C Inspiration MIS V 2100G e A B C C186 Vision 100 x 63 107x56 105x56 135 152 134 154 130 150 74 x 36 63 x 34 63 x 34 92 113 94 114 93 113 12 12 12 88 68 93 100x59x 86x41x 86x 41x 42 47 47 12 139 135 10 4 4 30 11 C 40 11 C lt 60 above above ambient ambient 1 3 1 4 sJoyeqnoul Bulsunn Nursing incubators This page is intentionally blank Adejsaulojloud pue Buiwem juejul AsAINs JeWeYW lt OLGO Hod y Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Beaver MP5 ISIS A amp SI REA Mediprema ID Number 3552 A 3555 SI REA Available since 1997 General Dimensions L W H 104 x 53 x 130 153 cm 104 x 60 x 130 153 cm Lockable wheels 2 out of 4 VHA mattress height 93 116 cm Mattress tilt 10 non continuous A 20 10 continous SI REA Ground clearance 13 cm 3555 SI REA
7. Illumination area The control panel can be locked or covered to prevent accidental changes to set parameters Relative humidity of the air in the enclosure is monitored and regulated by the device A list of the European standards with which the device is claimed to be compliant In this report all dimensions are given to the nearest cm except for the ground clearance wheelbase height An internal non structural layer of the canopy or crib designed to reduce the baby s radiant heat loss by providing an internal surface with a higher temperature May be fitted to only side walls or the canopy roof Number and publication date of any relevant evaluation report featuring the device or an earlier model obtainable from www pasa nhs uk cep A white lamp to facilitate visual infant assessment and therapeutic procedures Useful if ambient light levels are reduced such as during transportation or ward quiet periods or at night Phototherapy devices are now available in a number of physical configurations overhead lamps which may be attached via a rail or pole mounted on a wheeled stand or placed on the incubator canopy see Canopy flat area Other devices deliver light underneath the infant or surround the baby from many angles The provision of gas cylinder holders enables continued oxygen therapy and suction during transport Distance between the floor and lowest central region of an incubator or warming device This sho
8. 12 Report 05103 Market survey infant warming and phototherapy Nursing incubators SATIS Mediprema Nursing amp medical Control panel location Above canopy on rotating arm touch screen control Control panel lock Yes Air temperature Min 202C Max 37 C Override 39 C Skin temperature Min 352C Max 37 C Override 39 C Warm up time 20 mins 25 C to 37 C Humidification 35 80 at 39 C Override 90 Water reservoir External bottle 1L feeds secondary internal tank Oxygen control Inlet for external flow controlled supply optional analyser Trending history 2hr trends for air and skin temperatures and weights longer histories available Computer network Yes Win 95 98 2000 XP operating systems for technical and clinical monitoring Alarms Light on top of control panel condition message on display adjustable volume programmable thresholds for temperature and oxygen alarms Maintenance Access Canopy tilts open Air filter access in rear panel Water system Water bottle autoclavable should be replaced every 24hrs water tank should be drained every 12hrs tank includes germicidal UV lamp incubator should be cleaned every 8 days Consumables Air filter every 6mths UV lamp annual skin temperature probes Service training Service manual FOC available on disk training is chargeable co
9. Between the front and rear double walls Access to the infant Mattress slides out 18 cm Access doors Front and rear sides pull down Hand ports 6 additional 2 in short walls configured as required 20 Report 05103 Market survey infant warming and phototherapy Nursing incubators V 2100G A B C ATOM Nursing amp medical Control panel location Front panel Control panel lock Flip cover conceals buttons photo shows cover in up position Air temperature Min 23 C Max 37 C Override 39 C Skin temperature Min 35 C Max 37 5 C Override 392C Warm up time lt 60 mins from 25 C ambient temperature Humidification Min 40 Max 95 90 for type A Water reservoir Removable tank in front panel 1 3L capacity Oxygen control Oxygen sensor on all models Internal oxygen controller for B and C types external flowmeter control also possible Trending history No Computer network Printer connection on Type C to print weight Alarms Lights on control panel indicate condition red light on top of sensor unit near top of canopy Maintenance Access Canopy tilts open for cleaning Air filter access on rear panel Water system Empty and refill every 24hrs Consumables Air filters every three months skin temperature probes Service training Service manual 85 Training is F
10. Consumables Skin sensor 120 00 sensor covers x10 10 00 resuscitator circuits x3 9 00 Evaluation report NA MRRP Servo controlled 6 500 00 Manual control 5 500 00 38 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Viamed Infant Resuscitation Cabinet Various ID Number 0310002 Available since 1986 cabinet 1984 resuscitator 1992 suction controller General r 3 4 Dimensions H W D 66 x 65 x 28 cm closed 1 yi F Mattress size 66 x 35 cm i I Nursing amp medical l f aire a Front of heater Heater control Manual 4 settable levels T Examination light Yes Photos courtesy of Viamed Description Fold out cabinet plus externally wall mounted Ceratherm 600 2 radiant warmer see separate product page for details Sold as a complete unit Products manufactured by Viamed except where stated otherwise Options Storage options Shelf amp 3 small bins rail clamp dovetail rail Standard package includes Ceratherm 600 2 Nufer low suction controller amp jar mattress APGAR timer Tom Thumb resuscitator patient circuit Intersurgical cabinet Hospital Metalcraft Ltd Optional features accessories Suction controller Therapy Equipment or Oxylitre jar Therapy Equipment or Vaxsax Maintenance Consumables Suction tubes patient circuit ta
11. Description Conductive gel mattress with underbed heating in mobile enclosed baby compartment Options Storage options 1 or 2 swivel drawers open to front or side standard rail Standard package includes Optional features accessories VHA oxygen delivery amp monitoring suction APGAR timer canopy lid nebuliser Baby compartment Crib size L W H 75 x 49 cm Mattress size Walls Four sides fold down and have 7cm inner walls Tubing ports 4 ventilation tube 52 Report 05103 Market survey infant warming and phototherapy Warming therapy BabyTherm 8000 CosiTherm Drager Nursing amp medical Control panel location Front of unit below enclosure Surface temperature Min 35 C Max 37 C Override 30 35 C and 37 38 5 C APGAR timer Optional Oxygen control Optional Maintenance Consumables None Service training Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb compliance method not supplied ISO9001 TUV Product Services 0123 certificate not seen Supplier s Quality System ISO9001 T V Product Services 0123 certificate not seen Device complies with EN60601 1 EN60601 2 35 EN55001 EN55014 Financial Consumables None Evaluation report Evaluation 324 BabyTherm 8000 OC Apr 1997 MRRP 5 150 00 53 Report 05103 Mark
12. No Examination light Optional APGAR timer Yes Oxygen control Optional Trending history Yes up to 96hrs Computer network Optional RS232 Alarms Adjustable sound levels Maintenance Consumables Air filters every three months skin temperature probes covers Service training Service manual available following training training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance IS09001 EN46001 15013485 BSI 0086 Supplier s Quality System IS09001 15013485 BSI 0086 Device complies with IEC601 1 IEC601 2 IEC601 2 19 IEC601 2 21 Financial Consumables Air filters x10 53 30 disposable skin temperature sensors x 50 672 75 reusable skin temperature sensors 155 25 reflective probe covers x50 14 50 Evaluation report MDA 02090 July 2002 MRRP 27 945 00 30 118 31 depending on options 59 Warming therapy Supplier GE Healthcare Ohio 3400 3400 Ohmeda 3400 6612 6001 902 Number 4400 6613 6051 902 Available since 1996 General 3400 104 x 76 x 183 203 cm Dimensions HWD 4400 114 x 76 x 183 203 cm Lockable wheels 2 out of 4 3400 98 118 cm VHA mattress height 4400 98 130 cm Mattress tilt 10 Ground clearance 14 5 cm Weight incl
13. 4 one on each side long sides tilt up head end opens horizontally from the middle foot end slides up Hand ports 4 two in each long side 28 Report 05103 Market survey infant warming and phototherapy Transport incubators NITE Mediprema Nursing amp medical Control panel location Below compartment on long side Control panel lock No Air temperature Min 28 C Max 372C Override 39 C Skin temperature Min 35 C Max 372C Override 38 C Warm up time 20mins 20 C to 36 C Humidification No Oxygen control Analyser included Trending history Yes 2hrs to 1 week Computer network IMM software for maintenance Up to 3 alarm messages displayed red light on top of sensor housing top Alarms of canopy Transport Battery life 15mins at 39 C then degrades over 45mins Battery indicator Display indicates when there is insufficient voltage to produce the set temperature conditions The power supply can also be indicated incl the percentage charge remainging in the battery Warning messages indicating low battery are also displayed Charging time 10hrs Gas cylinders Fittings for 2 x gas cylinders takes Air Liquide B5 size dia 150mm length 620mm Security Holes along mattress tray sides for optional straps Maintenance Access Canopy tilts open Consumables Air filters skin temper
14. 86 8 88 89 91 92 92 93 7 Table 2 Comparison of nursing incubatorsspecifications 8 Table 3 Warming therapy device types 34 Table 4 Mobile complex care warming units features and specifications 36 Table 5 Phototherapy lamps features and specifications 19 Report 05103 Market survey infant warming and phototherapy Summary A new NHS purchasing framework agreement for infant warming and phototherapy equipment IWpF was established by NHS Purchasing and Supplies Agency NHS PASA in March 2005 This makes it easier quicker and cheaper for NHS organisations to purchase a range of neonatal care products Constraints imposed by European legislation and standing financial instructions are removed as these were taken into consideration when drawing up the framework which covers all NHS Trusts in England Northern Ireland Scotland and Wales This comparative report has been updated following the contract renewal in March 2006 One of the original suppliers has been replaced and a mobile warming device removed Several typographic and editorial errors have also been corrected This report provides an extensive independent information resource to help purchasers identify the full range of products and issues that can influence suitability An assessment of each department s technical and clinical needs can be compared to the products on the NHS PASA IWpF website 1 to select the best value product Approxi
15. Air temperature Min 28 C Max 37 C Override 39 C Skin temperature Min 35 C Max 37 C Override 38 C Warm up time 18mins 25 C to 37 Humidification Levels 1 2 amp 3 produce a range of 45 70 at 36 C Water reservoir Directly into drawer in front panel level visible from front 2 5L capacity Oxygen control Inlet for external flow controlled supply analyser optional for 3555 SI REA Trending history Optional Computer network Optional DOS Win 95 Win 98 operating systems for technical amp clinical monitoring Alarms Lights on control panel indicate alarm condition Maintenance Access Canopy tilts open Air filter access on rear panel Water system Drain and clean every 24hrs Consumables Air filters every 6mths Skin temperature probes covers Service training Service manual FOC available on disk training is chargeable cost not supplied additional connectors required Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 IEC60601 1 19 Financial Consumables Air filters x3 188 15 skin sensor 123 86 Evaluation report NA MRRP 3552 A 5 888 89 3555 SI REA 7 571 90 VHA adds 768 4
16. Alarms Condition indicated by LEDs on control panel Audible alarms silenced for 10mins Maintenance Access Canopy tilts open A tray is available for disinfecting the heater Water system Underneath mattress tray Consumables Air filter every 90 days located in rear panel silver nitrate for water tank Service training Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance ISO9001 DNV 0434 Supplier s Quality System Device complies with IEC60601 1 IEC60601 2 IEC60601 2 19 Financial Consumables Evaluation report NA MRRP SW 3 192 00 DW 3 297 60 VHA extra 1 673 00 23 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Medical Imaging Systems Vision 2186 Fanem ID Number 090 009 800 LCD 090 010 800 ELV Available since General Dimensions LW H 96 x 51 x 127 147 cm Photo courtesy Lockable wheels 4 out of 4 of MIS VHA mattress height 93 113 cm Mattress tilt 1 2 Ground clearance 13 5 cm Weight incl VHA 93 kg Description Two types of display available LCD with back light or electroluminescent ELV Options Storage options 2 small amp 1 large drawer or cabinets each side IV pole amp shelves for use above unit Standard package includes Servo controll
17. MRRP 2041 4 995 00 2043 7 995 00 2032 8 250 00 49 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Drager Resuscitaire Air Shields ID Number 82A0 60CEU Available since 1994 te General Dimensions H W D 115 x 75 x 185 206 cm Lockable wheels 4 out of 4 as E lt 5 VHA mattress height 90 109 cm a Mattress tilt 10 Ground clearance Weight incl VHA 127 kg 3 X 5 Description Warmer unit intended for resuscitation use also suitable for complex care Uses quartz heating element Options Storage options Large drawers shelves trays IV pole Standard package includes VHA APGAR timer 2 gas cylinder fittings Optional features accessories Blender resuscitator suction X ray tray Baby compartment Crib size LW H Mattress size 66 x 53 cm Walls All walls fold down and also removeable Tubing ports Slots in rear wall and gaps between walls Treatment distance 74cm 50 Report 05103 Market survey infant warming and phototherapy Warming therapy Resuscitaire Air Shields Nursing amp medical Control panel location On stand below heater Manual control 0 100 in 10 increments Automatically adjusted down if ambient temp exceeds 26 C Skin temperature Min 34 C Max 37 C Override 382C
18. Warm up time lt 50mins 28 C to 38 5 C with 50 ambient RH Humidification Min 30 Max 95 Water reservoir Directly into drawer at foot end 1L capacity level visible on outside uses distilled water Oxygen control lt 65 optional Trending history Yes up to 96hrs Computer network Optional RS232 Thermalink Alarms Four volume levels two tones Temperature difference alarm can be set at 0 5 or 1 0 C Condition message on control panel and large alarm light on top of panel Maintenance Access Giraffe canopy tilts open for cleaning Omnibed canopy can be raised Air filter access behind water reservoir Water system Reservoir drawer is removable Clean weekly between patients Consumables Air filters every three months temperature probes Service training Service manual available following training training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS09001 EN46001 15013485 BSI 0086 Supplier s Quality System IS09001 15013485 BSI 0086 Device complies with IEC601 1 IEC601 2 IEC601 2 19 IEC601 2 21 Omnibed Financial Consumables Air filters x10 53 30 disposable temperature sensors x50 672 75 reusable temperature sensors 155 25 Evaluation report MDA 02090 July 2002 Giraf
19. West Yorkshire BD20 7DT 1 Year 01535 634542 01535 635582 www viamed co uk Viamed UK Ardo Medical AG Switzerland Medestime France Nufer Medical AG Switzerland Report 05103 Market survey infant warming and phototherapy Appendix Manufacturing standards for medical devices Table 6 Standards relevant for the design and manufacture of infant warming and phototherapy equipment Manufacturing standard Description BS EN 1SO013485 2003 Quality systems applied to medical devices Particular BS EN 1S013485 2001 requirements for the application of ISO9001 BS EN 1S013485 1996 ISO13485 1996 EN55011 1991 Specification for limits and methods of measurement of radio disturbance characteristics of industrial scientific and medical ISM radio frequency equipment BS EN60529 Specification for degrees of protection provided by enclosures IPX4 equipment can withstand splashing liquid BS EN60601 1 1990 Medical electrical equipment General requirements for safety IEC60601 1 1988 BS EN60601 1 2 2002 Medical electrical equipment General requirements for safety IEC60601 1 1988 Collateral standard Electromagnetic compatibility Requirements and tests BS EN60601 2 19 1997 Medical electrical equipment Particular requirements for safety IEC60601 2 19 1990 Specification for baby incubators BS EN60601 2 20 1997 Medical electrical equipment Particular requirements for safety IEC60601 2 20 1990 Specification fo
20. s Recommended Retail Price MRRP Devices are often configurable with a variety of drawer types and sizes and may be accessorised with additional shelves trays and poles rails 100 Report 05103 Market survey infant warming and phototherapy Appendix Suction Superstructure amp trolley options Supplier s quality system Surface temperature Treatment distance Treatment timer Trending history Tubing ports VHA mattress height Walls Warm up time Water reservoir Water system Weighing scales Wheelbase height X ray tray A device suitable for resuscitation should provide suction may be known as an aspirator to remove mucous from the infants airways This may be connected to the piped vacuum supply in the wall or operate using the Venturi effect from a pressurised air supply cylinder or piped supply Transport incubators are designed to operate in several environments in hospital in an ambulance or helicopter and in transit between these The frame trolley to which the incubator is fastened may be more suitable for one mode than another The supplier should maintain an accredited Quality System for the supply and servicing of the devices Unless otherwise stated CEDAR has been supplied with copies of certificates obtained from a Quality System audit Pre set values of the mattress surface temperature may be slightly different from the actual temperature achieved if the ambient te
21. APGAR timer 1 skin temperature sensor Optional features accessories VHA foot pedals extra crib type fold down walls or fixed bassinet shape weighing scales ICU unit only resuscitation kit flowmeters venturi aspirator amp bottle gas amp suction inlets blender 2 x E size gas bottle holders amp pressure reduction valves with flowmeters resuscitator halogen or fluorescent examination lamp Baby compartment Crib size L W H 81 x 57 cm ICU model Mattress size 64 x 44 cm ICU model 63 x 33 cm bassinet Walls ICU model has fold down walls on front and sides rear wall is removable Tubing ports Gaps between walls and cut outs in rear wall Treatment distance 62 Report 05103 Market survey infant warming and phototherapy Warming therapy Multisystem 2051 Fanem Nursing amp medical Control panel location Front of stand below heater Manual control 0 100 indicated by 4 LED bar Skin temperature Min 25 C Max C Override 38 C Other temperature No Irradiance heater 560 W power Heater swing away Yes Examination light Yes fluorescent tube or spot halogen APGAR timer Yes Oxygen control Optional flowmeter provision Trending history No Computer network No Alarms LEDs indicate alarm condition Maintenance Consumables Skin temperature probes covers adh
22. Centre for Evidence based Purchasing Room 152C Skipton House 80 London Road London SE1 6HL Tel 020 7972 6080 Fax 020 7972 5795 E mail cepo pasa nhs uk All evaluation reports published since 2002 are available in full colour to download from our website www pasa nhs uk cep Visit our website for a comprehensive list of publications details of forthcoming evaluations services and contacts S C Peirce A J Hedges D C Crawford CEDAR Cardiff Medicentre University Hospital of Wales Heath Park Cardiff CF14 4UJ Tel 029 2068 2120 Fax 029 2075 0239 E mail diane crawford cardiffandvale wales nhs uk For more information on CEDAR visit www cedar wales nhs uk Crown Copyright 2006 Apart from any fair dealing for the purposes of research or private study or criticism or review as permitted under the Copyright Designs amp 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 the Controller of Her Majesty s Stationery Office HMSO Information on reproduction outside these terms can be found on the HMSO website www hmso gov uk or e mail hmsolicensing cabinet office x gsi gov uk Report 05103 Market survey infant warming and phototherapy Contents Summary 1 Introduction 2 Infant Warming and phototherapy Framework IWpF Purpose of this report Creating the optimal thermal environment for infants Neon
23. Ey Available since 2000 General pores TS m Dimensions H W D 114 x 66 x 147 238 cm Lockable wheels 4 out of 4 v i A VHA mattress height 81 111 cm Mattress tilt 12 Ground clearance 9 5 cm Weight incl VHA 131 kg 3 3 s y Description Dual purpose unit converts from incubator to radiant warmer by raising canopy details given in incubator section Options Storage options Single large drawer with organiser tray pulls through from either side included in price Rails are non standard dovetail design Additional IV poles and shelves available Standard package includes X ray tray VHA APGAR timer controlled humidity as an incubator Optional features accessories Oxygen control weighing scales access iris tubing port in foot end gas cylinder holder RS232 connection Thermalink examination light Baby compartment Crib size L W H Mattress size 66 x 48 cm Walls Front and sides fold down Tubing ports 8 Treatment distance 58 Report 05103 Market survey infant warming and phototherapy Warming therapy Giraffe Omnibed Ohmeda Nursing amp medical Control panel location At rear above compartment Manual control 0 100 in 5 increments Skin temperature Min 35 C Max 37 5 C Other temperature NA came heater 400 W Heater swing away
24. H W D 90 x 73 x 27 cm closed Mattress size 62 x 62 cm Nursing amp medical Control panel location Below heater Heater control IW980 baby servo control IW990 manual control Examination light Yes Photo supplied courtesy of Fisher amp Paykel Description Wall mounted fold out cabinet based around manual 990 or baby servo 980 controlled radiant heater Uses same heater as for Mobile Infant Warmer and CosyCot see relevant product pages for warmer details Options Storage options Yes Standard package includes IW980CAB Baby controlled Infant Warmer skin temp sensor IW990CAB Manual controlled Infant Warmer Both Neopuff Infant Resuscitator test lung 10 x patient circuits mattress 2 Xx O2 flowmeters suction jar amp filter halogen light APGAR timer Optional features accessories Left or right opening Maintenance Consumables Skin sensor amp covers resuscitator circuits Service training Service manual 22 00 training is chargeable 160 Medical Devices Directive Manufacturers MDD Class IIb warmer Full Quality Assurance compliance NB IS09001 EN46001 IS013485 T V Product Services 0123 Supplier s Quality System ISO9001 TUV Product Services 0123 Device complies with IEC60601 1 IEC60601 1 2 IEC60601 2 21 all devices ISO8382 resuscitators Financial
25. Light source 8 fluorescent tubes 8 blue or 4 blue 4 white Peak spectrum 400 500 nm Treatment distance 40 50 cm Irradiance Illumination area Nursing amp medical Power control No Treatment timer Optional Alarms No Maintenance Lamp hours meter No replacement interval 2000 hrs Consumables Tubes Service training Medical Devices Directive Manufacturer s MDD compliance NB Class unknown compliance method not supplied ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with Financial Consumables Blue tubes 29 white tubes 12 Evaluation report NA MRRP Mixed 4 4 949 23 8 Blue 1 028 62 86 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Genesys Medical Solutions neoBLUE Natus 10069 with stand i EMBer 40761 without stand Available since 2002 General Dimensions L W H 52 x 27 x 183 cm Photo courtesy of Natus Lockable wheels 2 out of 5 Medical Incorporated VHA mattress height 77 120 cm Head tilt 40 Wheelbase height 10 cm Weight 3 6 kg lamp only 18 kg with stand Available with mobile stand or as lamp only having rubber feet for Description placement on incubator canopies A red light allows the user to centre the area of illumination on the infant Light Light sou
26. Mediprema France Weyer GMBH Germany Fisher amp Paykel Supplier Healthcare UK GE Healthcare Unit 16 Cordwallis Park 71 Great North Road Clivemont Road Hatfield Maidenhead Berkshire Hertfordshire S16 7BU AL9 7EN Warranty 1 year 1 year Tel 01628 626136 01707 263570 Fax 01628 626146 01707 271013 www gehealthcare com Website www fphcare com 3 uken index html Manufacturer EINE RE Ohmeda Medical USA Healthcare New Zealand 93 Dr ger Medical UK Ltd The Willows Mark Road Hemel Hempstead Hertfordshire HP2 7BW 1 year 01442 213542 01442 240327 www draeger com MT internet UK uk index jsp Drager Germany amp USA Genesys Medical Solutions UK Ltd Gibbs House Kennel Ride ASCOT Berks SL5 7NT 1 year 0870 6009940 0870 6009941 www nibsp web com genesysmedicalsolutions Natus Medical Ltd USA Report 05103 Market survey infant warming and phototherapy Appendix Supplier Warranty Tel Fax Website Manufacturer Inspiration Healthcare Ltd Medical Imaging Systems Unit 14 Barshaw Park TE iigently iteaing Estate Leycroft Road ehuren ane Beaumont Leys Kingsbury Leicestershire kondon LE4 1ET NW9 8AU 2 years 1 Year 0116 2351010 0208 205 9500 0116 2350150 0208 205 0585 www inspiration www medical imaging healthcare co uk systems co uk Atom Medical International Inc Japan Fanem Brazil 94 Viamed 15 Station Road Cross Hills Keighley
27. be encouraged 2 The IWpF project fulfilled these recommendations Report 05103 Market survey infant warming and phototherapy Introduction Infant Warming and phototherapy Framework IWpF The NHS Purchasing and Supply Agency NHS PASA has developed a national contract for infant warming and neonatal phototherapy equipment IWpF This framework agreement was designed to stabilise prices and encourage more manufacturers to supply quality products to the UK and circumvents the need for purchasing departments to tender for larger purchases of neonatal care equipment 3 This reduces the time involved and may also provide lower prices than are available to individual organisations The equipment covered by this contract includes e nursing incubators e transport incubators e warming devices radiant warmers and heated mattresses e phototherapy lamps for hyperbilirubinaemia Not every device in the IWpF contract is listed in this report Items which might be considered as accessories do not have separate product pages but may be listed on the main item product pages Purpose of this report The information in the comparative tables and product pages has been compiled from documents supplied by the manufacturing supplying companies from their websites and from the NHS PASA IWpF website 1 It is designed as a first stop brochure to allow quick and simple comparisons between similar devices so that purchasers can identify whi
28. courtesy of Viamed eign 4 6 kg NC2 2 8 kg NC3 Table top or in bed device with a separate control unit and a choice of three mattress sizes interchangeable Rigid base with covered foam mattress Description Suitable for examination changing and treatment Control box can be hung from a horizontal rail Nursing amp medical Control panel location Separate control unit Surface temperature Min 28 C Max 38 C at 24 C ambient temperature Warm up time 90 mins for largest mattress NC1 Alarms Variable volume Maintenance Consumables None Service training Service manual FOC training is chargeable TBA Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance ISO9001 15013485 TUV Product Service 0123 Supplier s Quality System BS EN ISO9001 15013485 CMDCAS certificate not seen Device complies with EN60601 1 EN60601 2 EN60601 2 35 Financial Consumables None Evaluation report NA MRRP NC1 2 100 00 NC2 2 100 00 NC3 2 050 00 incl control box 12 Report 05103 Market survey infant warming and phototherapy Phototherapy How neonatal phototherapy works Bilirubin is a by product of the break down of red blood cells which is normally excreted by the liver Neonates and especially premature babies may have livers that are not mature enough to perfo
29. indication of the radiant heat capability of the warmer but these should not be compared directly between devices as there are many variables that can affect the ability of the heater to warm the infant A lower power may not be less effective than a higher value for difficulties with comparing irradiance values see the Phototherapy introduction A heated mattress can maintain a warmed environment for a short duration after the power is removed especially if the baby is covered Alternatively a battery can power a mobile warming unit during transferral from one department to another 33 VE Report 05103 Market survey infant warming and phototherapy Table 3 Warming therapy device types Mobile Mobile complex care unit Free standing Free standing Table top wall TeS tanon radiant with out warming comp abi lamp with baby amp ceiling cabinets unit mattress lamp mattress support mounts heating only CosyCabinet Isis Radiant ISIS Ambiance fant Warming Variotherm Easy isis ambiance ISIS Ambiance BOW Mediprema Mediprema SHS fae Mediprema Mediprema Paykel Kanmed Weyer Infant i i scr ston CosyCot Thermocare Thermocare Ceratherm with See Ceramotherm eee ae Fisher amp 2000 KCE 2000 K DINO Mobil ae Paykel Weyer Weyer Nufer evel evel Viamed Multisystem Variotherm 2000 BabyTherm Mobile Infant Cerain 2051 REA KCE 8000 Warmer Fisher Nufer Fanem Weyer Dr ger amp Paykel Resuscitair
30. 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 are listed in the product pages Where these reports refer to previous models this has Report 05103 Market survey infant warming and phototherapy Introduction been made clear These reports are available from the NHS PASA Centre for Evidence based Purchasing CEP 5 Procurement issues lt 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 consumables and maintenance may be relatively high and vice versa Additional features can add to the total cost and complexity of a device and may be unnecessary in some cases Storage facilities for accessories and baby clothes shelves for placing equipment during interventions and poles for affixing accessories can be important considerations The installation of equipment including electrical and gas supplies and related labour costs for fitting wall ceiling and cabinet mounted warmers should be included in the total cost Some user training is included in the purchase price by all suppliers further details of which can be found on the IWpF website 1 The cost of technical manuals and service training for technical support staff is given in the product pages where a
31. pad with cover and padded nest for conductive heating Nest is machine washable and can be drawn together Description around the baby using pull cords 2 are supplied in the purchase price Device can be battery powered 12 24V or used inside an enclosed incubator Mattresses and nests are available in other sizes Nursing amp medical Control panel location Separate box can be hung from a horizontal rail Surface temperature Min 34 C Max 38 C water temperature Warm up time 4 C hr at 22 C ambient temperature Alarms Yes Maintenance Consumables Nests change at least annually anti algae solution mattress uses tap water change every three months Service training Service manual FOC available on disk training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance ISO9001 15013485 Intertek Semko 0413 Supplier s Quality System ISO9001 ISOQAR Device complies with EN60601 1 EN60601 2 EN60601 2 35 Financial Consumables Re useable nests each 65 anti algae solution x20 95 Evaluation report NA MRRP 1 995 70 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Thermocare Convenience Weyer Avai
32. page is intentionally blank Adejsaulojloud pue Buiwem juejul AsAINs JeWeYW lt OLGO Hod y 2 Report 05103 Market survey infant warming and phototherapy Transport incubators Supplier Beaver NITE Mediprema ID Number 5020 not incl trolley Available since General Dimensions L W H 96 x 58 x 54 cm Mattress tilt 10 non continuous Mattress size 53 x 39 cm Double walls No Tubing ports 1 at head end Weight 36 5 kg The baby compartment is heated primarily using a grid of fine wires set into Description the top surface of the canopy bit like a radiant warmer A secondary source of heating Scavenging heat from the power supply is located under the mattress tray Several trolley options are available Options Superstructure amp trolley options 5032 protection amp carrying structure 601 07 5076 short superstructure 1 782 38 5049 light superstructure w o trolley 3091 91 5071 TC3000 trolley 2775 83 5070 trolley 2147 83 5035 resuscitation trolley 2251 21 Standard package includes Oxygen analyser skin temperature probes Optional features accessories Clinical technical history modules cover light ventilator shelves amp rails Thr or 2hr battery packs Access to the infant Mattress slides out Long side or head end for resuscitation Access doors
33. placed on a cold surface A manually operated device to blow oxygen air into an infant s lungs during resuscitation This may use a small bag that is squeezed by hand or operate semi automatically whereby respiratory pressures are regulated by the device and only the duration of inspiration and expiration are operated manually This is not the same as a ventilator which operates entirely automatically although a device may operate in both modes The availability and cost of service manuals and training for medical equipment technicians technologists FOC free of charge Some user training is included in the purchase price by all suppliers Oxygen is delivered to the infant to maintain a pre set concentration in the enclosure Hoods are available so that the oxygen can be concentrated within a small volume around the infant s head Range of pre set core skin temperature values usually measured at the abdomen All incubators and some warmers have a normal and extended range An Override function must also be used to select a temperature in the extended range Some warmers and all incubators can be operated so that the heat output is regulated to maintain a set core skin temperature usually measured at the abdomen For radiant warmers a reflective adhesive patch should be used to attach the probe to the skin surface to shield the sensor from the heater Equipment features and consumables included in the Manufacturer
34. shown Weight incl VHA 90 kg Description Mediprema promote continuous self checking of the controls and sensors feet to head air circulation to reduce heat loss with open ports doors and silent operation of ports and doors Options Storage options Left and right cupboards or shelves swing aside tray IV pole extra rails Standard package includes 1 skin probe X ray tray 8555 SI REA Optional features Powered VHA extended mattress pull out 120 trending amp key press history For 3555 SI REA weighing scales and 2 double walls Baby compartment Canopy size L W H 3552 A 89 x 45 x 34 cm 3555 SI REA 89 x 45 x 50 cm Mattress size 61 x 39 cm Double walls 3552 A no 3555 SI REA optional for head and foot walls Tubing ports 3552 A 3 3555 SI REA 10 Canopy flat area 89 x 35 cm Air circulation Feet to head Access to the infant Mattress slides out 75 optional 120 Access doors 3553 A 2 side opening doors in front 3555 SI REA 2 side opening doors each in front and rear walls Hand ports 3552 A 4 3555 SI REA 6 2 additionally at head and foot ends 10 Report 05103 Market survey infant warming and phototherapy Nursing incubators MP5 ISIS A amp SI REA Mediprema Nursing amp medical Control panel location Front panel Control panel lock No
35. site Compatibility of trolley fixation equipment and the power supply in the vehicle is vital whether it be ambulance plane or helicopter A transport incubator must include an internal power source i e a rechargable battery and should have some means for reducing the movement of the infant within the enclosure All the features appropriate for intensive care nursing incubators may be desirable during transportation and should be securely mounted These include e an effective warming system to keep the baby at a stable temperature e awarmed internal surface of the canopy to reduce radiant heat loss to cold surfaces e humidification to reduce evaporative heat loss e mechanical and or manual devices for supporting respiration preferably using warmed and humidified air e oxygen enrichment possibly using a blender e rails or poles for accessories infusion pumps additional monitors etc e temperature monitoring e examination light e oxygen and medical air supplies Not all this equipment may be provided by the supplier of the transport incubator but means to attach such devices should be available Contact the supplier for information regarding specific accessory features The MHRA publications Transfer of Neonates in Ambulances Sept 2001 and Safe use of Ambulance Stretcher Trolleys DB2003 04 Mar 2003 provide useful advice and may be downloaded from www mhra gov uk 26 Transport incubators This
36. temperature Min 35 C Max 37 C Override 382C Alarms Variable volume settable thresholds red light under heater Maintenance Consumables Skin temperature probes covers Service training Service manual FOC available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance ISO13485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 EN60601 2 21 Financial Consumables Evaluation report NA MRRP 2930 3 228 96 2950 incl VHA 5 042 59 66 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Ceramotherm Weyer ID Number 2112 2212 f Available since 2001 aid s r DE General Dimensions H W D 56 x 56 x 154 194 cm Lockable wheels 2 out of 4 Photo courtesy of Central Medical VHA mattress height 89 129 cm Supplies Mattress tilt Yes Ground clearance 10 cm Weight incl VHA 8 7 kg heater 16 kg stand Description Ceramic heater with mobile stand 2112 Ceramotherm 2100 2212 Ceramotherm 2200 Includes examination light Heaters can be calibrated for other treatment distances 65 90cm Heater Heat source Ceramic element s Treatment distance 65cm de
37. temperature at the abdomen close to core temperature and at a peripheral site usually the foot Products with peripheral temperature measurement as a standard or optional feature are capable of dual temperature monitoring Kangaroo nursing using skin to skin contact with a parent for warming sick and premature neonates is becoming increasingly popular as it also encourages parent child bonding Some incubators provide a special kangaroo mode whereby the infant s temperature is monitored whilst the incubator temperature is maintained separately Other incubators may allow kangaroo nursing care but do not specifically label this as a feature The frequency and level of access to the baby that nurses and medical staff require varies 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 trolley wheelbase height of Report 05103 Market survey infant warming and phototherapy Nursing incubators other mobile equipment and the incubator s ground clearance will indicate whether they can be used together Key incubator dimensions and characteristics are compared in Table 2 Report 05103 Market survey infant warming and phototherapy Table 1 Comparison of nursing incubators features Supplier Beave
38. tubes 35 White tubes 31 50 Evaluation report NA MRRP 1 295 00 89 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Viamed BiliCrystal System Medestime Light Light source Blue green fluorescent tubes DZC 11 75W Peak spectrum Broadband peak at 446 nm plus lines at 435 nm and 545 nm Nursing Power control No Treatment Timer Yes up to 12 hrs with buzzer not Bulle 2 Alarms No Maintenance Lamp hours meter Mono Duo no Bulle yes replace after 3000 hrs Consumables Tubes hammocks Service training Training TBA Medical Device Directive Manufacturers MDD Class unknown Full Quality Assurance compliance NB ISO9001 15013485 EN46001 SNCF 0499 rant ey s Quality BS EN ISO9001 IS013485 CMDCAS certificate not seen Device complies with IEC60601 1 Financial Consumables Tubes each bought in 6 s or 8 s 20 Hammocks each 20 Evaluation report NA 90 Report 05103 Market survey infant warming and phototherapy Phototherapy BiliCrystal Mono Duo 2 Medestime ID Number Mono 2110101 2110105 Duo 2110102 68 x 62 cm 2110103 68 x 77 cm Available since Description Overhead lamp on mobile stand with one Mono or two Duo hoods Duo two hoods are controlled simultaneously are horizontally adjustable and is available in two sizes
39. which could fall within the definition of a medical device The CE mark means that a product can be marketed in any country within the EU as there are no further country specific requirements The European harmonised standards have been developed to provide more specific guidance for manufacturers It is not necessary to meet the applicable standards in order to be compliant with the Essential requirements but it is the simplest method for a manufacturer to obtain the CE mark In the UK the British Standards Institute BSI publishes European Standards with the prefix BS EN The ISO and IEC standards also cover countries beyond the EU borders and may have slightly different requirements to the European standards Under the MDD a medical device is classed I Ila Ilb or III according to the risk associated with its use All the devices in this report are medium risk either lla or Ilb In order to prove conformity with the MDD for these devices a manufacturer must follow one of the routes in Table 7 The route used by manufacturers in this report has been documented in the product pages where known Table 7 Routes for proving conformity with the Medical Devices Directive Device Class Routes to satisfying the Medical Devices Directive amp obtaining CE marking lla or Ilb Full Quality Assurance System covering design production and quality monitoring of the process lla Declaration of Product Verification e g batch test
40. 2 11 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Beaver SATIS Mediprema ID Number 3600 Available since 2003 e General 4 i pR ige Dimensions L W H 102 x 58 x 159 182 cm 2 A Lockable wheels 2 out of 4 I SS Photo courtesy of VHA mattress height 94 117 cm i Mediprema Mattress tilt 20 10 Ground clearance 13 cm 3 4 M Weight incl VHA 90 kg U U g Description Same continual self checking as ISIS models Humidification is by ultrasonic nebulisation and includes a UV germicidal lamp in the internal water tank Options Storage options Left and right cupboards or shelves swing aside tray IV pole extra rails Standard package includes 1 skin probe 2 water bottles 2 bottle supports Optional features Powered VHA extended mattress pull out trending amp key press memory weighing scales double walls oxygen analyser peripheral skin temperature Baby compartment Canopy size L W H 89 x 46 x 50 cm Mattress size 61 x 38 cm Double walls At head foot ends long sides optional Tubing ports 10 Canopy flat area 89 x 35 cm Air circulation Feet to head Access to the infant Mattress slides out 75 optional 120 Access doors 2 side opening doors in front and rear Hand ports 6 2 each long side 1 each head and foot ends
41. 20 cm diameter Nursing amp medical Power control No Treatment timer No Alarms Overheating of unit Maintenance Lamp hours meter Yes replace after 2500 hrs Consumables Bulb air filter check quarterly Service training Service manual in user manual training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance ISO9001 EN46001 IS013485 BSI 0086 Supplier s Quality System ISO9001 IS013485 BSI 0086 Device complies with IEC 60601 1 IEC60601 1 2 IEC60601 2 50 Financial Consumables Evaluation report NA MRRP 2 700 00 82 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Medical Imaging Systems Biliberco OO6FB Fanem ID Number 006005800 mixed tubes 006009800 white tubes Available since General Dimensions L W H 87 x 43 x 102 cm Lockable wheels 2 out of 4 VHA mattress height NA Head tilt NA Wheelbase height 12 5 cm Weight 53 kg Description Mobile cabinet with light box on which a clear bassinet is placed The neonate lies on a clear gel mattress and a curved reflector covers the bassinet Optional extras include a heated mattress IV pole and 1 or 2 drawers 30 mattress tilt optional Light Light source 7 fluoresc
42. 5 super LEDs blue Peak spectrum 450 460 nm Treatment distance 30 cm minimum for babies less than 2 5kg irradiance 35 40 uW m2 nm Illumination area 25 cm Nursing amp medical Power control Yes 20 100 in 10 increments Treatment timer Yes Alarms No Maintenance Lamp hours meter Yes replace after 20 000 hrs or when irradiance is reduced by 25 Consumables LEDs replaced as a single source unit Service training Medical Devices Directive Manufacturers MDD Class unknown compliance method not supplied compliance NB ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with Financial Consumables Evaluation report NA MRRP BTB 1 695 88 BTI 1 672 53 BTP 1 868 11 85 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Medical Imaging Systems Octofoto Fanem ID Number 006018700 4blue 4white pran 006019700 8blue SEP Available since General Dimensions L W H 94 x 60 x 126 164 cm Lockable wheels 3 out of 3 VHA mattress height 76 124 cm approx Head tilt 180 Wheelbase height e T Weight 23 kg t Standard overhead fluorescent unit with optional number of blue amp white ePecriplon tubes 4 or 8 blue Light
43. 7 cm Mattress size 65 x 50 cm Double walls Optional in canopy roof Tubing ports 10 Canopy flat area Information not supplied Air circulation Up front amp back walls down head amp foot walls Access to the infant Mattress slides out Yes Access doors 2 front and back plus two smaller doors at the head and foot ends Hand ports 4 14 Report 05103 Market survey infant warming and phototherapy Nursing incubators Caleo Drager Nursing amp medical Control panel location Variable attaches to extension pole on either side Control panel lock Yes Air temperature Min 28 C Max 37 C Override 20 27 52C and 37 5 39 C Skin temperature Min 34 C Max 37 C Override 38 C Warm up time 20 mins 20 C to 31 C at 20 C ambient temperature Humidification Optional 30 99 in 1 increments or auto set according to air temperature Water reservoir External bottle 2 8L or can use a water bag Oxygen control Optional 21 75 in 1 increments Trending history 3hrs 7days Computer network Optional 2 x RS232 and 1 x nurse call Alarms Lamp on top of sensor unit at head end and message on control panel Maintenance Access Canopy roof tilts and is removable Water system External bottle and pipe are removable for cleaning There is a cleani
44. 9 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 EN60601 2 21 Financial Consumables Skin temperature sensor 123 86 reuseable suction containers 108 99 Evaluation report NA MRRP 6 372 96 VHA extra 1 166 88 43 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Infant Warming System Kanmed AB ID Number BB 100 Available since 1999 Baby Bed 1996 Baby Warmer Complete General Dimensions H W D 75 x 51 x 125 159 cm Lockable wheels 2 out of 4 VHA mattress height 70 104 cm Ts Mattress tilt 12 J Ground clearance 16 cm 3 y Weight incl VHA ase eel Photo courtesy of Medical Systems Description Baby Warmer Complete plus mobile crib suitable for long term care see separate product page for mattress details Options Storage options Shelf below crib 2 drawers IV pole Standard package includes Baby Warmer Complete water mattress heating pad 2 nests control unit Baby Bed BB 01 mobile crib with VHA tent pole tent drawer Optional features accessories VHA larger bed size for twins canopy lid Baby compartment Crib size L W H 67 x 45 x 24 cm Mattress size 66 x 45 cm Walls Front and side walls fold down Tubing ports Sl
45. I 0086 Device complies with IEC 60601 1 IEC60601 1 2 EN60601 1 50 Financial Consumables Evaluation report NA MRRP 1922 1 549 96 1925 4 617 83 76 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Beaver Cradle 360 Mediprema ID Number 1926 Fs Available since 1990 amp General Ty r Dimensions LWH 64x 90 x 150 182 cm i Lockable wheels 2 out of 4 ay Saa VHA mattress height 97 129 cm Head tilt NA s9 Wheelbase height 17 cm emn m Weight 65 kg Tubular light box providing whole body irradiation Neonate lies on a mesh hammock which slides out to the front Screens at ends reduce stray light Description Enclosure temperature is monitored but not regulated and will reach approximately 33 C The top half can be raised manually altering the irradiance and the air temperature inside the Cradle Light Light source 16 fluorescent tubes TL 20W 52 Peak spectrum 450 460 nm Treatment distance Fixed irradiance 5 mW cm per half hood at the centre Illumination area Whole body Nursing amp medical Power control Top half can be raised decreasing the total irradiance Treatment timer 1 min 40 hrs Alarms No Maintenance Lamp hours meter Yes Consumables Tubes hammocks machine washable 2 included in purchase price Service training
46. IV pole Standard package includes APGAR timer X ray tray 1 skin probe Optional features accessories VHA Ov air vacuum panel blender oxygen analyser fold down front wall cylinder holder resuscitator ventilator Baby compartment Crib size L W H Mattress size 65 x 51 cm Walls Front and rear are removable sides fold down front can also fold down as an option Tubing ports Slots in rear wall Treatment distance 42 Report 05103 Market survey infant warming and phototherapy Warming therapy ISIS Radiant Mediprema Nursing amp medical Control panel location Above head end touch screen Manual control No Skin temperature Min 35 C Max 372C Override 38 C Other temperature Air temperature Min 28 C Max 37 C Override 39 C ae heater 1200 W Heater swing away 90 Examination light Yes APGAR timer Yes Oxygen control Optional gas distribution panel Trending history Yes when attached to a PC Computer network Yes RS232 Alarms LED alarm message display Maintenance Consumables Skin temperature probe suction containers Service training Service manual FOC available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS013485 G MED 045
47. OC for 1st day 750 day thereafter Medical Devices Directive Manufacturer s MDD compliance NB Class IIb Full Quality Assurance _ IS09001 15013485 EN46001 TUV Product Services 0123 Supplier s Quality System ISO9001 IS013485 EN46001 CQS Ltd Device complies with IEC601 1 IEC601 2 IEC601 4 IEC601 2 19 EN55011 ISO7767 Financial Consumables Air filters x5 95 disposable temperature probes x10 250 Evaluation report Report 05061 Sept 2005 MRRP A 7 400 00 B 9 000 00 C 12 500 00 21 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Medical Imaging Systems C186 TS Fanem ID Number 92000800 DW 92001800 SW i i Available since General Dimensions L W H 107 x 56 x 134 154 cm Lockable wheels 4 out of 4 VHA mattress height 94 114 cm Mattress tilt 12 non continuous Ground clearance 13 5 cm Weight incl VHA 68 kg Description Basic incubator available as single SW or double walled DW version Air is humidified passively without control or monitoring although an active humidification module is available Available in four trim colours Options Storage options 2 small amp 1 large drawer on each side IV pole shelves for use above unit Standard package includes 1 skin temperature s
48. Purchasing and Supply Agency Centre for Evidence based Purchasing Report 06046 Market survey infant warming and phototherapy update September 2006 www pasa nhs uk cep Health and social care working together About evaluation reports The Centre for Evidence based Purchasing provides independent and objective evaluations of medical devices available on the UK market Specialist centres mainly in NHS Trusts do the evaluations under contract to the NHS Purchasing and Supply 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 expect these products to be representative of those on the market but cannot guarantee this Prospective purchasers should satisfy themselves about any modifications that might have been made after our evaluation The Centre for Evidence based Purchasing formerly the Device Evaluation Service transferred from the Medicines and Healthcare products Regulatory Agency to NHS PASA on 1 September 2005 We are currently undergoing extensive redesign to help us provide the information that purchasers want in the way they want it presented Please visit our website to keep updated Meanwhile newly published evaluation reports will continue to be e mailed to subscribers and posted on our website How to obtain evaluation publications To order evaluation reports or to sign up for our e mail alert service contact
49. Service manual FOC available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with IEC60601 1 IEC60601 1 2 EN60601 2 50 Financial Consumables Evaluation report MDA 01160 December 2001 MRRP 6 999 68 1 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Central Medical Supplies Bili Compact Weyer ID Number WY1816 Available since 2003 General Dimensions L W H 52 5 x 22 x 9 cm lamp 70 x 60 x 139 206 cm Photo courtesy stand of Central Medical Lockable wheels 2 out of 4 Guppies VHA mattress height 103 149 cm stand Head tilt Tilt and swivel Wheelbase height 17 cm stand Weight 4 8 lamp 18 kg stand Description Lamp sold separately for use on top of incubator or with mobile stand Light Light source 10 fluorescent tubes blue BAM PL 9 52 Peak spectrum 450 460nm Treatment distance 20 cm Irradiance 3 mW cm2 Illumination area 30 x 60 cm Nursing amp medical Power control No Treatment timer No Alarms No Maintenance Lamp hours meter Yes Consumables Tubes replace after 1000 1200 hrs Service trainin
50. VHA 91 kg Description Radiant heater units with manual baby control and optional weighing scales Incorporates dovetail rails unique to Ohmeda products Options Shallow or deep drawers open at front of unit or rotate 360 Rails are Storage options non standard dovetail design Additional IV poles and shelves available Standard package VHA X ray tray APGAR timer examination light includes Optional features i RS232 connection accessories Baby compartment Crib size L W H Mattress size 3400 48 x 66 cm 4400 61 x 77 cm Walls Four fold down walls Tubing ports Slots in rear wall Treatment distance Report 05103 Market survey infant warming and phototherapy 60 Report 05103 Market survey infant warming and phototherapy Warming therapy Ohio 3400 3400 Ohmeda Nursing amp medical Control panel location At rear below heater can be rotated to face towards the back of the product e g to face the anaethetist during surgery Manual control 0 100 in 5 increments Skin temperature Min 35 C Max 37 5 C Other temperature NA sear heater 540 W Heater swing away Yes Examination light Yes APGAR timer Yes Oxygen control No Trending history No Computer network Optional RS232 Alarms Adjustable sound levels Maintenance Consumables Skin temperature probes cov
51. acturer s stated lamp replacement interval Other light sources have an expected lifetime although the output should not decrease for halogen or LED sources The therapeutic wavelengths for the degradation of bilirubin in vitro are in the visible blue light range Sources are usually either blue or blue green white or a mixture of the two Blue light can have adverse effects on carers Symptoms such as nausea and headaches and make assessment of the infant s colour impossible White lights may be included to balance the light colour to offset these problems or an intense white light source which includes the blue wavelengths may be used for therapy Phototherapy lamps can use fluorescent tubes blue or white halogen bulbs white or filtered or blue LEDs light emitting diodes The number of locking wheels out of the total number of wheels Warming devices may be operated at a set level of output indicated in of maximum or as a certain number of output levels The classification of the device according to the European Medical Devices Directive REF and the means by which the device has achieved a CE mark Unless otherwise stated CEDAR has been supplied with copies of certificates See Appendix for a brief explanation Indicates whether the mattress level can be altered relative to the incubator canopy roof for example to allow easier access from the ports and doors or reduce the treatment distance for neonatal photother
52. ance strength decreases Blue light is a hazard to the retina so that an infants eyes must be protected from direct phototherapy light Most manufacturers of neonatal phototherapy devices also produce proprietary eye protection accessories However these are not specific to a light source and may be used interchangeably 74 GZ Report 05103 Market survey infant warming and phototherapy Table 5 Phototherpay lamps features and specifications Supplier Beaver CMS Drager oo 8g Model vg Q E 6 AS Ff lt o i Installation mobile stand Y v v4 Y pole mounted incubator top s v V enclosed surface v4 Power control Treatment timer Y Y Y Lamp hours meter y v s v V Light colour Blue White Mixed P R B Lamp replacement interval hrs 2000 1000 1000 Light source FI FI FI FI H Treatment distance 36 NA 50 30 43 cm FI fluorescent tubes LED light emitting diodes H halogen bub GE l Healthcare Medical Imaging Systems amp o N z o 52 5 8 2s oa 20 m co m m 8 Y v Y v v Z Y v 7 Vv v4 v4 7 B W BWM W B BM 2500 2000 20000 H Halide FI H LED FI NA 38 NA 30 GMS neoBLUE b LED 31 GMS neoBLUE mini LED 31 Amelux v BM 2000 3000 3000 FI 35 Viamed Bilicrystal Mono Duo Be FI 25 800 10000 hrs depending on intensity used Bulle 2 FI NA Adeisau oloud Report 05103 Market survey infant
53. and LED sources remain steady until they fail Particularly comparisons cannot be made between manufacturers who quote irradiance in mW cm2 and those who quote spectral irradiance in uW m2 nm The first is the sum of the output energy over a particular bandwidth i e over a range of wavelengths and the second is a measure at the peak of the output spectrum To summarise a higher irradiance value does not necessarily indicate a more effective therapy Heating Phototherapy lamps may also act as a source of radiant heat to an infant Halogen bulbs can produce a significant amount of heat although the bulb itself may be remote from the point of delivery of the light e g Giraffe Spot and Ohmeda BiliBlanket Blue fluorescent tubes produce less heat than white ones and LED sources do not produce a significant heating effect Although a phototherapy lamp can be useful as supplementary heating careful temperature monitoring and adjustment of any additional warming devices will be required to avoid overheating Treatment Manufacturers state a minimum treatment distance for each device For lamps that are designed to be used resting on the canopy of an incubator the distance from the lamp to the mattress neonate should be established so that this is not violated It is important to treat as large a surface area as possible of the infant s body As the source to mattress distance increases the illuminated area gets larger but the irradi
54. apy Larger bassinets may require staff to reach further to provide nursing care but are appropriate for surgery and may accommodate twins The extent to which a mattress can be extended outside the enclosure to allow increased access to the neonate head up tilt Trendelenburg head down tilt reverse Trendelenburg Manufacturer s Recommended Retail Price the list price of the standard package as given on the PASA IWpF website NHS purchasers can access the current IWpF contract prices from the NHS PASA website See the Contract details sections of the Introduction Where powered VHA is an option and not included in this price the additional cost is provided where known Features or additional items that are available if required They may be charged per item as an additional cost or be available as standard in a different device specification at a higher price 99 Report 05103 Market survey infant warming and phototherapy Appendix Other temperature control Oxygen control Oxygen monitoring Peak spectrum Peripheral temperature Positionaing aid Power control phototherapy Powered VHA Pre warm mode Resuscitator Service training Servo controlled oxygen Skin temperature Skin temperature servo control Standard package includes Storage options Radiant warmers may operate in a mode that regulates the air temperature at the mattress surface The heated mattress device
55. arance 12 cm Weight incl VHA 70 kg Description Conductive gel mattress with underbed heating in mobile enclosed baby compartment Options Storage options Shelves and drawers IV pole Standard package includes Optional features accessories APGAR timer thermometer oxygen therapy Baby compartment Crib size L W H 76 x 51 cm Mattress size 75 x 50 cm Walls Four fold down walls sides also retract into base Tubing ports 2 46 Report 05103 Market survey infant warming and phototherapy Warming therapy Thermocare 2000 K Weyer Nursing amp medical Control panel location Front of unit Surface temperature Min 35 C Max 37 C Override 30 35 C and 37 382C APGAR timer Optional Oxygen control No Maintenance Consumables None Service training Service manual FOC training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class IIb Full Quality Assurance IS09001 15013485 TUV Rheinland 0197 Supplier s Quality System ISO9001 ISOQAR Device complies with BS EN60601 1 BS EN60601 2 35 Financial Consumables None Evaluation report NA MRRP 5 830 00 47 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Thermocare Variotherm 2000 Wey
56. at set intervals Alarms Condition is indicated on the display together with a light on the control panel Maintenance Access Canopy tilts open A tray is available for the disinfection of the heater unit Water system Removable tank in drawer accessed from rear panel autoclavable every patient Consumables Air filter every 3mths located in rear panel O2 cell every 6mths Service training Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS09001 DNV 0434 Supplier s Quality System Device complies with IEC60601 1 IEC60601 2 IEC60601 2 19 Financial Consumables Evaluation report NA MRRP LCD 7 762 80 ELV 10 021 00 VHA extra 1 689 00 20 Report 05103 Market survey infant warming and phototherapy Transport incubators How transport incubators work Transportation of babies can require different levels of intensive care support depending on whether they are very premature and require high levels of warming therapy and ventilation or larger sick babies being transferred for specialist surgery who require intensive monitoring but minimal thermal support The best choice of transport incubator will depend on the characteristics of the patient group regularly requiring transportation and the distance to be covered between hospitals or between separate buildings on the same
57. atal phototherapy Standards Contract details Evaluation reports Procurement issues Organisation of this report Disclaimer Nursing incubators 5 How incubators work Beaver MP5 ISIS A amp SI REA Mediprema 10 SATIS Mediprema 12 Dr ger Caleo Dr ger 14 Isolette C2000 Air Shields 16 GE Healthcare Giraffe amp Omnibed Ohmeda 18 Inspiration V 2100G A B C ATOM 20 Medical Imaging Systems C186 TS Fanem 22 Vision 2186 Fanem 24 Transport incubators 26 How transport incubators work Beaver NITE Mediprema 28 Medical Information Systems IT158 TS Fanem 30 Warming therapy 32 How warming therapy devices work Grouping of devices in this report Thermal control Fisher amp Paykel CosyCabinet Fisher amp Paykel 38 Viamed Infant Resuscitation Cabinet Various 39 Contents Beaver ISIS Ambiance Mediprema ISIS Radiant Mediprema Central Medical Supplies Infant Warming System Kanmed AB Thermocare 2000 K Weyer Thermocare Variotherm 2000 Weyer Drager Resuscitaire Air Shields BabyTherm 8000 CosiTherm Drager BabyTherm 8004 8010 Drager Fisher amp Paykel CosyCot Fisher amp Paykel GE Healthcare Giraffe Omnibed Ohmeda Ohio 3400 3400 Ohmeda Medical Imaging Systems Multisystem 2051 Fanem Central Medical Supplies Variotherm Easy Care Weyer Viamed Ceratherm 600 2 with DINO Mobil Nufer Beaver ISIS Ambiance Mediprema Central Medical Supplies Ceramotherm Weyer Fisher a
58. ature sensors covers Service training Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 EN60601 2 20 EN60601 2 21 Financial Consumables Evaluation report NA MRRP 13 765 34 no trolley 29 Report 05103 Market survey infant warming and phototherapy Transport incubators Supplier Medical Information Systems IT158 TS Fanem ID Number 158001800 Available since General Dimensions L W H 102 x 57 x 88 119 cm incl trolley Mattress tilt No Mattress size 63 x 32 cm Double walls Yes Tubing ports 3 1 at head end and 1 either side of access door Weight 87 kg incl accessories Description Triangular tube shaped baby compartment with folding transport trolley Includes basic humidification Options Superstructure amp trolley options Variable or fixed height trolley 2 locking wheels stretcher type for ambulance fixation Standard package includes Two batteries 1 skin temperature sensor 1 air filter elastic cuffs for hand ports Optional features accessories Air temperature control only or skin and air temperature control IV pole shelves Access to the infant Mattress slides out Head end Access
59. available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ila compliance method not supplied ISO9001 TUV Product Services 0123 certificate not seen Supplier s Quality System ISO9001 T V Product Services 0123 certificate not seen Device complies with EN60601 1 EN60601 1 2 Financial Consumables Evaluation report MDA 01162 December 2001 MRRP 3 000 00 80 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier GE Healthcare BiliBlanket Plus Ohmeda ID Number 6600 0415 912 Available since 1996 General Dimensions L W H 2 7 x 11 x 28 cm light box Lockable wheels NA VHA mattress height NA Head tilt NA Wheelbase height NA Weight 3 2 kg light box Description A filtered white light source delivering blue therapeutic light via fibre optics to a plastic pad on which the neonate lies Optional transillumination cable Disposable vests can secure the pad to the baby for kangaroo care Light Light source Filtered tungsten halogen lamp Peak spectrum 450 nm Treatment distance Skin surface irradiance 45 uW m nm Illumination area 10 x 15 cm pad area Nursing amp medical Power control Continuously variable 19 45 uW m2 nm Treatment t
60. bulb white Peak spectrum 400 500nm Treatment distance 40 50 cm irradiance Illumination area Nursing amp medical Power control No Treatment timer Optional Alarms No Maintenance Lamp hours meter Consumables Bulb Service training Medical Devices Directive Manufacturers MDD Class unknown compliance method not supplied compliance NB ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with Financial Consumables Evaluation report NA MRRP BP 816 13 BB 596 62 84 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Medical Imaging Systems Bilitron 3006 Fanem ID Number 00600 900 Available since General Dimensions L W H 12 x 23 x 5 cm BTI 4 x 10 x 30 cm BTB 50 x 50 x 100 140 cm BTP Lockable wheels 2 out of 3 BTP Image not available VHA mattress height 70 110 cm BTP Head tilt Yes BTP and BTB Wheelbase height 1 kg lamp 2 kg rail mela 9 kg lamp stand Small super LED lamp available with rail attachment for bassinets and Descrioiio incubators BTB lamp only for use on incubator canopies BTI or with p mobile stand BTP LCD display and RS232 output for a PC or printer Optional attachment allows device to be used as a radiometer Light Light source
61. ch products are most likely to suit their individual requirements The report provides information of interest to neonatal clinicians nurses and managers technologists and equipment managers and procurement Staff Inclusion in this report does not constitute an endorsement of any of the devices or companies nor does it replace the need for departments to carry out their own 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 weight babies Premature babies have greater difficulty maintaining their body temperature than full term babies and adults because they have a larger surface area relative to their volume Heat is lost through the skin by radiation infra red convection warming the air conduction contact with surfaces and evaporation of moisture from the skin The latter is highly effective for cooling the body and is particularly a problem if the skin is uncovered and the air has low humidity Report 05103 Market survey infant warming and phototherapy Introduction Three different types of devices have been developed to actively warm neonates and infants e Incubators use warm air circulating in a closed environment to transfer heat through the skin Humidification is frequently added to minimise cooling and dehydration e Radiant warmers provide infra red radiation which penetrates and transfers heat to the upper sk
62. ction of air flow within an incubator enclosure Some devices attempt to maintain a warm air curtain across the access ports doors Range of pre set air temperature values All incubators and some warmers have a normal and extended range An Override function must also be used to select a temperature in the extended range Audible and visual alarms are required to provide feedback to the carer of abnormal sensor and equipment conditions as specified in the relevant standards The product pages only document unusual features such as adjustable volume levels A newborn infant is assessed at 1 and 5 mins after birth and again at 10 min if there are difficulties according to set criteria Activity Pulse Grimace Appearance and Respiration An APGAR timer provides tones at these set intervals to prompt the assessment The date that the device was first placed on the market as given on the PPQ NHS Pre Purchase Questionnaire The warmer may have the option of a battery to maintain operation for example between delivery room and intensive care or the operating theatre Display indicating battery power remaining or the output power level Duration that the transport incubator can be run off the battery pack provided Transport incubators can be powered from the mains from the battery or from a 12V or 24V dc supply i e in an ambulance or helicopter Current standard practice is often to use 100 oxygen for re
63. d incubator with one piece canopy Options Storage options Single large drawer with organiser tray pulls through from either side included in price Rails are non standard dovetail design Additional IV poles and shelves available Standard package includes X ray tray VHA controlled humidity Optional features Oxygen control weighing scales access iris tubing port in foot end gas cylinder holder RS232 connection Thermalink examination light Baby compartment Canopy size L W H Mattress size 66 x 48 cm Double walls Yes on long sides Tubing ports 8 Canopy flat area Air circulation Bi directional up both long sides Additional air curtain boost button increases the fan speed for extended access procedures Access to the infant Mattress slides out Slides out either sides mattress rotates 360 Access doors 2 one on each long side Hand ports 4 two in each long side optional access or iris port in foot end iris sleeves can be installed on each port 18 Report 05103 Market survey infant warming and phototherapy Nursing incubators Giraffe amp Omnibed Ohmeda Nursing amp medical Control panel location Above canopy at head end Control panel lock Air temperature Min 202C Max 37 C Override 39 C Skin temperature Min 35 C Max 37 C Override 37 52C
64. doors 2 front and head end Hand ports 3 with iris covers 30 Report 05103 Market survey infant warming and phototherapy Transport incubators IT158 TS Fanem Nursing amp medical Control panel location Below baby compartment on long side Control panel lock No Air temperature Min 30 C Max 39 C Skin temperature Optional Min 34 C Max 37 5 C Override 38 C Warm up time 1hr Humidification Yes sponge soaked in 450ml distilled water amp placed under mattress tray lasts 12 hrs Oxygen control Inlet at head end of compartment Trending history No Computer network No Alarms LED and message on display panel Transport Battery life 4 hrs Battery indicator Four LEDs indicate power output to heater Charging time 30 hrs LED indicates when charge is completed Gas cylinders 2 X E size cylinders fit horizontally between incubator and trolley Security Two straps attached to mattress tray Maintenance Access Hood is detachable Consumables Air filters replace every three months sponges Service training Medical Devices Directive Manufacturer s MDD compliance NB ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with IEC60601 1 IEC60601 2 IEC60601 2 20 Financial Consumables Evaluation r
65. e Consumables None Service training Service manual FOC training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS09001 EN46001 TUV Rheinland 0197 Supplier s Quality System ISO9000 ISOQAR Device complies with EN60601 1 EN60601 2 21 Financial Consumables None Evaluation report NA MRRP 3 850 00 64 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Viamed Ceratherm 600 2 with DINO Mobil Nufer ID Number 0310041 DINO Mobil i Available since 1998 General Dimensions H W D 70 cm length Photo courtesy of Lockable wheels 2 out of 4 Viamed VHA mattress height 75cm Mattress tilt No Ground clearance 5 5 cm Weight incl VHA 4 9 kg heater Description Ceramic heater available with mobile stand or with additional baby surface Suitable for examination treatment and changing DINO Mobil Includes examination lamp Also available as a wall ceiling mounted heater Heater Heat source Ceramic element Treatment distance 80 cm Irradiance heater lt 10 mW cm2 600 W power Positioning aid NA Nursing amp medical Manual control 4 levels can be set to any value between 20 99 Skin temperature No Alar
66. e one Ceratherm Air Shields an Nufer Ohmeda BabyTherm Variotherm 2000 8004 8010 REA C Drager Weyer Giraffe Omnibed Ohmeda Indicates devices intended for use as a resuscitation unit Heated mattresses Thermocare Convenience Weyer Baby Warmer Complete Kanmed Amecosy ARDO Ade1 y Buie M Warming therapy This page is intentionally blank Adejsauiojloud pue Buiwem juejul A8AINs JeyWeYW lt OLGO YodeyY 35 Report 05103 Market survey infant warming and phototherapy Warming therapy Table 4 Mobile complex care warming units features and specifications Supplier Model Powered VHA Manual control Skin temperature control Other temperature control Pre warm mode APGAR timer Examination light X ray tray Weighing scales Oxygen monitoring Trending history Computer network Battery Resuscitation suction resuscitator oxygen delivery blender Dimensions L W cm Height cm Mattress L W cm VHA mattress height cm Mattress tilt Weight incl VHA kg Beaver 3 S z amp ks T F D O O Y v Y Y v Y v Y O O Y Y Y Y O O O O O 110x67 62x 103 ooo 125 159 109 139 183 213 70 x 27 70 x 40 65 x 51 66 x 45 75 x 50 75x 50 73 79 86 106 70 104 85 115 85 115 15 15 12 202 10 4202 10 59 62 110 41 70 90 v included as standard O available as an optional extra Central Medical Suppl
67. ed for growth recovery and development The environment can be controlled either by maintaining the air temperature or the baby s core skin temperature measured at the abdomen at a pre set value All the incubators in this document include e air temperature control mode e skin temperature control mode e tilting mattress e aminimum 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 improve this function and low air velocity over the baby s skin reduces convective heat loss Humidified air also reduces heat lost due to evaporation of moisture from the skin and is beneficial for the respiratory tract Controlled humidification is particularly used 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 be achieved 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
68. ed humidity X ray tray double walls 1 skin temperature sensor 1 air filter elastic cuffs for hand ports Optional features Display type VHA weighing scales servo controlled oxygen pulse oximeter Baby compartment Canopy size L W H 86 x 41 x 47cm Mattress size 63 x 34 cm Double walls Yes Single panel covers top of canopy and rear wall separate panel inside front access door Tubing ports 4 Canopy flat area Air circulation Head to feet Access to the infant Mattress slides out 1 3 of the mattress length Access doors 1 Hand ports 6 additional 2 in head iris and foot ends can be configured differently 24 Report 05103 Market survey infant warming and phototherapy Nursing incubators Vision 2186 Fanem Nursing amp medical Control panel location Front panel below canopy LCD or ELV options Control panel lock Yes Air temperature Min 202C Max 372C Override 392C Skin temperature Min 34 C Max 37 C Override 382C Warm up time 40 mins rise time to 11 C above ambient Humidification Min 30 Max 95 Water reservoir Tank in drawer 1L capacity Oxygen control Inlet for externally controlled flow Optional servo controlled supply up to 65 Trending history Yes up to 24hrs weight 8 days Computer network Yes RS232 serial port can print
69. ensor 1 air fiter elastic cuffs for the hand ports Optional features Double walls VHA weighing scales humidification of oxygen heater disinfection tray Baby compartment Canopy size L W H 86 x 41 x 47 cm Mattress size 63 x 34 cm Double walls Optional DW model has double walls in roof and one long side Tubing ports 4 Canopy flat area Air circulation Head to feet Access to the infant Mattress slides out 1 3 of the mattress length Access doors 1 Hand ports 6 additional 2 in head iris and foot ends can be configured differently 22 Report 05103 Market survey infant warming and phototherapy Nursing incubators C186 TS Fanem Nursing amp medical Control panel location Front panel below canopy Control panel lock No Air temperature Min 202C Max 37 C Override 392C Skin temperature Min 34 C Max 37 C Override 382C Warm up time 30 mins rise time to 11 C above ambient Humidification Approx 60 to 90 not user set not controlled monitored 1L capacity Water reservoir Directly into inlet at head end of base Oxygen control Inlet for externally regulated flow In normal operation concentrations of 27 40 are achieved but air intake can be occluded to increase the oxygen concentration up to 75 Trending history No Computer network No
70. ent tubes 4 white 3 blue as standard or 7 white Peak spectrum 400 500 nm Treatment distance NA 14 5 uW m nm mixed tubes with reflector uraciance 12 1 uW m2 nm mixed tubes without reflector Illumination area NA Nursing amp medical Power control No Treatment timer Optional Alarms No Maintenance Lamp hours meter No replacement interval 2000hrs Consumables Tubes air filter Service training Medical Devices Directive Manufacturer s MDD compliance NB Class unknown complicance method not supplied ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with Financial Consumables Evaluation report NA MRRP Mixed tubes 1 769 44 White tubes 1 710 49 83 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Medical Imaging Systems Bilispot OO6BP or OO6BB Fanem 006 002 800 O06BP ID Number 006 003 800 006BB Available since General Dimensions L W H 145 176 cm OO6BP height Lockable wheels 5 out of 5 VHA mattress height Head tilt Yes Wheelbase height n WE Weight 13 kg 006BP Large spot light available with mobile stand OO6BP or for mounting on BeScrplon Fanem incubators warmers OO6BB Light is applied at an oblique angle Light Light source Dichroic halogen
71. eport NA MRRP 4 823 56 incl trolley 31 Report 05103 Market survey infant warming and phototherapy Warming therapy How warming therapy devices work Today there are many types of baby warmers available on the UK market Infant radiant warmers can be bought as mobile lamps mounted permanently on a wall ceiling or in a cupboard or as a mobile cot unit Heated mattresses are commonly foam gel or water filled pads heated electrically which conduct heat to the baby s skin through direct contact Radiant warmers and heated mattresses may be used together or separately and require regular monitoring of the baby s core and skin temperature and adjustment of warmer controls to avoid overheating or cooling Some cot units offer combined radiant and mattress warming When a heated mattress is used alone the baby should be covered up However if radiant warmers are used either alone or in combination with a heated mattress then manufacturers generally recommend that the baby is not covered to provide maximum heat transfer to the baby s skin The combined use of a radiant warmer and heated mattress will alter the relative effects of heat transfer to and from the baby s skin compared with when these devices are used separately The best temperature settings when warming units are used together are likely to be different from those required when they are used alone in order to achieve the same core and skin temperat
72. er ID Number 2032 Thermocare 2000 KCE rn 2041 Variotherm 2000 REA C 2043 Variotherm 2000 REA KCE Available since 2003 General Variotherm 2000 REA KCE shown Dimensions H W D 2041 114 x 59 x 186 cm 2032 2043 Photo courtesy of Central Medical 114 x 59 x 183 213 cm Supplies Lockable wheels 4 out of 4 VHA mattress 2041 96cm height 2043 2032 85 115 cm Mattress tilt 20 10 Ground clearance 12 cm Weight incl VHA 2041 80 kg not incl VHA 2032 2043 90 kg All models use Ceramotherm overhead radiant heaters The Variotherm REA C uses a Ceramotherm 1200 heater and does not have powered Beschiplen VHA Both KCE models use Ceramotherm 2200 heaters and underbed conductive heating The Thermocare additionally has a fold up canopy with higher side walls Options Storage options Shelves and drawers IV pole Standard package includes Optional features accessories Variotherm 2000 REA C can be upgraded to Ceramotherm 2200 VHA 748 swing away heater and underbed conductive warming vacuum suction unit gas flowmeters and distributors resuscitation bag and PEEP valve APGAR timer gas bottle holder higher side walls for Variotherm models blender Baby compartment Crib size L W H 76 x 51 cm Mattress size 75 x 50 cm Four walls fold down side walls also retract into base Variotherm models
73. erm 8000 OC Apr 1997 Evaluation 235 BabyTherm 4200 Dec 1994 MRRP 8004 8 147 00 8010 9 390 00 10 490 00 incl phototherapy lamp 55 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Fisher amp Paykel CosyCot Fisher amp Paykel ID Number IW930 series IW950 series Available since 1996 General Dimensions H W D 77 x 111 x 174 189 cm Lockable wheels 4 out of 4 VHA mattress height 93 108 cm Mattress tilt 102 Ground clearance 12 cm Weight incl VHA 60 kg Description Manual 950 series or baby 930 series controlled models with the option of two crib sizes Options Storage options Large drawer under bassinet with integral shelf mounting poles pole mounted shelves Standard package includes IW930 includes 1 skin sensor and 10 sensor covers also 2 procedure timers Optional features accessories VHA crib size storage phototherapy lamp See neoBLUEmini in phototherapy section flowmeter oxygen delivery Neopuff infant resuscitator X ray tray gas cylinder rack pressure relief valve oxygen supply hose Baby compartment Crib size L W H 65 x 65 cm 75 x65 cm Mattress size 62 x 62 cm 62x 72 cm Walls Front and sides drop down or can be removed Tubing ports 6 Treatment distance 68 cm 56 Report 05103 Market survey infant warming and p
74. ers Service training Service manual available following training training is chargeable not required for 1st line maintenance cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance ISO9001 EN46001 15013485 BSI 0086 Supplier s Quality System IS09001 15013485 BSI 0086 Device complies with IEC60601 1 IEC60601 2 IEC60601 2 19 Financial Consumables Evaluation report MDA 00390 Ohio 3400 MRRP 3400 8 129 72 4400 9 794 72 61 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Medical Imaging Systems Multisystem 2051 Fanem ID Number 004 O 800 Available since General Dimensions H W D 63 x 107 x 183 203 cm Lockable wheels 4 out of 4 VHA mattress height 90 110 cm Mattress tilt 12 8 ICU model 10 bassinet Ground clearance 13 5 cm Weight incl VHA 90 kg incl accessories O Description Radiant warmer unit with two style of crib ICU with fold down walls or a fixed bassinet style shape Bassinet unit can have integral phototherapy tubes and a silicon mattress Options Storage options Large shelf under crib with or without 2 or 4 drawers Small shelves and IV poles from central column Standard package includes X ray plate slot
75. esive pads suction resuscitation circuits Service training Training is chargeable trainer s expenses only Medical Devices Directive Manufacturer s MDD compliance NB Class unknown compliance method not supplied ISO9000 DNV 0434 certificate not seen Supplier s Quality System Device complies with Financial Consumables Evaluation report NA MRRP ICU crib 3 745 56 5 131 46 Bassinet crib 3 178 00 63 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Variotherm Easy Care Weyer ID Number 2020 f Available since 2003 ie General Dimensions H W D 91 x 56 x 190 cm Photo courtesy of Lockable wheels 4 out of 4 3 ie VHA mattress height 95cm Mattress tilt Yes Ground clearance 13 5 cm Weight incl VHA 62 kg Description Ceramic heater with additional baby support surface suitable for examination and changing Uses Ceramotherm 1100 Includes examination light Heater Heat source Ceramic element s Treatment distance 80 cm lrradiance heater 2 18 mW em2 600 W power Positioning aid NA Nursing amp medical Manual control Continuously variable output intensity not displayed on 1100 models Skin temperature No Alarms Yes regulates radiated intensity rather than temperature Maintenanc
76. et survey infant warming and phototherapy Warming therapy Supplier Drager BabyTherm 8004 8010 Drager ID Number 3208817 8004 320848 8010 Available since 1997 General Dimensions H W D 32 x 75 x 200 221 cm Lockable wheels 2 out of 4 VHA mattress height 89 118cm Mattress tilt 202 15 Ground clearance 13 cm 110 kg 8004 Weight incl VHA 120 kg 8010 8010 uses underbed conductive warming 8010 and 8004 use radiant heaters and 8004 includes an X ray tray The overhead unit can include BeScnpian halogen phototherapy lamps for hyperbilirubinaemia as an option Peripheral skin temperature is measured in addition to core skin temperature Options Storage options 1 or 2 swivel drawers open to front or side Standard package includes Peripheral temperature measurement X ray tray 8004 RS232 connector Optional features accessories Phototherapy lamps integrated into overhead heater VHA higher side walls 8010 only oxygen therapy aspirator APGAR timer canopy lid Baby compartment Crib size L W H 75 x 49 cm Mattress size Walls Four sides fold down and have 7cm inner walls Both models have 15cm walls the 8010 can optionally have 23cm Tubing ports 4 ventilation tube Treatment distance 80 cm 54 Report 05103 Market survey infant warming and phototherapy Warming therapy
77. ever direct comparisons between the values given by manufacturers are not generally possible There are several reasons why an irradiance value provided by a manufacturer is not a good indicator of the relative clinical effectiveness of a lamp e The best wavelengths for therapy are not known therefore one shape of spectrum may be more effective than another with the same total irradiance A source may have all its energy concentrated in a narrow peak e g LEDs or distributed across a wide band of wavelengths e g white light sources e irradiance values are usually given at the recommended treatment distance which varies between manufacturers e The device used to measure the irradiance a radiometer will have a variable sensitivity to different wavelengths and should be calibrated individually for each type of source measured Even then the amount of 73 Report 05103 Market survey infant warming and phototherapy Phototherapy light collected by the radiometer the input optics can have a large effect on the measured value e The output can vary from one lamp to another even when they are of the same type and age i e there is some natural variation in the production of the lamps The European Standard EN60601 2 50 allows for a 25 variation in irradiance from that stated by the manufacturer e The output of fluorescent tubes declines with age so they must be replaced at intervals specified by the manufacturer Halogen
78. ey Includes digital thermometer skin temperature as standard but air temperature as an option single control box and two hammocks Dimensions L W H 68 x 54 x 116 132 cm Lockable wheels 2 out of 4 Head tilt Yes Wheelbase height NA Weight 25 kg Source 2 x 6 tubes Treatment distance 25 cm for Mono irradiance 4 Mono 8 Bulle mW cm2 Illumination area NA MRRP 6 375 00 BiliCrystal Trans Medestime ID Number 2110106 Available since Description System comprising Bulle high walled cradle treatment timer and reflector canopy mounted on a folding trolley Designed to fold together for easy storage and transferal between wards etc Dimensions L W H 68 x 45 x 114 cm Lockable wheels 2 out of 4 Head tilt NA Wheelbase height NA Weight 10 kg Source 6 tubes amp reflector Treatment distance NA Irradiance 8 9 mW cm2 Illumination area NA MRRP 3 725 00 92 Report 05103 Market survey infant warming and phototherapy Appendix Suppliers contact details Central Medical Supplies Supplier Beaver Medical Plc ltd BMP House CMS House 21 Mansion Close Basford Lane Moulton Park Leek Northampton Staffordshire NN36 6RU 113 7DT Weyer 2 years Warranty 1 year Kanmed 1 year Tel 01604 499427 01538 399541 Fax 01604 492212 01538 399572 www beavermedical com www centralmedical co uk ukhomepage htm Website Kanmed AB Sweden Manufacturer
79. facturer may state a particular temperature increase at a set ambient temperature Location and capacity of the reservoir for humidification Special instructions for cleaning the humidification water system and the interval if different from the rest of the device Scales under the mattress support so that the infant does not have to be removed from the device for weighing The distance from the ground to the top of the base of a mobile lamp heater or phototherapy This should be less than the ground clearance of incubators or complex care units that it may be used with Drawer or gap under the mattress into which an X ray plate can be inserted so that the infant does not have to be moved for imaging However this can impair image quality and increase the radiation dose 9 therefore some radiographers may prefer to place the X ray plate immediately beneath the infant 101 Report 05103 Market survey infant warming and phototherapy Appendix Acknowledgements We would like to thank all the suppliers and manufacturers who assisted in the production of this report by providing documentation information and feedback We would also like to thank Dr Merran Thomson Queen Charlotte and Chelsea Hospital Hammersmith Mr Richard Aldridge St Mary s Hospital Paddington and Ms Michele Worden Countess of Chester Hospital Chester for their advice and proof reading References 1 http nww pasa nhs uk medsurg shared medica
80. fault irradiance heater power 2 28 30 mW cm 2100 600W 2200 2 x 400W Positioning aid Yes on stand Nursing amp medical Manual control Continuously variable set and output intensity displayed Skin temperature No Alarms Yes regulates radiated intensity rather than temperature Maintenance Consumables None Service training Service manual FOC available on disk training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance ISO9001 EN46001 TUV Rheinland 0197 Supplier s Quality System ISO9001 ISOQAR Device complies with EN60601 1 EN60601 2 21 Financial Consumables None Evaluation report NA MRRP 2100 3 113 00 2200 3 311 00 67 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Fisher amp Paykel Mobile Infant Warmer Fisher amp Paykel ID Number IW910 IW920 Available since 1996 General Dimensions H W D 65 x 19 x 151 191 cm Lockable wheels 5 out of 5 Photo courtesy of Fisher amp Paykel VHA mattress height 86 126 cm Mattress tilt No Ground clearance 12 cm ra Weight incl VHA 22 kg a i Description Manual IlW920 or baby servo IW910 controlled mobile heater Includes examination light prewarm set
81. fe Omnibed MRRP Giraffe 14 500 15 007 50 depending on port options Omnibed 27 900 27 945 19 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Inspiration V 2100G A B C ATOM ID Number A ATCM6484R B ATCM6485R C ATCM6486R Available since 2000 General Dimensions L W H 100 x 58 x 126 146 cm Lockable wheels 2 out of 4 VHA mattress height 89 109 cm Mattress tilt 12 Ground clearance 12 cm Weight incl VHA 88 kg Description Three versions of a single model incubator with increasing functionality The mattress tilt mechanism can also be used to raise the mattress within the canopy Options Storage options Large or small drawers pull or swing open IV pole Standard package includes VHA 1 central amp 1 peripheral skin temperature probe 2 access port covers air filter dust cover 2 oxygen sensors Optional features Type B includes peripheral temperature and oxygen controller Type C additionally includes weighing scales Ports at head and foot ends can be configured as iris ports or patient circuit holders Baby compartment Canopy size L W H 100 x 59 x 42 cm Mattress size 74 x 36 cm Double walls Front and rear sides Tubing ports Variable depending on options 5 10 Canopy flat area 83 x 23 cm Air circulation
82. field and the infant should have as much of the body surface as possible exposed to the therapeutic light 98 Report 05103 Market survey infant warming and phototherapy Appendix irradiance Kangaroo mode Lamp hours meter Light colour Light source Lockable wheels Manual control Manufacturer s MDD compliance Mattress elevation Mattress size Mattress sliding access Mattress tilt MRRP Optional features This is how the amount of radiation on a surface is measured whether it is visible light phototherapy or infra red radiant warmers The units are mW cm2 which is the radiant power per unit area summed over a range of wavelengths Some manufacturers quote uW m nm instead where it is measured at a single wavelength Values stated by different manufacturers cannot be compared as they may use different wavelength ranges and be measured by different devices See also Phototherapy Introduction for information about comparing values The infant s temperature can be monitored whilst it is outside the incubator allowing a parent to provide skin to skin care Research has indicated that premature babies are able to maintain their core and peripheral temperatures well during this contact The light output of phototherapy lamps using fluorescent tubes gradually decreases with usage so timers displaying the total number of treatment hours should be used to prompt tube replacement after the manuf
83. g Service manual FOC training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS09001 15013485 TUV Rheinland 0197 Supplier s Quality System ISO9000 ISOQAR Device complies with EN60601 1 EN60601 2 EN60601 2 50 Financial Consumables Tubes 22 Evaluation report NA MRRP Lamp 1 895 00 Stand WY2003 695 00 78 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Drager Micro Lite Air Shields ID Number 2M22310 m Available since Er EEA General Dimensions L W H o cn lth Lockable wheels VHA mattress height Head tilt Yes Wheelbase height 12 7 cm w a Weight S5 9 kg stand 6 kg lamp n Description White light bulbs with UV and IR filters Can be used with or without stand on top of incubator roof Light Light source 3 quartz halogen bulbs 50W each Peak spectrum Treatment distance 43 cm irradiance lt 10 uW m nm 400 520nm blue light Illumination area Nursing amp medical Power control No Treatment timer Yes Alarms No Maintenance Lamp hours meter Yes bulb life gt 1000 hrs Consumables Bulbs Service training Medical Devices Directive Manufacturer s MDD compliance NB C
84. hototherapy Warming therapy CosyCot Fisher amp Paykel Nursing amp medical Control panel location Front of stand below heater Manual control 0 100 both models Skin temperature Min 34 52C Max 37 5 C Other temperature NA irradiance heater power lt 32 mW cm2 at 68 cm Heater swing away Yes Examination light Yes APGAR timer Yes Oxygen control Optional flowmeter delivery and blender Trending history No Computer network No Alarms Yes Maintenance Consumables Skin sensors amp covers resuscitator circuits Service training Service manual 22 training is chargeable 160 Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance _ ISO9001 EN46001 15013485 TUV Product Services 0123 Supplier s Quality System ISO9001 TUV Product Services 0123 Device complies with IEC60601 1 IEC60601 1 2 IEC60601 2 21 Financial Consumables Skin temperature sensor 120 00 sensor covers x10 10 00 resuscitator circuits x10 41 00 Evaluation report NA MRRP IW950 manual 3 525 00 IW930 servo 3 945 00 VHA adds 475 oY Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier GE Healthcare Giraffe Omnibed Ohmeda ID Number 6650 O0 902
85. ies g O c o Po Ogee sE g EX su ESE GR Sto F FASS O s v V y J of O O v O O O O 75x51 114x59 114x59 Dr ger E E cu fae gt O a 0 oS gt a m O O Y v O O Y O O O O O O O 114x59 95x62 186 123 152 75x 50 75 x 49 96 89 118 20 10 20 15 80 83 weight without VHA 36 Warming therapy Report 05103 Market survey infant warming and phototherapy Table 4 contd Drager F amp P GE Healthcare MIS pA o E Gy Go k 8 3 S z 2 5 O 5 T gt ae 2a lO SO SO N o ro ro O 2 ao D O E BN A O O Ka O O v O v v v O v y v V v y v V v V v O A v v A v V v V v y O O v y v v v v v A v v O V v V v O O V v V O O O O O v O O v O O O O O O O O O O O O O O O O O O O O O 95x62 95x62 115x75 77x111 114x66 104x76 114x76 63x 107 1238 152 123 152 185 206 174 189 147 238 183 203 183 203 183 203 Seem 66x48 66x48 77x61 ae 79X49 75x49 66x53 62 x 72 63 x 33 89 118 89 118 90 109 93 108 81 111 98 118 98 130 90 110 o o o o o o o o o 12 8 20 15 20 159 107 10 12 10 10 83 83 127 60 131 91 91 no X ray tray but includes a gap beneath the mattress for plates 3 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Fisher amp Paykel CosyCabinet Fisher amp Paykel ID Number IW980CAB IW990CAB Available since 1999 General Dimensions
86. ilt 15 MC non continuous 15 CC Ground clearance NA Weight incl VHA 59 kg MC 62 kg CC Description Radiant heater unit with two baby compartment options 29 1 with a bassinet maternity crib MC or 29 2 with a fixed cot with fold down sides care crib CC Uses air or baby temperature control Also available as mobile warmer without crib and wall mounted warmer Options Storage options One large or two smaller drawers Standard package includes Optional features accessories VHA crib type oxygen analyser maintenance amp trending software resuscitator ventilator Baby compartment Crib size LW H 28 x 71 cm MC 41 x 71 cm CC Mattress size 27 x 70cm MC 40 x 70 cm CC Walls Care crib CC has four fold down walls Tubing ports None Treatment distance 75cm 40 Report 05103 Market survey infant warming and phototherapy Warming therapy ISIS Ambiance Mediprema Nursing amp medical Control panel location Touch screen on front of heater Manual control No Skin temperature Min 352C Max 37 C Override 382C Other temperature Air temperature Min 28 C Max 37 C Override 39 C Irradiance heater power 650 W Heater swing away Yes Examination light Yes APGAR timer No Oxygen control No Trending history Up to 2hrs as standard optional module p
87. imer No Alarms Overheating of light box Maintenance Lamp hours meter Yes lifetime of 800 10000 hrs depending on intensity used Consumables Bulbs disposable pad covers and vests Service training Service manual in user manual training is chargeable not required for first line maintenance cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class lla Full Quality Assurance IS09001 EN46001 15013485 BSI 0086 Supplier s Quality System IS09001 15013485 BSI 0086 Device complies with IEC 60601 1 IEC60601 1 2 Financial Consumables Bulbs each 43 25 Covers x50 32 00 Vests each 1 18 Evaluation report Evaluation 391 April 2000 MRRP 2 567 10 81 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier GE Healthcare Giraffe Spot PT Lite Ohmeda ID Number 6600 0845 811 Available since 2002 General Dimensions L W H 20 x 30 x 13 cm Lockable wheels NA VHA mattress height NA Head tilt Flexible arm Wheelbase height NA Weight 4 2 Kg Light box with flexible arm delivering spot light therapy Fixes to Ohmeda PESCHPHON dovetail rails Light Light source Metal halide lamp Peak spectrum 430 440 nm Treatment distance 38 cm irradiance 35 uW m2 nm Illumination area
88. in layers e Heated mattresses warm the baby s skin surface by conduction Monitoring of the infant s temperature and adjustment of the device s thermal output levels is required to maintain an optimal environment as the infant s physical condition changes Neonatal phototherapy Phototherapy lamps transfer radiant energy into the skin specifically to achieve a therapeutic reduction in the bilirubin concentration in the blood Blue or blue green light interacts with the bilirubin molecules in the superficial blood vessels These devices 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 manufacturer claims that the device meets the Essential Requirements of the European Medical Devices Directive 4 CEDAR have requested evidence from each supplier which demonstrates this conformity A list of relevant standards and an explanation of how compliance is demonstrated is contained in the Appendix Each product page includes information about the standards with which the manufacturer claims compliance 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 IWpF website which was published in March 2005 In order to obtain up to date details of prices and products users should consult the website 1 from a computer linked to NHSnet Some user training
89. ing conformity by the OR manufacturer AND Product Quality Assurance i e how a unit is tested at the end of the production lib Type testing of the OR device AND Production Quality Assurance i e how a device IS produced The assessment of the Quality Assurance type testing and verification must be carried out by a Notified Body This is an organisation that has been accredited to carry out these tasks in accordance with various EU directives Each device is then labelled with a CE mark incorporating the Notified Body s four digit code number which is also documented on the product pages in this report NB CEDAR has requested that suppliers provide evidence of the method by which each device has achieved its CE mark 96 Report 05103 Market survey infant warming and phototherapy Appendix Glossary Access door s Access doors both sides Air circulation Air temperature Alarms APGAR timer Available since Battery complex care units Battery indicator Battery life Blender Canopy crib size Canopy flat area Charging time Complex care Computer network Consumables Control box Large rectangular door in one or more incubator walls allowing greater access to the baby e g for more complex procedures or for the baby or equipment X ray tray headbox etc to be moved in or out of the enclosure Allows easier access for procedures requiring more than one carer The dire
90. kin temperature probes covers air filters every three months Service training Service manual 1st copy FOC 34 70 thereafter Training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb compliance method not supplied ISO9001 Kerma Medical Quality 0344 certificate not seen Supplier s Quality System IS09001 1ISO46001 IS013485 TUV Gmbh 0123 certificate not seen Device complies with IEC601 1 IEC601 2 19 Financial Consumables Disposable skin sensors x10 150 00 Evaluation report Evaluation 375 Air Shields Isolette Feb 1999 previous model MRRP 10 050 00 17 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier GE Healthcare Giraffe amp Omnibed Ohmeda ID Number 6651 902 Giraffe Available since 6650 HHH 902 Omnibed 7 Fo 2001 2000 General 114 x 66 x 147 177 cm Dimensions L W H Omnibed raised canopy 208 Giraffe 238 cm incubator Lockable wheels 4 out of 4 shown VHA mattress height 81 111 cm Mattress tilt 12 Ground clearance 9 5 cm Weight incl VHA 131 kg Description The Omnibed acts as a combined incubator and radiant warmer unit see warming therapy section The top of the canopy can be raised electrically to operate as a warmer The Giraffe is a standar
91. lable since 2003 ci General Control box L W H NA Cable length 2 m Mattress size 72 x 60 cm Weight 12 kg Photo courtesy of Central Medical Supplies Table top gel mattress on heating pad suitable for examination treatment Description and changing Nursing amp medical Control panel location Top surface of support at rear Surface temperature Min 35 C Max 37 C Override 30 34 5 C and 37 5 38 52C Warm up time Approx 30mins Alarms Yes Maintenance Consumables None Service training Service manual FOC training is chargeable 75 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS09001 15013485 TUV Product Service 0197 Supplier s Quality System ISO9001 ISOQAR Device complies with EN60601 1 EN60601 2 35 Financial Consumables NA Evaluation report NA MRRP 2 695 00 71 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Viamed Amecosy NC1 NC2 NC3 ARDO 1910010 NC1 ID Number 1910011 NC2 1910012 NC3 Available since 1997 General Control box L W H 25 x 24 x 7 cm Cable length 3m mains to control box 1 8m control box to mattress Mattress size 60 x 77 cm NC1 84 x 46 cm NC2 65 x 33 cm NC3 4 2 kg control box 5 5 kg NC1 Image
92. lass unknown compliance method not supplied ISO9001 TUV Product Services 0123 certificate not seen Supplier s Quality System ISO9001 T V Product Services 0123 certificate not seen Device complies with Financial Consumables Evaluation report MDA 00091 January 2001 MRRP 2 750 00 79 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Drager Photo Therapy 4000 Drager ID Number 2M22310 ae Available since General 1994 Dimensions L W H 69 x 60 x 107 162cm stand 47 x 29 x 13 cm lamp Lockable wheels 4 out of 4 VHA mattress height 77 132 cm Head tilt Yes Wheelbase height 13 cm Weight en 13 6 kg 3 i J Description Single hood for use with or without mobile stand slots into holder Separate on off switches for blue and white tubes Light Light source 4 blue 2 white fluorescent tubes 6 blue tubes optional additional blue tubes are not monitored for lamp hours Peak spectrum 460 nm Treatment distance 30 cm irradiance 2 4 mW cm2 4 blue tubes 3 4 mW cm 6 blue tubes Illumination area Nursing amp medical Power control No Treatment timer No Alarms No Maintenance Lamp hours meter Yes replace after 1000 hrs Consumables Blue amp white tubes Service training Service manual 5
93. ldiagnostics infantwarming stm Or go to nww pasa nhs uk choose Il from the A Z index or search for infant and follow the link to Infant warming and phototherapy 2 Competition Commission Report ISBN 0117022179 2004 Drager Medical AG amp Co KGaA and Hillenbrand Industries Inc A report on the proposed acquisition of certain assets representing the Air Shields business of Hill Rom Inc a subsidiary of Hillenbrand Industries Inc Can be accessed from http www competition commission org uk rep_pub reports 2004 489drager htm 3 Crawford DC Peirce SC Champken Woods N Establishing an infant warming and phototherapy procurement framework Journal of Neonatal Nursing 11 3 96 101 Dec 2005 4 Council Directive 93 42 EEC Medical Devices Directive Official Journal of the European Communities OJEC 36 L169 1 43 12 July 1993 5 http www pasa nhs uk evaluation publications 6 Wentworth SDP Neonatal phototherapy today s lights lamps and devices Infant 1 1 14 19 January 2005 7 Biarent D Bingham R Richmond S Maconochie I Wyllie J Simpson S Nunez AR Zideman D European Resuscitation Council Guidelines for Resuscitation 2005 Section 6 Paediatric life support Resuscitation 67 S1 S97 S133 2005 8 BS EN 60601 2 50 2002 Medical electrical equipment Part 2 50 Particular requirements for the safety of infant phototherapy equipment 9 Wentworth SDP Mutch SJ Incubators and x ra
94. mately 50 IWpF products have been grouped as nursing incubators 8 product listings transport incubators 2 warming therapy 23 including 2 resuscitation cabinets 12 complex care units 6 mobile devices and 3 warming mattresses and phototherapy lamps 16 An overview of relevant clinical and procurement issues is provided for each section The information presented here comprises comparative tables of key dimensions and features and a product summary page for each model This market survey contains data provided by the nine UK suppliers and the NHS PASA IWpF website In some cases further evaluation information is available in previously published reports These are noted on the relevant product pages Prices quoted are the suppliers list prices from the PASA website NHS organisations can obtain discounted prices via the NHS PASA IWpF website 1 Suppliers may have other similar products not included in the IWpF contract Any NHS organisation interested in purchasing items not listed on the IWpF must conduct the relevant competitive tender exercise depending on the value of the order The contract is subject to ongoing review to encompass new suppliers and new technologies For further information about the contract please contact NHS PASA infantwarmings pasa nhs uk Following acquisition of Air Shields by Drager Medical the UK Competition Commission recommended that price stabilisation and increased market competition should
95. mp Paykel Mobile Infant Warmer Fisher amp Paykel Viamed Ceratherm 600 2 Nufer Central Medical Supplies Baby Warmer Complete Kanmed AB Thermocare Convenience Weyer Viamed Amecosy NC1 NC2 NC3 ARDO Phototherapy 40 42 44 48 50 52 54 56 58 60 62 64 65 66 67 68 69 70 71 12 73 How neonatal phototherapy works lrradiance light sources Heating Treatment Report 05103 Market survey infant warming and phototherapy Beaver Ampliflux 1 or 2 Hoods Mediprema Cradle 360 Mediprema Central Medical Supplies Bili Compact Weyer 76 Tf 78 Report 05103 Market survey infant warming and phototherapy Contents Drager Micro Lite Air Shields Photo Therapy 4000 Drager GE Healthcare BiliBlanket Plus Ohmeda Giraffe Spot PT Lite Ohmeda Medical Imaging Systems Biliberco OO6FB Fanem Bilisoot OO6BP or OO6BB Fanem Bilitron 3006 Fanem Octofoto Fanem Genesys Medical Solutions neoBLUE Natus Fisher amp Paykel Genesys Medical Solutions neoBLUEmini Natus Viamed Amelux ARDO BiliCrystal Bulle 2 Medestime BiliCrystal Mono Duo 2 Medestime BiliCrystal Trans Medestime BiliCrystal IV 2 Medestime Appendix Suppliers contact details Manufacturing standards for medical devices A brief guide to the Medical Devices Directive Glossary Acknowledgements References Tables Table 1 Comparison of nursing incubators features ie 80 81 82 83 85
96. mperature is particularly high or low The recommended distance from an overhead unit radiant warmer or phototherapy lamp to the mattress The value given is often a minimum distance The source mattress distance should be measured as overheating or under treatment can occur if not correctly positioned Phototherapy may be prescribed for a particular time alternatively intense sources may have an upper limit to the duration of a single therapeutic episode The timer may count up or down but may not necessarily alarm or turn off the lamp at the end of the pre set period The device can display variations in physiological parameters or device settings over several hours Alternatively the device may store a history of instructions This feature may only be available when the device is connected to a PC Gaps in the enclosure walls containing grommets which help to hold tubing or wires Slots without tubing support or gaps between walls are not included in the numerical value Height range of the mattress surface for devices with an integrated mattress and powered VHA For devices on mobile stands this is the height range of the mattress surface which should be used for treatment This will depend on the recommended treatment distance and the height range of the stand The walls of a complex care unit may fold down or be removable to facilitate better access to the infant The time to reach a therapeutic temperature from ambient The manu
97. ms Yes Maintenance Consumables None Service training Service manual 1st copy FOC 25 thereafter training TBA Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance ISO9001 EN46001 TUV Product Service 0123 Supplier s Quality System IS09001 15013485 CMDCAS certificate not seen Device complies with BS EN60601 2 BS EN60601 2 BS EN60601 2 21 Financial Consumables None Evaluation report NA MRRP 3 300 00 65 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Beaver ISIS Ambiance Mediprema ID Number 2930 2950 with VHA To Available since a i General f 84 x 67 x 177 cm Dimensions HWD 95 x 67 x 169 192 cm Lockable wheels 2 out of 4 VHA mattress height 79 102 cm Mattress tilt No ae tg Ground clearance 11 5 cm z lt Weight incl VHA 2930 36 kg 2950 49 kg E i pi Radiant warmer using air temperature control rather than manual output Description power Optional oxygen analysis and technical history software module not incl O2 probe Also available as a wall ceiling mount Heater Heat source Ceramic Treatment distance 75 cm irradiance heater 650 W power Positioning aid No Nursing amp medical Manual control NA Air temperature Min 28 C Max 37 C Override 39 C Skin
98. n controlled humidity weighing scales gas bottle holder Baby compartment Canopy size L W H 41 cm mattress to hood Mattress size 81 x 41 cm tray size Double walls Yes front and rear long sides Tubing ports 10 Canopy flat area Air circulation Up front and rear long sides down foot short side Access to the infant Mattress slides out Access doors 1 additional door optional Hand ports 6 2 additional ports in head and foot walls 16 Report 05103 Market survey infant warming and phototherapy Nursing incubators Isolette C2000 Air Shields Nursing amp medical Control panel location Front panel below enclosure Control panel lock Yes Air temperature Min 20 C Max 37 C Override 39 C Skin temperature Min 34 C Max 372C Override 38 C Warm up time lt 35mins at 22 C ambient temperature Humidification Optional Min 30 Max 95 Water reservoir Drawer in front panel 1L capacity Oxygen control Optional Min 21 Max 65 Trending history 2 24 hrs 7 days for weight Computer network Yes RS232 VueLink software Alarms Increasing volume with alarm duration light on sensor module near top of enclosure Maintenance Access Canopy tilts open or can be removed Water system Reservoir is removable from the drawer Consumables S
99. ng mode whereby the water heater is boiled dry Consumables Air filters every two months water connection tube weekly or every patient temperature probes O2 sensor annually Service training Service manual 52 available on disk training is chargeable cost not suppied Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance ISO9001 TUV Product Services 0123 certificate not seen Supplier s Quality System ISO9001 T V Product Services 0123 certificate not seen Device complies with EN60601 1 EN60601 2 EN60601 2 19 Financial Consumables Evaluation report Evaluation 04020 Mar 2004 MRRP 9 947 00 powered VHA extra 15 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Drager ID Number Isolette C2000 Air Shields 83 D2A2 10 ee Ie Available since 2000 General Dimensions L W H 99 x 67 x 133 152 cm Lockable wheels 3 out of 4 1 directional lock VHA mattress height 90 111 cm Mattress tilt 12 Ground clearance 11 5 cm Weight incl VHA 90 kg Description Options Storage options Swivel opening drawers single deep or double shallow shelves IV pole Standard package includes X ray tray 2 humidity reservoirs Optional features VHA servo controlled oxyge
100. otherapy Phototherapy Supplier Viamed Amelux ARDO ID Number 1910000 Available since 2004 B General Dimensions L W H 72 x 69 x 115 160 cm Photo courtesy Lockable wheels 2 out of 3 of Viamed VHA mattress height 80 125 cm Head tilt Yes E Wheelbase height 7 5 cm Weight 18 kg w Standard option uses 4 blue and 2 white tubes 6 blue tubes available as a Description separate model The four blue and two white blue tubes are operated independently Light Light source 4 blue 18W71 and 2 white 18W950 fluorescent tubes Peak spectrum 430 440 nm Treatment distance 35 cm Irradiance 3 5 mW cm2 4 blue tubes Illumination area 46 x 23 cm Nursing amp medical Power control Can select 2 or 4 blue tubes Treatment timer Yes does not switch off or alarm Alarms No Maintenance Lamp hours meter Counts operating time of four blue lights Replace after 2000 hrs Consumables Tubes Service training Service manual FOC training is chargeable TBA Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS09001 15013485 TUV Product Service 0123 Supplier s Quality System BS EN ISO9001 IS013485 CMDCAS certificate not seen Device complies with EN60601 1 EN60601 2 EN60601 2 50 Financial Consumables Blue
101. ots in rear wall and gaps between walls Ag Report 05103 Market survey infant warming and phototherapy Warming therapy Infant Warming System Kanmed AB Nursing amp medical Control panel location Separate box hangs from rail below crib Surface temperature Min 34 C Max 38 C water temperature APGAR timer No Oxygen control No Maintenance Consumables Nests change at least annually anti algae solution mattress uses tap water change every three months Service training Service manual FOC training 70 person expenses Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb warmer Full Quality Assurance IS09001 15013485 Intertek Semko 0413 Supplier s Quality System ISO9001 ISOQAR Device complies with EN60601 1 EN60601 2 EN60601 2 35 Baby Warmer Complete Financial Consumables Re useable nests each 65 anti algae solution x20 95 Evaluation report NA MRRP 3 995 00 45 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Thermocare 2000 K Weyer ID Number WY2030 Available since 2003 General Dimensions H W D 114 x 59 x 109 139 cm Photo Lockable wheels 4 out of 4 Caer VHA mattress height 85 115 cm ie Mattress tilt 20 10 Ground cle
102. pered connectors jar liners Service training Training charge TBA Tom Thumb Resuscitator service manual 30 available on disk or website Suction controller service manual 30 PPM only Ceratherm see warmer product pages Medical Devices Directive Manufacturer s MDD compliance NB Viamed Tom Thumb Resuscitator Class Ila Full Quality Assurance ISO9001 15013485 BSI 0086 Therapy Equipment suction controller Class lla Production Quality Assurance ISO9002 EN46002 BSI 0086 Oxylitre suction controller Class Ila Full Quality Assurance ISO9001 BS EN46001 Amtac 0473 Nufer Ceratherm see warmer product pages Supplier s Quality System BS EN ISO9001 15013485 CMDCAS certificate not seen Device complies with Suction controller 1S010079 3 BS7259 Pt2 Ceratherm see warmer product pages Financial Consumables Patient circuit 9 00 Vacsax liners x25 35 10 suction tubing 1 50 metre Evaluation report NA MRRP 3 300 00 39 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Beaver ISIS Ambiance Mediprema ID Number 2931 2951 Maternity Crib 2932 2952 Care Crib Available since General Dimensions H W D 62 x 103 x 170 190 cm Lockable wheels 2952 Care Crib 2 out of 4 with VHA shown VHA mattress height 73 79 cm Mattress t
103. r Drager GE Healthcare Inspiration MIS MP5 MP5ISIS V 2100G V 2100G V 2100G Vision Model ISIS A SVREA SATIS Caleo Isolette Giraffe Omnibed A B c C186 2186 Peripheral 7 J y v temperature Controlled humidificaton n 4 lt Bs NN X ray tray Weighing scales O Kangaroo mode Oxygen monitoring Servo controlled O2 Double walls O Mattress elevation Powered VHA O Access doors both sides Hand ports 4 Trending O history Computer O network Control panel lock cover v included as standard no X ray tray but includes a gap beneath the mattress for plates O available as an optional extra t air is humidified but not monitored or controlled O lt v v v v V O O SAES H EOR reo lt O O O O O SKO S OOC O O HESS O RO OES IOE ES SO O lt D O O SSS MA MS SN HS SS lt D gt 7 O O S S D O OS NSN D T D 4 6 4 6 V V S O SON e O O O e ee lt O S S v v v v v v sJoyeqnoul Bulsunn Report 05103 Market survey infant warming and phototherapy Table 2 Comparison of nursing incubators specifications Supplier Beaver Drager MP5 ISIS MP5 ISIS Model A SI REA SATIS Caleo Isolette a 104x53 104x60 102x58 117x69 99x67 Height cm 130 153 130 153 159 182 122 152 133 152 Mattress L W cm 61x39 61x39 61x38 65 x 50 81 x 41 ve eters 93 116 93 116 94 117 80 110 90 111 height cm Mattress tilt 10 202 10
104. r transport incubators BS EN60601 2 21 1997 Medical electrical equipment Particular requirements for safety IEC60601 2 21 1994 Specification for infant radiant warmers BS EN60601 2 35 1997 Medical electrical equipment Particular requirements for safety IEC60601 2 35 1996 Specification for blankets pads and mattresses intended for heating in medical use BS EN60601 2 50 2001 Medical electrical equipment Particular requirements for the safety IEC60601 2 50 2000 of infant phototherapy equipment ISO7767 1997 Oxygen monitors for monitoring patient breathing mixtures Withdrawn replaced by 1SO021647 2004 IS08382 1988 Resuscitators intended for use with humans BS EN ISO9001 2000 Quality management systems Requirements ISO9001 2000 IS010079 1999 Medical suction equipment BS7259 1993 withdrawn BS British Standard EN European harmonised standard ISO International Organisation for Standardisation IEC International Electrotechnical Commission A brief guide to the Medical Devices Directive The European Union Council published the Medical Devices Directive MDD in June1993 4 93 42 EEC and it became mandatory in June 1998 It sets out the 95 Report 05103 Market survey infant warming and phototherapy Appendix Essential requirements which a medical device must comply with in order to be eligible for CE marking These are necessarily written in very general terms as they cover all products
105. rce Blue and yellow LEDs with diffuser Peak spectrum 450 475 nm Treatment distance 30 5 cm Irradiance 12 15 uW m nm low 30 35 uW m2 nm high Illumination area 50 x 25 cm Nursing amp medical Power control 2 intensity settings Treatment timer No Alarms No Maintenance Lamp hours meter No Check output every 6mths can be adjusted by technician Consumables Blue diodes replaced in groups of 6 Device can continue in use with a few non working diodes Service training Service manual fault finding and PPM FOC available on disk Training is not required for 1st line maintenance PPM calibration or repair Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance _ EN46001 ISO9001 IS013485 TUV Rheinland 0197 Supplier s Quality System Working towards ISO9001 Device complies with EN60601 1 EN60601 1 2 EN60601 1 2 50 Financial Consumables Blue diodes 1200 Evaluation report MHRA 04143 Dec 2004 MRRP 2 850 00 with stand 2 710 00 no stand 8 7 Report 05103 Market survey infant warming and phototherapy Phototherapy Supplier Fisher amp Paykel Genesys Medical Solutions neoBLUEmini Natus ID Number 10102 Available since 2004 General Dimensions L W H 19 x 14 x 5 cm lamp only Arm extends lt 81 cm
106. rm this task adequately so that the levels in the blood increase resulting in hyperbilirubinaemia neonatal jaundice This is treated by phototherapy because the light at blue or blue green wavelengths converts the bilirubin molecule into a form that is either easier to excrete or is less toxic to the neonate The effective spectrum for this process has been identified in vitro to peak at around 450nm blue light However light with longer wavelengths blue green light can penetrate further into the skin so that these may be more therapeutic in vivo some devices use strong white light sources that include significant output at the blue end of the spectrum The use of these and mixed light sources does not interfere with visual assesment of the neonate s colour and can prevent or alleviate the side effects of intense blue light on carers e g headaches and nausea However they may have a reduced therapeutic effect compared to pure blue or blue green sources Irradiance light sources The level of light output at different wavelengths is the spectrum of the source Different light sources produce different shapes of light spectrum for example the fluorescent tubes used in various devices in this report are not the same type between manufacturers and therefore have different spectra lrradiance values provide an indication of the strength of the light and in this context represents a total light level over the 400 550nm range How
107. rovides up to a week Computer network Yes RS232 for clinical and technical monitoring interrogation Alarms Variable volume settable thresholds red light under heater Maintenance Consumables Skin temperature sensors covers Service training Service manual FOC available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 EN60601 2 21 Financial Consumables Evaluation report NA MRRP 2951 5 404 03 MC 2952 6 082 84 CC incl powered VHA 41 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Beaver ISIS Radiant Mediprema ID Number 4200 Available since 2004 PPP General mn nAi Dimensions H W D 62 x 103 x 170 190 cm J Lockable wheels 2 out of 4 VHA mattress height 86 106 cm i 7 G 4 Mattress tilt 15 7 Ground clearance 16 cm Weight incl VHA 110 kg J Desertor Radiant warmer bed unit suitable for resuscutation with additional air p temperature controlled mode whereby ambient temperature is measured and temperature at the mattress surface is estimated Options Storage options Drawers trays
108. s in this report operate by regulating the temperature of the heating element or the estimated temperature at the mattress surface The facility to administer oxygen either by flow meter or servo control is required for providing oxygen enrichment of an enclosed space or resuscitation of ventilation Supply can be via a hospital piped gas supply or from cylinders attached to the unit both oxygen and air are advisable see Blender Measurement and display of the oxygen concentration in the air Hoods may be available to concentrate the gas around the infant s head Approximate wavelength of the light at which the source is strongest The range of therapeutic light covers 400 550nm nanometres x10 2m BS EN60601 2 50 Additionally measures skin temperature at a peripheral site usually the foot Core peripheral difference can be used as an indicator of cold stress Indicates the manufacturer s recommended treatment distance from the radiant heater Indicates whether the light output can be varied Vertical height adjustment VHA allows the height of the mattress surface to be altered to a suitable working height for carers and for seated relatives e g for Kangaroo care or wheelchairs users The ability to alter the working height of the device is considered necessary for the health and safety of staff in the UK A stand by mode maintaining a warm mattress surface temperature to prevent the rapid cooling of a naked baby when
109. spiratory resuscitation However there is growing evidence that room air can be as effective and that 100 oxygen may result in adverse effects New ERC guidelines indicate that anything between air 21 and 100 oxygen is considered reasonable 7 External dimensions of the baby compartment Area of upper canopy surface for compatibility with phototherapy lamps which stand on the canopy see Format Time to full battery charge from complete discharge An infant requiring sustained warming therapy possibly with the inclusion of oxygen enrichment and humidification This indicates a device in which the infant can be safely left unattended The device can be connected to a printer PC or network to communicate trending data or for central monitoring or analysis Accessories or parts that may require replacement at specific intervals more frequently than once per year Ordering multiples and list prices are given where Known Warming mattresses may have a separate control box connected to the warming device by a cable of Report 05103 Market survey infant warming and phototherapy Appendix Control panel lock cover Controlled humidification Device complies with Dimensions Double walls Evaluation report Examination light Format Gas cylinders Ground clearance Hand ports Head tilt Heater swing away Heater control resuscitation cabinets Humidification ID number
110. st not supplied additional connectors required Medical Devices Directive Manufacturer s MDD compliance NB Class llb Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BSI 0086 Device complies with EN60601 1 EN60601 2 IEC60601 1 19 Financial Consumables Air filters x3 188 15 skin sensor 123 86 Evaluation report NA MRRP 10 072 35 VHA add 1 436 96 13 Report 05103 Market survey infant warming and phototherapy Nursing incubators Supplier Drager Caleo Drager ID Number 3209940 Available since 2000 General Dimensions L W H 117 x 69 x 122 152 cm Lockable wheels 3 out of 4 1 directional lock VHA mattress height 80 110 cm Mattress tilt 132 a P Ground clearance 13 cm Weight incl VHA 137 kg not incl VHA Y Incubator with large baby compartment which tilts as a whole i e not just Description the mattress Can accommodate twins up to 5kg combined weight Canopy is removable for increased access Vertical corners are opaque and fixed but all side walls fold down Options Storage options Large single drawer IV pole shelves Standard package includes X ray tray Optional features VHA humidity servo controlled oxygen weighing scales double walls Baby compartment Canopy size L W H 80 x 56 x 1
111. tand Includes examination lamp Several variants of wall or ceiling mounting are also available Heater Heat source Ceramic element Treatment distance 80 cm irradiance heater power lt 10 mW cm2 600 W Positioning aid No Nursing amp medical Manual control 4 levels can be set to any value between 20 99 Skin temperature No Alarms Yes Maintenance Consumables None Service training Service manual 1st manual FOC 25 thereafter training TBA Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance ISO9001 EN46001 TUV Product Service 0123 Supplier s Quality System BS EN ISO9001 15013485 CMDCAS certtificate not seen Device complies with EN60601 1 EN60601 2 EN60601 2 21 Financial Consumables None Evaluation report NA MRRP 1 900 00 69 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Central Medical Supplies Baby Warmer Complete Kanmed AB ID Number BW 50 001 Available since 1996 b General Control box L W H 21x17x12 cm Cable length 3m mains to control box 1m control box to mattress Mattress size 65 x 45 x 8 cm incl nest Photo courtesy of Central Medical Supplies approx 6 kg mattress etc weignt 3 kg control unit Water mattress and heating
112. ting APGAR and 2 countdown timers Heater Heat source Metal element Treatment distance 65 cm lrradiance heater lt 32 mWiem2 450W power Positioning aid No Nursing amp medical Manual control 0 100 in 5 increments Skin temperature Min 34 5 C Max 37 5 C Alarms Yes Maintenance Consumables Skin sensors amp covers Service training Service manual 22 training is charged 160 Medical Devices Directive Manufacturer s MDD compliance NB Class Ilb Full Quality Assurance _ ISO9001 EN46001 15013485 TUV Product Services 0123 Supplier s Quality System ISO9001 TUV Product Services 0123 Device complies with IEC60601 1 IEC60601 1 2 IEC60601 2 21 Financial Consumables Skin sensor 120 00 sensor covers x10 10 00 Evaluation report NA MRRP Manual IW920 2 525 00 Servo IW910 2 945 00 68 Report 05103 Market survey infant warming and phototherapy Warming therapy Supplier Viamed Ceratherm 600 2 Nufer ID Number 0310040 Available since 1998 General Dimensions H W D 61 x 82x 170 195 cm Photo courtesy of Lockable wheels 2 out of 3 Viamed VHA mattress height 90 115cm Mattress tilt Yes Ground clearance 6 cm Weight incl VHA 4 9 kg heater Description Ceramic heater available with mobile s
113. uld exceed the wheelbase height of accessories Small door sufficient to allow a single arm to perform nursing and medical care usually supplied with catches that can be opened with the elbow for aseptic access Some may be configured as iris ports which have a rotating flexible sleeve that can be partially closed e g to secure tubing Specialised clamps may be available for some devices as optional extras Overhead therapy devices such as radiant warmers and phototherapy lamps may be positioned at an angle other than directly over the mattress and still direct the heat light at the infant Can facilitate simultaneous therapy from several lamps The hood of an overhead radiant heater unit should be able to be moved out of the way for example so that a portable X ray device can be positioned over the infant The overhead heater may have manual control or baby servo control of output Humidifiers may be an optional extra for some incubator models and the product page will list range of pre set humidity values Note that humidity is more difficult to monitor and regulate than temperature and that achievable values depend on the ambient humidity Product code on the IWpF contract on the NHS PASA website for ordering information The mattress area that is covered by a therapeutic level of light at the recommended treatment distance this is 60 x 30 cm unless otherwise stated 8 The irradiance will decrease from the centre of the
114. ures Regular patient observations are especially important where more than one heat source is used Babies should not be placed onto cold warmer units as heat will be conducted away from their skin surface and lost to the environment causing rapid cooling This is especially true of warming mattresses as these are designed to be particularly conductive although the use of surface temperature settings below normal skin temperature can be used to deliberately cool a hyperthermic infant Grouping of devices in this report The devices in this report have been grouped according to the physical design and therapeutic use to facilitate comparison of like with like However the range of device types is very diverse and purchasers should consider which types of warmer will best suit their own needs Most warming devices in this section can be used to provide warmth during infant resuscitation in combination with the appropriate accessories and facilities However some devices are specifically designed for this use others are for long term complex care and some best suited to short procedures examination treatment and changing The device types are summarised in Table 3 e Resuscitation cabinets pages 38 39 designed primarily for resuscitation and assessment in the delivery room and include as a 32 Report 05103 Market survey infant warming and phototherapy Warming therapy minimum a resuscitator suction and APGAR timer Can be
115. useful for installation in rooms with limited space e Complex care units pages 40 63 radiant warmer and or heated mattress in a self contained mobile unit These include side walls so that the baby can be left unattended Optional features accessories can include a resuscitator ventilator gas delivery and blender drip stand battery examination light and phototherapy lamp These allow for flexible use of space and equipment and may also be used for transportation between departments or surgery in the open cot e Free standing lamps with baby support pages 64 65 a mobile unit for use during treatment examination or changing but not suitable for leaving the infant unattended e Free standing lamps pages 66 69 mobile overhead radiant devices intended primarily for long term use with open cribs e Table top wall ceiling mount radiant warmers for use on fixed or mobile surfaces or for long term care with a portable bassinet Fixed position or mounted on a flexible arm e Heated mattresses pages 70 72 warmed portable surfaces for table top use or for placement inside a cot Several radiant warmers are available as different device types so there are no separate product pages for table top wall ceiling mount warmers as the heaters are described on other pages Note that complex care units solely using heated mattresses have fewer features than those including radiant warmers Thermal control Heater power and irradiance give an
116. vailable Also on the product pages are costs for common consumables i e component items or accessories which are replaced at set intervals 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 on page 2 Each section has an introduction that provides general information to consider when choosing a device and guidance on interpreting the product pages and comparative tables Product pages provide an overview of the key features of each product A Glossary explaining the terms used in the comparative tables and product pages is included in the Appendix The Appendix also contains a table with the contact details of the suppliers 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 continuous improvements that suppliers and manufacturers make to their ranges and specifications means that prospective purchasers should seek up to date details from the suppliers before making a final decision Blank rows on the product pages indicate that specific information was not provided by the supplier Report 05103 Market survey infant warming and phototherapy Nursing incubators How incubators work Nursing incubators provide a warm stable microenvironment for small and sick babies so that the energy they would use to keep warm can instead be us
117. warming and phototherapy Phototherapy Supplier Beaver Ampliflux 1 or 2 Hoods Mediprema ID Number 1922 1 hood 1925 2 hoods Available since 1986 General Dimensions L W H 71 x 100 x 133 167 cm Photo courtesy Lockable wheels ie j j i 7 j i of Mediprema VHA mattress height 97 131 cm Head tilt 90 Wheelbase height x yo Weight 1922 29kg 1925 45kg One or two lamp hoods on one stand For 1925 model the two lamps are controlled as a single unit control box on top of stand For 1922 model PESGUPHON the control in on the front of the hood White tubes are available as an option Includes one set of protective eyewear Light Light source 6 fluorescent tubes per lamp TL 20W 52 Peak spectrum 450 460 nm Treatment distance 36 cm irradiance 3 7 mW cm per hood using blue tubes only Illumination area Nursing amp medical Power control No Treatment timer 0 12 hrs 1925 allows temporary treatment interruption Alarms No Maintenance Lamp hours meter Yes Check every 500hrs replace every 2000hrs Consumables Tubes Service training Service manual FOC available on disk training is chargeable cost not supplied Medical Devices Directive Manufacturer s MDD compliance NB Class Ila Full Quality Assurance IS013485 G MED 0459 Supplier s Quality System ISO9001 BS
118. y trays help or hindrance Journal of Neonatal Nursing 10 5 148 150 2004 102

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