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Thermometer review: UK market survey 2005

Contents

1. 54 Electronic contact Proact ST871 flexible tip 55 Electronic contact SureTemp Plus 56 Electronic contact Thermotek Instant 57 Electronic contact Zeal M5003 58 Infrared sensing thermometers 59 Table 4 Comparing infrared ear thermometers 63 Infrared sensing Braun Thermoscan Pro 64 Infrared sensing First Temp Genius 65 Infrared sensing Gentle Temp MC 510 E 66 Infrared sensing IVAC Core Check 67 Infrared sensing LCT 200 Ear Thermometer 68 MHRA 04144 Thermometer review UK market survey 2005 Contents Infrared sensing Microlife IRTDA1 69 Infrared sensing Microlife IRTDE1 70 Infrared sensing Proact ST613 71 Infrared sensing TB 100 Thermo Buddy 72 Infrared sensing Thermo Tek Plus 718 Table 5 Comparing infrared forehead thermometers 74 Infrared sensing Exergen Temporal Scanner 2000 75 Infrared sensing Exergen Temporal Scanner 5000 76 Infrared sensing FS 100 ACORN 77 Infrared sensing Microlife FR1DM1 78 Infrared sensing Thermofocus 79 Infrared sensing ThermoTek NoTouch 960 80 Acknowledgements 81 References 82 MHRA 04144 Thermometer review UK market survey 2
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3. 1 27 Supplier S Brannan amp Sons Ltd Address Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816600 Fax 01946 816625 Website www brannan co uk e mail sales brannan co uk Manufacturer Manufactured in 17 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass UHS UN507 Rectal Mercury in glass thermometer with a peak hold maximum device for measuring temperature under all circumstances Blue mark at the tip denotes use for rectal temperature measurement Intended use Hospital community and home use Measurement site Rectum Patient group Adults children and infants Size LWD 110mm x 6mm x 5mm Weight 6 gm User information Shake thermometer well to ensure all mercury has returned to the bulb Care should be taken to avoid breakage especially within the rectum Special features Protective plastic case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration information not supplied Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 ISO 13481 5 2003 BS EN 13485 2003 Manufacturer claims com
4. Mercury in glass Brannan Easy Read 11 456 3 Mercury in glass thermometer with a peak hold maximum device for measuring temperature under e all circumstances Intended use Hospital community and home use Measurement site Oral and axilla Patient group All ages except young children Size LWD 130mm x 12mm x 9mm Weight 8 gms User information Shake thermometer well to ensure all mercury has returned to the bulb Care should taken to avoid breakage especially within the mouth Special features Easy to read temperature scale protective case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of batch samples tested for accuracy using method stated in BS691 40 1 0 152 Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO9001 2000 Manufacturer claims compliance to BS691 CE mark Yes Code 0088 Notified Body LRQA Coventry UK Price ex VAT 1 86 Supplier S Brannan amp Sons Ltd Address Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816600 Fax 01946 816625 Website www brannan co uk e ma
5. MHRA 04144 Thermometer review UK market survey 2005 Chemical EZEtemp Disposable Thin flexible plastic strip with heat responsive inden tations which turn from green to black when they exceed their designated temperature Intended use Hospital primary care and home Measurement site Oral and axilla Patient group Adults and children Size LWD 90mm x 10mm Weight K User information Place thermometer s sensor area in usual oral or lt axilla position so it is surrounded by warm tissue Remove the tab after 1 3 minutes and read imme diately Last black dot indicates temperature reading Special features Non toxic mercury free not affected by ambient temperature changes therefore measurements can be repeated thermometer and wrapper is latex free individually wrapped designed for single patient use light and easily portable with proper care can be reused during the course of an illness for a single patient Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory quality assurance check from each batch in accordance with BS EN ISO 9001 2000 Calibration traceable to UKAS certified Master Standards Thermometer care Cleaning probe tip Wipe with an alcohol swab or wash with hot soapy water rinse wipe dry Cleaning body As for cleaning probe tip Storage conditions 5 year expiry date from date of manufacture printed
6. Manufactured in USA 35 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact thermometers How they measure temperature A resistance thermometer thermistor makes use of the change of electrical resistance in a metal wire with temperature the higher the temperature the greater the resistance Usually a coil of pure platinum wire is wound onto a ceramic plug and mounted in a steel tube but other configurations may be used Electronic circuitry is also required to digitally measure the resistance calculate the temperature using stored calibration data and display the temperature reading In the 1950s large battery powered devices were developed for continuous temperature monitoring Most are now incorporated into multi parameter patient monitoring systems but one stand alone device is available on the UK market This offers simultaneous monitoring of two body sites using detachable wires connected to thermistor sensors The international standard BS EN 12470 part 4 20 published 4 years ago details appropriate accuracy and calibration methods for these clinical thermometers This standard requires the maximum error measured in the laboratory to be 0 1 C over the operating temperature range 25 C to 45 Micro electronics led to the development of compact electronic thermometers in the 1970s Usually the metal covered thermistor makes skin contact in the mouth axilla or rectum These are light and easily porta
7. axilla and rectal a Patient group Adults children and infants Size LWD 165mm x 37mm x 50mm 5 Weight 65 gm User information Press on off switch to initiate a self check and dis q play last reading Place probe tip at the measure ment site until reading complete four beeps Switch off to conserve battery Special features Memory of last reading auto shutdown after 10 minutes non use audible fever alarm when measured temperature gt 37 5 C user selectable display units F or C waterproof unit supplied with a set of probe covers Antitheft device No Low battery indicator Battery icon is displayed Self check on start up Yes Calibration Factory calibration Thermometer care Cleaning probe tip Gently wipe with cotton bud slightly moistened with water Allow to dry before attaching a probe cover and taking temperatures Cleaning body Gently wipe with a cloth slightly moistened with water Storage conditions Home ideally store inside original packaging when not in use Store at room temperature or less Maintenance and ongoing costs Disposable covers available 4 5p each 45 for 1000 Battery Alkaline AAA size x2 batterries 3V Battery lite 1800 measurements approx Maintenance No maintenance required Manufacturing standards I509001 2000 EN ISO 13488 2000 Manufacturer claims compliance with Price ex VAT 13 95 EN60601 1 1990 EN60601 1 TE Q upplier roact Medica 7757 ED
8. 54 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Proact ST871 flexible tip Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture reading intended use Hospital community and home Measurement site Oral axilla and rectal ex Patient group Adults children and infants Size LWD 135mm x 25mm x 13mm N Weight 16 gm User information Press on off switch to display last reading and initi 2 cm ate a self check When L is displayed place probe tip at the measurement site until reading complete four beeps Switch off to conserve battery Clean before and after each patient measurement Special features Flexible tip memory of last reading audible fever alarm when measured tempera ture gt 37 5 C auto shutdown after 10 minutes non use user selectable display units either F or C waterproof unit supplied with a plastic storage case Antitheft device No Low battery indicator Continuous full flashing screen display Self check on start up Yes Calibration Factory calibration Thermometer care Cleaning probe tip Wipe with swab moistened with a soapy solution but do not soak Do not clean with alcohol Cleaning body As for probe tip Storage conditions Ideally store inside original packaging when not in use Store at room temperature or less Maintenance and ongoing costs Disposable covers no covers avail
9. Alexander DT Silverstone FA Wolf Klein G O Donnell R Grander J Determination of normal ear temperature with an infrared emission detection thermometer Ann Emerg Med 1995 25 97 99 Roy S Powell K Gerson LW Temporal artery measurements in healthy infants children and adolescents Clin Pediatr 2003 42 433 437 Williamson PR Lancaster Ga Craig JV Smyth RL Meta analysis of method comparison studies Statistics in Medicine 2002 21 2013 2025 Department of Health Sterilization disinfection and cleaning of medical equipment guidance on decontamination from Microbiological Advisory Committee to Department of Health Medical Devices Agency DoH 2002 may be downloaded from www mhra gov uk http www mhra gov uk select medical devices search for mobile communication systems McEvoy H Simpson R Machin G New blackbody standard for the evaluation and calibration of tympanic ear thermomters at NPL United Kingdom Thermosense XXVI Proceedings of SPIE 2004 5405 54 60 BS EN ISO 9001 2000 Quality management systems Requirements BSi 2000 82 MHRA 04144 Thermometer review UK market survey 2005 References 14 15 16 17 18 19 20 21 22 23 24 25 26 BS EN ISO 13485 1996 Quality systems Medical devices Particular requirements for the application of ISO 9001 BSi 1996 BS EN ISO 13488 1996 Quality systems Medical devices Particular requirements for the application
10. Business Park claims compliance with Shoreham Road Henfield prEN12470 3 1997 PM 5 95 mark Yes Code 0044 Fax 01273 493986 Notified Body RWTUV Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 90 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact O Temp l MC 204 E Electronic contact thermometer using a thermistor to sense temperature Audible tone when temperature rise is lt 0 1 C in 16 seconds Display continues for 10 minutes and then turns off Intended use Hospital community and home use Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 124mm x 19mm x 12 5mm Weight 15 gm User information Compact user information booklet 2 cm provided Only use within acceptable ambient condi tions See general advice for measuring oral axilla and rectal temperature Special features Waterproof last measurement memory displays L or H if measured temperature is below or above the stated operating range see Table 3 supplied with plastic stor age case Antitheft device No Low battery indicator W symbol displayed Self check on start up Yes Calibration Factory calibration traceable to national reference standards Verify accuracy in an authorised laboratory at least every two years Thermometer care Cleaning probe tip For home use wipe wi
11. During oral measurement ensure the thermometer tip is placed in the left or right sublinguial pocket as other areas in the mouth are cooler and the diagnosis of fever may be missed Hold mouth closed for at least 4 minutes during oral measurement to obtain an accurate measurement e During axilla measurement place the thermometer bulb high in the armpit and hold arm to chest for 10 minutes Place the thermometer bulb at a depth of 2 5 cm 1 inch within the rectum for o minutes to achieve a stable accurate temperature reading e Although a rare occurrence thermometers can be bitten or accidentally broken during patient measurement Consequently their oral use in infants young children and confused adults is contraindicated 11 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass thermometers Overall comparison of manutfacturer s data All mercury in glass thermometers in this review have a laboratory accuracy of 0 1 C 0 15 C and an operating range of 35 C to 42 C except the sub normal thermometers which have an extended operating range usually 25 C to 40 C at a lower accuracy of 0 2 C 0 3 C see Table 1 These thermometers all operate effectively regardless of the ambient temperature and humidity but in some circumstances additional measurement time may be required to enable the mercury to achieve thermal equilibrium with surrounding tissues Electronic interference which can be generated by s
12. E 2 Size LWD 92mm x 20mm o VVeight User information 2 cm Use fingers to hold the strip at both ends onto the forehead after they have been seated or lying for over 5 minutes Self reading is possible when facing a mirror Use in air tempera tures between 18 C and 27 C Note normal temperatures for comparison when ill ness is suspected Use a more accurate thermometer if fever is indicated Special features Supplied with a plastic storage box store in protective case when dry after cleaning keep away from ultra violet sunlight dampness and heat Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of samples from each batch to 0 2 C Thermometer care Cleaning probe tip Wipe with a soft cloth or tissue moistened with water Cleaning body Wipe with a soft cloth or tissue moistened with water Storage conditions Shelf life 5 years Keep out of heat and direct sunlight Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards 1509001 2000 mark Yes Code CE0088 Notified Body LRQA Coventry UK Price ex VAT 2 54 Supplier S Brannan amp Sons Ltd Address Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816625 Fax 01946 816625 Website www brannan co uk e
13. by warm tissue Ten seconds after removal read the last blue dot ignore skipped dots Discard immediately after use Special features otored in individual sterile packaging shorter time to reading than mercury in glass thermometers designed for single use ambient temperature must be less than 35 C preferably less than 30 Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration tested for accuracy Do not use after expiry date on package Thermometer care Cleaning probe tip not applicable Cleaning body not applicable Storage conditions Shelf life 2yrs from date of manufacture Store at less than 30 C Can be reset when exposed to temperatures above 35 C by placing in freezer for at least an hour and then placing in room temperature for one day Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 ISO 13485 1996 Price ex VAT 7 0 pence each 174 67 Manufacturer claims compliance with per 2500 ASTM E 825 87 Supplier 3M Health Care Ltd CE mark Yes Code 0086 Address 3M House Morley Street Notified Body British Standards Loughborough LE11 1EP Institute Telephone 01509 611611 Fax 01509 613326 Website www 3mhealthcare co uk e mail innovation uk mmm com Manufacturer 3M Co Manufactured in USA 29
14. check on start up Yes Calibration Factory calibration using standards traceable to National Institute of otandards and Technology USA Recalibration required Thermometer care Cleaning probe tip Varies depending on the specification of the detachable probe Cleaning body Wipe down with Isopropyl alcohol and soft cleaning cloth Storage conditions 50 C to 65 C 0 to 95 RH Maintenance and ongoing costs Disposable covers No reusable or disposable probes Battery Alkaline C size x6 9V Battery lite 900 hours minimum Maintenance Return to manufacturer if Price ex VAT 356 00 approx E440 SELF GAL message does not go away Supplier Technomed Manufacturing standards Address Amerikalaan 716199 AE 809001 2000 15014001 1996 NOE ALTRO EN13485 1996 Manufacturer claim Pr Langs EN UL2601 00 bo pre da Fax 31 434086888 1 EN58001 EN50082 EN1441 Website www technomed n1 CE mark Yes Code 0336 e mail rtilli technomed n1 Notified Body TNO Certification Manufacturer YSI Manufactured in USA 39 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Digitemp UN518 Electronic contact thermometer using a thermistor to sense temperature Audible tone when temperature rise is lt 0 1 C in 8 seconds Intended use Hospital community and home use Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 125mm x 20mm x 10mm Weight
15. information Sue Ord NHS Purchasing and Supplies Geoff Smith MHRA Rob Simpson and Dr Graham Machin National Physical Laboratory Professor E F Ring School of Computing University of Glamorgan Dr Matthew Thompson Deparment of Primary Health Care University of Oxford We would also like to thank all the manufacturers and suppliers who contributed to this review 81 MHRA 04144 Thermometer review UK market survey 2005 10 11 12 13 References Wunderlich C On the Temperature in Disease A Manual of Medical Thermometery translated into English Bathhurst Woodman W New Sydenham Society London 1972 Device Bulletin MDA DB 2000 03 Blood pressure measurement devices mercury and non mercury Medical Devices Agency 2000 Braun SK Preston P Smith RAEN Getting a better read on thermometry Research Nursing 1998 March 57 60 Health and Safety Executive L5 The controls of substances hazardous to health regulations 2002 Approved codes of practice and guidance 4th edition HES Books 2002 Mackowiak PA Wasserman SS Levine MM A critical appraisal of 98 6 degrees F the upper limit of the normal body temperature and other legacies of Carl Reinhold Agust Wunderlich JAMA 1992 268 1578 1580 Sund Levander M Forsberg C Wahren LK Normal oral rectal tympanic and axillary body temperature in adult men and women systematic literature review Scand J Caring Sci 2002 16 122 128 Chamberlain JM Terndrup TE
16. is placed in a cooler environment Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards BS EN ISO 9001 2000 Price ex VAT 61 pence each 2 45 pack of 4 Manufacturer claims compliance Supplier Insight Medical Products Ltd with ASTM E1299 96 Address Units 1 4 Silk Mill Studios CE mark Yes Code 0086 2 Charlton Road Tetbury Notified Body BSI Product n ias 8DY elephone services Fax 01666 500115 Website wayne insightmedical net e mail www insightmedical net Manufacturer Medical Indicators Manufactured in USA 33 MHRA 04144 Thermometer review UK market survey 2005 Chemical Insight Nextemp Thin flexible plastic strip with heat responsive inden tations which turn from green to black when they exceed their designated temperature Intended use Hospital primary care and home Measurement site Oral and axilla ro T Patient group Adults and children Size LWD 91mm x 9mm Weight er User information Place under tongue like a traditional mercury ther mometer Read temperature immediately after with drawal Discard immediately 2 cm Special features Stored in individual sterile packaging mercury free no halgonated nitrobenzines Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory cal
17. of ISO 9002 BSi 1996 BS EN ISO 14001 1996 Environmental management systems Specifications with guidance for use BSi 1996 BS EN 12470 1 2000 Clinical thermometers Part 1 Metallic liquid in glass thermometers with maximum device BSi 2000 BS EN 12470 2 2001 Clinical thermometers Part 2 Phase change type dot matrix thermometers BSi 2001 BS EN 12470 3 2000 Clinical thermometers Part 3 Performance of compact electrical thermometers non predictive and predictive with maximum device BSi 2000 BS EN 12470 4 2001 Clinical thermometers Part 4 Performance of electrical thermometers for continuous measurement BSi 2001 BS EN 12470 5 2003 Clinical thermometers Part 5 Performance of infra red ear thermometers with maximum device BSi 2003 ASTM E 667 98 Specification for Clinical Thermometers Maximum Self Registering Mercury in Glass ASTM International 1998 original approved standard was published as ASTM E 667 79 and the last previous edition was ASTM E 667 97 ASTM E 825 98 Standard specification for phase change type disposable fever thermometer for intermittent determination of patient temperature ASTM International 1998 previously approved standards were published as ASTM E 1112 98 and ASTM E 1112 86 ASTM E 1112 00 Standard specification for electronic thermometer for intermittent determination of patient temperature ASTM International 2000 previously approved standards were published as ASTM E 825 9
18. of their changing colour prevents user contact with the chemicals and provides a robust contact thermometer suitable for most clinical measurement sites Most are low cost and may be designed for single use or multiple use for a single patient The time taken to achieve thermal equilibrium is less than for mercury in glass so measurement time is usually about a minute Some incorporate a temperature offset which compensates for the difference in heat transfer characteristics between sublingual tissues and a water bath The international standard EN 12470 part 2 18 published 4 years ago details appropriate accuracy and calibration methods for these clinical thermometers This standard requires the maximum error measured in the laboratory to be 0 1 C and 0 2 C over a minimum operating temperature range 35 4 to 40 4 C Some chemical thermometers were already on the market so manufacturers may state compliance with ASTM E 825 23 which requires the maximum laboratory error to be 0 1 C from 37 C to 39 C and 0 2 C from 35 8 C to 36 9 C and 39 1 C to 41 0 C Manufacturer s advice on clinical use Do not use within 30 minutes of patient taking exercise bathing eating drinking or smoking During oral measurement if applicable ensure the thermometer tip is placed in the left or right sublingual pocket with the dot side under the patient s tongue Other areas in the mouth are cooler and the diagnosis of fever may be mis
19. on wrap per Store in dry conditions Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards BS EN ISO 9001 2000 Manufacturer Price ex VAT 14 pence 140 per 1000 claims compliance with ASTM E1299 96 77 500 Eo CE mark Yes Code 0086 PON Notified Body BSI Product Services SW19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer Medical Indicators Manufactured in USA 30 MHRA 04144 Thermometer review UK market survey 2005 Chemical EZEtemp Traxit Adhesive plastic thermometer designed to be placed under the arm for up to 48 hours Heat responsive indentations which turn from green to black when they exceed their designated tempera ture Intended use Hospital primary care and home Measurement site Axilla Patient group Newborns children patients in ICU and recovery Size LWD 33mm x 32mm Weight lt 1gm 2 cm User information Place adhesive surface in usual axilla position cover with arm for three minutes Lift arm to read Last black dot indicates temperature Special features Can remain in place for 48 hours for repeated reading extended range 31 6 C to 41 9 C suitable for hypothermic patients constant wearable source of temperature measurement in hairless or shaved axilla causing minimal p
20. 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 The MHRA is an executive agency of the Department of Health ISBN 1 84182 919 6 MHRA 04144 Thermometer review UK market survey 2005 Contents s Ue oe OE OR OAAR AE Saku OE RI FEE 1 Introduclion 2 Procurement ISSU S 5 Clinicalissues 5 Measurement environment 7 Lifetime COS 7 Manufacturing standards 9 Mercury in glass thermometers 11 Table 1 Comparing mercury in glass thermometers 13 Mercury in glass Brannan dual scale 11 455 8 14 Mercury in glass Brannan Easy Read 11 456 3 15 Mercury in glass Brannan ovulation 11 020 3 16 Mercury in glass Brannan solid stem 11 455 2 17 Mercury in glass UHS UN507 Rectal 18 Mercury in glass UHS UN508 19 Mercury in glass UHS UN5081 dual scale 20 Mercury in glass UHS UN509 subnormal 21 Mercury in glass Zeal M0110 22 Mercury in glass Zeal M1010 23 Mercury in glass Zeal M2010 24 Mercury in glass Zeal M2510 25 Chem
21. so it would be inappropriate to use these when they have been temporarily stored outside these temperatures eg in a car boot during a UK winter or on a windowsill on a hot summer s day Some models may produce reading errors when subject to electronic interference which can be generated by radio communications equipment eg mobile phones or some types of hospital equipment eg surgical diathermy generators 61 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing thermometers Fast reading time of a few seconds is promoted as a major advantage for users of this type of thermometer A few models also offer an extended measurement range but these readings are less accurate eg 0 3 C or 1 0 C Comparison of manufacturer s data forehead thermometers Six infrared forehead thermometers have been included in this review One of these is designed to be positioned 3cm from the skin surface the others need to be moved over the skin surface to achieve a reading Laboratory accuracy of 0 1 G is stated for one model and 0 2 C for the other five However this level of accuracy is achieved under fairly restrictive ambient temperature conditions to see Table 5 for details Consequently most infrared forehead thermometers may be unsuitable for routine use for home visits or outdoors as the thermometer could easily be exposed to ambient temperatures below or above this range Clinical factors see manufacturer s ad
22. traceable to their standards and is commercially available 12 The costs of transportation and any internal or external calibration service should be fully investigated before the procurement decision is finalised It may be useful to involve the scientists or engineers responsible for medical equipment management in these pre purchase negotiations Maintenance costs For some models the maintenance costs can be equal to the purchase cost over the life of the thermometer for others the purchase cost is so low that any repair work is not cost effective Savings in lifetime equipment cost may be assisted by involving the scientists engineers responsible for medical equipment management in the pre purchase negotiations with the manufacturer Options for maintenance are that the manufacturer requires all maintenance re calibration and repair work to be performed at their facilities provides service manuals and training to local medical engineering support staff so maintenance re calibration and or repair work can be performed within the local hospital e intends the thermometer to be discarded if a fault occurs other than when covered by the warranty period Theft Most thermometers are small portable medical devices which are prone to loss through theft Each product summary identifies those models which offer anti theft options Manufacturing standards CE marking Manufacturers of medical devices placed on the market in
23. whatever the weather infrared sensing and compact electrical thermometers can have lower accuracy under the same conditions Chemical phase change thermometers may offer a viable alternative particularly those which permit a storage temperature up to 50 C Electromagnetic interference Another consideration particularly in hospitals and ambulances is the risk of false readings when the thermometer is exposed to electromagnetic interference Possible strong sources include the surgical diathermy generator in theatre or defibrillators Mobile communication systems including porters and emergency services two way radios also pose a risk as outlined in recent MHRA information posted on their website 11 Mercury and chemical thermometers will be unaffected but interference may cause a fault in some electronic thermometers Those which comply with the International otandard for electromagnetic compatibility EN 60601 1 2 are likely to be immune to most sources of interference but may still be affected by surgical diathermy electrosurgery equipment Lifetime cost For some models the lifetime cost can more than double the purchase cost of the thermometer Indeed some companies will offer the base unit free of charge because they expect to recoup the purchase price through their charges for consumables maintenance etc MHRA 04144 Thermometer review UK market survey 2005 Procurement issues User training Training of clinical
24. wipe probe window with cotton swab slightly moistened with alcohol Allow to dry for 5 minutes before taking temperatures Cleaning body Wipe with a soft cloth moistened with alcohol Do not submerge in water Storage conditions 20 to 50 G Maintenance and ongoing costs Disposable covers required 8 43 per 200 Battery Alkaline AA size x2 3V x Pri VAT 67 00 Battery life 6 months 1000 measurements 2 5 Maintenance Not required Supplier VVelch Allyn UK Lid Address Cublington Road Manufacturing standards AUN ISO 9002 1994 amp ISO 13488 2000 Buckinghamshire Manufacturer claims compliance with HP22 AND EN60601 1 1988 EN60601 1 2 2001 Telephone 01296 689900 EN60601 1 4 2000 ASTM E1965 98 and Fax 02023 659694 others 7 vvelchallynuk CE mark Yes Code 0297 a Notified Body DQS Germany Manufacturer Braun GmbH Manufactured in Germany 64 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing First Temp Genius Infrared detector measures emitted radiation from inner ear detecting peak value to predict the tem e perature at one of three body sites Oral is default E intended use Hospital and primary care Measurement site Ear Patient group Adults children and infants Size LWD 216mm x 56mm x 76mm base 24mm x 69mm x 51mm Weight 200 gm base 312 gm User information zum Operators manual video and CD are available for training users No adjustment of external
25. 005 Summary This issue of Evaluation surveys the stand alone clinical thermometers currently available in the UK market This is an independent source of information on a wide range of thermometers Fifty five models are included in this review obtained from sixteen suppliers Some UK companies did not wish to participate in this review particularly those primarily retailing to the general public for home use An overview of clinical and procurement issues is provided in the introductory sections of the report Four distinct measurement methods have been developed for measuring clinical temperature This report summarises key features of each thermometer type mercury in glass thermometers 12 models chemical thermometers 7 models electronic devices which use the thermal contact method 20 models and infrared sensing electronic devices which assess body temperature from the electromagnetic emissions from blood vessels beneath the skin surface 16 models The information we report has been reproduced in a systematic manner A product summary page for each model presents key information about each product using information and documentation supplied by participating device manufacturers and or UK supplier Prices quoted on product summary pages are the supplier s list price During this review period the NHS Purchasing and Supplies Agency PaSA has separately undertaken a contract renewal process for clinical thermometers Informal c
26. 10 gm User information Press on off switch to initiate a self check After L is 2cm displayed place probe tip at the measurement site until reading complete four beeps repeated 8 times Special features Memory of last reading waterproof unit supplied with a plastic storage case Antitheft device No Low battery indicator is displayed Self check on start up Yes Calibration Factory calibration traceable to national standards Thermometer care Cleaning probe tip information not supplied Cleaning body information not supplied Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof 3p each 3 for 100 Battery type LR41 battery 1 5V Battery lite 2000 measurements Maintenance information not supplied Manufacturing standards EN ISO 9001 2000 EN 46002 1996 Manufacturer claims compliance with ISO 12470 3 2000 CE mark Yes Code 0482 Notified Body Medcert Germany Price ex VAT 3 85 Supplier Universal Hospital Supplies Address Unit 6 George House Millmarsh Industrial Estate Enfield AN3 7QJ Telephone 0845 0820182 Fax 0845 0820180 Website www uhs co uk e mail sales uhs co uk Manufacturer Microlife Manufactured in Taiwan 40 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Filac FasTemp Electronic contact thermometer using a thermistor to sense temperature rise and predict final tempera
27. 1296 689900 with IEC 601 1 1985 EN60601 Fax 02023 659694 1 2 2000 ASSTM E1112 00 Website CE mark Yes Code 0050 e mail welchallynuk mail welchallyn com T Manufacturer Welch Allyn Notified Body NSAI Ireland Manufactured in The United States 96 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Thermotek Instant Electronic contact thermometer using a thermistor to sense temperature rise and an algorithm to pre dict final temperature Beeps when temperature reading is displayed intended use Hospital primary care and home Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 165mm x 35mm x 18mm Weight 16gm User information 2 cm Compact user information booklet provided Only use within acceptable ambient conditions Special features Flexible soft tip with thermistor covered by a chromium plated cup pre reading dis play of room temperature denoted by r measurement start is automatic LCD dis play in C or F memory function can store up to 4 temperatures and the measure ment time for up to 64 hours automatic shut off after 1 minute use only within acceptable ambient conditions supplied with a protective cap for the sensor Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration May be tested in a water bath Thermometer care Cleaning probe tip Clean after each measure
28. 2 for 5000 Battery Alkaline 9V battery Battery life 8000 measurements approx Maintenance Daily inspection for damage to the sensor and display Technical serv ice manual and training is available for medical engineers Fixed price manufacturer repair is 95 00 Price ex VAT 400 00 Manufacturing standards SO90001 2000 Manufacturer claims edd compliance with EN60601 1 EN60601 1 Close Ee 2 EN55011 RG22 4BS CE mark Yes Gode 0086 Telephone 01256 388284 Notified Body BSI Product Services Fax 01256 388860 Website www alarismed co uk e mail see website Manufacturer Alaris Medical Systems Manufactured in USA 67 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing LCT 200 Ear Thermometer Infrared detector measures emitted radiation from Inner ear and calculates an ear temperature read i ing Beeps when reading is displayed Intended use Home use Measurement site Ear Patient group All ages especially babies children and elderly Size LWD 150mm X 35mm x 45mm Weight 55 gm User information pum Instructions include advice to straighten ear canal and correct placement of probe Note the highest of three readings in the same ear for critical situations as variations 0 2 0 3 C are to be expected Beep indicates measurement is complete Special features Display backlight for easy reading bleeps when temperature reading completed automatically
29. 2001 EN12470 5 2003 SCR sales actamed co uk CE mark Yes Code 0197 Manufacturer Exergen Corporation Notified Body TUV Rheinland Manufactured in USA 76 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing FS 100 ACORN Infrared detector measures maximum emitted radia tion from the skin surface over the temporal artery P to predict the core body temperature 1 P Intended use Primary care and home use i Measurement site Forehead Patient group Adults children and infants Size LWD 116mm x 36mm x 32mm Weight 50 gm User information Place on centre of forehead skin and move laterally for 3 5 seconds If perspiration on forehead meas ure skin temperature behind ear moving probe upwards Do not use when unit is too hot or cold seg 2 cm Special features Last measurement displayed on initial activation measures 40 times per second to obtain peak value automatically turns off after 1 minute Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Information not supplied Thermometer care Cleaning probe tip Clean with cotton bud soaked in alcohol and leave for 1 hour Cleaning body Wipe with a soft cloth moistened with water or alcohol Storage conditions Information not supplied Maintenance and ongoing costs Disposable covers not required Battery Lithium CR 2032 3V battery Battery lite 6000 measurements app
30. 2032 3V battery Battery lite 1000 measurements approx Maintenance None required except replacement of probe covers Manufacturing standards EN ISO 9001 2000 EN Price ex VAT 25 00 46002 1996 Manufacturer E oe ONE win r wisi m prEN12470 5 2000 Shoreham Road Henfield CE mark Yes Code 0044 West Sussex BN5 9SL Notified Body RWTUV Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 69 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Microlife IR1DE1 Infrared detector measures emitted radiation from the inner ear and converts this into a temperature reading indicated by an audible beep Probe cover not required Intended use Hospital Measurement site Ear B Patient group Adults children and infants Size LWD 153mm x 40mm x 31mm Weight 53 gm User information 2 Instructions include advice to straighten ear canal and correct placement of probe Position probe and press start button Audible beep when reading is displayed Clean probe tip with alcohol to avoid build up of ear wax and avoid cross infection between patients wait 5 minutes to dry Special features Memory of 12 readings last reading displayed for 2 seconds when switched on automatic switch off after 1 minute audible fever alarm when temperature gt 37 5 C audible alarm if read
31. 60 12 81 OV GE WE 295 G x peeyelo4 BLP S O LO u 3g 95001 0 09 gt 6 Ly 96 OF 7 99s G i due13Z3 UI OP 96 OOO e u 00 0 09 gt R SS OF slassodsid lo dd dui913z3 UILU m Oo HO u dd 7600 960 GE 9982 CO l Or LOG duie WE uon oBue Spinooe Oo ebues Do o eDueJ o L 110591 Bugejedo Aeldsip paleis 107 1 5 5 5717 ES EE eIdSIQ pisino Ba p s no 1seuiu ye W9 jueiquiy 1seuDiH ql ALARLAR BAL Koejnooe si Bulpeas s ulp l Ae dsip L S AO1 J BUIUIEM le 1 Aoeunooy pelels s eunjoejnue N Aeldsid o14nje1edujo pue Seino55v s1ojeulounou 62 zeldel 6004 oNins Mf M9SIA9J JOJOWOWISY PT LYO VHHIN 28 MHRA 04144 Thermometer review UK market survey 2005 Chemical 3M Tempa DOT Single Use Thin flexible plastic strip with heat responsive inden tations which turn from orange to blue when they exceed their designated temperature intended use Hospital and primary care n Measurement site Oral and axilla Patient group Adults children and infants b Size LWD 91mm x 9mm Weight 1 gm c User information dip Do not use within 15 minutes of exercise Place the 2 cm sensor dots in the usual oral position or in the axil la with tab parallel with the body so the sensor is surrounded
32. 6004 oNins Mf M9IA9J JOJOWOWISY Pr LYO VHHIN see page 13 for details of the abbreviations used in Table 3 38 MHRA 04144 Thermometer review UK market survey 2005 Electronic monitoring YSI 4000A Dual channel electronic contact thermometer using thermistors embedded within reusable or disposable probes Designed for simultaneous continuous mon itoring at two sites Intended use Hospital especially surgical recovery and ICU Measurement site Range of internal and external probes available Patient group Adults children and infants Size LWD 223mm x 76mm x 115mm Weight 960 gm User information Portable dual channel dual display device for patient temperature monitoring User can independently select HI and LO alarm threshold values An audible alarm can warn users when reading lies outside a pre selected range Take normal precau tions to avoid alternate site injuries if patient is subject to electrosurgery Special features Able to set normal temperature range for each probe self calibration at 37 C opti mises performance at each ambient temperature visual and then audible alarms are activated if temperatures are too Hi or Lo 15 second pulse counter self test pro cedure on start up includes illumination of all segments of the display supplied with carrying pole mounting handle Antitheft device No Low battery indicator LO battery illuminates when 25 hours left Self
33. 7 and ASTM E 825 81 ASTM E 1965 98 Standard specification for infrared thermometers for intermittent determination of patient temperature ASTM International 1998 BS EN 60601 1 Medical electrical equipment Part 1 General requirements for safety BSi 1990 83 MHRA 04144 Thermometer review UK market survey 2005 References 27 28 29 30 BS EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests BSi 2002 BS 691 1987 Subnormal range ovulation and dual scale clinical maximum thermometers mercury in glass solid stem BSi 1987 BS 6985 1989 Dual scale and ovulation clinical maximum thermometers mercury in glass enclosed scale BSi 1989 Medical Device Alert action Infra red Ear Thermometers Home Use MDA 2003 010 Medicines and Healthcare products Regulatory Agency 2003 may be downloaded from www mhra gov uk 84
34. AT 249 49 costs 50 00 Supplier Tyco Healthcare m 2 154 Fareham Road ISO 9002 ISO13485 Manufacturer Gosport PO13 OAS claims compliance with EN60601 Telephone 01329 224114 1 1990 ASTM E1112 86 Fax 01329 224334 CE mark Yes Code 0123 253 7 e mail marketinguk tycohealth com Notilied Body TUV Product Service Manufacturer Tyco Healthcare Kendall Manufactured in USA 65 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing GentleTemp MC 510 E Infrared detector measures emitted radiation from inner ear and uses to predict ear temperature intended use Hospital primary care and home Measurement site Ear Patient group Adults children and infants Size LWD 93mm x 46mm x 57mm Weight 90 gm User information Movement of unit in the ear enables the maximum temperature to be detected Three repeated meas urements warms the device so ten minutes must elapse before further readings Do not use a portable phone near the unit Avoid getting liquid in the unit Special features Two measurement modes fast 1 3 seconds and one for difficult measurement con ditions automatically turns off after 1 minute readings in F or C default supplied with carrying case and a set of probe covers Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Factory calibration traceable to national reference standards Calibr
35. CE mark Yes Code 0044 Shoreham Road Henfield Notified Body RWTUV West Sussex BN5 9SL Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 48 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT1951 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture Audible tone when temperature rise is lt 0 1 C in 8 seconds intended use Hospital primary care and home k Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 145mm x 22mm x 15mm Weight 15 gm User information On off switch at thermometer end During measure sem ment the current temperature is displayed continu ously and a flashing C is displayed Audible tone 10 beeps when temperature rise is 0 1 C in 8 seconds Turn off by pressing the end button briefly Special features Waterproof illuminated display backlight memory for last maximum reading auto matic switch off after 10 minutes non use H or L indicates that the temperature is above or below the measurement range see Table 3 supplied with a push on plastic cover to protect sensor Antitheft device No Low battery indicator V displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Waterb
36. Diverse technologies have been developed to replace the mercury thermometer Many are promoted as being quick and simple to use for the clinical practitioner and painless for the patient However we are aware of the difficulty experienced by users in obtaining accurate reliable and cost effective substitute devices This issue of evaluation provides guidance on relevant procurement issues reviews the alternative technologies available for the intermittent measurement of temperature in the human body summarises products available in the UK based on the manufacturer s documentation A systematic search for suppliers of stand alone thermometers was undertaken in December 2003 which included informal consultation with the NHS PaSA Product information was initially requested from the UK distributors in February 2004 Samples of each thermometer were later obtained for photography During photography a 20mm marker was placed beside each model to provide an indication of size No technical performance tests have been performed on these samples other than measurement of the dimensions and weight including batteries The information we report has been reproduced in a systematic manner from that provided by participating device manufacturers and suppliers Normal temperature The normal body temperature is affected by several factors Temperature has a diurnal variation and is approximately 0 5C higher in the afternoon Temperature al
37. Europe are required to meet the relevant European Union Medical Devices Directive and be labelled with CE marking A classification of medical devices has been established denoting the risk of the device for the patient Class III having the highest risk Differences in their mode of operation and the consequent risk to the patient will alter the appropriate classification for the thermometer More specifically class with a measuring function is usual for mercury in glass and chemical thermometers MHRA 04144 Thermometer review UK market survey 2005 Procurement issues class lla for most electronic and infrared sensing thermometers class llb for continuous surveillance of temperature in anaesthesia intensive care or emergency care The routes to CE marking chosen by most manufacturers were through full quality assurance ie the manufacturer s design and manufacturing process audited and certified by a Notified Body Most have used the general quality system standard such as ISO9001 13 and others comply with additional requirements important for medical device manufacturers as outlined in ISO 13485 14 or ISO 13488 15 Where a manufacturer has taken a structured approach to environmental management they can also seek ISO 14001 registration 16 Notified body This is an organisation authorised by their national Competent Authority In the UK the Competent Authority is the MHRA The same system operates in all EU cou
38. January 2005 MHRA 04144 Thermometer review UK market survey 2005 Department of Health best choice best practice www mhra dov uk nww medical devices nhs uk About MHRA evaluation reports What you can expect The Device Evaluation Service DES aims to provide independent and objective evaluations of medical devices available on the UK market Specialist centres mainly in NHS Trusts do the evaluations under long term contract to and in accordance with protocols approved by the Medicines and Healthcare products Regulatory Agency MHRA The evaluations are usually of a unit supplied by the manufacturer We would expect this unit to be representative of the product on the market but cannot guarantee this Prospective purchasers should satisfy themselves with respect to any modifications that might be made to the product type after MHRAS evaluation The reports are intended to supplement not replace information already available to prospective purchasers The MHRA DES does not have access to any information held by the Agency in its capacity as the Competent Authority for the UK apart from any information already in the public domain The reports will contain data given by the manufacturer on the regulatory status of their devices but apart from this they are not an indicator of the regulatory status of a product Occasionally DES refers products to the regulatory arm of the MHRA for considerations of breaches of the le
39. MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing thermometers ASTM E 1965 98 25 which requires the laboratory error to be better than 0 2 C in the range 37 39 C and over the ambient range 16 C to 40 C unless otherwise specified by the manufacturer Both standards require the manufacturer to verify clinical repeatability in a representative group of patients by comparing their results with a reference thermometer in another site EN 12470 5 specifies the patient group should comprise at least 100 patients covering the intended age range at least 30 being febrile These clinical tests may legitimately exclude patients on medications known to affect body temperature eg antipyretics barbiturates thyroid preparations and antipsychotics or recently immunised Currently no specific international standards have been published for infrared forehead thermometers which are new innovations but ASTM 1965 98 25 includes testing procedures for skin thermometers which some manufacturers may consider applicable to their product Manufacturer s advice on clinical use The key issues covered in the user instructions for infrared ear thermometers are Check the ear canal is clean dry and normal in appearance and is not obstructed or containing vernix inflammation blood or excessive earwax Note the general angle of the ear canal Ensuring the thermometer lens is clean and covered with a new intact probe cov
40. Oo HO Oo 0 LT 3 40 98 OV S y ce OF 001 81 5 o 99S ey cE Oo HO dd 08 01 S o dV dt GOT I91S 10604 99S 001 O V0 OOI 3 30 p leis jou OF G ce ey c 07 LIA LHI OHIOON 998 00L Oo HO Oo 0 E 3 40 p le15 10u Or OL eo GV 66 GOT Lya HI ae S HEA 06 Oo HO Oo 0 J9 96 0 OF l 6t 96 OF 2 02 11 002 1 7 m oso e cr Sc Oo HO Uo OT 49 06 SL cct t Sl LY 8 S OF 3109 OVAI 999 eo y Vt Oo HO dd 08 0 OV 01 eo dV Vt OF dwa hU D E ME ven A Emus dial ier O 098 2 991 IO JE UF do 7oG6 GC OGL SP 951 GOT IUS 1 15414 999 Gov Oc Oo HO Oo OT e 40 7096 SI OV 01 dy 996 GOT ueosouloeu uneJg Ds eBuei uonnjose sBue amp Koeinooe Oo Bueu Do O Ke dsiq Ke jdsiq Bumeiado fejdsip peres gone oj aBuei Koeinooe 25 r p s no episino s 1seyubiy 18 l JUSIQUIYY 189 d r Koejnooe Duipeei y Aeyds p 191898ulouusu L 15940 BuiuJeM le eJv 1seuDiu Aoeunooy paS s eJnjoejnue y 5 Aeyds q aimieieduie pue Aoeinooy si91 uuouui 9u 1eo Duisues pojejjul p QEL 6004 oNins JOMICW Mf M9SIA9J Jo euloulJ9U PE LYO VHHIN 63 MHRA 04144 Thermometer review UK mark
41. Tam 7757 Address 9 13 Oakley Hay Lodge CE mark Yes Code 0434 Great Folds Road Oakley Notified Body DNV Norvvay Hay Business Park Northants NN18 9AS Telephone 0870 909 7400 Fax 0870 909 7500 Website www proactmedical co uk e mail sales proactmedical co uk Manufacturer MSR Manufactured in Taiwan 52 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Proact ST8336 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture reading Intended use Hospital community and home Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 125mm x 19mm x 11mm Weight 11 4 gm User information Press on off switch to display last reading and initi 2 cm ate a self check When L is displayed place probe tip at the measurement site until reading complete four beeps Switch off to conserve battery Clean before and after each patient measurement Factory set display units either F or C Special features Fixed or flexible probe tip versions available memory of last reading audible fever alarm when measured temperature gt 37 5 C auto shutdown after 10 minutes non use waterproof unit supplied with a plastic storage case Antitheft device No Low battery indicator Triangle symbol displayed Self check on start up Yes Calibration Factory calibtration Thermometer care Cleaning probe tip Cle
42. Thuringen Office for Merton LONDON Measurement and Calibration SW19 3UU Germany Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer Geratherm Manufactured in Germany 58 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing thermometers How they measure temperature An infrared IR thermometer contains an optical sensor usually a thermopile which can detect the infrared emissions from any hot object The magnitude and spectrum of infrared energy emitted depends on internal temperature of the body temperature of the thermometer which is also radiating IR energy emissivity which describes the efficiency of the surface for radiating electromagnetic radiation and is a dimensionless number between 0 smooth shiny surface and 1 dark rough surface e filtering effect of optical components including the probe cover Infrared ear thermometers are designed to sense the temperature of the tympanic membrane within the ear The measured temperature is an average across the visualised area The field of view may encompass adjacent ear structures approximately 2 C cooler than the tympanic membrane typically 37 3 C An instrumentation offset is usually applied which incorporates information about the thermometer s temperature and filtering effect of the optical components Some devices also try to correct for the effect of averaging making assumpti
43. able Battery type 563 silver oxide battery 1 55V Battery life 200 hours or 18 months Maintenance no maintenance required Manufacturing standards I509001 2000 EN ISO 13488 2000 Price ex VAT 4 00 Manufacturer claims compliance with EN60601 1 1990 EN60601 1 2 1992 Supplier Proact Medical Lid EN 12470 3 1998 Address m Oakley Hay Lodge reat Folds Road Oakley CE mark Yes Code 0434 Hay Business Park Notified Body DNV Norway Northants NN18 9AS Telephone 08 0 909 7400 Fax 0870 909 7500 Website www proactmedical co uk e mail sales proactmedical co uk Manufacturer MSR Manufactured in Taiwan 55 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact SureTemp Plus Electronic contact thermometer using a thermistor to sense temperature Predict mode default esti mates final temperature for one of four body sites in approximately 4 15 seconds depending on specif ic body site Monitor mode snail icon needs 3 to 5 minutes for an accurate reading intended use Hospital and primary care Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 215mm x 81mm x 62mm Weight 35 gm 2 cm User information Detailed user manual provided Many different options are available to the user User must become familiar with the device and user manual Stated accuracy in monitor mode only Special features Liquid crystal illuminated display separate pro
44. accordance with local waste management policies Re calibration Measurement accuracy should be checked regularly and especially if the device has been dropped or subjected to extremes of temperature or humidity Some manufacturers of electronic contact thermometers recommend that professional users arrange for a periodic technical inspection for accuracy but frequently no instructions were provided in the information supplied Waterproof electronic contact reusable chemical and mercury in glass thermometers may all be immersed in a well controlled water bath so the reading can be accurately calibrated ie compared with a thermometer traceable to national standards for a range of temperatures A local medical physics clinical engineering department a certified test house or the manufacturer may be able to provide this service Some manufacturers sell specific electronic devices for checking thermometer accuracy which are designed for use by local medical technologists A few of these devices will have been checked against thermometers traceable to national standards and so may require recalibration at regular intervals by the manufacturer MHRA 04144 Thermometer review UK market survey 2005 Procurement issues Some manufacturers recommend recalibration at their premises and others offer no advice at all Recently the UK National Physical Laboratory has developed a calibration device suitable for infrared sensing thermometers which is
45. an and China 42 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact IVAC Temp Plus II Electronic contact thermometer using a thermistor to sense temperature rise and predict the final reading Indicated by an audible beep Monitor mode also provided Intended use Hospital and primary care Measurement site Oral axilla monitor only amp rectal Patient group Adults children and infants Size LWD 175mm x 73mm x 57mm Weight 341 gm User information Detailed user manual includes advice on probe positioning Special features Liquid crystal illuminated display separate holders for oral and rectal probes loading probe starts measurement rotating pinwheel icon indicates good tissue contact pulse timer 15 30 and 60 seconds push button probe removal recalls last read ing stated accuracy applies in monitor mode not the predictive default mode sup plied with probe cover dispenser set of covers and wall mounting home base Antitheft device Home base system Regular return is needed for continued usage Low battery indicator Battery Low display then Replace battery Self check on start up Yes Calibration Factory calibration uses ALARIS probe simulator Re calibration is advised using a water bath or electronic probe simulator 6 display readings obtain able from the manufacturer Thermometer care Cleaning probe tip See cleaning body Cleaning body Clean instrument surface with 1096
46. an with soapy water It can be submerged but not soaked Do not clean with alcohol Cleaning body As for probe tip Storage conditions Ideally store inside original packaging when not in use Store at room temperature or less Maintenance and ongoing costs Disposable covers no covers available Battery type SG3 silver oxide battery 1 55V Battery life 200 hours or 18 months Maintenance No maintenance required Manufacturing standards EN ISO 13485 2003 Manufacturer Price ex VAT 3 00 claims compliance with EN60601 Supplier Proact Medical Ltd Address 9 13 Oakley Hay Lodge 12470 3 1998 Great Folds Road Oakley CE mark Yes Code 0434 Hay Business Park Notified Body DNV Norvvay Northants NN18 9AS Telephone 0870 909 7400 Fax 0870 909 7500 VVebsite www proactmedical co uk e mail sales proactmedical co uk Manufacturer MSR Manufactured in Taiwan 53 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Proact ST871 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture reading Intended use Hospital community and home Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 135mm x 24mm x 13mm Weight 13 gm User information Press on off switch to display last reading and initi 2cm ate a self check When L is displayed place probe tip at the measurement site until r
47. ath calibration check is possible do not exceed 60 C Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours then wipe with a moist towel Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery IEC type SR41 silver oxide high drain 1 55V Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Manufacturing standards Price ex VAT 5 06 4 777v 7 Supplier Microlife Healih Management 46002 1 996 Manufacturer Address Units 6 amp 7 Henfield Business Park claims compliance with Shoreham Road Henfield prEN12470 3 1997 West Sussex BN5 9SL CE mark Yes Code 0044 Telephone 01273 494401 Notified Body RWTUV Fax Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 49 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT1961 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture Audible tone when temperature rise is lt 0 1 C in 8 seconds Intended use Hospital primary care and home Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 145mm x 26mm x 20mm We
48. atient disturbance hypoallergenic and non toxic easy to read Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory quality assurance check from each batch in accordance with BS EN ISO 9001 2000 Thermometer care Cleaning probe tip not applicable Cleaning body Patient bathing is tolerated Storage conditions 5 year expiry date from date of manufacture printed on wrap per Store in dry conditions Carefully controlled environment not required Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards BS EN ISO 9001 2000 Manufacturer Price ex VAT 70 pence 70 per 100 claims compliance with ASTM E1299 96 775 EE Eo CE mark Yes Code 0086 kn Tere LONI Notified Body BSI Product Services SVV19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer Medical Indicators Manufactured in USA 31 MHRA 04144 Thermometer review UK market survey 2005 Chemical Forehead Thermometer Reusable plastic strip comprising a liquid crystal dis play and scale markings for fever assessment when placed on the skin Zone showing green colour indi cates the temperature intended use Hospital and home use Measurement site Forehead Patient group Adults children and infants
49. ation recommended annually when used professionally Testing equipment MC 510MS is available for purchase Thermometer care Cleaning probe tip Wipe lightly with a soft dry cloth or cotton swab then attach a probe cover and store in storage case Cleaning body Wipe with a soft dry cloth Storage conditions 20 C to 60 C 30 to 95 RH Maintenance and ongoing costs Disposable covers required 21p each 4 21 for 20 Battery Lithium CR2032 3V battery Battery life 5000 measurements approx Maintenance User manual contains a basic fault finding procedure Supplier pro vides an as required repair and maintenance service Faulty units must be returned to the supplier Turn around is typically 7 days Manufacturing standards ISO9001 2000 EN ISO d 19488 2000 Manufacturer Supplier Omron Healthcare UK Ltd claims compliance with Address Opal Drive Fox Milne ASTM E 1965 98 EN12470 Milton Keynes MK15 ODG 5 2003 Telephone 01908 258 285 CE mark Yes Code 0197 u 5 5 n ebsite omron healthcare com Notified Body TUV e mail info omronhealthcare uk eu omron com Rheinland Manufacturer Microlife AG Manufactured in Taiwan and China 66 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing IVAC Core Check Infrared detector measures emitted radiation from Inner ear and calculates ear temperature reading intended use Hospital and primary care 3 Measurement site Ear Patient gro
50. attery symbol flashes Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip clean with swab moistened with 7096 isopropyl solution Cleaning body clean with swab moistened with 7096 isopropyl solution Storage conditions 20 C to 50 C Maintenance and ongoing costs Disposable covers No probe cover Battery Lithium CR 2032 3V battery Battery life 1000 measurements approx Maintenance None required Manufacturing standards EN ISO 9001 2000 EN 46002 1996 No information supplied on compliance with international standards CE mark Yes Code 0044 Price ex VAT 25 00 Notified Body RWTUV Supplier Microlife Health Management Address Units 6 amp 7 Henfield Business Park Shoreham Road Henfield West Sussex BN5 9SL Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 78 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Thermofocus Non contact infrared detector measures emitted radiation to predict the oral or rectal temperature Correct distance 3cm from the forehead is indicat ed by optical aiming lights intended use Hospital primary care and home Measurement site Forehead e m pF Patient group Adults children and infants danan Size LVVD 165mm x 40mm x 20mm Weight 99 gms U
51. ature is displayed Keep the lens clean Special features Automatically shuts down after 30 seconds of non use error messages when elec tromagnetic interference is detected copper shielding can protect the electronics from most high electromagnetic sources found in a hospital pulse timer Antitheft device Physical restraints available for purchase Low battery indicator Battery icon is displayed flashing Self check on start up Yes Calibration Calibration uses thermometers traceable to national standards Certificate is provided with the new unit following any recalibration Accuracy can be checked using a portable black body master available from the company 495 Manufacturer can perform re calibration of thermometer and master Thermometer care Cleaning probe tip Wipe down with alcohol or any hospital approved disinfectant Do not immerse Cleaning body Device is suitable for ethylene oxide gas or gas plasma sterilisation Storage conditions 20 C to 50 C Maintenance and ongoing costs Disposable covers optional caps 5p 50 for 1000 sheaths 14p 35 for 250 probe wraps 2 8p each Battery Alkaline 9V battery Battery lite 15000 measurements Price ex VAT 375 00 Maintenance Repairs during 6 year war ranty period are free of charge Pe 2000 Way Manufacturing standards Wakefield WF2 7AW EN 46003 1999 Manufacturer claims Telephone 01924 200550 compliance with EN 60601 1 1990 n AEE EN60601 1 2
52. be red required for rectal readings pulse timer last temperature recall in predictive mode indicator of poor tissue con tact heater warms probe before applying to patient displays last reading on switch on four different sites can be selected Biotech mode controls programmable options not waterproof not suitable for use with flammable anaesthetics Antitheft device Three security options available Low battery indicator Battery symbol continually indicates voltage level Self check on start up Yes Calibration Calibration in factory using reference thermometer traceable to national standards Recalibration every 6 months is advised at two temperatures using Model 9600 calibration tester available from the manufacturer Thermometer care Cleaning probe tip As needed clean the thermometer and probe with 7096 isopropyl alcohol solution 1096 chlorine bleach solution or a non staining disinfectant Cleaning body Wipe with damp cloth warm water or mild detergent solution Storage conditions 25 C to 55 C 15 to 95 RH Maintenance and ongoing costs Disposable covers required 2 75p each 27 50 per 1000 Battery Alkaline AA size x8 4 5V Battery life 5000 measurements Maintenance Checks every six Price ex VAT 150 00 months are recommended Supplier Welch Allyn UK Ltd Manufacturing standards Address Cublington Road Aston ISO 9002 1994 EN ISO 13485 U J 22 4 Manufacturer claims compliance Telephone 0
53. behind ear C Patient group Adults children and infants Size LWD 178mm x 45mm x 32mm Weight 120 gm User information pem Place probe on the skin centrally in the forehead depress button and slowly move laterally the hair line Then lift the probe and touch on the neck moving the probe upwards just behind the ear lobe and release the button to read the temperature Core arterial body temperature is displayed if the temperature is between 34 5 C to 42 C Outside this range the skin surface temperature is displayed Keep the lens clean Special features Automatically shuts down after 30 seconds of non use error meassages when elec tromagnetic interference is detected error messages when target temperature is lt 42 C or gt 15 5 C Antitheft device No Low battery indicator Battery icon is displayed flashing Self check on start up Yes Calibration Calibration uses thermometers traceable to national standards Certificate is provided with the new unit Accuracy can be checked using a portable black body available from the company costing 230 which operates at two tem peratures 86 C and 40 C Thermometer care Cleaning probe tio Wipe with alcohol prep or swab moistened with alcohol or water Cleaning body Wipe with disinfectant alcohol or bleach solutions Prevent liquids from entering the sensor area Do not immerse Storage conditions 20 C to 50 C Maintenance and ongoing costs Disposabl
54. ble In predictive mode they can produce temperature readings in a matter of seconds Predictive mode samples the temperature rise of the sensor at regular intervals and uses a mathematical algorithm based on experimental data to predict the eventual steady state temperature Some models also offer a monitor mode which continually updates the temperature reading of the sensor These may default to monitor mode if the ambient temperature is too cool or hot as predictive mode is prone to greater errors under these conditions The international standard covering these devices is BS EN 12470 part 3 19 published 5 years ago In this standard the maximum permitted laboratory error is 0 1 C for the operating temperature range of at least 35 5 C to 42 C when working in monitor mode Many of these thermometers were designed earlier than this date and a few manufacturers state compliance with ASTM E 1112 24 which only requires the maximum laboratory error to be 0 1 C between 37 C to 39 C Clinical accuracy may be poorer than these figures when the thermometer is used in predictive mode especially if the ambient temperature or temperature of the thermometer is outside the manufacturer s specified range eg after storage in a cold car boot Manufacturer s advice on clinical use The key issues covered in the user instructions for continuous temperature monitoring and compact electronic thermometers are Ensure the self check on start up is er
55. ble 3 sup plied with plastic storage case Antitheft device No Low battery indicator V symbol displayed Self check on start up Yes Calibration Factory calibration traceable to national reference standards Verify accu racy in an authorised laboratory at least every two years Thermometer care Cleaning probe tip For home use wipe with damp cloth water or alcohol For profes sional use immerse in 70 isopropyl alcohol 95 dilution gigasept FF 5 dilution lysoforium 3000 69 dilution or aseptisol 496 dilution for up to 24 hours Cleaning body As for probe tip Storage conditions 10 C to 60 C 10 to 95 RH Maintenance and ongoing costs Disposable covers not required waterproof Available at 21p each 4 21 for 20 Battery IEC type SR41 silver oxide high drain 1 55V Battery life 200 hours usage Maintenance Uneconomical to repair Manufacturer will replace if a fault occurs dur ing 2 year warranty period Manufacturing standards 509001 2000 EN ISO Price ex VAT 8 95 13488 2000 Manufacturer isi T ith EN Supplier Omron Healthcare UK Ltd vo Address Opal Drive Fix Milne 60601 1 1998 prEN12470 Milton Keynes MK15 0DG 3 1997 EN60601 1 2 EN Telephone 01908 258 285 980 EN 1041 EN 1441 Fax 01908 258 286 GE mark Yes Code 0197 Website www omron healthcare com Notified Bodv TUV e mail info omronhealthcare uk eu omron com p Manufacturer Microlife AG Rheinland Manufactured in Taiw
56. check When L is displayed place probe 23 tip at the measurement site until reading completed four beeps repeated 10 times Turn off by pressing the end button briefly Replace thermometer when ERR is displayed Special features Waterproof memory for last maximum reading automatic switch off after 10 minutes non use self test includes a check for ambient temperature lt 32 C and displays L to indicate that measurement can proceed a reading of H or L indicates that the temperature is above or below the measurement range see Table 3 Antitheft device No Low battery indicator V displayed Self check on start up Yes Calibration Factory calibration traceable to national standards Waterbath calibration check is possible do not exceed 60 C Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours then wipe with a moist towel Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery IEC type SR41 silver oxide high drain 1 55V Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Manufacturing standards Price ex VAT 3 36 EN ISO 9001 2000 EN 46002 1996 Manufacturer Supplier Microlife Health Management i i Address Units 6 amp 7 Henfi
57. chlorine bleach solution 396 hydrogen peroxide cidex betadine or a mild detergent in warm water Apply with dampened sponge brush or cloth and wipe dry with a clean cloth towel Storage conditions 31 C to 60 C 5 95 RH Maintenance and ongoing costs Disposable covers required 4 7p each 237 38 for 5000 Battery Alkaline AA size x3 4 5V Battery life 1 year Maintenance Daily inspection for damage Annual preventative maintenance rec ommended Service manual and train price ex VAT 400 00 ing for medical engineers is available Supplier Alaris n standards Address The Crescent Jays Close 9001 2000 Manufacturer claims com Basingstoke Hampshire pliance with EN 601 1 1977 EN RG22 4BS 55011 1991 EN60601 1 2 1993 Telephone 01256 388284 CE mark Yes Code 0526 de N id Notified Body British Standards e mail see website Institute Manufacturer Alaris Medical Systems Inc Manufactured in USA 43 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT1671 Electronic contact thermometer using a thermistor to continually monitor the temperature Audible tone when temperature rise is 0 1 C in 16 seconds intended use Hospital and home Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 120mm x 16mm x 10mm Weight agm User information Press On off switch to display last reading and initi ate a self
58. cturer claims compliance Henfield Business Park with prEN12470 3 1997 Shoreham Road Henfield CE mark Yes Code 0044 West Sussex BN5 9SL Notified Body RWTUV Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 46 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT1921 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture Audible tone when temperature rise is lt 0 1 C in 8 seconds Intended use Hospital primary care and home Measurement site Oral and axilla Patient group Adults children and infants Size LWD 130mm x 18mm x 10mm Weight 10 gm User information 2 cm On off switch at thermometer end During measure m ment the current temperature is displayed continu ously and a flashing C is displayed Audible tone 10 beeps when temperature rise is gt 0 1 C in 8 seconds Turn off by pressing the on off button again Replace ther mometer when ERR is displayed Special features Flexible probe tip waterproof illuminated display backlight memory for last maxi mum reading automatic switch off after 10 minutes non use H or L indicates that the temperature is above or below the measurement range see Table 3 supplied with a plastic storage case Antitheft device No Low battery indicator V
59. cturing standards ISO 9001 2000 ISO 13481 5 2003 BS EN 13485 2003 Manufacturer claims com pliance with BS691 CE mark Yes Code 0197 Notified Body TUV Rheinland Price ex VAT 80 pence Supplier Universal Hospital Supplies Address Unit 6 George House Millmarsh Industrial Estate Enfield AN3 7QJ Telephone 0845 082 0182 Fax 0845 082 0180 Website sales uhs co uk e mail www uhs co uk Manufacturer Universal Hospital Supplies Manufactured in China 19 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass UHS UN5081 dual scale Mercury in glass thermometer with a peak hold maximum device for measuring temperature in both Centigrade Celsius and Fahrenheit scales Intended use Hospital community and home use Measurement site Oral and axilla Patient group Adults children and infants axilla Size LWD 105mm x 6mm x 5mm Weight 6gm User information Shake thermometer well to ensure all mercury has returned to the bulb Care should be taken to avoid breakage especially within the mouth Special features Protective plastic case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration information not supplied Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not requir
60. d Battery lite 5000 measurements approx Maintenance Annual calibration check 5 00 per unit VAT p amp p Manufacturing standards EN ISO 13485 2003 Manufacturer Price ex VAT 20 38 claims compliance with EN60601 1 1990 EN60601 1 2 1992 EN Supplier PROACT Medical Ltd Address 9 13 Oakley Hay Lodge 12470 5 2000 Great Folds Road Oakley CE mark Yes Code 0434 Hay Business Park Notified Body DNV Norvvay Northants NN18 9AS Telephone 0870 909 7400 Fax 0870 909 7500 VVebsite www proactmedical co uk e mail sales proactmedical co uk Manufacturer MSR Manufactured in Taiwan 71 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing TB 100 Thermo Buddy Infrared detector samples maximum emitted radia tion from ear to predict ear temperature Other I objects can be measured Intended use Primary care and home use Measurement site Ear and surface temperature of a range of objects bath feed etc Patient group Adults children and infants Size LWD 160mm x 41mm x 30mm Weight 68 gm User information Normal temperature range information provided Repeat reading three times for infants lt 90 days and children 3 years with abnormal temperature readings Do not use near fire Special features Last measurement displayed on initial activation measures 12 times per second to obtain peak value night light illumination memory function can store up to 8 temper atures au
61. displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours see data sheet for other cleaners Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery IEC type SR41 silver oxide high drain 1 55V Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Price ex VAT 5 91 Manufacturing standards EN ISO 9001 2000 EN Supplier Microlife Health Management 46002 1996 Manufacturer claims Address hs E m mpliance with prEN12470 3 1997 ucunu P wir I i d x Shoreham Road Henfield ed TED one West Sussex BN5 9SL Notified Body RWTUV Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 47 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT1931 Gold Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture Audible tone when temperature rise is lt 0 1 C in 8 seconds intended use Hospital primary care and home Measurement site Oral axilla and rectal Patient gro
62. dress Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816600 Fax 01946 816625 Website www brannan co uk e mail sales brannan co uk Manufacturer Manufactured in 16 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Brannan solid stem 11 455 2 Mercury in glass thermometer with a peak hold maximum device for measuring temperature under all circumstances Intended use Hospital community and home use Measurement site Axilla Patient group All ages except young children Size LWD 120mm x 6mm x 5mm Weight 4 gm User information Shake thermometer well to ensure all mercury has returned to the bulb Care should be taken to avoid breakage 2 cm Special features Protective case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of batch samples tested for accuracy using method stated in BS691 40 1 0 15 C Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO9001 2000 Manufacturer claims compliance to BS691 CE mark Yes Code 0088 Notified Body LRQA Coventry UK Price ex VAT
63. e covers optional caps 3 5p each 175 for 5000 sheaths 14p 35 for 250 Battery Alkaline 9V battery Battery life 7500 measurements Price ex VAT 95 00 Maintenance Repairs during 3 year Susa Ar warranty period are free of charge 7 Calder Island Way Manufacturing standards EN 46003 1999 Manufacturer claims l 01924 200518 compliance with EN60601 1 1990 Website www actamed co uk 1 2 2001 EN12470 5 2003 e mail sales actamed co uk n Yes Code 0197 Manufacturer Exergen w Body TUV Rheinland Manufactured in USA 5 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Exergen Temporal Scanner 5000 Infrared detector measures maximum emitted radia tion from skin over a superficial artery and predicts core arterial temperature Each click emitted indi cates a rise in the maximum reading Intended use Hospital community Measurement site Forehead and behind the ear Patient group Adults children and infants Size LWD 200mm x 50mm x 30mm Weight 235 gm User information 2 cm Place probe on the skin centrally in the forehead depress button and slowly move laterally to the hair line Then lift the probe and touch on the neck moving the probe upwards just behind the ear lobe and release the button to read the temperature Core arterial body temperature is displayed if the temperature is between 34 5 C to 42 C Outside this range the skin surface temper
64. e like a traditional mercury ther 2 cm mometer but achieves equilibrium more rapidly Remove the tab after 1 3 minutes and read imme diately Last black dot indicates temperature reading Special features Reusable as display is reset after 30 seconds at room temperature with proper stor age can be reused during the course of an illness for a single patient mercury free supplied in a plastic storage box Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of samples from each batch to 0 2 C using ther mometers traceable to national reference standards Thermometer care Cleaning probe tip Wipe with luke warm water or light disinfectant Wipe dry before storing in case Cleaning body As for probe tip Storage conditions Shelf life 5 years Keep out of heat and direct sunlight Maintenance and ongoing costs Disposable covers not applicable Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards BS EN ISO 9001 2000 Manufacturer claims compliance with ASTM E1299 96 CE mark Yes Code CE 0088 Notified Body LRQA Coventry UK Price ex VAT 1 27 per pack Supplier S Brannan amp Sons Ltd Address Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816625 Fax 01946 816625 Website www brannan co uk e mail sales brannan co uk Manufacturer Medical Indicators
65. e of mercury in glass thermometers is extensive and based on laboratory accuracy of mercury in glass thermometers supported by factory calibration referenced to national standards well established clinical measurement protocols embedded within nurse training for decades MHRA 04144 Thermometer review UK market survey 2005 Procurement issues Some of the newer technologies have been the subject of independent comparative clinical trials with more established measurement methods Assessment of the pooled mean difference between measurements and the 95 per cent levels of agreement is more informative than the correlation coefficient as it can distinguish between bias in the results and random error respectively 9 This data provides a better indication of the reliability and repeatability of readings in clinical practice oeveral factors can reduce accuracy and increase measurement errors The most common is incorrect sensor placement Another is local environmental conditions being outside ambient temperature and humidity range stated by the manufacturer see comparison tables Some thermometers check the ambient temperature and produce an error message or prevent measurement if these conditions are not met Time to reading opeed of measurement is often quoted in manufacturing literature and is reproduced in the comparative tables However of greater practical value is the total time required to measure and record a reading f
66. eading complete four beeps Switch off to conserve battery Clean before and after each patient measurement Special features Memory of last reading audible fever alarm when measured temperature gt 37 5 C auto shutdown after 10 minutes non use user selectable display units F or C waterproof unit supplied with a plastic storage case Antitheft device No Low battery indicator Continuous full flashing screen display Self check on start up Yes Calibration Factory calibration Thermometer care Cleaning probe tip Wipe with swab moistened with a soapy solution but do not soak Do not clean with alcohol Cleaning body As for probe tip Storage conditions Ideally store inside original packaging when not in use Store at room temperatue or less Maintenance and ongoing costs Disposable covers no covers available Battery type 563 silver oxide battery 1 55V Battery life 200 hours or 18 months Maintenance no maintenance required Manufacturing standards ISO9001 2000 EN ISO 13488 2000 Price ex VAT 3 50 Manufacturer claims compliance with EN60601 1 1990 EN60601 1 2 1992 Supplier Proact Medical Ltd EN 12470 3 1998 Address d Oakley Hay Lodge reat Folds Road Oakley CE mark Yes Code 0434 Hay Business Park Notified Body DNV Norway Northants NN18 9AS Telephone 0870 909 7400 Fax 0870 909 7500 Website www proactmedical co uk e mail sales proactmedical co uk Manufacturer MSR Manufactured in Taiwan
67. ear is required Three beeps and DONE is displayed when measurement is complete e Special features Tympanic mode predicts the temperature reading at one of three sites oral rectal or core or a direct reading CAL medical technologists can adjust the default site surface mode continually updates the reading for skin assessment extended range with 0 3 C accuracy 15 second TIMER mode storage case available for pur chase supplied with a thermometer holder incorporating a probe cover dispenser Antitheft device No Low battery indicator Yes two stage warning battery icon Self check on start up Yes Calibration Factory calibration of each unit uses reference thermometers traceable to national standards Recalibration after potential damage and every six months is recommended A user calibration system Genius calibrator 3000PC is available for purchase and use by medical technologists Thermometer care Cleaning probe tip Wipe using isopropanol on a cotton bud dry with lint free soft cloth and dry for 45 minutes Cleaning body Wipe with mild detergent or bleach 10 solution Dry for 45 mins Storage conditions 20 C to 50 C Maintenance and ongoing costs Disposable covers required 4 7p each 59 24 for 1260 Battery Alkaline 9V battery Battery life 5 000 measurements approx Maintenance Six month checks are recommended Full refurbishment and calibra tion outside 3 year warranty period price ex V
68. ed waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 ISO 13481 5 2003 BS EN 13485 2003 Manufacturer claims com pliance with BS691 GE mark Yes Gode 0197 Notified Body TUV Rheinland Price ex VAT Supplier Address Telephone Fax Website e mail Manufacturer Manufactured in 20 80 pence Universal Hospital Supplies Unit 6 George House Millmarsh Industrial Estate Enfield AN3 7QJ 0845 082 0182 0845 082 0180 sales uhs co uk www uhs co uk Universal Hospital Supplies China MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass UHS UN509 subnormal Mercury in glass thermometer with a peak hold maximum device for measuring temperature under all circumstances i Intended use Hospital community and home use Measurement site Oral axilla and rectal Patient group Adults children and infants axilla Size LWD 105mm x 6mm x 5mm Weight 2 gm User information Shake thermometer well to ensure all mercury has 2cm returned to the bulb Care should be taken to avoid breakage especially within the mouth or rectum Special features Protective plastic case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration information not supplied Thermometer care Cleaning probe tip Wipe with light disinfectant pri
69. eld Business Park claims compliance with Shoreham Road Henfield prEN12470 3 1997 West Sussex BN5 9SL CE mark Yes Code 0044 Telephone 01273 494401 Notified Body RWTUV Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 44 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT16F1 Electronic contact thermometer using a thermistor to continually monitor the temperature Audible tone when temperature rise is 0 1 C in 16 seconds intended use Hospital community and home use S Measurement site Oral axilla and rectal B Patient group Adults children and infants Size LWD 128mm x 20mm x 13mm Weight agm User information Press on off switch to display last reading and initi 2 cm ate a self check When L is displayed place probe tip at the measurement site until reading completed four beeps repeated 10 times Turn off by pressing the on off button again Special features Memory for last maximum reading automatic switch off after 10 minutes non use supplied with a plastic storage case self test includes a check for ambient tempera ture lt 32 C and displays L to indicate that measurement can proceed a reading of H or L indicates that the temperature is above or below the measurement range see Table 3 Antitheft device No Low battery indicator V displayed Self check on sta
70. er if required Only use the probe cover recommended by the manufacturer e Straighten the ear canal giving a clear view of the eardrum and position the thermometer head so the sensor will be directed at the tympanic membrane and not cooler ear structures For children 1 year the ear lobe should be pulled straight back For older patients pull the ear lobe up and back Incorrect placing can give falsely low temperature readings 30 Failing to seal the ear canal opening may result in a lower reading Do not use excessive force to insert the probe into the ear as this may injure the ear canal or ear drum The patient should not exercise or talk during temperature taking Do not measure in the ear which has just been lying on a pillow or mattress Do not take a patient reading within 30 minutes of a bath shower or swimming Always wait two minutes before repeating a measurement in the same ear 60 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing thermometers Always compare measurements from the same ear Using the maximum of three repeated measurements is recommended for infants less than 100 days old children under three years with compromised immune system and when the user is learning to use the thermometer The key issues important for forehead and skin thermometers are Do not use on a perspiring forehead or if covered with makeup etc The presence of oils and perspiration o
71. et survey 2005 Infrared sensing Braun Thermoscan Pro Infrared detector measures emitted radiation from the inner ear and predicts ear temperature Intended use Hospital and primary care Measurement site Ear Patient group Adults children and infants Size LWD 155mm x 35mm x 45mm Weight 120 gm User information Detailed user manual provided Information on range for normal temperature readings is supplied for site and patient age group Special features Displays last reading on switch on switch off after 1 minute of non use error when probe cover is absent flashing POS is displayed if detector cannot find a tempera ture equilibrium within the ear light display changes from flashing to continuous when reading is completed Err is displayed if ambient temperature is gt 40 C or lt 10 C or fluctuating repeat after thermometer remains in room temperature for 30 minutes immune to most electromagnetic fields supplied with a set of 20 probe cov ers and thermometer stand for storing the covers Antitheft device Optional as part of a recharging base station Low battery indicator Battery symbol C symbol and displayed The thermome ter will still operate correctly Self check on start up Yes Calibration Calibration in factory using reference thermometers traceable to national standards Accuracy can be verified using their special calibration tester Thermometer care Cleaning probe tip Gently
72. gislation governing medical devices DES plays no further part in any regulatory investigation that ensues and does not have advance notification of any regulatory action that may follow How to obtain MHRA reports To order evaluation reports a copy of the publications catalogue or to sign up for our e mail alert service contact MHRA Orders Department Room 1207 Hannibal House Elephant amp Castle London SE1 6TQ Tel 020 7972 8181 Fax 020 7972 8105 E mail des mhra gsi gov uk Visit www mhra gov uk for a comprehensive list of publications details of forthcoming evaluations services and contacts Colour reports Full colour versions of all reports published after 2002 are available from the NHSNet at nww medical devices nhs uk Thermometer review UK market survey 2005 Dr Diane Crawford Norma Greene amp Dr Stephanie Wentworth CEDAR Clinical Engineering Device Assessment and Reporting 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 2005 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
73. heck if ambient temperature is less than 28 C When Lo is displayed and C is flashing place in the correct measurement position brief guidance provided until an audible beep indicates the thermometer is ready for reading Press on off switch briefly to turn off the thermometer after use To briefly display the last temperature reading start by pressing the on off switch for more than 3 seconds 2 cm Special features Waterproof last measurement memory automatic turn off after 8 minutes supplied with plastic storage case Antitheft device No Low battery indicator symbol appears in lower right of display Self check on start up Yes Calibration Batch samples are calibrated using reference thermometers traceable to national standards Manufacturer recommends user verifies accuracy every 2 years Thermometer care Cleaning probe tip Use either alcohol swab or wash with soapy water and dry Alternatively immerse in a specified commercial disinfectant for 30 minutes Cleaning body As for probe tip Storage conditions 20 C to 55 Maintenance and ongoing costs Disposable covers not required waterproof Battery type LR41 battery 1 5V Battery life 200 hours continuous use Maintenance 2 year warranty Manufacturing standards EN12470 3 2000 Quality management Price ex VAT 4 05 to BS EN ISO 9001 2000 ELL I upplier ea GE mark Yes Code 0118 Address 8 Deer Park Road Notified Body
74. ibration of samples from each batch using a reference ther mometer traceable to national reference standards Thermometer care Cleaning probe tip not applicable Cleaning body not applicable Storage conditions Shelf life of 5 years Controlled storage conditions not required Exposure to temperatures over 50 C can be tolerated Green dots return when the thermometer is placed in a cooler environment Maintenance and ongoing costs Disposable covers not required Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards BS EN ISO 9001 2000 Manufacturer claims compliance with ASTM E1299 96 CE mark Yes Code 0086 Notified Body BSI Product Services Price ex VAT 2 40 Supplier Insight Medical Products Ltd Address Units 1 4 Silk Mill Studios 2 Charlton Road Tetbury Gloucester GL8 8DY Telephone 01666 500055 Fax 01666 500115 Website wayne insightmedical net e mail www insightmedical net Manufacturer Medical Indicators Manufactured in USA 34 MHRA 04144 Thermometer review UK market survey 2005 Chemical Spot Check Flexible plastic strip with heat responsive indenta tions which turn from green to black when they exceed their designated temperature Intended use Hospital community and home Measurement site Oral Was Patient group Adults children and infants Size LWD 78mm x 11mm adim Weight lt 1gm S User information Place under tongu
75. ical phase change thermometers 26 Table 2 Comparing chemical thermometers 28 Chemical 3MTM Tempa DOTTM Single Use 29 Chemical EZEtemp Disposable 30 Chemical EZEtemp Traxit 31 Chemical Forehead Thermometer 32 Chemical Insight Traxit 33 Chemical Insight Nextemp 34 Chemical Spot Check 35 MHRA 04144 Thermometer review UK market survey 2005 Contents Electronic contact thermometers 36 Table 3 Comparing electronic contact thermometers 38 Electronic monitoring YSI 4000A 39 Electronic contact Digitemp UN518 40 Electronic contact Filac Faslemp 41 Electronic contact FlexTemp MC 205 E 42 Electronic contact IVAC Temp Plusll 43 Electronic contact Microlife MT1671 44 Electronic contact Microlife MT16F1 45 Electronic contact Microlife MT18F1 46 Electronic contact Microlife MT1921 47 Electronic contact Microlife MT1931 Gold 48 Electronic contact Microlife MT1951 49 Electronic contact Microlife MT1961 90 Electronic contact O Temp l MC 204 E 51 Electronic contact Proact ST714 52 Electronic contact Proact ST8336 53 Electronic contact Proact ST871
76. ight 15 gm User information On off switch at thermometer end During measure ment the current temperature is displayed continu ously and a flashing C is displayed Audible tone 10 beeps when temperature rise is gt 0 1 C in 8 seconds Turn off by pressing the end button briefly Special features Flexible probe tip waterproof illuminated display backlight memory for last maxi mum reading automatic switch off after 10 minutes non use H or L indicates that the temperature is above or below the measurement range see Table 3 supplied with a push on plastic cover to protect sensor Antitheft device No Low battery indicator V displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Waterbath calibration check is possible do not exceed 60 C Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery IEC type SR41 silver oxide high drain 1 55V Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Manufacturing standards R EN ISO 9001 2000 EN Supplier Microlife Health Management 46002 1996 Manufacturer Address Units 6 amp 7 Henfield
77. il sales brannan co uk Manufacturer Manufactured in 15 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Brannan ovulation 11 020 3 Mercury in glass thermometer with a peak hold maximum device for measuring daily variations in temperature Intended use Home use Measurement site Oral Patient group Women Size LWD 130mm x 12mm x 9mm E i Weight 8 gm User information n Shake thermometer vvell to ensure all mercury has ES returned to the bulb Care should be taken to avoid breakage especially within the mouth Special features Easy reading broad scale plate charts for monitoring periodic changes in tempera ture during ovulation protective case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of batch samples tested for accuracy using method stated in BS691 40 1 0 15 C Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Baitery life not applicable Maintenance not applicable Manufacturing standards ISO9001 2000 Manufacturer claims compliance to BS691 CE mark Yes Code 0088 Notified Body LRQA Coventry UK Price ex VAT 5 35 Supplier S Brannan amp Sons Ltd Ad
78. imum thermometers have been around for well over 100 years Heat expands mercury in the bulb pushing it along a capillary tube so reading the scale markings at the leading edge of the mercury column will provide the temperature reading At least four minutes is needed for the mercury temperature in the bulb to match the surrounding tissues and produce an accurate reading A constriction just above the bulb means mercury remains in position in the capillary tube by the scale markings as the thermometer cools so the temperature can be easily read Clinical mercury thermometers sold to UK hospitals have been calibrated on a batch sampling basis for many years using a water bath and a reference thermometer which is traceable to a national standard In 2000 this practice was incorporated into the international standard EN 12470 part 1 17 Some manufacturers may claim compliance with earlier national standards for example ASTM E667 22 or BS 691 28 Following harmonisation some configurations of clinical mercury thermometers traditionally used in the UK were not described in the international standard so BS 6985 29 was published to cover these Manufacturer s advice on clinical use The key issues in the use of mercury in glass maximum thermometers are e Shake the thermometer to return all the mercury to the bulb before each patient reading Do not use within 30 minutes of patient taking exercise bathing eating drinking or smoking
79. ing is too high or low illuminated display for 5 seconds after unit is turned on and after measurement error H when ambient is too high and L when ambient is too low extended temperature measurement range for bath water etc supplied with plastic storage case and supply of alcohol wipes Antitheft device No Low battery indicator Two stage battery warning Low and Battery icon will flash Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip Wipe with alcohol swab or cotton tissue moistened with 70 iso propyl alcohol Cleaning body As for probe tip but ensure no liquid enters the case Storage conditions 25 C to 55 C Maintenance and ongoing costs Disposable covers No probe cover Battery Lithium CR2032 3V battery Battery lite 1000 measurements approx Price ex VAT 25 00 Maintenance None except cleaning Supplier Microlife Health Management of probe Address Units 6 amp 7 Henfield Business Park n Blanes s sn Ed nicl Manufacturer claims compliance Telephone 01273 494401 with ASTM E 1965 98 Fax 01273 493986 CE mark Yes Code 0044 Website www microlife com m e mail Derek Tyrell microlife uk com Notified Body RWTUV Manufacturer Microlife AG Manufactured in Taiwan 70 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Proact ST613 Tympanic Infrared detector measures emitted radia tion fro
80. ircumstances Some infrared sensing devices will measure low temperatures but these values may be less accurate as they are beyond the temperature range used for clinical validation Accurate measurement of body temperature well below the normal range is likely to be particularly relevant for emergency rescue teams emergency admissions staff working in post operative intensive care and possibly community healthcare workers It is also important for clinicians to know that different body sites respond at different speeds to rewarming of the body and for example the rectal site may lag behind the tympanic membrane measurements in some situations MHRA 04144 Thermometer review UK market survey 2005 Procurement issues The purchase cost of stand alone thermometers identified in this review is highly variable Prices range from 7 pence each for a disposable chemical thermometer to 400 for some models of electronic contact and infrared sensing thermometers and 356 for a dual channel device for continuous temperature monitoring When making a purchasing decision it is important to consider a range of issues before determining which device is the best choice and achieves best practice Although there may be a strong marketing drive for certain models of thermometers a structured approach to procurement is advised Where possible seek independent evidence of temperature accuracy and measurement repeatability in clinical use and take the time
81. is is derived from clinical studies of core temperature 4 and those obtained in the mouth 5 rectum 6 axilla 6 ear 7 and on the forehead 8 in healthy teenagers and adults Unfortunately the temperature differences noted between body sites are only approximations because the clinical studies on which they are based are often limited Some thermometers automatically encode the physiologic offset figure into the thermometer s displayed value so the temperature at familiar body sites eg oral is MHRA 04144 Thermometer review UK market survey 2005 Introduction predicted from measurements at other sites eg ear or forehead Other thermometers do not automatically add the physiologic offset and provide the actual temperature measured at that site Clearly it is vital to know from the operator s manual for a particular thermometer which process is operating Given the variation of normal temperature depending on body site the threshold for clinical action may need to be adjusted depending on the thermometer being used Since individual differences also contribute to the variation of normal temperature range some manufacturers therefore recommend that ideally individual temperature records should be established when in normal health This is particularly important for patient groups in whom changes in temperature might be of clinical significance such as young children and patients with immunosuppression In addition in h
82. ize LWD 100mm x 5mm Weight 20 gms User information Shake down the thermometer to ensure mercury is below the last reading on the scale Place ther s mometer tip in the rectum taking care to avoid breakage Leave in place for 3 minutes remove and read Clean as laid down by the infection control protocol then store in a clean area for re use Special features Protective plastic case Antitheft device not applicable Low battery indicator not applicable Self check on start up not applicable Calibration Every thermometer is tested at two temperatures using a reference thermometer traceable to national standards Thermometer care Cleaning probe tip Use either an alcohol swab or wash with soapy water and dry Cleaning body As for probe tip Storage conditions Store in a sterile clean area Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 Manufacturer claims compliance with BS EN 12470 1 2000 CE mark Yes Code 0086 Notified Body BSI Product Services Price ex VAT 1 01 10 08 pack 10 Supplier GH Zeal Ltd Address 8 Deer Park Road Merton LONDON SW19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer ZEAL Group Manufactured in information not supplied 23 MHRA 04144 Thermome
83. l protocol then store in a clean area for re use 2 cm Special features Protective plastic case Antitheft device not applicable Low battery indicator not applicable Self check on start up not applicable Calibration Every thermometer is tested at two temperatures using a reference thermometer traceable to national standards Thermometer care Cleaning probe tio Use either an alcohol swab or wash with soapy water and dry Cleaning body As for probe tip Storage conditions Store in a sterile clean area Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 Manufacturer claims compliance with BS EN 12470 1 2000 CE mark Yes Code 0086 Notified Body BSI Product Services Price ex VAT 75 pence 7 50 pack 10 Supplier GH Zeal Ltd Address 8 Deer Park Road Merton LONDON SW19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer ZEAL Group Manufactured in information not supplied 22 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Zeal M1010 Traditional re usable thermometer designed to be used rectally for taking normal body temperatures range 35 42 C Intended use Hospital community and home use Measurement site Rectum Patient group Children and adults S
84. lean area Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 Manufacturer claims compliance with BS EN 12470 1 2000 CE mark Yes Code 0086 Notified Body BSI Product Services Price ex VAT 95 pence 9 50 pack 10 Supplier GH Zeal Ltd Address 8 Deer Park Road Merton LONDON SW19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer ZEAL Group Manufactured in information not supplied 25 MHRA 04144 Thermometer review UK market survey 2005 Chemical phase change thermometers How they measure temperature A chemical phase change thermometer comprises a piece of plastic with small cavities each containing a chemical mixture of slightly different proportions Some devices on the market comprise a mixture of two organic chemicals which are soluble in each other each having a distinct melting point By altering the ratio of the two chemicals and incorporating a dye the colour will change at the precise temperature the mixture melts Other manufacturers of chemical thermometers use three cholesteric liquid crystal compounds and vary the concentration of a soluble additive to achieve a visual change at specific temperatures These chemical dots are covered with a clear polymeric film which allows observation
85. m inner ear and predicts the core tempera ture of the body intended use Hospital community and home Measurement site Ear Patient group Adults children and infants Size LWD 137mm x 37mm x 51mm Weight 91 gm batteries User information One button operation User information includes a 2 cm list of precautions during use Use of a mobile phone near the thermometer may cause a reading error Special features Movable probe tip to improve placement in the ear canal switch off after 1 minute of non use displays last reading on switch on error warning when ambient tempera ture is out of range supplied with protective cap and a set of disposable covers Antitheft device No Low battery indicator Battery icon is displayed flashing Self check on start up Yes Calibration Factory calibration for 1 year Return to Proact for calibration for a black body calibration check is recommended after an abnormal event eg impact Thermometer care Cleaning probe tip Gently wipe with cotton bud slightly moistened with water Allow to dry for 5 minutes before attaching a probe cover and taking temperatures Cleaning body Use soft dry cloth to clean the body of the thermometer Storage conditions Ideally store inside original packaging when not in use Store at room temperature or less Maintenance and ongoing costs Disposable covers required 4 5p each 45 for 1000 Battery Alkaline AAA size x2 batterries 3V are supplie
86. mail sales brannan co uk Manufacturer information not supplied Manufactured in information not supplied 32 MHRA 04144 Thermometer review UK market survey 2005 Chemical Insight Traxit Adhesive plastic thermometer designed to be placed under the arm for up to 48 hours Heat responsive indentations which turn from green to black when they exceed their designated tempera ture Intended use Hospital primary care and home Measurement site Axilla Patient group Children and infants Size LWD 33mm x 32mm Weight lt 1gm 2 cm User information Place adhesive surface in usual axilla position cover with arm for three minutes Lift arm to read Last black dot indicates tempera ture Special features Constant wearable source of temperature measurement can remain in place for 48 hours for repeated reading latex free adhesive subsequent readings almost instan taneous and cause minimal patient disturbance easy to read Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of samples from each batch using a reference ther mometer traceable to national reference standards Thermometer care Cleaning probe tip not applicable Cleaning body not applicable Storage conditions Shelf life of 5 years Controlled storage conditions not required Exposure to temperatures over 50 C can be tolerated Green dots return when the thermometer
87. ment using a cotton swab soaked in 70 alcohol solution Cleaning body As for probe tip Storage conditions 20 C to 55 C 5 95 RH Maintenance and ongoing costs Disposable covers not required Battery Silver oxide 1 5V battery Battery life 2 years Maintenance Maintenance and servicing information is not provided User manual contains a basic fault finding procedure Supplier provides an as required repair and maintenance service Faulty units must be returned to the supplier Turn around is typically 5 days Manufacturing standards Price ex VAT 13 99 ISO9001 2000 EN ISO 13488 2000 Manufacturer claims compliance with BEL EA Address Waldeck House Waldeck EN60601 ASTM E1965 98 ASTM n ado ad E 1112 98 Berkshire CE mark Yes Code 0120 Telephone 01628 773233 Notified Body TUV Product Service Fax 7 VVebsite www pmsinstruments co uk e mail sales pmsinstruments co uk Manufacturer SAAT Ltd Manufactured in Israel 57 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Zeal M5003 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture reading Extended display range 28 42 C S intended use Hospital and primary care Measurement site Oral axilla and rectal Patient group Adults and children Size LWD 129mm x 18mm x 10mm Weight 20 gm User information Press on off switch to initiate self test including a c
88. mporarily store or use their diagnostic equipment outdoors eg a car boot Some models may produce reading errors when subject to electronic interference which can be generated by some types of hospital equipment or radio communication devices eg mobile phones Accuracy in clinical use can be similar to the quoted laboratory accuracy and accuracy of mercury in glass thermometers provided users follow the manufacturer s advice on clinical use and the environment is appropriate 37 ulul cV 8c Oo LO G OF qo 7e00L 8c 81 6 crv S GE L OF 00SIN leez o 5 G V SV c Oo FO O dd p rddns jou T 91 y v cet L OF 6 5j ouueu L 99S 9 EF Z 9e Oo LO 9 Jg 7096 GL 07 01 19 L OF SNId duiejeung Oo 988 0 ey ce Do 0 E 38 08 01 9 ey ce LOF di lqix li 128 1oe0Jd 29 01 F cE Oo LO 3 48 08 01 OV S c L OF 128 19 0Jg D 99S 09 er ct Oo L0 0 48 08 01 OV S dy ct L OF 8EE8LS 10FO1d is 5 G er ct Oo L0 0 o 48 08 crv S ey dt HOT VLLLS Peod O utu dy c Oo ED p rddns jou 9 JO 98 86 8l d v dt L OF duie O amp 98S 0c 7 c Oo L O perddns jou 3 JO 98 0 82 8l cv Vk LOT LOB LLIN SHIOJOIN 5 29 0c 6 r ct Oo LO perddns jou 3 4 98 8c 81 Vt LOT LGG LLIN SHIOAOIIN 5 09 6
89. n the skin can decrease emissivity and lower the temperature reading potentially missing the presence of fever Avoid environments with moving air from air conditioning or a draught as these can artefactually lower skin temperature Avoid measuring when the patient s skin is close to a lamp warmer or exposed to sunlight through a window as this can increase skin temperature and may falsely predict a raised body temperature Wait several minutes before taking a temperature if the patient has recently been exposed to any activity which could affect the normal temperature of the head eg exercising bathing showering shampooing or drying hair recently been wearing a hat or scarf or had a cold sponge or compress on their head e Move hair away to avoid it obstructing the skin reading Comparison of manufacturer s data ear thermometers Ten infrared ear thermometers have been included in this review eight provide a reading of ear temperature one converts the measurement into an oral temperature and another offers users the option of predicting the oral default rectal or axilla temperature Measurement accuracy of 0 2 C for an operating range of 35 8 C to 41 C or greater is obtained from manufacturers laboratory measurements Table 4 Clinical factors see manufacturer s advice above can cause additional errors and usually lead to an underestimation of body temperature All models need a restricted ambient temperature range
90. nfrared detector measures emitted radiation from Inner ear and converts this into an oral equivalent temperature reading Intended use Hospital primary care amp home use Measurement site Ear Patient group Adults children and infants s Size LVVD 165mm x 38mm x 25mm Weight 8 gm udi User information Gently pull middle ear back and up straighten ear canal Keep holding ear during measurement Use same ear for all measurements Wait two minutes between readings in the same ear Check room temperature indicated by r is less than 33 C before positioning probe in the ear Special features Long beep when temperature measurement is completed automatically turns off 1 minute after last measurement memory function can store up to 8 temperatures and the measurement time for up to 64 hours supplied with protective cap and set of probe covers Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Information not supplied Thermometer care Cleaning probe tip Do not touch the probe tip with fingers Cleaning body Use soft dry cloth to clean the body of the thermometer Storage conditions Information not supplied Maintenance and ongoing costs Disposable covers required 7p each 70 for 1000 Battery Lithium CR2032 3V battery Battery life 5 years Maintenance User manual contains a basic fault finding procedure Supplier pro vide
91. ntries and a number of Notified Bodies have branches in the USA Japan etc International safety and performance standards Where papers have been received which document compliance with relevant international standards these are listed in the Product Summary These may be internal documents from the manufacturer claiming compliance based on their own assessment tests or copies of certificates from an independent test house declaring the outcome of type testing International standard EN 12470 comprises five parts each covering a specific thermometer type 17 18 19 20 21 Some products in this review were designed to these standards during their development prEN12470 or in compliance with earlier standards eg those of the American Society of Testing and Materials ASTM 22 23 24 25 EN60601 1 26 is the relevant standard for all electrical medical devices in particular electronic contact thermometers and those performing infrared sensing Compliance with EN 60601 1 2 27 demonstrates that electromagnetic compatibility has been tested demonstrating that performance of the thermometer will not be affected by electrical interference from most types of medical and communication equipment eg mobile phones and does not generate significant electromagnetic interference for other devices 10 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass thermometers How they measure temperature Mercury in glass max
92. o c u dad 7e00L OP Ga 08 0 2 0 ieuuougns eosun ulul p cv GE Uo LO u 9 ag 0001 cy SE 910 10 ere s rena 809 ulul p cv GE Oo LO u 08 0001 dy ev Ge 910 OF 80S NN ulul p dr GE Oo LO u 9 dad 0001 dy Ge SLO V T e984 ZOSNN ulul p dy 96 Oo LO u 9 ag 7e00L oV gt y S 910 VOT ul pllog ueuueig ulul p GP GE Oo LO u 3 dad 7e00L ev St 910 OF uone nAQO ueuugJg ulul p dy 96 Oo LO u J ag 0001 eV cv S 910 VOF peeu Asea3 ueuueig ulul p GP 96 Oo LO u dad 7e00L y G 910 V T eleos end uPuueig uon oue oue Do De Do O awaq njosal E Keideip 4 09 00 Hu AUPIWNY oimeied eDueij oenooe e10 Keldsig 1 IdsID jueiquiy feidsig jado opis apsmo P uejjueiquuy Dugejedo 1seuDiH SH UIOUL U DuipeaiJ o i i 1seuDiu ye d jno SI Bul sse D ul Ain l ly ks r oeJno9e peal JI qoq Ae dsip dun le Quy 1 Aoeunooy pelels s JeJnjoejnue N 159M07 DUIUIEM Ae ds q eimieieduie pue Aoeinooy si91 uuouui9u sseJD ui ANIHIN 6004 oNins Mf M9SIA9J JOJOWOWISY Pr LYO VHHIN oldel 13 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Brannan dual scale 11 455 3 Mercury in glass thermometer wi
93. oduct Services Price ex VAT 95 pence 9 50 pack 10 Supplier GH Zeal Ltd Address 8 Deer Park Road Merton LONDON SW19 3UU Telephone 020 8542 2283 Fax 020 8543 7840 Website www zeal co uk e mail scientific zeal co uk Manufacturer ZEAL Group Manufactured in information not supplied 24 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Zeal M2510 Traditional re usable thermometer designed to be used rectally for sub normal hypothermia body temperatures range 24 40 C Intended use Hospital community and home use Measurement site Rectum Patient group Children and adults Size LWD 100mm x 5mm Weight 20 gms User information Shake down the thermometer to ensure mercury is below the last reading on the scale Place ther mometer tip in the rectum taking care to avoid breakage Leave in place for 3 minutes remove and read Clean as laid down by the infection control protocol then store in a clean area for re use 2 cm Special features Protective plastic case Antitheft device not applicable Low battery indicator not applicable Self check on start up not applicable Calibration Every thermometer is tested at two temperatures using a reference thermometer traceable to national standards Thermometer care Cleaning probe tip Use either an alcohol swab or wash with soapy water and dry Cleaning body As for probe tip Storage conditions Store in a sterile c
94. ome hospital medical devices or radio communications equipment eg mobile phones does not affect mercury in glass thermometers Accuracy in clinical use can be similar to the quoted laboratory accuracy providing users follow general advice on clinical use and allow sufficient measurement time 12 lass thermometers ing mercury in g Table 1 Compar eDueiJ Ju uu inse ui v puo q si Dulpeai y u uA Dumeoipui ejdsiq Koejnooe 1991 JO pue uonounj 1284109 JO WOO e je eq oj pasu seJnjeJeduie ualduy AuiunuJuloo SU ui pesn u uA saloeJnooeul pue sule qoud eonpoJ Aew aBuei 1usiquie p pu lxz ueujeJnseeui JO a10jad einteiadwa jueiquie y uo 34010111591 ewu Aoe1nooe pojels 1s uBiu au ye jou aie pe ejdsip euiog Sen eA paAeldsip sow lle 10 peureijqo si oeunooe 1S UD MH esn jepu u Al l qeye d l jueujeJnseeui uey YONW eq uayo ueo jueuleJnsee N UIWE OV vc Oo 6 u 9 ag 7e00L 05 gt OP pe C 201 OLSCIN leoz uiu OP Oo c u 3 dd 001 OG gt OP pe 020 207 OLOCIN leez paiddns jou 2 S 210 P u D ag 00 0S gt v G SL0 VOF OLOLIN 897 JE ev S OO e u C ag 96001 OS gt ev S SL0 VOT OLLON Ieez ulul p OV 92 U
95. ons about the relative size of the tympanic membrane in the field of view Most models display the temperature of the tympanic membrane but an infrared ear thermometer may be designed to predict the temperature reading for another body site usually oral by applying a physiologic offset based on data obtained by the manufacturer in clinical testing 25 Surface temperature of regions of peripheral skin or other objects may also be measured using models with a wide display range see comparison table These direct readings will have a lower measurement accuracy but will incorporate an instrumentation offset to compensate for the thermometer s internal temperature Forehead thermometers repeatedly sample the skin temperature seeking peak values caused by the presence of the temporal artery lying under the surface Instrumentation offset values and physiological offset values are then applied to predict the temperature at another site usually oral All these devices use computational software to rapidly predict the temperature but the algorithms will vary between manufacturers as they are based on their own clinical trials In the relevant international standard EN 12470 part 5 21 manufacturers need to achieve a laboratory accuracy of 40 2 in the operating range 35 5 42 C perform clinical testing at a room temperature between 18 and 24 C and conduct repeatability studies in the same ear Some manufacturers claim compliance with 99
96. onsultation between the evaluator and PaSA staff has ensured that most of the thermometers and disposable covers forming part of the 2005 7 contract are included in this review NHS and other UK organisations eligible to use the national NHS purchasing contract are advised to seek a listing of available products by contacting PaSA using www pasa nhs uk or phoning 01924 328829 MHRA 04144 Thermometer review UK market survey 2005 Introduction Mercury in glass thermometers have been used clinically by the medical profession for over a century since their introduction by Carl Wunderlich in 1871 1 He demonstrated the value of the thermometer as an objective measure of health or progression of disease by systematically recording axillary temperature on 25 000 adults Since then extensive clinical experience of using mercury in glass thermometers for measuring oral rectal and axilla temperature has resulted in body temperature being recognised as a vital clinical sign and a keystone of nursing and medical practice and patient record keeping More recently environmental concerns have led some European countries to ban their use 2 At present there are no plans to restrict the use of mercury in glass clinical thermometers in the UK However it is important that staff are trained to ensure safe handling during normal use and in the event of a mercury spillage 3 Alternative technologies for clinical temperature measurement are being purchased
97. onverts this into an ear tempera ture reading indicated by an audible beep Intended use Hospital primary care and home fe Measurement site Ear Patient group Adults children and infants Size LWD 141mm x 26mm x 20mm Weight 45 gm User information Instructions include advice to straighten ear canal and correct placement of probe Position probe and 2 cm press start button Audible beep when reading is displayed Wait at least 30 seconds after 3 5 readings Do not twist the cone con taining the probe Special features Memory of last reading displayed for 2 seconds when switched on automatic switch off after 1 minute audible fever alarm when temperature gt 37 5 C illuminated dis play for 5 seconds after unit is turned on and after measurement error H when ambient is too high and L when ambient is too low extended temperature measure ment range for bath water etc supplied with a set of probe covers and thermometer stand for loading the covers Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip Wipe with swab moistened with 7096 isopropyl alcohol Cleaning body Wipe with swab moistened with 7096 isopropyl alcohol Storage conditions 25 C to 55 C Maintenance and ongoing costs Disposable covers required 8 pence 3 50 for 40 pieces Battery Lithium CR
98. or a single patient which may include installation of the probe cover electronic self checking mode selection cleaning disposal of consumables undressing and or positioning of the patient checking ears for wax prior to aural measurement etc A local trial may be useful for objectively comparing this factor for different thermometer types or models Cleaning and infection control issues Infection control issues should be included in the procurement decision Although general guidance on sterilisation disinfection and cleaning of medical equipment has been provided by the MHRA Microbiological Advisory Committee 10 it is very important to follow the cleaning and decontamination instructions provided by the manufacturer Cleaning instructions vary considerably for thermometers in this review even different models within the same thermometer type have diverse requirements both in methods and materials A summary of any information provided by the manufacturer can be found in the product summary pages Despite the use of sterile covers some thermometers can only be wiped with a soft dampened cloth In certain clinical situations this may be considered an unacceptable risk for cross contamination Alternative solutions for high risk situations could include mercury devices and a few compact electrical thermometers are waterproof so they can be immersed in a 7096 alcohol solution for up to 24 hours chemical thermometers for single pa
99. or to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 ISO 13481 5 2003 BS EN 13485 2003 Manufacturer claims com pliance with BS691 GE mark Yes Gode 0197 Notified Body TUV Rheinland Price ex VAT 1 60 Supplier Universal Hospital Supplies Address Unit 6 George House Millmarsh Industrial Estate Enfield AN3 7QJ Telephone 0845 082 0182 Fax 0845 082 0180 Website sales uhs co uk e mail www uhs co uk Manufacturer Universal Hospital Supplies Manufactured in China 21 MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass Zeal M0110 Traditional re usable thermometer designed to be placed under the arm or used orally for taking nor mal body temperatures range 35 42 C Intended use Hospital community and home use Measurement site Oral axilla Patient group Children and adults Size LWD 100mm x 5mm Weight 20 gms User information Shake down the thermometer to ensure mercury is below the last reading on the scale Place ther mometer tip in the usual oral cavity or axilla posi tion Take care to avoid breakage when using orally Leave in place 3 minutes orally or 8 minutes for axilla readings remove and read Clean as laid down by the infection contro
100. ospitalised patients frequent monitoring is important to detect shifts in temperature that might correlate with changes in clinical condition eg monitoring response to antimicrobial therapy monitoring rewarming after some types of surgery Fever An evaluation in temperature is part of the normal response to infection and many other disease processes The precise temperature that is used to define fever varies between clinicians and may even vary depending on the patient population eg a lower definition of fever may be used in some immunosuppressed patients In general the upper limit of normal temperature varies from 37 0 to 38 0 C and most clinicians will use fever to be a temperature that exceeds some figure in this range However review of manufacturer s data reveals that some manufacturers provide specific advice on the normal temperatures that can be expected for their device and some document an upper limit of normal which is different from 37 C Hypothermia Hypothermia can occur accidentally eg from environment or intentionally such as during certain types of surgery So it can also be important to reliably measure body temperatures well below 36 C Reviewing the operating range for these thermometers it would appear that only a few devices can match the sub normal mercury thermometer The large electrical continuous monitor and three compact electronic models in monitor mode could provide accurate readings under these c
101. oup Adults children and infants Size LWD 125mm x 20mm x 13mm Weight 12 gm User information 2cm On off switch at thermometer end During measure ment the current temperature is displayed continu ously and a flashing C is displayed Audible tone 10 beeps when temperature rise is gt 0 1 C in 8 seconds Turn off by pressing the end button briefly Replace ther mometer when ERR is displayed Special features Waterproof illuminated display backlight memory for last maximum reading auto matic switch off after 10 minutes non use H or L indicates that the temperature is above or below the measurement range see Table 3 supplied with a plastic stor age case Antitheft device No Low battery indicator V displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery IEC type SR41 silver oxide high drain 1 55V Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Price ex VAT 5 06 t s Supplier Microlife Health Management EN ISO 9001 2000 EN 46002 1996 Add ase Unis amp 7 Manufa
102. overs required 4 7p each 235 07 for 5 000 Battery Alkaline 9V battery Battery life 2000 readings Maintenance Technical IFU manual and training for medical technologists is avail able No user serviceable parts Price ex VAT 198 85 Manufacturing standards Supplier Tyco Healthcare ISO9002 ISO 13485 Manufacturer Address EE n Road claims compliance with EN60601 1 Gosport PO13 OAS 2 1993 ASTM E1112 1998 Telephone 01329 224114 CE mark Yes Code 0123 Fax 01329 224334 Notified Body TUV Product Service Website e mail marketinguk tycohealth com Manufacturer Tyco Healthcare Kendall Manufactured in USA 41 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact FlexTemp MC 205 E Electronic contact thermometer using a thermistor to sense temperature rise Audible tone when tempera ture rise is 0 1 C in 16 seconds Display continues for 10 minutes and then turns off Intended use Home use Measurement site Oral axilla and rectal Patient group Adults children and infants Size LWD 178mm x 60mm x 14mm Weight 11 gm User information Compact user information booklet provided Only use within acceptable ambient conditions See gen eral advice for measuring oral axilla and rectal temperature Special features Flexible probe tip waterproof last measurement memory displays L or H if meas ured temperature is below or above the stated operating range see Ta
103. pliance with BS691 CE mark Yes Code 0197 Notified Body TUV Rheinland Price ex VAT Supplier Address Telephone Fax Website e mail Manufacturer Manufactured in 18 1 45 Universal Hospital Supplies Unit 6 George House Millmarsh Industrial Estate Enfield AN3 7QJ 0845 082 0182 0845 082 0180 sales uhs co uk www uhs co uk Universal Hospital Supplies China MHRA 04144 Thermometer review UK market survey 2005 Mercury in glass UHS UN508 Mercury in glass thermometer with a peak hold maximum device for measuring temperature under all circumstances Intended use Hospital community and home use Measurement site Oral and axilla Patient group Adults children and infants axilla Size LWD 111mm x 6mm x 5mm Weight 6 gm User information Shake thermometer well to ensure all mercury has returned to the bulb Care should be taken to avoid breakage especially within the mouth or rectum Special features Protective plastic case Antitheft device no Low battery indicator not applicable self check on start up not applicable Calibration information not supplied Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Baitery life not applicable Maintenance not applicable Manufa
104. pment eg mobile phones Measurement accuracy in clinical use can be similar to the quoted laboratory accuracy and that of mercury in glass thermometers provided users follow the manufacturer s advice on clinical use 27 Table 2 Comparing chemical thermometers sBuipe iu juenbesqns 10 spuooes G pue 1911 eui 10 seinuiul SI U NE aui sBuIpeai elixe 10 eAISeupy eDueJ 1ueujeJnseoeui y puo q si Buipe iu y uaum Dume2ipui Aejdsig KoeJnooe 1seuBiu 10 pue uonounj 1984109 JO WOO e je eq oj pasu seJnjeJeduie ualduy AuiunuJulO9 SU ui pesn u uA saloeJnooeul pue suu qoid eonpoJ Aew aBuei eJnye1eduje 1usiquie p pu lx3 ueujejnseeui Buunp JO 8J0Jeq eunjeJeduije jueiquie y uo suomuiseJ ewu Ao e4nooe pojels 1seufiu au le JOU aie pe ejdsip euiog Sen eA paAeldsip sow lle 10 peureiqo si oeunooe 1S UD MH esn jedlu u Al llIqeye d l jueujeJnseeui uey YONW eq uayo up jueuleJnsee N ulul GlP GES Q l0 u dd 9600 960 09 gt 6 LY GGS LOT yo uo 1ods UILU GS OO u dd 9600 960 09 gt V Ov 996 LOT EYE 65 15 S 0 eu 95001 960 os 6 Ly 96 OF xea 1uBisu uue z Oo 3 48 001 LY O IXEJ 1ubisul peoueJo ov Ge OO eju 4g 95001 9
105. r c Oo LO perddns jou e 4 98 86 8l cv Vt LOT PIOS L 6L LIN SHIOAIN 29 OE 6 ey cE Oo v perddns jou Jd 98 8c 81 d y Vt L OF LZ6LLIN 9H OJ9 N Q 5 OG 6 cy ce Oo 10 p rddns jou 3 J9 98 06 8c 81 oV Vt OF 48 LIN 91 OJ9 A 5 09 6 v cE Oo LO p llddns jou 3 JO G8 OF 8c 81 GV YE LOT LA9L LIN SHIOOIN 5 09 6 r ce Oo HO penddns jou 9 EL 9688 0E 82 8l y vt LOF LZ9LLIA SMIOOIIN vd peuddnsiouu coy 9 O VO peiddns jou Jg S6 SL 91 ly 896 LOF II Snid d l l OVAI c ulul 6 r c Oo LO p rddns ou 9 d 98 8c 81 ve L OF 3 S02 OIN Awe xeld 99S Bp Oo LO e 4 7096 Ol 86 81 cr 0996 HOT duie se4 oellg 98S 06 09 662v 2826 0 1010 p liddns jou 3 JO pariddns you GZ GI Ov v OF 8LGNN d t libiq O S nonulluoo 0S Oo LO u ag 96 08 0 GV SC L OF VOOOr ISA QO o uonnjose bu eDuei Kven uu Aupiuny 757 3 Bum 7 c To eDueiKejdsig Kejdsig Sugedo 57 1u lquy i 1 Buneiedo Duipeoi o p s no episino is uDlu le jueiquiv 1S UD H 128juoo uul eoid Koejnooe si Buipeai sDulpea oluoJ129 3 o ejdsip 159401 il BUIUIEM le Jv Iseubiy Aoeunooy pelels s eJnjoejnue N ejdsig e1njej1eduio pue 5 1 1261400 231u004 199 3 QEL
106. ror free some models will not measure temperature if the ambient temperature is outside the specified range 36 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact thermometers Do not use within 30 minutes of patient taking exercise bathing eating drinking or smoking e Hold mouth closed for 5 minutes before oral measurement Hold arm to chest for 5 minutes before axilla measurement e During oral measurement ensure the thermometer tip is placed in the left or right sublingual pocket as other areas in the mouth are cooler and the diagnosis of fever may be missed Overall comparison of manufacturer s data The manufacturers stated accuracy data for a single model of a dual channel continuous monitoring thermometer and 19 compact electronic thermometers are compared in Table 3 All devices achieve a laboratory accuracy of 0 1 C for the whole or part of their display range The operating range ambient temperature and humidity range for which this accuracy applies is wider for the continuous monitoring thermometer than the compact models Testing the ambient temperature is often included in the electronic self check Most models display an error message and may not perform a measurement sequence if the thermometer is too cold or hot to produce the best accuracy Some models will automatically switch to continuous monitoring mode under these conditions which can be less frustrating for clinical users who te
107. rox Maintenance Information not supplied Warranty period 1 year Manufacturing standards No information about Quality Management Standards was supplied Manufacturer claims compliance with EN 60601 1 1998 EN60601 1 2 prEN 12470 5 CE mark Yes Code 0120 Notified Body SGS England Price ex VAT 12 22 Supplier Healthbrands Ltd Address Curlews Boarley Lane Sandling Maidstone ME14 3BS Telephone 01795 520101 Fax 01795 520052 Website www hubdic com e mail jmerrett healthbrands co uk Manufacturer HuBDIC Co Ltd Manufactured in S Korea 77 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Microlife FR1DM1 Infrared detector measures emitted peak radiation from the forehead and ambient temperature to e predict the body temperature indicated by an d audible long beep Intended use Home use Measurement site Forehead Patient group Adults children and infants z Size LVVD 122mm x 42mm x 43mm VVeight 48 gm User information Place thermometer head on patients forehead 2 cm and press start button No probe movement required Special features Audible fever alarm when temperature gt 37 5 C audible alarm if reading is above or below the operating range automatically turns off after 1 minute illuminated dis play backlight memory for 12 readings last reading displayed for 2 seconds on switch on Antitheft device No Low battery indicator Yes b
108. rt up Yes Calibration Factory calibration of each unit prior to dispatch Waterbath calibration check is possible do not exceed 60 C Thermometer care Cleaning probe tip Wipe in cotton swab moistened with 7096 isopropyl alcohol 9596 dilution with water Cleaning body As for probe tip Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery 1 5V IEC type SR41 silver oxide high drain Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Price ex VAT 3 36 Manufacturing standards EN ISO 9001 2000 EN 46002 1996 Supplier Microlife Health Management Manufacturer claims compliance Address Units 6 amp 7 Henfield Business Park with prEN12470 3 1997 Shoreham Road Henfield CE mark Yes Code 0044 West Sussex BN5 9SL Notified Body RWTUV Telephone 01273 494401 Fax 01273 493986 Website www microlife com e mail Derek Tyrell microlife uk com Manufacturer Microlife AG Manufactured in Taiwan 45 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Microlife MT18F1 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera ture Audible tone when temperature rise is lt 0 1 C in 8 seconds Intended use Hospital primary care and home Measurement site Oral axilla and rectal Patient gr
109. ry indicator Battery symbol displayed Self check on start up Yes Calibration Information not supplied Thermometer care Cleaning probe tip Clean infrared sensor with a dry soft tissue allow it to dry before covering Occasionally clean the external part of the soft tip with a 70 alcohol solu tion not touching the sensor Cleaning body Occasional clean of external surface with 70 alcohol solution Storage conditions Always store in protective stand when not in use Maintenance and ongoing costs Disposable covers not required Battery Lithium CR2032 3V battery Battery life 5 years Maintenance User manual contains a basic fault finding procedure Supplier pro vides an as required repair and maintenance service Faulty units must be returned to the supplier Turn around is typical ly 5 days Price ex VAT 34 00 Manufacturing standards i _ Supplier PMS Instruments Ltd 509001 2000 ISO 13488 2000 Address Waldeck House Waldeck Manufacturer claims compliance with Road Maidenhead EN60601 ASTM E 1965 98 Berkshire CE mark Yes Code 0123 Telephone 01628 773233 Fax 01628 770562 Notified Body TUV Product Service Website www pmsinstruments co uk e mail sales pmsinstruments co uk Manufacturer SAAT Lid Manufactured in Israel 80 MHRA 04144 Thermometer review UK market survey 2005 Acknowledgements Acknowledgements We thank the following for helpful discussions and background
110. s an as required repair and maintenance service Faulty units must be returned to the supplier Turn around is typically 5 days Manufacturing standards ISO9001 2000 EN ISO 13488 2000 ce ex VAT a Manufacturer claims compliance Supplier PMS Instruments Ltd with EN60601 ASTM E 1965 98 Address Waldeck House Waldeck ASTM E 1112 98 GMP Road Maidenhead I Berkshire GE 157 ode Die Telephone 01628 773233 Notified Body TUV Product Service r 01628 770562 Website www pmsinstruments co uk e mail sales pmsinstruments co uk Manufacturer SAAT Ltd Manufactured in Israel 73 Table 5 Comparing infrared forehead thermometers eDueJ 1ueujeJnseeui au puo q si Buipe iu aimn1eiadua y uaum Duneo2ipui ejdsiq KoeJnooe 159401 JO pue uonouni 1984109 JO WOO e je ad 0 pasu seJnjeJeduie ualguy AuunuJulO9 eui ui pesn uauM SBIOEINDDEUI pue sule qoud np l Aew Hue JUsIQUIe p pu lxq ueujejnseeui Buunp JO 840Jeq Nadua jueiquie y uo Suo 111S91 ON Aoe4nooe paleis 1s uBiu au je jou aie pe ejdsip sen eA pe ejdsip sow e 10 peureiqo si oeJnooe 1s uBiH esn jedlu ul Al l qeye d l jueujeJnseeui uey 1e1eq YONW eq u ljo ueo 4 298 6 veb vV9 OO Jg 101 OV 9 96 91 ZO 200100
111. s suspected Repair with in warranty period requires return to Price ex VAT 60 00 UK supplier Manufacturing standards Supplier Henleys Medical Supplies ISO9002 Manufacturer claims compli Address Browntields Welwyn ance with ASTM E 1965 98 Garden City Herts AL7 1AN Telephone 01707 333164 Notified Body CISQ Italy Website www henleysmed com e mail sales henleysmed com Manufacturer Tecnimed Srl Manufactured in Italy 19 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing ThermoTek NoTouch 960 Infrared detector measures emitted radiation from temple to calculate an equivalent oral reading Intended use Primary care and home use Measurement site Forehead Y Patient group Adults children and infants Size LWD 115mm x 62mm x 38mm Weight 76 gm AR User information Clean lateral forehead and temple removing svveat make up etc Do not use within 30 minutes of exer cise or if skin is scarred or affected by skin disor ders Place on one side and up to 1 inch from fore head and move in a circle until long bleep is heard Special features Memory function can store up to 8 temperatures and the measurement time for up to 64 hours avold direct sunlight radiant heat or airflovv on skin during measure ment after a 2 minute rest use same measurement area to repeat readings sup plied vvith a protective stand Antitheft device No Low batte
112. sed The patient should hold their tongue down on the strip and keep their mouth closed for 1 minute For axilla measurement if applicable hold arm to chest for 3 minutes after placing the chemical thermometer high in the armpit e Read within 30 seconds after removal from the measurement site 26 MHRA 04144 Thermometer review UK market survey 2005 Chemical phase change thermometers Overall comparison of manutfacturer s data Currently on the UK market there are several different configurations including thermometers for oral use and strips for application to the forehead or axilla Several chemical thermometer models have equivalent laboratory accuracy 0 1 C to the mercury in glass maximum thermometers see Table 2 One model has a lower accuracy 1 0 C but this is only intended for first line assessment of fever status not for clinical diagnosis or monitoring temperature changes Typical time to reading is one minute considerably less than for mercury in glass thermometers Appropriate storage conditions vary considerably but some models offer a 5 year shelf life and can tolerate temporary storage at extreme temperatures quickly returning to normal operation when they are returned to be within the manufacturer s stated ambient range Some models may need to reset by storage in a refrigerator None are prone to error from electronic interference which can be generated by hospital or radio communications equi
113. ser information Press face button for forehead measurements scm Press house button for other measurement sites eg navel Do not use on a perspiring forehead Changing the point of measurement will obtain different results Use in a draught free room at a constant temperature away from air conditioning vents Keep sensor clean and undamaged Low ambi ent temperatures 5 C to 16 C increase measurement errors indicated by low 5 warning Special features okin near the infant s navel may also be used for measurement turns off after 20 seconds non use multiple uses for assessing the surface temperature of other body sites bath food etc supplied with protective cap for probe tip Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Factory calibration performed on each device prior to dispatch Recalibration is only possible on the manufacturers premises Thermometer care Cleaning probe tip Clean using a cotton swab soaked in 70 alcohol solution Cleaning body Wipe with a soft clean cloth moistened with alcohol or soapy solution Storage conditions Store in a dry and clean place at a room temperature between 10 C and 60 Maintenance and ongoing costs Disposable covers not applicable non contact device Battery Alkaline AAA size x4 batteries LROS 1 5V Battery lite 10000 measurements or 3 years Maintenance Perform accuracy self check if poor function i
114. so varies with extremes of age and tends to be lower for example in the elderly Other factors that can affect normal temperature include gender temperature rises MHRA 04144 Thermometer review UK market survey 2005 Introduction CORE body temperature normal range 36 8 C to 37 9 C 4 Oral Temperature 376C 5 Forehead Temperature s6 Ia 8 Ear Temperature 35 6 37 4 C Axilla Temperature Increasing temperature Rectal Temperature Figure 1 Comparison of the normal temperature ranges by body site in women around the time of ovulation and exercise Consequently it is best to define normal temperature as a range rather than a specific value When measuring temperature in patients several other factors are also important and will affect the normal range site of measurement eg oral axillary rectal ear type of thermometer used eg mercury infrared electronic chemical change clinical reason that temperature is being measured eg detection of fever in a newborn monitoring of rewarming after cardiac surgery etc The variation in normal temperature between body sites is probably the key factor in thermometry and there have been attempts to determine the difference in temperature between different body sites sometimes called the physiological offsets Figure 1 summarises temperatures that can be expected between different sites Th
115. staff in the correct use of new models of clinical thermometers is essential and can be included as part of the procurement arrangements Clinical risk from inaccurate measurements may be reduced by staff undertaking a competency based training programme Review of assessment and nursing protocols is also advised as manufacturer s instructions may describe specific precautions or preparation of the patient Staff time for these activities is an additional consequence of choosing a new model Disposable sterile covers The manufacturers of some thermometers recommend the use of specific disposable covers to help reduce the risk of cross infection for those devices that can not be adequately cleaned Depending on the thermometer selected the annual consumable budget cost for probe covers in a 700 bedded hospital could vary from 9 000 3p each ex VAT to 81 000 27p each ex VAT assuming 4 readings per patient per day Batteries All electronic thermometers listed are battery powered Product summaries describe the battery type and battery lifetime usually in terms of the number of measurements and whether a low battery indicator is provided Users are advised to remove alkali batteries from thermometers if the thermometer is unused for long periods eg over month Lithium and silver oxide batteries are less prone to corrosion so devices powered by these batteries are better suited for intermittent use All batteries should be disposed of in
116. stores last 5 readings to monitor temperature trends automatic switch off after 1 minute of non use optional fever alarm optional music playing during measurement supplied with carrying case and a set of 20 disposable hygienic probe covers Antitheft device No Low battery indicator Battery symbol displayed Self check on start up Yes Calibration Factory calibration of batch samples Thermometer care Cleaning probe tip Gently wipe with cotton bud slightly moistened with alcohol Allow to dry for 1 hour before taking temperatures Cleaning body Use soft dry cloth to clean the body of the thermometer Storage conditions 20 C to 50 C Maintenance and ongoing costs Disposable covers required 13p each 2 57 for 20 Battery Lithium CR2032 3V battery Battery lite 1000 measurements approx Maintenance See instructions for use 1 year warranty Manufacturing standards ISO9001 2000 Iso 113485 1996 l Price ex VAT 29 77 Manufacturer claims compliance with ASTM 1965 98 Supplier S Brannan amp Sons Ltd CE mark Yes Code 0434 Address Leconfield Indsutrial Estate Notified Body DNV Norway Cleator Moor 25 SQ Telephone 01946 816625 Fax 01946 816625 Website www brannan co uk e mail sales brannan co uk Manufacturer Manufactured in 68 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing Microlife IR1DA1 Infrared detector measures emitted radiation from the inner ear and c
117. ter review UK market survey 2005 Mercury in glass Zeal M2010 Traditional re usable thermometer designed to be used orally for taking sub normal hypothermia body temperatures range 24 40 C Intended use Hospital community and home use Measurement site Oral Patient group Children and adults Size LWD 100mm x 5mm Weight 20 gms User information Shake down the thermometer to ensure mercury is 2 cm below the last reading on the scale Place ther mometer tip in the usual oral cavity taking care to avoid breakage Leave in place for 3 minutes remove and read Clean as laid down by the infection control protocol then store in a clean area for re use Special features Protective plastic case Antitheft device not applicable Low battery indicator not applicable Self check on start up not applicable Calibration Every thermometer is tested at two temperatures using a reference thermometer traceable to national standards Thermometer care Cleaning probe tio Use either an alcohol swab or wash with soapy water and dry Cleaning body As for probe tip Storage conditions Store in a sterile clean area Maintenance and ongoing costs Disposable covers not required waterproof Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO 9001 2000 Manufacturer claims compliance with BS EN 12470 1 2000 CE mark Yes Code 0086 Notified Body BSI Pr
118. th a peak hold maximum device for measuring temperature under all circumstances Intended use Hospital community and home use Sa Measurement site Oral b Patient group All ages except young children b Size LWD 110mm x 6mm x 5mm Weight 4 gm User information Shake thermometer well to ensure all mercury has returned to the bulb Care should be taken to avoid breakage especially within the mouth or rectum Special features Protective case Antitheft device no Low battery indicator not applicable Self check on start up not applicable Calibration Factory calibration of batch samples tested for accuracy using method stated in BS691 40 1 0 152 Thermometer care Cleaning probe tip Wipe with light disinfectant prior to use Cleaning body As for probe tip Storage conditions Store below 42 C Maintenance and ongoing costs Disposable covers not required Battery not applicable Battery life not applicable Maintenance not applicable Manufacturing standards ISO9001 2000 Manufacturer claims compliance to BS691 CE mark Yes Code 0088 Notified Body LRQA Coventry UK Price ex VAT 1 27 Supplier S Brannan amp Sons Ltd Address Leconfield Indsutrial Estate Cleator Moor CA25 5Q Telephone 01946 816600 Fax 01946 816625 Website www brannan co uk e mail sales brannan co uk Manufacturer Manufactured in 14 MHRA 04144 Thermometer review UK market survey 2005
119. th damp cloth water or alcohol For pro fessional use immerse in 70 isopropyl alcohol 95 dilution gigasept FF 5 dilu tion lysoforium 3000 6 dilution or aseptisol 496 dilution for up to 24 hours Cleaning body As for probe tip Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Available at 21p each 4 21 for 20 Battery IEC type SR41 silver oxide high drain 1 55V Battery life 200 hours usage Maintenance Uneconomical to repair Manufacturer will replace if a fault occurs dur ing 2 year warranty period Manufacturing standards I809001 2000 EN ISO Price ex VAT 5 95 13488 2000 Manufacturer ET T ith EN Supplier Omron Healthcare UK Ltd GANAS COMPUNE Wi Address Opal Drive Fox Milne 60601 1 1998 EN12470 3 Milton Keynes MK15 0DG EN60601 1 2 Telephone 01908 258 285 CE mark Yes Code 0197 Fax 01908 258 286 Notified Body TUV Website www omron healthcare com Rheinland e mail info omronhealthcare uk eu omron com Manufacturer Microlife AG Manufactured in Taiwan and China 91 MHRA 04144 Thermometer review UK market survey 2005 Electronic contact Proact ST714 Electronic contact thermometer using a thermistor to sense temperature rise to predict the final tempera N ture reading Visually resembles tympanic ear ther mometers but DO NOT insert into ear canal s intended use Hospital community and home Measurement site Oral
120. tient use which can be safely incinerated autoclavable and disposable probes are available for the continuous monitoring device one model of infrared sensing thermometer which can be cleaned by gas sterilisation MHRA 04144 Thermometer review UK market survey 2005 Procurement issues Measurement environment Effect of room ambient temperature The product pages document the manufacturer s recommended temperature and humidity conditions for warehouse storage and transportation This is frequently a wide range eg from 25 C to 55 C While the thermometer is likely to be required for clinical use it should be stored in the temperature range listed in the comparative tables ie those appropriate for stated accuracy as most require between thirty minutes to an hour to acclimatise to the ambient temperature In particular most electronic thermometers sample the ambient temperature during the start up checks and use this information to predict the temperature reading of tissue at the measurement site Some manufacturers require that specific thermometer models should not be stored under direct sunlight and should also be protected from vibrating shock GPs district nurses and emergency healthcare workers using thermometers in the community or outdoors can encounter problems as they may get very cold or hot for example when stored in the car boot between domiciliary visits Although mercury in glass thermometers perform well
121. to read the small print To assist in this process this review summarises published manufacturers data using a standardised format When purchasing new thermometers it is useful to try and standardise on a limited range of models within a single hospital or primary care trust community health board Medical and nursing staff can then become familiar with these models and their normal temperature ranges especially trainees in rotational posts It can also simplify the purchasing and storage of consumable items maintenance arrangements and staff training programmes Careful study of the individual requirements of each speciality using thermometers is an important starting point This section provides an overview of the issues which may be considered as part of the specification process Ideally the thermometer which is eventually selected should aim to accommodate all specific requirements without being over complex Clinical issues Accuracy Display resolution especially on a digital readout does not indicate the accuracy of the temperature reading Measurements using a water bath at a controlled temperature may be used to ascertain the laboratory accuracy the figure usually quoted by manufacturers and documented in the comparison tables in this review Some manufacturers may supply on request the physiologic offsets used in their thermometers and results of clinical trials indicating the expected clinical errors Clinical experienc
122. tomatically turns off after 30 seconds melody heard through patient s ear during measuring sequence to calm infants and children extended temperature measurement range for bath water etc supplied with carrying case and set of probe covers Antitheft device No Low battery indicator Yes battery icon Self check on start up Yes Calibration Information not supplied Thermometer care Cleaning probe tip Gently wipe with cotton bud slightly moistened with alcohol Allow to dry for 1 hour before taking temperatures Cleaning body Use soft dry cloth to clean the body of the thermometer Storage conditions 20 C to 50 C 096 to 95 RH Maintenance and ongoing costs Disposable covers required 7 6 p each 3 05 for 40 Battery Lithium CR 2032 3V battery Battery lite 6000 measurements Maintenance Information not supplied Warranty period 1 year Manufacturing standards EN45001 Manufacturer claims com Price ex VAT 18 32 pliance with EN 60601 1 1998 Supplier Healthbrands Ltd EN60601 1 2 1993 prEN12470 5 Address Curlews Boarley Lane EN61000 4 3 EN61000 4 4 Sandling Maidstone EN61000 4 5 ME14 3BS CE mark Yes Code 0120 Telephone 01795 520101 T Fax 01795 520052 Notified Body SGS United Kingdom 000 merce oM e mail jmerrett healthbrands co uk Manufacturer HuBDIC Co Ltd Manufactured in S Korea 12 MHRA 04144 Thermometer review UK market survey 2005 Infrared sensing ThermoTek Plus 718 I
123. ture reading Intended use Hospital or community use Measurement site Oral and axilla Rectal optional Patient group Adults children and infants Size LWD 203mm x 81mm x 67mm Weight 275 gm User information Operators manual video and CD are available for training users Special features Liquid crystal illuminated display predictive mode for fast temperature readings direct mode for monitoring and hypothermic patients last temperature recall 30 sec ond pulse timer push button probe removal graphic icons eg turtle icon for indicat ing continuous monitoring mode called direct mode arrow icons indicate reading is outside measurement range wall mounting base rectal probes and isolation chamber available as optional extras Antitheft device Yes If selected in Biotech mode Low battery indicator Yes Self check on start up Yes Calibration Factory calibration of each unit uses thermometers traceable to national standards Accuracy checks are recommended every 6 months and after suspected damage Calibration plug 202099 which is traceable to national standards may be purchased for users to check accuracy Thermometer care Cleaning probe tip Use damp cloth with diluted detergent Cleaning body Use a cloth or sponge soaked in a mild detergent solution Storage conditions Not to exceed 30 days at storage temperature 20 55 C 10 9596 relative humidity non condensing Maintenance and ongoing costs Disposable c
124. up Adults children and infants Size LWD 125mm x 20mm x 12mm Weight 8 gm User information 2 cm Press on off switch Information on normal tempera ture range at three sites is provided Turn off by pressing the on off button again Automatic turn off after 10 minutes Special features Gold tip avoids potential allergic reactions eg to nickel flexible probe tip water proof illuminated display backlight memory for last maximum reading H or L indi cates that the temperature is above or below the measurement range see Table 3 supplied with a plastic storage case Antitheft device No Low battery indicator V displayed Self check on start up Yes Calibration Factory calibration of each unit prior to dispatch Thermometer care Cleaning probe tip Immerse in 7096 isopropyl alcohol 9596 dilution with water for up to 24 hours Cleaning body As for probe tip if thermometer is intact Storage conditions 10 C to 60 C Maintenance and ongoing costs Disposable covers not required waterproof Battery 1 5V IEC type SR44 silver oxide high drain Battery life 3000 uses Maintenance Technical inspection to verify accuracy is recommended every two years for professional users Manufacturing standards EN ISO 9001 2000 EN 46002 1996 Manufacturer Price ex VAT 5 91 claims compliance with Supplier Microlife Health Management prEN12470 3 1997 Address Units 6 amp 7 Henfield Business Park
125. up Adults children and infants L x Size LWD 190mm x 38mm x 76mm i Weight 266 gm m User information B User manual includes a diagram of correct place ment in the ear Contra indicated when an examin Sm sation reveals the infection or damage within the ear Use near electrosurgery cauterising devices causes reading errors Special features New measurement not displayed unless cover is replaced unit detects replacement of new probe cover temperature displayed for up to four minutes supplied with ther mometer holder incorporating a set of probe covers and dispenser Antitheft device Return to base unit after 40 measurements Low battery indicator Batt Low then when replacement needed Self check on start up Yes Calibration No information supplied about factory calibration Recalibration after suspected damage every 10000 readings or six months is advised IVAC CORECHECK calibrator two infrared sources at 26 C and 38 C can be purchased Thermometer care Cleaning probe tip Gently wipe probe window with cotton swab slightly moistened with alcohol Allow to dry for 45 minutes before taking temperatures Cleaning body Clean with 70 isopropanol solution not on display window lt 40 chlorine bleach solution gluteraldehyde or a mild detergent or a disinfectant Storage conditions 35 C to 60 C 15 to 95 RH Maintenance and ongoing costs Disposable covers required 6 7 p each 334 9
126. vice on Page 61 can cause additional errors and will reduce accuracy in clinical use Probe covers are optional for two and not required for four of these models Fast reading time is also promoted as a major advantage for users However some temporal artery thermometers are contraindicated when the forehead is sweaty or covered with lotions For an accurate measurement the patient must be resting in a comfortable room environment away from draughts air conditioning and heat sources A local clinical assessment should be made as to whether this is feasible in practice 62 eDueJ 1ueujeJnseoeui v puo q si Buipe iu y uaum Dume2ipui Aejdsig Aoejnooe 1seuBiu JO pue uonounj 1994109 JO WOO e qeni0Juloo e Je q oj peeu seunjejeduio JUSIQUIY o AuiunuJulO9 SU ui p sn u uA saloeJnooeul pue sule qoud eonpoJ Aew aBuei eJnyej1eduje 1uaidue p pu lx3 o ueujeunseeuJ Sulinp JO 9J0Jeq 1uaidwue y uo suonouiseJ ewu Aoe4nooe paleis 1seufiu au 16 jou aie pe ejdsip Sen eA paAeldsip sow lle 10 peureiqo si Aoeinooe 1s uBiH 2 esn eoiui o UI Al l qeye d l jueujeJnseeui uey s n q YONW eq u ljo up 1uawuainseaN dam 99S Vov 9 v Oo L O dd 66 OP 91 Voer 9 ve OF 912 Sn d el ouueu Blad 99S 09

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