Thermometer review: UK market survey 2005

Thermometer review: UK market survey 2005
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Evaluation report
EVALUATION
January 2005
MHRA 04144
Thermometer review:
UK market survey 2005
best choice • best practice.
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nww.medical-devices.nhs.uk
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Thermometer review:
UK market survey 2005
Dr Diane Crawford, Norma Greene & 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: [email protected]
For more information on CEDAR visit www.cedar.wales.nhs.uk.
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The MHRA is an executive agency of the Department of Health.
ISBN [1 84182 919 6]
Contents
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Procurement issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Clinical issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Measurement environment . . . . . . . . . . . . . . . . . . 7
Lifetime cost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Manufacturing standards . . . . . . . . . . . . . . . . . . . 9
Mercury in glass thermometers . . . . . . . . . . . . . . . . . . 11
Table 1 Comparing mercury in glass thermometers . . 13
Mercury in glass: Brannan dual scale (11/455/3). . . . . 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
MHRA 04144: Thermometer review: UK market survey 2005
Mercury in glass: Zeal M0110 . . . . . . . . . . . . . . . . . . . 22
Mercury in glass: Zeal M1010 . . . . . . . . . . . . . . . . . . . 23
Mercury in glass: Zeal M2010 . . . . . . . . . . . . . . . . . . . 24
Mercury in glass: Zeal M2510 . . . . . . . . . . . . . . . . . . . 25
Chemical (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
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 FasTemp . . . . . . . . . . . . . . . 41
Electronic contact: FlexTemp (MC-205-E) . . . . . . . . . . 42
Electronic contact: IVAC Temp Plus II . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . 50
Electronic contact: O-Temp II (MC-204-E) . . . . . . . . . . 51
Electronic contact: Proact ST714. . . . . . . . . . . . . . . . . 52
MHRA 04144: Thermometer review: UK market survey 2005
Electronic contact: Proact ST8336. . . . . . . . . . . . . . . . 53
Electronic contact: Proact ST871. . . . . . . . . . . . . . . . . 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: GentleTemp (MC-510-E) . . . . . . . . . 66
Infrared sensing: IVAC Core Check . . . . . . . . . . . . . . . 67
Infrared sensing: LCT-200 Ear Thermometer . . . . . . . 68
Contents
Infrared sensing: Microlife IR1DA1 . . . . . . . . . . . . . . . 69
Infrared sensing: Microlife IR1DE1 . . . . . . . . . . . . . . . 70
Infrared sensing: Proact ST613 . . . . . . . . . . . . . . . . . . 71
Infrared sensing: TB-100 (Thermo Buddy). . . . . . . . . . 72
Infrared sensing: ThermoTek Plus 718 . . . . . . . . . . . . 73
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
MHRA 04144: Thermometer review: UK market survey 2005
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
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).
MHRA 04144: Thermometer review: UK market survey 2005
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
consultation 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.
1
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.
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:
z provides guidance on relevant procurement issues
MHRA 04144: Thermometer review: UK market survey 2005
z reviews the alternative technologies available for the intermittent measurement
of temperature in the human body
z 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
also 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
2
Introduction
CORE body temperature
Increasing temperature
(normal range 36.8qC to 37.9qC[4])
~ 0.55qC
~ 0.7qC
Oral
Temperature
36.0 ~ 37.6qC
[5]
~ 0.85qC
~ 1.1qC
~ 1.25qC
Rectal
Temperature
34.4 ~ 37.8qC
[6]
Axilla
Temperature
35.5 ~ 37.0qC
[6]
Ear
Temperature
35.6 ~ 37.4qC
[7]
Forehead
Temperature
36.1 ~ 37.3 qC
[8]
Figure 1 Comparison of the normal temperature ranges by body site
MHRA 04144: Thermometer review: UK market survey 2005
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:
z site of measurement (eg oral, axillary, rectal, ear)
z type of thermometer used (eg mercury, infrared, electronic, chemical change)
z 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. This 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
3
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
hospitalised 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
MHRA 04144: Thermometer review: UK market survey 2005
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
circumstances. 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.
4
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 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.
MHRA 04144: Thermometer review: UK market survey 2005
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 experience of mercury in glass thermometers is extensive and based on:
z laboratory accuracy of mercury in glass thermometers, supported by factory
calibration referenced to national standards
z well established clinical measurement protocols embedded within nurse
training for decades
5
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.
Several 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.
MHRA 04144: Thermometer review: UK market survey 2005
Time to reading
Speed 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 for 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:
z mercury devices and a few compact electrical thermometers are waterproof so they can be immersed in a 70% alcohol solution for up to 24 hours
z chemical thermometers for single patient use which can be safely incinerated
z autoclavable and disposable probes are available for the continuous monitoring
device
z one model of infrared sensing thermometer which can be cleaned by gas
sterilisation.
6
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.
MHRA 04144: Thermometer review: UK market survey 2005
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 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
Standard 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.
7
Procurement issues
User training
Training of clinical 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.
MHRA 04144: Thermometer review: UK market survey 2005
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 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.
8
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 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 prepurchase negotiations with the manufacturer. Options for maintenance are that the
manufacturer:
z requires all maintenance, re-calibration and repair work to be performed at their
facilities
z 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
MHRA 04144: Thermometer review: UK market survey 2005
z 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 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:
z class I (with a measuring function) is usual for mercury in glass and chemical
thermometers
9
Procurement issues
z class IIa for most electronic and infrared sensing thermometers
z class IIb 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
countries and a number of Notified Bodies have branches in the USA, Japan, etc.
MHRA 04144: Thermometer review: UK market survey 2005
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
Mercury in glass thermometers
How they measure temperature
Mercury in glass maximum 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:
MHRA 04144: Thermometer review: UK market survey 2005
z Shake the thermometer to return all the mercury to the bulb before each patient
reading.
z Do not use within 30 minutes of patient taking exercise, bathing, eating,
drinking or smoking.
z 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.
z During axilla measurement place the thermometer bulb high in the armpit and
hold arm to chest for 10 minutes.
z Place the thermometer bulb at a depth of 2.5 cm (1 inch) within the rectum for
5 minutes to achieve a stable accurate temperature reading.
z 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
Mercury in glass thermometers
Overall comparison of manufacturer'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 some hospital medical devices or
radio-communications equipment (eg mobile phones) does not affect mercury-inglass thermometers.
MHRA 04144: Thermometer review: UK market survey 2005
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
< 42
< 42
< 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
+0.1 / -0.15
+0.1 / -0.15
+0.1 / -0.15
+0.1 / -0.15
+0.1 / -0.15
+0.1 / -0.15
Brannan Dual scale
Brannan Easy-Read
Brannan Ovulation
Brannan Solid Stem
UN507 (Rectal)
UN 508
13
35 ~ 42
24 ~ 40
+0.1 / -0.15
+0.1 / -0.15
+0.2 / -0.30
+0.2 / -0.30
Zeal M0110
Zeal M1010
Zeal M2010
Zeal M2510
Some displayed temperatures are not at the highest stated accuracy.
Minimal restrictions on the ambient temperature before or during measurement.
Extended ambient temperature range may reduce problems and inaccuracies when used in the community.
Ambient temperatures need to be at a comfortable room temperatue for correct function and/ or highest accuracy.
Display indicating when the temperature reading is beyond the measurement range.
E
F
G
0.2°C
D
n/a
0.2°C
0.1°C
0.1°C
0.2°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
C
G
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Display
resolution
24 ~ 40
24 ~ 40
35 ~ 42
35 ~ 42
25 ~ 40
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
35 ~ 42
Display
range(°C)
Thermometer display
Highest accuracy is obtained for all/ most displayed values.
BD
G
G
G
G
G
G
G
G
G
G
G
Lowest
accuracy
(eg outside operating
range)
Measurement accuracy can often be much better than measurement repeatability in clinical use.
0 ~ 100%
BD
BD
BD
BD
BD
BD
BD
BD
BD
BD
BD
Warning
if reading is
outside
display
range
B
< 50
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
0 ~ 100%
Ambient
humidity RH
Are all
readings
at highest
stated
accuracy?
**
24 ~ 40
< 50
< 50
< 50
< 42
25 ~ 40
+0.2 / -0.30
UN509 (Subnormal)
35 ~ 42
< 42
35 ~ 42
+0.1 / -0.15
UN5081 (Dual Scale)
< 42
< 42
< 42
Operating
range
(°C)
Ambient temperature range
(°C)
Manufacturer’s Stated Accuracy (highest)
Mercury in glass thermometers - Accuracy** and Temperature Display
Highest
accuracy
(°C)
Mercury in glass
thermometers
Table 1
MHRA 04144: Thermometer review: UK market survey 2005
3min
3 min
not supplied
3 min
4 min
4 min
4 min
4 min
4 min
4 min
4 min
4 min
Typical time
to reading
(oral)
Table 1 Comparing mercury in glass thermometers
Mercury in glass:
Brannan dual scale (11/455/3)
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
Patient group: All ages except young children
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.
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 (+0.1 / -0.15°C).
MHRA 04144: Thermometer review: UK market survey 2005
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:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816600
01946 816625
www.brannan.co.uk
[email protected]
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
14
Mercury in glass:
Brannan Easy Read (11/456/3)
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: 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 be taken to avoid
breakage, especially within the mouth.
2 cm
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 (+0.1 / -0.15°C).
MHRA 04144: Thermometer review: UK market survey 2005
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:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816600
01946 816625
www.brannan.co.uk
[email protected]
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
15
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
Weight:
8 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.
2 cm
Special features
Easy reading broad scale plate; charts for monitoring periodic changes in temperature 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 (+0.1 / -0.15°C)
MHRA 04144: Thermometer review: UK market survey 2005
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):
£5.35
Supplier:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816600
01946 816625
www.brannan.co.uk
[email protected]
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
16
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 (+0.1 / -0.15°C). .
MHRA 04144: Thermometer review: UK market survey 2005
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):
£1.27
Supplier:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816600
01946 816625
www.brannan.co.uk
[email protected]
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
17
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.
2 cm
Special features
Protective plastic case.
Antitheft device: no
Low battery indicator: not applicable
Self-check on start-up: not applicable
Calibration: information not supplied .
MHRA 04144: Thermometer review: UK market survey 2005
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 compliance with BS691
CE mark: Yes Code: 0197
Notified Body: TUV Rheinland
Price (ex VAT):
£1.45
Supplier:
Address:
Universal Hospital Supplies
Unit 6, George House,
Millmarsh Industrial Estate,
Enfield AN3 7QJ
0845 082 0182
0845 082 0180
[email protected]
www.uhs.co.uk
Universal Hospital Supplies
China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
18
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.
2 cm
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
MHRA 04144: Thermometer review: UK market survey 2005
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 compliance with BS691
CE mark: Yes Code: 0197
Notified Body: TUV Rheinland
Price (ex VAT):
80 pence
Supplier:
Address:
Universal Hospital Supplies
Unit 6, George House,
Millmarsh Industrial Estate,
Enfield AN3 7QJ
0845 082 0182
0845 082 0180
[email protected]
www.uhs.co.uk
Universal Hospital Supplies
China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
19
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.
2 cm
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
MHRA 04144: Thermometer review: UK market survey 2005
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 compliance with BS691
CE mark: Yes Code: 0197
Notified Body: TUV Rheinland
Price (ex VAT):
80 pence
Supplier:
Address:
Universal Hospital Supplies
Unit 6, George House,
Millmarsh Industrial Estate,
Enfield AN3 7QJ
0845 082 0182
0845 082 0180
[email protected]
www.uhs.co.uk
Universal Hospital Supplies
China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
20
Mercury in glass:
UHS UN509 (subnormal)
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, 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
returned to the bulb. Care should be taken to avoid
breakage, especially within the mouth or rectum.
2 cm
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
MHRA 04144: Thermometer review: UK market survey 2005
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 compliance with BS691
CE mark: Yes Code: 0197
Notified Body: TUV Rheinland
Price (ex VAT):
£1.60
Supplier:
Address:
Universal Hospital Supplies
Unit 6, George House,
Millmarsh Industrial Estate,
Enfield AN3 7QJ
0845 082 0182
0845 082 0180
[email protected]
www.uhs.co.uk
Universal Hospital Supplies
China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
21
Mercury in glass:
Zeal M0110
Traditional re-usable thermometer designed to be
placed under the arm or used orally for taking normal 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
2 cm
below the last reading on the scale. Place thermometer tip in the usual oral cavity or axilla position. 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 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.
MHRA 04144: Thermometer review: UK market survey 2005
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):
75 pence (£7.50 pack 10)
Supplier:
Address:
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
ZEAL Group
information not supplied
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
22
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
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 thermometer 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
MHRA 04144: Thermometer review: UK market survey 2005
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:
Address:
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
ZEAL Group
information not supplied
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
23
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 thermometer 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
MHRA 04144: Thermometer review: UK market survey 2005
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):
95 pence (£9.50 pack 10)
Supplier:
Address:
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
ZEAL Group
information not supplied
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
24
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
2 cm
below the last reading on the scale. Place thermometer 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.
MHRA 04144: Thermometer review: UK market survey 2005
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):
95 pence (£9.50 pack 10)
Supplier:
Address:
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
ZEAL Group
information not supplied
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
25
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.
MHRA 04144: Thermometer review: UK market survey 2005
These chemical dots are covered with a clear polymeric film which allows
observation 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°C 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
z Do not use within 30 minutes of patient taking exercise, bathing, eating,
drinking or smoking.
z 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 missed.
The patient should hold their tongue down on the strip and keep their mouth
closed for 1 minute.
z For axilla measurement, if applicable, hold arm to chest for 3 minutes after
placing the chemical thermometer high in the armpit.
z Read within 30 seconds after removal from the measurement site.
26
Chemical (phase change) thermometers
Overall comparison of manufacturer'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 equipment (eg mobile phones).
MHRA 04144: Thermometer review: UK market survey 2005
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
<50
<50
<50
35 ~ 40
35 ~ 41.9
35.5 ~ 40.4
35.5~ 41.9
±0.1
±0.1
±1.0
±0.1
±0.1
±0.1
EZEtemp
Disposable
EZEtemp
Traxit
Forehead
Thermometer
Insight Traxit
Nextemp
Spot Check
28
0% - 100%
0% - 100%
0% - 100%
0% - 100%
0% - 100%
BE
BE
BE
BF
BE
BE
BF
Highest accuracy is obtained for all/ most displayed values.
Some displayed temperatures are not at the highest stated accuracy.
Minimal restrictions on the ambient temperature before or during measurement.
Extended ambient temperature range may reduce problems and inaccuracies when used in the community.
Ambient temperatures need to be at a comfortable room temperatue for correct function and/ or highest accuracy.
Display indicating when the temperature reading is beyond the measurement range.
Adhesive thermometer for axilla readings. Time taken is 3 minutes for the first reading and 5 seconds for subsequent readings.
D
E
F
G
@
35 ~ 41.9
35 ~ 40.4
35 ~ 41.9
35 ~ 40
35 ~ 41.9
35 ~ 40.4
35.5 ~
40.4
Display
range (°C)
C
0.1°C
0.1°C
0.1°C
1.0°C
0.1°C
0.1°C
0.1°C
Display
resolution
Thermometer display
B
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Warning if
Lowest
reading is
accuracy
outside
(eg outside
display
operating
range
range)
Measurement accuracy can often be much better than measurement repeatability in clinical use.
18 - 27
<50
0% - 100%
0% - 100%
Ambient
humidity RH
Are all
readings
at highest
stated
accuracy?
**
35 ~ 41.9
<50
<35
35.5 ~ 40.4
+0.1/ -0.2
3M Tempa.DOT
35.5 ~ 40.4
Ambient temperature
range (°C)
Operating
range (°C)
Highest
accuracy
(°C)
Chemical
thermometers
Manufacturer’s Stated Accuracy (highest)
Table 2 Chemical thermometers - Accuracy** and Temperature Display
MHRA 04144: Thermometer review: UK market survey 2005
1 min
1 min
2 - 3 min
(axila)
15 sec
(forehead)
@ 5 sec ~
3 min
1 min
1 min
Typical time to
reading (oral)
Table 2 Comparing chemical thermometers
Chemical:
3MTM Tempa.DOTTM Single-Use
Thin flexible plastic strip with heat responsive indentations which turn from orange to blue when they
exceed their designated temperature.
Intended use: Hospital and primary care
Measurement site: Oral and axilla
Patient group: Adults, children and infants
Size (LWD): 91mm x 9mm
Weight:
<1 gm
User information
2 cm
Do not use within 15 minutes of exercise. Place the
sensor (dots) in the usual oral position or in the axilla with tab parallel with the body, so the sensor is
surrounded by warm tissue. Ten seconds after removal read the last blue dot, ignore
skipped dots. Discard immediately after use.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Stored 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°C.
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
Manufacturer claims compliance with
ASTM E 825-87
CE mark: Yes Code: 0086
Notified Body: British Standards
Institute
Price (ex VAT):
7.0 pence each (£174.67
per 2500)
Supplier:
Address:
3M Health Care Ltd
3M House, Morley Street,
Loughborough LE11 1EP
01509 611611
01509 613326
www.3mhealthcare.co.uk
[email protected]
3M Co
USA
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
29
Chemical:
EZEtemp Disposable
Thin flexible plastic strip with heat responsive indentations 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:
<1gm
User information
Place thermometer's sensor area in usual oral or
axilla position so it is surrounded by warm tissue.
Remove the tab after 1 ~ 3 minutes and read immediately. Last black dot indicates temperature reading.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 on wrapper). Store in dry conditions.
Maintenance and ongoing costs
Disposable covers not applicable
Battery: not applicable
Battery life: not applicable
Maintenance: not applicable
Manufacturing standards
Price (ex VAT):
BS EN ISO 9001:2000 Manufacturer
claims compliance with ASTM E1299Supplier:
96;
Address:
CE mark: Yes Code: 0086
Notified Body: BSI Product Services
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
30
14 pence (£140 per 1000)
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
Medical Indicators
USA
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 temperature.
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:
<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.
MHRA 04144: Thermometer review: UK market survey 2005
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 patient 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 wrapper). 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):
claims compliance with ASTM E1299Supplier:
96.
Address:
CE mark: Yes Code: 0086
Notified Body: BSI Product Services
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
31
70 pence (£70 per 100)
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
Medical Indicators
USA
Chemical:
Forehead Thermometer
Reusable plastic strip comprising a liquid crystal display and scale markings for fever assessment when
placed on the skin. Zone showing green colour indicates the temperature.
Intended use: Hospital and home use
Measurement site: Forehead
Patient group: Adults, children and infants
Size (LWD): 92mm x 20mm
Weight:
<1gm
2 cm
User information
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 temperatures between 18°C and 27°C. Note normal temperatures for comparison when illness 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.
MHRA 04144: Thermometer review: UK market survey 2005
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
ISO9001:2000
CE mark: Yes Code: CE0088
Notified Body: LRQA, Coventry, UK
Price (ex VAT):
£2.54
Supplier:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816625
01946 816625
www.brannan.co.uk
[email protected]
information not supplied
information not supplied
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
32
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 temperature.
Intended use: Hospital, primary care and home
Measurement site: Axilla
Patient group: Children and infants
Size (LWD): 33mm x 32mm
Weight:
<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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Constant wearable source of temperature measurement; can remain in place for 48
hours for repeated reading; latex free adhesive; subsequent readings almost instantaneous 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 thermometer 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 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: 0086
Notified Body: BSI Product
Services
Price (ex VAT):
61 pence each (£2.45 pack of 4)
Supplier:
Address:
Insight Medical Products Ltd
Units 1-4, Silk Mill Studios,
2 Charlton Road, Tetbury,
Gloucester GL8 8DY
01666 500055
01666 500115
[email protected]
www.insightmedical.net
Medical Indicators
USA
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
33
Chemical:
Insight Nextemp
Thin flexible plastic strip with heat responsive indentations 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): 91mm x 9mm
Weight:
<1gm
User information:
Place under tongue like a traditional mercury thermometer. Read temperature immediately after withdrawal. 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 calibration of samples from each batch using a reference thermometer traceable to national reference standards.
MHRA 04144: Thermometer review: UK market survey 2005
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:
Address:
Insight Medical Products Ltd
Units 1-4, Silk Mill Studios,
2 Charlton Road, Tetbury,
Gloucester GL8 8DY
01666 500055
01666 500115
[email protected]
www.insightmedical.net
Medical Indicators
USA
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
34
Chemical:
Spot Check
Flexible plastic strip with heat responsive indentations which turn from green to black when they
exceed their designated temperature.
Intended use: Hospital, community and home
Measurement site: Oral
Patient group: Adults, children and infants
Size (LWD): 78mm x 11mm
Weight:
<1gm
User information
Place under tongue like a traditional mercury thermometer but achieves equilibrium more rapidly.
Remove the tab after 1 -3 minutes and read immediately. Last black dot indicates temperature reading.
2 cm
Special features
Reusable as display is reset after 30 seconds at room temperature; with proper storage 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 thermometers traceable to national reference standards.
MHRA 04144: Thermometer review: UK market survey 2005
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
Price (ex VAT):
£1.27 per pack
Notified Body: LRQA, Coventry, UK
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
35
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816625
01946 816625
www.brannan.co.uk
[email protected]
Medical Indicators
USA
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.
MHRA 04144: Thermometer review: UK market survey 2005
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°C.
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 portable. 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:
z Ensure the self check on start up is error free, some models will not measure
temperature if the ambient temperature is outside the specified range.
36
Electronic contact thermometers
z Do not use within 30 minutes of patient taking exercise, bathing, eating,
drinking or smoking.
z Hold mouth closed for 5 minutes before oral measurement. Hold arm to chest
for 5 minutes before axilla measurement.
z 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 temporarily store or use their diagnostic equipment outdoors, eg a car
boot.
MHRA 04144: Thermometer review: UK market survey 2005
Some models may produce reading errors when subject to electronic interference,
which can be generated by some types of hospital equipment or radiocommunication 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
38
0 ~ 50
15 ~25
18 ~ 28
18 ~ 28
16 ~ 40
18 ~ 28
18 ~ 28
18 ~ 28
18 ~ 28
18 ~ 28
18 ~ 28
18 ~ 28
18 ~ 28
5~40
5~40
5~40
10~40
16~40
Operating
range (°C)
25 ~ 45
34 ~ 40
35.5 ~ 42
34 ~ 42
35.8 ~ 41
34 ~ 42
34~ 42
34~ 42
34~ 42
34~ 42
34~ 42
34~ 42
32~ 42
32~ 43
32~42
32~ 42
32~ 43
26.7~43.3
32~43.4
35.5~42.9
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
±0.1
YSI 4000A
Digitemp (UN518)
Filac FasTemp
FlexTemp (MC-205-E)
IVAC Temp Plus II
Microlife MT1671
Microlife MT16F1
Microlife MT18F1
Microlife MT1921
Microlife MT1931 Gold
Microlife MT1951
Microlife MT1961
O-Temp
Proact ST714
Proact ST8338
Proact 871
Proact 871(flexible tip)
Suretemp Plus
ThermoTek Instant
Zeal M5003
see page 13 for details of the abbreviations used in Table 3
18 ~ 28
5~42
Ambient
temperature
range (°C)
0 ~ 100%
not supplied
15 ~ 95%
10 ~ 80%
10 ~ 80%
10 ~ 80%
0 ~ 80%
30 ~ 85%
30 ~ 85%
30 ~ 85%
30 ~ 85%
30 ~ 85%
30 ~ 85%
30 ~ 85%
30 ~ 85%
15% - 95%
30 ~ 85%
10 ~ 95%
not supplied
0 - 95%
Ambient
humidity RH
Manufacturer’s Stated Accuracy (highest)
CD
BF
BE
BE
BE
BE
BE
CF
CF
CF
CF
CF
CF
CF
CF
BF
CF
CF
CF
BD
G
G
G
G
G
G
G
G
G
G
G
G
G
G
G
G
G
G
n/a
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
not supplied
not supplied
not supplied
not supplied
not supplied
not supplied
not supplied
±0.2
0.1°C
0.01°C
0.1°C
0.1°C
0.1°C
0.01°C
0.01°C
0.1°C
0.1°C
not supplied
not supplied
0.1°C
0.1°C
0.01°C
0.1°C
Display
resolution
28 ~ 42
32 ~ 43.4
26.7 ~ 43.3
32 ~ 43
32 ~ 43
32 ~ 43
32 ~ 43
32 ~ 42
32 ~ 42.9
32 ~ 43.9
32 ~ 43.9
32 ~ 42.9
32 ~ 42.9
32 ~ 43.9
32 ~43.9
26.7 ~ 42.2
32 ~ 43.9
30 ~ 43
32 ~ 42.99
0 ~ 50
Display range
(°C)
Thermometer display
not supplied
not supplied
Are all
Warning if
Lowest
readings reading is
accuracy
at highestoutside
(eg outside
stated
display
operating
accuracy?
range
range)
Electronic contact thermometers - Accuracy** and Temperature Display
Highest
accuracy
(°C)
Electronic
contact
thermometers
Table 3
MHRA 04144: Thermometer review: UK market survey 2005
1 min
5 sec
6 sec
10 sec
10 sec
60 sec
5 sec
1 min
20 sec
20 sec
60 sec
30 sec
20 sec
60 sec
60 sec
not supplied
1 min
4 sec
60 - 90 sec
continuous
Typical time
to reading
(oral)
Table 3 Comparing electronic contact thermometers
Electronic monitoring:
YSI 4000A
Dual channel electronic contact thermometer using
thermistors embedded within reusable or disposable
probes. Designed for simultaneous continuous monitoring 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
2 cm
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 precautions to avoid alternate site injuries if patient is subject to electrosurgery.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Able to set normal temperature range for each probe; self calibration (at 37°C) optimises 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 procedure 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-check on start-up: Yes
Calibration: Factory calibration using standards traceable to National Institute of
Standards 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 life: 900 hours minimum
Maintenance: Return to manufacturer if Price (ex VAT):
‘SELF CAL’ message does not go away.
Manufacturing standards
ISO9001:2000; ISO14001:1996;
EN13485:1996. Manufacturer claims
compliance with EN 60601-1; UL26011; EN58001; EN50082; EN1441
CE mark: Yes Code: 0336
Notified Body: TNO Certification
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
39
£356.00 approx (E440)
Technomed
Amerikalaan 716199 AE,
Maastricht-Airport
Netherlands
+31 434086868
+31 434086888
www.technomed.n1
[email protected]
YSI
USA
Electronic contact:
Digitemp (UN518)
Electronic contact thermometer using a thermistor to
sense temperature. Audible tone when temperature
rise is <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:
10 gm
User information:
Press on/off switch to initiate a self check. After ‘L’ is
displayed place probe tip at the measurement site
until reading complete (four beeps repeated 8
times).
2 cm
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
MHRA 04144: Thermometer review: UK market survey 2005
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 life: 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:
Address:
Millmarsh
Universal Hospital Supplies
Unit 6, George House,
Industrial Estate, Enfield
AN3 7QJ
0845 0820182
0845 0820180
www.uhs.co.uk
[email protected]
Microlife
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
40
Electronic contact:
Filac FasTemp
Electronic contact thermometer using a thermistor to
sense temperature rise and predict final temperature 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.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Liquid crystal illuminated display; predictive mode for fast temperature readings;
direct mode for monitoring and hypothermic patients; last temperature recall; 30 second pulse timer; push button probe removal; graphic icons (eg turtle icon for indicating 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/10-95%
relative humidity, non condensing.
Maintenance and ongoing costs
Disposable covers: 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 available. No user serviceable parts.
Price (ex VAT):
£198.85
Manufacturing standards
ISO9002, ISO 13485 Manufacturer
claims compliance with, EN60601-12:1993; ASTM E1112:1998
CE mark: Yes Code: 0123
Notified Body: TUV Product Service
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
41
Tyco Healthcare
154 Fareham Road,
Gosport PO13 OAS
01329 224114
01329 224334
[email protected]
Tyco Healthcare (Kendall)
USA
Electronic contact:
FlexTemp (MC-205-E)
Electronic contact thermometer using a thermistor to
sense temperature rise. Audible tone when temperature 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
2 cm
User information:
Compact user information booklet provided. Only
use within acceptable ambient conditions. See general advice for measuring oral, axilla and rectal temperature.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Flexible probe tip; 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 storage case.
Antitheft device: No
Low battery indicator: ‘T’ 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 with damp cloth (water or alcohol). For professional use immerse in 70% isopropyl alcohol (95% dilution), gigasept FF(5% dilution),
lysoforium 3000 (6% dilution) or aseptisol (4% 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 during 2 year warranty period.
Manufacturing standards
ISO9001:2000; EN ISO
13488:2000; Manufacturer
claims compliance with EN
60601-1:1998; prEN124703:1997; EN60601-1-2; EN
980; EN 1041; EN 1441
CE mark: Yes Code: 0197
Notified Body: TUV,
Rheinland
Price (ex VAT):
£8.95
Supplier:
Address:
Omron Healthcare UK Ltd
Opal Drive, Fix Milne
Milton Keynes MK15 0DG
01908 258 285
01908 258 286
www.omron-healthcare.com
[email protected]
Microlife AG
Taiwan and China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
42
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) & 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.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 reading; stated accuracy applies in monitor mode not the predictive (default) mode; supplied 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) obtainable from the manufacturer.
Thermometer care
Cleaning probe tip: See ‘cleaning body’
Cleaning body: Clean instrument surface with 10% chlorine bleach solution, 3%
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 recommended. Service manual and train- Price (ex VAT):
£400.00
ing for medical engineers is available.
Manufacturing standards
9001:2000. Manufacturer claims compliance with EN 601-1:1977; EN
55011:1991; EN60601-1-2:1993
CE mark: Yes Code: 0526
Notified Body: British Standards
Institute
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
43
Alaris
The Crescent, Jays Close,
Basingstoke, Hampshire
RG22 4BS
01256 388284
01256 388860
www.alarismed.co.uk
(see website)
Alaris Medical Systems Inc
USA
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:
8gm
User information
Press On/off switch to display last reading and initi2 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 end button briefly. Replace
thermometer when ‘ERR’ is displayed.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Waterproof; memory for last maximum reading; automatic switch off after 10 minutes
non use; self-test includes a check for ambient temperature <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: ‘T’ 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 70% isopropyl alcohol (95% 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
EN ISO 9001:2000; EN
46002:1996. Manufacturer
claims compliance with
prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Price (ex VAT):
£3.36
Supplier:
Address:
Microlife Health Management
Units 6 & 7, Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
44
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
Measurement site: Oral, axilla and rectal
Patient group: Adults, children and infants
Size (LWD): 128mm x 20mm x 13mm
Weight:
8gm
User information
2 cm
Press on/off switch to display last reading and initiate 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.
MHRA 04144: Thermometer review: UK market survey 2005
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 temperature <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: ‘T’ 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: Wipe in cotton swab moistened with 70% isopropyl alcohol (95%
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):
Manufacturing standards
EN ISO 9001:2000; EN 46002:1996. Supplier:
Address:
Manufacturer claims compliance
with prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
45
£3.36
Microlife Health Management
Units 6 & 7,
Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Electronic contact:
Microlife MT18F1
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature. Audible tone when temperature rise is <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): 125mm x 20mm x 13mm
Weight:
12 gm
2 cm
User information:
On/off switch at thermometer end. During measurement the current temperature is displayed continuously 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. Replace thermometer when ‘ERR’ is displayed.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Waterproof; illuminated display/ backlight; memory for last maximum 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: ‘T’ displayed
Self-check on start-up: Yes
Calibration: Factory calibration of each unit prior to dispatch.
Thermometer care
Cleaning probe tip: Immerse in 70% isopropyl alcohol (95% 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
Manufacturing standards
Supplier:
EN ISO 9001:2000; EN 46002:1996. Address:
Manufacturer claims compliance
with prEN12470-3:1997
CE mark: Yes Code: 0044
Telephone:
Notified Body: RWTUV
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
46
Microlife Health Management
Units 6 & 7,
Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Electronic contact:
Microlife MT1921
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature. Audible tone when temperature rise is <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
2 cm
User information
On/off switch at thermometer end. During measurement the current temperature is displayed continuously 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 on/off button again. Replace thermometer when ‘ERR’ is displayed.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Flexible probe tip; waterproof; illuminated display/ backlight; memory for last maximum 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: ‘T’ displayed
Self-check on start-up: Yes
Calibration: Factory calibration of each unit prior to dispatch
Thermometer care
Cleaning probe tip: Immerse in 70% isopropyl alcohol (95% 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
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
Microlife Health Management
Units 6 & 7,
Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Manufacturing standards
Supplier:
EN ISO 9001:2000; EN
Address:
46002:1996. Manufacturer claims
compliance with prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Telephone:
47
Electronic contact:
Microlife MT1931 Gold
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature. Audible tone when temperature rise is <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): 125mm x 20mm x 12mm
Weight:
8 gm
2 cm
User information:
Press on/off switch. Information on normal temperature 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; waterproof; illuminated display/ backlight; memory for last maximum reading; ‘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: ‘T’ displayed
Self-check on start-up: Yes
Calibration: Factory calibration of each unit prior to dispatch.
MHRA 04144: Thermometer review: UK market survey 2005
Thermometer care
Cleaning probe tip: Immerse in 70% isopropyl alcohol (95% 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 SR41 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
claims compliance with
prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Price (ex VAT):
£5.91
Supplier:
Address:
Microlife Health Management
Units 6 & 7, Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
48
Electronic contact:
Microlife MT1951
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature. Audible tone when temperature rise is <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 22mm x 15mm
Weight:
15 gm
User information
2 cm
On/off switch at thermometer end. During measurement the current temperature is displayed continuously 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Waterproof; illuminated display/ backlight; memory for last maximum 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: ‘T’ 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 70% isopropyl alcohol (95% 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
EN ISO 9001:2000; EN
46002:1996. Manufacturer
claims compliance with
prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Price (ex VAT):
£5.06
Supplier:
Address:
Microlife Health Management
Units 6 & 7, Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
49
Electronic contact:
Microlife MT1961
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature. Audible tone when temperature rise is <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 25mm x 20mm
Weight:
15 gm
2 cm
User information:
On/off switch at thermometer end. During measurement the current temperature is displayed continuously 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Flexible probe tip; waterproof; illuminated display/ backlight; memory for last maximum 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: ‘T’ 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 70% isopropyl alcohol (95% 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
EN ISO 9001:2000; EN
46002:1996. Manufacturer
claims compliance with
prEN12470-3:1997
CE mark: Yes Code: 0044
Notified Body: RWTUV
Price (ex VAT):
£5.91
Supplier:
Address:
Microlife Health Management
Units 6 & 7, Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
50
Electronic contact:
O-Temp II (MC-204-E)
Electronic contact thermometer using a thermistor to
sense temperature. Audible tone when temperature
rise is <0.10C 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
provided. Only use within acceptable ambient conditions. See general advice for measuring oral, axilla
and rectal temperature.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 storage case.
Antitheft device: No
Low battery indicator: ‘T’ 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 with damp cloth (water or alcohol). For professional use immerse in 70% isopropyl alcohol (95% dilution), gigasept FF(5% dilution), lysoforium 3000 (6% dilution) or aseptisol (4% 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 during 2 year warranty period.
Manufacturing standards
ISO9001:2000; EN ISO
13488:2000; Manufacturer
claims compliance with EN
60601-1:1998; EN12470-3;
EN60601-1-2;
CE mark: Yes Code: 0197
Notified Body: TUV,
Rheinland
Price (ex VAT):
£5.95
Supplier:
Address:
Omron Healthcare UK Ltd
Opal Drive, Fox Milne,
Milton Keynes, MK15 0DG
01908 258 285
01908 258 286
www.omron-healthcare.com
[email protected]
Microlife AG
Taiwan and China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
51
Electronic contact:
Proact ST714
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature reading. Visually resembles tympanic ear thermometers but DO NOT insert into ear canal.
Intended use: Hospital, community and home
Measurement site: Oral, axilla and rectal
Patient group: Adults, children and infants
Size (LWD): 165mm x 37mm x 50mm
Weight:
65 gm
User information
2 cm
Press on/off switch to initiate a self check and display last reading. Place probe tip at the measurement 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 >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.
MHRA 04144: Thermometer review: UK market survey 2005
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 life: 1800 measurements (approx.)
Maintenance: No maintenance required
Manufacturing standards
ISO9001:2000; EN ISO 13488:2000.
Manufacturer claims compliance with Price (ex VAT):
EN60601-1:1990; EN60601-1Supplier:
2:1992; EN 12470-3:1998.
Address:
CE mark: Yes Code: 0434
Notified Body: DNV, Norway
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
52
£13.95
Proact Medical Ltd
9-13 Oakley Hay Lodge,
Great Folds Road, Oakley
Hay Business Park,
Northants NN18 9AS
0870 909 7400
0870 909 7500
www.proactmedical.co.uk
[email protected]
MSR
Taiwan
Electronic contact:
Proact ST8336
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature 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
2 cm
Press on/off switch to display last reading and initiate 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Fixed or flexible probe tip versions available; memory of last reading; audible fever
alarm when measured temperature >37.5°C; auto shutdown after 10 minutes nonuse; 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: Clean 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
claims compliance with EN606011:1990; EN60601-1-2:1992; EN
12470-3:1998.
CE mark: Yes Code: 0434
Notified Body: DNV, Norway
Price (ex VAT):
£3.00
Supplier:
Address:
Proact Medical Ltd
9-13 Oakley Hay Lodge,
Great Folds Road, Oakley
Hay Business Park,
Northants NN18 9AS
0870 909 7400
0870 909 7500
www.proactmedical.co.uk
[email protected]
MSR
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
53
Electronic contact:
Proact ST871
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature 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
2 cm
Press on/off switch to display last reading and initiate 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Memory of last reading; audible fever alarm when measured temperature >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 SG3 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):
Manufacturer claims compliance with
EN60601-1:1990; EN60601-1-2:1992; Supplier:
Address:
EN 12470-3:1998.
CE mark: Yes Code: 0434
Notified Body: DNV, Norway
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
54
£3.50
Proact Medical Ltd
9-13 Oakley Hay Lodge,
Great Folds Road, Oakley
Hay Business Park,
Northants NN18 9AS
0870 909 7400
0870 909 7500
www.proactmedical.co.uk
[email protected]
MSR
Taiwan
Electronic contact:
Proact ST871(flexible tip)
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature reading.
Intended use: Hospital, community and home
Measurement site: Oral, axilla and rectal
Patient group: Adults, children and infants
Size (LWD): 135mm x 25mm x 13mm
Weight:
16 gm
User information
2 cm
Press on/off switch to display last reading and initiate 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Flexible tip; memory of last reading; audible fever alarm when measured temperature >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 available
Battery: type SG3 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):
Manufacturer claims compliance with
EN60601-1:1990; EN60601-1-2:1992; Supplier:
Address:
EN 12470-3:1998.
CE mark: Yes Code: 0434
Notified Body: DNV, Norway
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
55
£4.00
Proact Medical Ltd
9-13 Oakley Hay Lodge,
Great Folds Road, Oakley
Hay Business Park,
Northants NN18 9AS
0870 909 7400
0870 909 7500
www.proactmedical.co.uk
[email protected]
MSR
Taiwan
Electronic contact:
SureTemp Plus
Electronic contact thermometer using a thermistor to
sense temperature. Predict mode (default) estimates final temperature for one of four body sites in
approximately 4 - 15 seconds, depending on specific 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:
357 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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Liquid crystal illuminated display; separate probe (red) required for rectal readings;
pulse timer; last temperature recall in predictive mode; indicator of poor tissue contact; 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 70% isopropyl
alcohol solution, 10% 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 x3, 4.5V
Battery life: 5000 measurements
Price (ex VAT):
£150.00
Maintenance: Checks every six
months are recommended
Supplier:
Welch Allyn UK Ltd
Address:
Cublington
Road, Aston
Manufacturing standards
Abbots, Buckinghamshire
ISO 9002:1994; EN ISO 13485;
HP22 4ND
Manufacturer claims compliance Telephone:
01296 689900
with IEC 601-1:1985, EN60601- Fax:
02023 659694
Website:
1-2:2000; ASSTM-E1112-00
e-mail:
[email protected]
CE mark: Yes Code: 0050
Manufacturer:
Welch Allyn
Notified Body: NSAI, Ireland
Manufactured in
The United States
56
Electronic contact:
Thermotek Instant
Electronic contact thermometer using a thermistor
to sense temperature rise and an algorithm to predict 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
Compact user information booklet provided. Only
use within acceptable ambient conditions.
2 cm
Special features
Flexible soft tip with thermistor covered by a chromium plated cup; pre-reading display of room temperature denoted by ‘r’; measurement start is automatic; LCD display in °C or °F; memory function can store up to 4 temperatures and the measurement 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.
MHRA 04144: Thermometer review: UK market survey 2005
Thermometer care
Cleaning probe tip: Clean after each measurement 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
ISO9001:2000; EN ISO 13488:2000;
Manufacturer claims compliance with
EN60601 ; ASTM E1965-98; ASTM
E-1112-98
CE mark: Yes Code: 0120
Notified Body: TUV Product Service
Price (ex VAT):
£13.99
Supplier:
Address:
PMS Instruments Ltd
Waldeck House, Waldeck
Road, Maidenhead,
Berkshire
01628 773233
01628 770562
www.pmsinstruments.co.uk
[email protected]
SAAT Ltd
Israel
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
57
Electronic contact:
Zeal M5003
Electronic contact thermometer using a thermistor to
sense temperature rise to predict the final temperature reading. Extended display range 28~ 42°C.
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
2 cm
check 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.
MHRA 04144: Thermometer review: UK market survey 2005
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°C
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
to BS EN ISO 9001:2000
CE mark: Yes Code: 0118
Notified Body: Thuringen Office for
Measurement and Calibration,
Germany
Price (ex VAT):
£4.05
Supplier:
Address:
GH Zeal Ltd
8 Deer Park Road,
Merton, LONDON
SW19 3UU
020 8542 2283
020 8543 7840
www.zeal.co.uk
[email protected]
Geratherm
Germany
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
58
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:
z internal temperature of the body
z temperature of the thermometer, which is also radiating IR energy
z 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)
z filtering effect of optical components, including the probe cover.
MHRA 04144: Thermometer review: UK market survey 2005
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 assumptions 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 ±0.2°C 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
59
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:
z 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.
MHRA 04144: Thermometer review: UK market survey 2005
z Ensuring the thermometer lens is clean and covered with a new intact probe
cover, if required. Only use the probe cover recommended by the
manufacturer.
z 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].
z Failing to seal the ear canal opening may result in a lower reading.
z Do not use excessive force to insert the probe into the ear as this may injure
the ear canal or ear drum.
z The patient should not exercise or talk during temperature taking.
z Do not measure in the ear which has just been lying on a pillow or mattress.
z Do not take a patient reading within 30 minutes of a bath/shower or swimming.
z Always wait two minutes before repeating a measurement in the same ear.
60
Infrared sensing thermometers
z Always compare measurements from the same ear.
z 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:
z Do not use on a perspiring forehead or if covered with makeup, etc. The
presence of oils and perspiration on the skin can decrease emissivity and lower
the temperature reading, potentially missing the presence of fever.
z Avoid environments with moving air, from air conditioning or a draught, as
these can artefactually lower skin temperature.
z 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
z 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.
z Move hair away to avoid it obstructing the skin reading.
MHRA 04144: Thermometer review: UK market survey 2005
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 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
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°C 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 advice on Page 61)
can cause additional errors and will reduce accuracy in clinical use.
MHRA 04144: Thermometer review: UK market survey 2005
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
10 - 40
5 ~ 40
5 ~ 40
5 ~ 40
32 ~ 42.2
32~ 42.2
32~ 42.2
32~ 42.2
±0.2
±0.2
±0.2
±0.2
±0.2
±0.2
±0.2
±0.2
Gentle Temp
IVAC Core Check
LCT-200(11/420/3)
Microlife IR1DA1
Microlife IR1DE1
Proact ST613
TB-100 (Thermobuddy)
Thermo Tek Plus 718
63
??
40 ~ 85%
BF
CE
BE
CE
not stated
10 ~ 80%
CF
CE
CF
BE
CF
not stated
0% - 95%
15 ~ 90%
30 ~ 80%
0 - 95%
CE
G
G
G
G
G
G
G
G
G
Highest accuracy is obtained for all/ most displayed values.
Some displayed temperatures are not at the highest stated accuracy.
Minimal restrictions on the ambient temperature before or during measurement.
Extended ambient temperature range may reduce problems and inaccuracies when used in the community.
Ambient temperatures need to be at a comfortable room temperatue for correct function and/ or highest accuracy.
Display indicating when the temperature reading is beyond the measurement range.
D
E
F
G
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
34.6 ~ 42.4
0 ~ 50
32 ~ 43
0 ~ 100
0 ~100
0 ~ 50
25 ~ 43.3
34 ~ 42.2
15.6 ~ 43.3
0.1/
0.01°C
0.1°C
20 ~ 42.2
Display
range (°C)
0.1°C
C
±1.0°C
±1.0°C
±1.0°C
±1.0°C
±0.3°C
±0.3°C
±0.3°C
Display
resolution
Thermometer display
B
Measurement accuracy can often be much better than measurement repeatability in clinical use.
16 ~ 40
10 ~ 40
18.3 - 32.2
10 ~ 40
15.6 ~35
15 - 95%
Ambient
humidity RH
Are all
Warning
Lowest
readings if reading accuracy
at highest- is outside (eg outside
stated
display
operating
accuracy?
range
range)
**
34.6 ~ 42.4
36 ~ 39
35.8 ~ 41
34 ~ 42.2
15.6 ~ 43.3
±0.2
First Temp Genius
10 ~ 40
35.5 ~ 42
±0.2
Ambient
temperature
range (°C)
Braun Thermoscan
Operating
range (°C)
Highest
accuracy
(°C)
Manufacturer’s Stated Accuracy (highest)
Infrared sensing ear thermometers - Accuracy** and Temperature Display
Infrared sensing ear
thermometers
Table 4
MHRA 04144: Thermometer review: UK market survey 2005
1 sec
1 sec
1 sec
1 sec
1 sec
varies
3 esc
1 sec
2 sec
3-7 sec
Typical
time to
reading
(oral)
Table 4 Comparing infrared ear thermometers
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.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 temperature equilibrium within the ear; light display changes from flashing to continuous
when reading is completed; ‘Err’ is displayed if ambient temperature is >40°C or
<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 covers 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 thermometer 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 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°C to 50°C
Maintenance and ongoing costs
Disposable covers required (£8.43 per 200)
Battery: Alkaline AA size x2 (3V)
Price (ex VAT):
Battery life: 6 months/ 1000 measurements
Maintenance: Not required
Supplier:
Manufacturing standards
ISO 9002:1994 & ISO 13488:2000.
Manufacturer claims compliance with
EN60601-1:1988; EN60601-1-2:2001;
EN60601-1-4:2000; ASTM E1965-98 and
others.
CE mark: Yes Code: 0297
Notified Body: DQS, Germany
64
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
£67.00
Welch Allyn UK Ltd
Cublington Road,
Aston Abbots,
Buckinghamshire
HP22 4ND
01296 689900
02023 659694
welchallynuk
@mail.welchallyn.com
Braun GmbH
Germany
Infrared sensing:
First Temp Genius
Infrared detector measures emitted radiation from
inner ear detecting peak value to predict the temperature at one of three body sites. Oral is default.
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)
2 cm
User information
Operators manual, video and CD are available for
training users. No adjustment of external ear is
required. Three beeps and ‘DONE’ is displayed when measurement is complete.
MHRA 04144: Thermometer review: UK market survey 2005
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 purchase; 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 calibration outside 3 year warranty period Price (ex VAT):
£249.49
costs £50.00
Manufacturing standards
ISO 9002: ISO13485 Manufacturer
claims compliance with EN606011:1990; ASTM E1112-86
CE mark: Yes Code: 0123
Notified Body: TUV Product Service
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
65
Tyco Healthcare
154 Fareham Road,
Gosport PO13 OAS
01329 224114
01329 224334
[email protected]
Tyco Healthcare (Kendall)
USA
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:
50 gm
User information
Movement of unit in the ear enables the maximum
temperature to be detected. Three repeated meas2 cm
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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Two measurement modes; fast (1-3 seconds) and one for difficult measurement conditions; 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. Calibration
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 provides 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
13488:2000;. Manufacturer
claims compliance with
ASTM E-1965-98; EN124705:2003
CE mark: Yes Code: 0197
Notified Body: TUV,
Rheinland
Price (ex VAT):
£39.95
Supplier:
Address:
Omron Healthcare UK Ltd
Opal Drive, Fox Milne,
Milton Keynes, MK15 0DG
01908 258 285
01908 258 286
omron-healthcare.com
[email protected]
Microlife AG
Taiwan and China
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in
66
Infrared sensing:
IVAC Core Check
Infrared detector measures emitted radiation from
inner ear and calculates ear temperature reading.
Intended use: Hospital and primary care
Measurement site: Ear
Patient group: Adults, children and infants
Size (LWD): 190mm x 38mm x 76mm
Weight:
266 gm
User information
User manual includes a diagram of correct placement in the ear. Contra-indicated when an examinsation reveals the infection or damage within the
ear. Use near electrosurgery/cauterising devices
causes reading errors.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 thermometer 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), <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 (£334.92 for 5000)
Battery: Alkaline 9V battery
Battery life: 8000 measurements (approx)
Maintenance: Daily inspection for damage to the sensor and display. Technical service manual and training is available for medical engineers. Fixed price manufacturer
repair is £95.00.
Price (ex VAT):
£400.00
Manufacturing standards
ISO90001:2000 Manufacturer claims
compliance with EN60601-1; EN60601-12; EN55011;
CE mark: Yes Code: 0086
Notified Body: BSI Product Services
Supplier:
Address:
Close,
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
67
Alaris
The Crescent, Jays
Basingstoke, Hampshire
RG22 4BS
01256 388284
01256 388860
www.alarismed.co.uk
(see website)
Alaris Medical Systems
USA
Infrared sensing:
LCT-200 Ear Thermometer
Infrared detector measures emitted radiation from
inner ear and calculates an ear temperature reading. 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
2 cm
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.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Display backlight for easy reading; bleeps when temperature reading completed;
automatically 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 life: 1000 measurements (approx)
Maintenance: See instructions for use, 1 year warranty
Manufacturing standards
ISO9001:2000; Iso 113485:1996
Manufacturer claims compliance with
ASTM 1965-98.
CE mark: Yes Code: 0434
Notified Body: DNV, Norway.
Price (ex VAT):
£29.77
Supplier:
Address:
S Brannan & Sons Ltd
Leconfield Indsutrial Estate,
Cleator Moor CA25 5Q
01946 816625
01946 816625
www.brannan.co.uk
[email protected]
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
68
Infrared sensing:
Microlife IR1DA1
Infrared detector measures emitted radiation from
the inner ear and converts this into an ear temperature reading (indicated by an audible beep).
Intended use: Hospital, primary care and home
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
2 cm
and correct placement of probe. Position probe and
press 'start' button. Audible beep when reading is
displayed. Wait at least 30 seconds after 3-5 readings. Do not twist the cone containing the probe.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Memory of last reading displayed for 2 seconds when switched on; automatic switch
off after 1 minute; audible fever alarm when temperature >37.5°C; 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 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 70% isopropyl alcohol
Cleaning body: Wipe with swab moistened with 70% 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 [CR2032] 3V battery
Battery life: 1000 measurements (approx)
Maintenance: None required except replacement of probe covers
Manufacturing standards
EN ISO 9001:2000; EN
46002:1996. Manufacturer
claims compliance with
prEN12470-5:2000
CE mark: Yes Code: 0044
Notified Body: RWTUV
Price (ex VAT):
£25.00
Supplier:
Address:
Microlife Health Management
Units 6 & 7, Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
69
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
Patient group: Adults, children and infants
Size (LWD): 153mm x 40mm x 31mm
Weight:
53 gm
User information
2 cm
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).
MHRA 04144: Thermometer review: UK market survey 2005
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 >37.5°C;
audible alarm if reading 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% isopropyl 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 life: 1000 measurements
Price (ex VAT):
(approx)
Maintenance: None, except cleaning Supplier:
of probe
Address:
Manufacturing standards
EN ISO 9001:2000; EN 46002:1996.
Manufacturer claims compliance
with ASTM E-1965-98
CE mark: Yes Code: 0044
Notified Body: RWTUV
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
70
£25.00
Microlife Health Management
Units 6 & 7,
Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Infrared sensing:
Proact ST613
Tympanic Infrared detector measures emitted radiation from inner ear and predicts the core temperature 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
list of precautions during use. Use of a mobile
phone near the thermometer may cause a reading
error.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
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 temperature 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 supplied
Battery life: 5000 measurements (approx.)
Maintenance: Annual calibration check £5.00 per unit + VAT + p&p
Manufacturing standards
EN ISO 13485:2003. Manufacturer
claims compliance with EN606011:1990; EN60601-1-2:1992; EN
12470-5:2000.
CE mark: Yes Code: 0434
Notified Body: DNV,Norway
Price (ex VAT):
£20.38
Supplier:
Address:
PROACT Medical Ltd
9-13 Oakley Hay Lodge,
Great Folds Road, Oakley
Hay Business Park,
Northants NN18 9AS
0870 909 7400
0870 909 7500
www.proactmedical.co.uk
[email protected]
MSR
Taiwan
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
71
Infrared sensing:
TB-100 (Thermo Buddy)
Infrared detector samples maximum emitted radiation from ear to predict ear temperature. Other
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
2 cm
Normal temperature range information provided.
Repeat reading three times for infants <90 days and
children <3 years with abnormal temperature readings. Do not use near fire.
MHRA 04144: Thermometer review: UK market survey 2005
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 temperatures; automatically 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, 0% 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 life: 6000 measurements
Maintenance: Information not supplied. Warranty period 1 year
Manufacturing standards
EN45001. Manufacturer claims compliance with EN 60601-1:1998;
EN60601-1-2:1993; prEN12470-5;
EN61000-4-3; EN61000-4-4;
EN61000-4-5
CE mark: Yes Code: 0120
Notified Body: SGS United Kingdom
Price (ex VAT):
£18.32
Supplier:
Address:
Healthbrands Ltd.
Curlews, Boarley Lane,
Sandling, Maidstone
ME14 3BS
01795 520101
01795 520052
www.hubdic.com
[email protected]
HuBDIC Co Ltd
S Korea
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
72
Infrared sensing:
ThermoTek Plus 718
Infrared detector measures emitted radiation from
inner ear and converts this into an oral equivalent
temperature reading.
Intended use: Hospital, primary care & home use
Measurement site: Ear
Patient group: Adults, children and infants
Size (LWD): 165mm x 38mm x 25mm
Weight:
78 gm
User information
Gently pull middle ear back and up straighten ear
2 cm
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
MHRA 04144: Thermometer review: UK market survey 2005
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 provides 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;
Manufacturer claims compliance
with EN60601; ASTM E-1965-98;
ASTM E-1112-98; GMP
CE mark: Yes Code: 0123
Notified Body: TUV Product Service
Price (ex VAT):
£34.00
Supplier:
Address:
PMS Instruments Ltd
Waldeck House, Waldeck
Road, Maidenhead,
Berkshire
01628 773233
01628 770562
www.pmsinstruments.co.uk
[email protected]
SAAT Ltd
Israel
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
73
74
36 ~ 39
±0.2
±0.2
Thermofocus
ThermoTek
NoTouch 960
not stated
not stated
not stated
not stated
up to 90%
up to 90%
Ambient
humidity RH
BF
CF
CF
BE
BF
BF
G
G
G
G
G
Warning
if reading
is outside
display
range
Highest accuracy is obtained for all/ most displayed values.
Some displayed temperatures are not at the highest stated accuracy.
No restrictions on the ambient temperature before or during measurement.
Extended ambient temperature range may reduce problems and inaccuracies when used in the community.
Ambient temperatures need to be at a comfortable room temperatue for correct function and/ or highest accuracy.
Display indicating when the temperature reading is beyond the measurement range.
D
E
F
G
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
0.1°C
Display
resolution
3.64 ~42.4
1 ~55
34 ~42.2
20 ~ 42.2
16 ~ 43
15.5 ~ 42
Display
range (°C)
Thermometer display
C
±1.0°C
±0.3°C
Lowest
accuracy
(eg outside
operating
range)
B
Measurement accuracy can often be much better than measurement repeatability in clinical use.
16 ~ 40
16 ~ 40
16~ 40
10 ~ 40
16 ~ 40
15.5 ~ 40
Ambient
temperature
range (°C)
All readings at
highest
stated
accuracy
**
16 ~ 36
36 ~ 39
±0.2
20 ~ 42.2
±0.2
FS-100(ACORN)
Microlife FR1DM1
16 ~ 43
±0.1
Exergen Temporal
Scanner 5000
15.5 ~ 42
Operating
range (°C)
±0.2
Highest
accuracy
(°C)
Manufacturer’s Stated Accuracy (highest)
Infrared sensing forehead thermometers - Accuracy** and Temperature Display
Exergen Temporal
Scanner 2000
Infrared sensing forehead thermometer
Table 5
MHRA 04144: Thermometer review: UK market survey 2005
3 sec
1 sec
1 sec
5 sec
0.1 sec
0.03 sec
Typical
time to
reading
(oral)
Table 5 Comparing infrared forehead thermometers
Infrared sensing:
Exergen Temporal Scanner 2000
Infrared detector measures maximum emitted radiation from skin over a superficial artery and predicts
arterial temperature. When button is released the
maximum reading will be displayed.
Intended use: Community.
Measurement site: Forehead, behind ear
Patient group: Adults, children and infants
Size (LWD): 178mm x 45mm x 32mm
Weight:
120 gm
User information
2 cm
Place probe on the skin centrally in the forehead,
depress button and slowly move laterally to the hairline. 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
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Automatically shuts down after 30 seconds of non use; error meassages when electromagnetic interference is detected; error messages when target temperature is
<42°C or >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 temperatures (36°C and 40°C).
Thermometer care
Cleaning probe tip: 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
Disposable covers optional: caps 3.5p each (£175 for 5000),
250)
Battery: Alkaline 9V battery
Price (ex VAT):
Battery life: 7500 measurements
Maintenance: Repairs during 3 year
Supplier:
warranty period are free of charge.
Address:
Manufacturing standards
EN 46003:1999 Manufacturer claims
compliance with EN60601-1:1990;
EN6061-1-2:2001; EN12470-5:2003;
CE mark: Yes Code: 0197
Notified Body: TUV, Rheinland
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
75
sheaths 14p (£35 for
£95.00
Actamed
Calder Island Way,
Wakefield WF2 7AW
01924 200550
01924 200518
www.actamed.co.uk
[email protected]
Exergen
USA
Infrared sensing:
Exergen Temporal Scanner 5000
Infrared detector measures maximum emitted radiation from skin over a superficial artery and predicts
core arterial temperature. Each click emitted indicates 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
2 cm
User information
Place probe on the skin centrally in the forehead,
depress button and slowly move laterally to the hairline. 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..
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Automatically shuts down after 30 seconds of non use; error messages when electromagnetic 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
Price (ex VAT):
£375.00
Battery life: 15000 measurements
Maintenance: Repairs during 6 year warSupplier:
Actamed Ltd
ranty period are free of charge
Address:
Manufacturing standards
EN 46003:1999 Manufacturer claims
compliance with EN 60601-1:1990;
EN60601-1-2:2001; EN12470-5:2003
CE mark: Yes Code: 0197
Notified Body: TUV, Rheinland
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
76
Calder Island Way,
Wakefield WF2 7AW
01924 200550
01924 200518
www.actamed.co.uk
[email protected]
Exergen Corporation
USA
Infrared sensing:
FS-100 (ACORN)
Infrared detector measures maximum emitted radiation from the skin surface over the temporal artery
to predict the core body temperature.
Intended use: Primary care and home use
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 measure skin temperature behind ear, moving probe
upwards. Do not use when unit is too hot or cold.
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
MHRA 04144: Thermometer review: UK market survey 2005
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 life: 6000 measurements (approx)
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:
Address:
Healthbrands Ltd.
Curlews, Boarley Lane,
Sandling, Maidstone
ME14 3BS
01795 520101
01795 520052
www.hubdic.com
[email protected]
HuBDIC Co Ltd
S Korea
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
77
Infrared sensing:
Microlife FR1DM1
Infrared detector measures emitted peak radiation
from the forehead and ambient temperature to
predict the body temperature (indicated by an
audible long beep).
Intended use: Home use
Measurement site: Forehead
Patient group: Adults, children and infants
Size (LWD): 122mm x 42mm x 43mm
Weight:
48 gm
User information
Place thermometer head on patient’s forehead
and press start button. No probe movement
required.
2 cm
Special features
Audible fever alarm when temperature > 37.5°C; audible alarm if reading is above or
below the operating range; automatically turns off after 1 minute; illuminated display/backlight; memory for 12 readings; last reading displayed for 2 seconds on
switch on.
Antitheft device: No
Low battery indicator: Yes, battery symbol flashes
Self-check on start-up: Yes
Calibration: Factory calibration of each unit prior to dispatch.
MHRA 04144: Thermometer review: UK market survey 2005
Thermometer care
Cleaning probe tip: clean with swab moistened with 70% isopropyl solution
Cleaning body: clean with swab moistened with 70% 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:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
78
Microlife Health Management
Units 6 & 7,
Henfield Business Park
Shoreham Road, Henfield,
West Sussex, BN5 9SL
01273 494401
01273 493986
www.microlife.com
[email protected]
Microlife AG
Taiwan
Infrared sensing:
Thermofocus
Non-contact infrared detector measures emitted
radiation to predict the oral or rectal temperature.
Correct distance (3cm from the forehead) is indicated by optical aiming lights.
Intended use: Hospital, primary care and home
Measurement site: Forehead
Patient group: Adults, children and infants
Size (LWD): 165mm x 40mm x 20mm
Weight:
99 gms
User information
2 cm
Press 'face' button for forehead measurements.
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 ambient temperatures (5°C to 16°C) increase measurement errors, indicated by ‘low 5’
warning.
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Skin 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°C
Maintenance and ongoing costs
Disposable covers not applicable, non-contact device
Battery: Alkaline AAA size x4 batteries [LR03] 1.5V
Battery life: 10000 measurements or 3 years
Maintenance: Perform accuracy self-check if poor function is suspected. Repair within warranty period requires return to
Price (ex VAT):
£60.00
UK supplier.
Supplier:
Henleys Medical Supplies
Manufacturing standards
Address:
Brownfields, Welwyn
ISO9002. Manufacturer claims compliGarden City, Herts AL7 1AN
ance with ASTM-E 1965-98.
Telephone:
01707 333164
CE mark: Yes Code: 0051
Fax:
01707 334795
Notified Body: CISQ, Italy
Website:
www.henleysmed.com
e-mail:
Manufacturer:
Manufactured in:
79
[email protected]
Tecnimed Srl
Italy
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
Patient group: Adults, children and infants
Size (LWD): 115mm x 62mm x 38mm
Weight:
76 gm
User information
Clean lateral forehead and temple, removing sweat,
make up, etc. Do not use within 30 minutes of exercise, or if skin is scarred or affected by skin disorders. Place on one side and up to 1 inch from forehead and move in a circle until long bleep is heard.
2 cm
MHRA 04144: Thermometer review: UK market survey 2005
Special features
Memory function can store up to 8 temperatures and the measurement time for up
to 64 hours; avoid direct sunlight, radiant heat or airflow on skin during measurement; after a 2 minute rest use same measurement area to repeat readings; supplied with a protective stand.
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 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 solution (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 provides an 'as required' repair and maintenance service. Faulty units must be returned
to the supplier. Turn around is typically 5 days.
Price (ex VAT):
£34.00
Manufacturing standards
ISO9001:2000; EN ISO 13488:2000;
Manufacturer claims compliance with
EN60601; ASTM E-1965-98;
CE mark: Yes Code: 0123
Notified Body: TUV Product Service
Supplier:
Address:
Telephone:
Fax:
Website:
e-mail:
Manufacturer:
Manufactured in:
80
PMS Instruments Ltd
Waldeck House, Waldeck
Road, Maidenhead,
Berkshire
01628 773233
01628 770562
www.pmsinstruments.co.uk
[email protected]
SAAT Ltd
Israel
Acknowledgements
Acknowledgements
We thank the following for helpful discussions and background 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.
MHRA 04144: Thermometer review: UK market survey 2005
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
References
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Mackowiak PA, Wasserman SS, Levine MM. A critical appraisal of 98.6 degrees
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Sund-Levander M Forsberg C, Wahren LK. Normal oral, rectal, tympanic and
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11 http:/www.mhra.gov.uk/ select ‘medical devices’ search for ‘mobile
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82
References
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18 BS EN 12470-2: 2001 Clinical thermometers - Part 2: Phase change type (dot
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thermometers for continuous measurement. BSi; 2001
MHRA 04144: Thermometer review: UK market survey 2005
21 BS EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red
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22 ASTM E 667-98 Specification for Clinical Thermometers (Maximum SelfRegistering, Mercury in Glass) ASTM International, 1998 (original approved
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1112-98 and ASTM E 1112-86)
24 ASTM E 1112-00 Standard specification for electronic thermometer for
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(previously approved standards were published as ASTM E 825-97 and ASTM E
825-81)
25 ASTM E 1965-98 Standard specification for infrared thermometers for
intermittent determination of patient temperature. ASTM International, 1998
26 BS EN 60601-1 Medical electrical equipment - Part 1: General requirements for
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83
References
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MHRA 04144: Thermometer review: UK market survey 2005
30 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
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