Cep08055 Espirometria

Buyers’ guide
Spirometers
CEP08055
March 2009
Contents 2
Introduction ............................................................................................. 3
Technical considerations......................................................................... 6
Operational considerations...................................................................... 9
Economic considerations ...................................................................... 11
Purchasing ............................................................................................ 13
Market review........................................................................................ 15
Comparison of handheld spirometers.................................................................... 17
Evidence of accuracy testing for handheld spirometers ........................................ 31
Comparison of desktop spirometers...................................................................... 32
Evidence of accuracy testing for desktop spirometers .......................................... 39
Comparison of PC-based spirometers .................................................................. 40
Evidence of accuracy testing for PC-based spirometers ....................................... 47
Choosing a spirometer .......................................................................................... 48
Acknowledgements ............................................................................... 51
Glossary................................................................................................ 52
References............................................................................................ 54
Appendix 1: Supplier contact details ..................................................... 58
Appendix 2: EU procurement procedure ............................................... 61
Author and report information................................................................ 63
CEP08055: March 2009

Introduction 3
Spirometry is the measurement of airflow and lung volume during a forced expiratory
manoeuvre from full inspiration [1]. It is the simplest and most common method for
assessing lung function and is one of the fundamental methods of diagnosing and
assessing airway diseases such as asthma and chronic obstructive pulmonary
disease (COPD). COPD is an umbrella term covering a range of long-term
conditions, including chronic bronchitis and emphysema, which damage the airways,
causing narrowing and making it harder for the patient to breathe.
There are two basic types of spirometer - those that measure a change in volume
and those that measure flow. In volume-displacement devices, expired volume is
recorded directly (with mechanical bellows or a piston) and flow is calculated as the
rate of change of volume. Flow-sensing devices measure airflow using, for example,
a rotating vane or an ultrasound flow sensor and calculate volume by integrating flow.
General
This buyers’ guide is intended to assist in the selection of spirometers for use in both
primary and secondary care. Information is presented in a standardised format to
help purchasers prepare a short-list. The 54 devices in this guide represent the
spirometers that were on the UK market in 2008. Models are presented
alphabetically by manufacturer. Abbreviations used in this report are defined in the
Glossary.
Scope
The spirometers were grouped into three categories:
Handheld: a spirometer that displays and records results and is intended to
be held in the hand during normal use.
Desktop: a spirometer that sits on a desk or is supported by a stand during
normal use.
PC-based: a spirometer that is operated by a PC and which records and
displays measurements via a PC.
Twenty-seven of the spirometers were handheld, ranging in price from £23 to £2129;
fourteen were desktop devices, ranging in price from £995 to £2850; thirteen were
PC-based, ranging in price from £525 to £1425.
All of the devices were capable of making basic spirometry screening measurements,
ie FEV1 and FVC. Some devices were capable of performing other measurements
and deriving additional parameters eg PEF, FEF25-75% and FEV1/FVC ratio.

Introduction 4
National guidance
DH clinical strategy
The Department of Health is currently developing a clinical strategy for COPD, which
aims to improve the quality and accessibility of COPD services. It is expected to be
published in early 2009.
NICE
Clinical guideline 12 [2], published by the National Institute for Health and Clinical
Excellence (NICE), covers the management of COPD in adults in primary and
secondary care. It recommends spirometry for diagnosis and regular monitoring and
that measurements should only be undertaken by suitably trained healthcare
workers.
To make a diagnosis from spirometry, the patient’s measurements must be

compared with reference values. Several sets of reference values have been
published; NICE recommends the use of those published by the European
Respiratory Society (ERS) in 1993 [3].
ATS/ERS
The American Thoracic Society (ATS) and ERS have published several articles on
the standardisation of spirometry, including a joint publication in 2005 [4]. This covers
definitions and guidance on equipment and patient-related procedures. It
recommends that spirometry systems should be evaluated using a computer-driven
mechanical syringe in order to test the range of exhalations that are likely to be
encountered in clinical practice.
For measurements relating to volume, ie FVC and FEV1, the accuracy and
repeatability of a spirometer is tested by delivering 24 volume-time waveforms using
the computer-driven syringe. With the spirometer set up as it would be used with a
patient, each waveform is presented five times under ambient conditions. The first
four waveforms are repeated under body temperature, ambient pressure and
saturated (BTPS) conditions, using air heated to 37±1˚C and a relative humidity
greater than 98%.
Accuracy is measured by comparing the mean of the five measurements with the
known value for each waveform. For ambient conditions the accuracy limits are
±3.5% or 0.1 litres, whichever is the greater. An accuracy error occurs if these limits
are exceeded. Acceptable spirometer performance is defined by fewer than three
accuracy errors for either FVC or FEV1 for all 24 waveforms [4].

Introduction 5
For BTPS conditions, the accuracy limits are ±4.5% or 0.2 litres, whichever is the
greater. Acceptable spirometer performance under BTPS conditions is defined as no
accuracy errors for the four waveforms tested [4].
Repeatability is assessed from the span of the five measurements for each
waveform. The repeatability limits are the same as those for accuracy for ambient
and BTPS conditions and a repeatability error is recorded if the span or percentage
span exceeds these limits [4]. Acceptable spirometer repeatability is defined as fewer
than three errors under ambient conditions and no errors under BTPS conditions.
For spirometers that measure peak flow (PEF), 26 flow-time waveforms are used. As
with the volume-time waveforms, they are delivered using a computer-driven
mechanical syringe, which must be accurate to ±2% for PEF.
The guideline states that each waveform should be delivered five times to two
devices of the same model to ascertain accuracy. The limits are ±12% or
±25 litres/minute, whichever is the greater [4]. Acceptable performance is defined as
fewer than three errors for all waveforms.
Repeatability of the PEF measurement is assessed by repeating waveforms 1, 4, 8

and 25 three times into 10 devices of the same model. The limits are ±6% or
±15 litres/minute, whichever is the greater and a repeatability error is recorded if the
span of measurements for each waveform exceeds these limits. Acceptable
performance is defined as fewer than seven errors [4].
The guideline defines calibration as the procedure for establishing the relationship
between sensor-determined values of flow or volume and the actual flow or volume.
No protocol is specified, but it recommends that calibration checks should be
undertaken at least daily using a 3 litre calibration syringe with an accuracy of
±15 millilitres or ±0.5%; the volume accuracy of the spirometer should be within
±3.5% [4]. If a spirometer uses a transducer whose primary measurement is flow,
then the syringe should be discharged at least three times to give a range of flows
between 0.5 and 12 litres/second (i.e. 3 litre injection times between 0.25 and
6 seconds); the volume readings should be independent of these flows.
British and international standard

BS ISO 26782 ‘Anaesthetic and respiratory equipment – Spirometers intended for the
assessment of pulmonary function in humans’ is currently in draft form [5]. It is
intended that the standard will include minimum safety requirements and an
alternative objective test methodology for assessing spirometer accuracy and
repeatability using a random panel of 10 mathematically derived waveforms.

Technical considerations 6
What does spirometry measure?

Spirometry is used to measure the rate at which the lung volume changes during
forced breathing manoeuvres [6]. The most common is the forced expiratory vital
capacity (FVC) manoeuvre, in which the subject inhales maximally and then exhales
as rapidly and completely as possible.
Three basic measurements are provided by the FVC manoeuvre:

• forced vital capacity (FVC), which is the volume expired during the test
• forced expiratory volume in one second (FEV1), which is the volume of air
exhaled in the first second of the FVC test
• forced expiratory ratio (FER) or the ratio of FEV1 to FVC. The volume of air
exhaled in the first second is a fairly constant fraction of FVC. It ranges from
0.7 to 0.8 in a normal adult and decreases with age [1]. The ratio helps to
quickly identify patients with airway obstructions in whom FVC is reduced and
is valuable for identifying the cause of low FEV1.
Another measure that is often obtained is the forced expiratory flow between 25%
and 75% of the FVC (FEF25-75%), also called the maximum mid-expiratory flow
(MMEF). It is calculated from the volume measured over the middle portion of the
FVC manoeuvre divided by the time required to exhale this volume [6]. It represents
the airflow in the medium and small airways and is more sensitive than FEV1 for
detecting early airway obstruction [1].
Depending on the type of spirometer (volume-displacement spirometer or flow-

sensing), the graphical presentation of the measurement varies, as the FVC results
can be plotted as either a volume-time curve (figure 1) or a flow-volume curve
(figure 2).

Volume-time and flow-volume curves

A volume-time curve, also known as a spirogram, plots the total volume exhaled by
the patient against time. FVC, FEV1 and FEF25-75% can be measured from the curve
as demonstrated in figure 1.
Figure 1. Volume-time curve for a normal adult [6]
A flow-volume curve plots airflow against total volume exhaled. FVC, FEV1, FEF25%
and FEF75%can be measured from the graph as shown in figure 2. In addition, peak
expiratory flow (PEF) can also be measured. PEF is dependent on patient effort as it
is a measure of how hard a patient can initially exhale; it is a valuable measure in
asthma patients [1].
Figure 2. Flow-volume curve for a normal adult [6]

Some spirometers can plot flow-volume loops (figure 3) which include the inspiratory
manoeuvre and the expiratory manoeuvre. The loops form distinct, easily
recognisable patterns to help diagnosis of lung disease [1].
Figure 3. Flow-volume loop for a normal adult [6]
Calibration
The majority of spirometers in this guide measure flow and calculate volume. The
calibration of such devices is complex and not easily performed by the end user.
Volume calibration checks using a 3 litre calibration syringe, as described in the
ATS/ERS guidelines [4], may be used as a satisfactory alternative [7] to check the
calibration of the flow sensor. It is recommended that these checks should be
performed at least daily [4]. If the spirometer is outside the specified accuracy limits,
it should be returned to the manufacturer or supplier for repair.

Operational considerations 9
Table 1 is a list of spirometer characteristics to be considered when purchasing.

These should be used in conjunction with the product information tables in the
Market review.
Table 1. Device considerations
Feature Description
Spirometers will either measure volume
displacement or rate of airflow. Volume displacement
Type of measurement sensor sensors include bellows. Flow sensors include
turbines, pneumotachographs, ultrasound and
pressure displacement sensors.
Devices are intended for either diagnosis or
Type of spirometry
screening/monitoring of disease.
A bronchodilator is a drug that relaxes and dilates
the bronchial passageways and aids breathing. It is
often used in the treatment of asthma. A post-
Post bronchodilator tests
bronchodilator test looks for a positive increase in
either FEV1 or FVC following administration, to
indicate disease.
Some spirometers incorporate algorithms that
provide an automatic diagnosis from measured
Automatic diagnosis capability
values when compared with the predicted normal for
a patient.
Some spirometers display the flow-volume and/or
Real time graphical display
volume-time curve during the test.
Parameters that can be measured or derived from
spirometry tests include: FVC, FEV1, FEV6,
Lung function parameters FEV1/FVC ratio (FER), FEF25-75% (MMEF), FET,
MEF50% and PEF. Some spirometers will measure
values for inspiration as well as exhalation.
Claims to meet ATS/ERS guidelines See National guidance in the Introduction
The ATS/ERS guidelines give limits of accuracy for a
spirometer in ambient and BTPS conditions. We
Measurement accuracy
have indicated for which spirometers there is
evidence of compliance with these accuracy criteria.
This can either be an integrated LCD screen or an
external PC display. Some LCD displays are
Type of display monochrome whilst others are colour. Users should
consider whether high visibility or brightly coloured
displays are important for their clinical application.

Operational considerations 10
Feature Description
A number of studies have established normal lung
function parameters for different age ranges,
Comparison with reference values
genders, heights and ethnicity. Some spirometers
store these to help with comparisons.
Printing can be via an integrated or external printer
or via a PC. Users should consider whether it is
Printing important to get a direct printout of results or whether
they can be printed later once patient data have
been transferred to a PC.
Most spirometers have an RS-232 or USB port for
downloading measurements to a PC. Use with a PC
normally requires additional software provided by the
Data transfer
manufacturer. Other interfaces that may be used
include infra-red, Bluetooth, modem or telephonic
transfer.
Some spirometers have internal memory to store test
measurements, either multiple entries or the last best
Memory capability
measurement. Other spirometers store patient
measurements directly to a database on a PC.
These factors may be important if the spirometer is
Physical size and weight
to be used in different clinics or at home by patients.
Devices in this guide are powered by mains,
Power
batteries or via USB for PC-based systems.
We have shown the list price excluding VAT. In most
cases these can be taken as a guide price since
List price
actual prices will be dependent on commercial
factors.
Consumables include mouthpieces, noseclips, filters
etc. We have shown current list prices excluding
Consumable prices
VAT. For some manufacturers / suppliers, prices
vary depending on quantity.

Economic considerations 11
Lifetime costs
This buyers’ guide has been designed to help readers decide which spirometer to
buy and the main economic consideration is lifetime cost. This includes costs of the
device, consumables, accessories, training and servicing. To achieve best value
when purchasing a spirometer, the following should be considered:
Consumables
• Sensors:
- Are these disposable or reusable?
- How often should reusable sensors be calibrated and what is their life
expectancy?
- Do disposable sensors require calibration before use?
- How many sensors are required?
- If reusable, how are they cleaned and sterilised?
• Noseclips:
- How many are required?
• Mouthpieces:
• Anti-bacterial or bacterial viral filters and flow mesh:

• Batteries:
- What is the expected operating life of a battery?
- Are these disposable or rechargeable?
- How much do replacements cost?

Economic considerations 12
Accessories
Are additional accessories (supplied at extra cost) required to use the spirometer, eg
a stand?
Training
We have indicated the training provided by the manufacturer/supplier in the Market
Review together with the associated cost. Most manufacturers provide a training
course at additional cost.
Servicing
Most manufacturers/suppliers provide servicing either on-site or at their own
premises. Servicing costs can be a fixed price or charged at an hourly rate. (See the
Market Review.)
Cost effectiveness of spirometry

We did not consider the wider question of whether spirometry testing is a cost
effective health intervention. A NICE report [8] considered the cost effectiveness of
using spirometry to screen for COPD in smokers and ex smokers in primary care. A
cost/benefit analysis was completed comparing opportunistic screening with current
practice. The analysis found that opportunistic screening was relatively cost effective.

Purchasing 13
Purchasing procedures
The Trust Operational Purchasing Procedures Manual provides details of the
procurement process [9].
European Union procurement rules apply to public bodies, including the NHS, for all
contracts worth more than £90,319 (from January 1st 2008) [10] (appendix 2). The
purpose of these rules is to open up the public procurement market and ensure the
free movement of goods and services within the EU. In the majority of cases, a
competition is required and decisions should be based on best value.
NHS Supply Chain (NHS SC) offers national contracts or framework agreements for
some products, goods and services. Use of these agreements is not compulsory and
NHS organisations may opt to follow local procedures.
Sustainable procurement
The UK Government launched its current strategy for sustainable development,
Securing the Future [11] in March 2005. The strategy describes four priorities in
progressing sustainable development:
• sustainable production and consumption – working towards achieving more with

less
• natural resource protection and environmental enhancement – protecting the
natural resources and habitats upon which we depend
• sustainable communities – creating places where people want to live and work,
now and in the future
• climate change and energy – confronting a significant global threat.
The strategy highlights the key role of public procurement in delivering sustainability.
This section identifies relevant sustainability issues and provides some guidance on
how these can be incorporated into procurement decision making processes.
Energy consumption
Suppliers should offer guidance on energy-efficient use of devices. Where devices
are in constant use, mains and battery energy should be included in whole-life cost
calculations.
Decontamination
Cost-effective decontamination, repair and refurbishment of the device should be
offered to extend serviceable life.

Purchasing 14
End of life disposal

Consideration should be given to the likely financial and environmental costs of
disposal at the end of the product’s life. Where appropriate, suppliers of equipment
placed on the market after the 13th August 2005 should be able to demonstrate
compliance with the UK Waste Electrical and Electronic Equipment (WEEE)
regulations (2006) [12]. The WEEE regulations place responsibility for financing the
cost of collection and disposal on the producer. Electrical and electronic equipment is
exempt from the WEEE regulations where it is deemed to be contaminated at the
point at which the equipment is scheduled for disposal by the final user. However, if it
is subsequently decontaminated such that it no longer poses an infection risk, it is
again covered by the WEEE regulations, and there may be potential to dispose of the
unit through the normal WEEE recovery channels.

Market review 15
Method
Product identification
We identified spirometers on the UK market by searching medical literature,
marketing literature from known suppliers, and the internet.
Collation of product information

Product information was derived from the suppliers’ or manufacturers’ product
brochures or specifications published in user manuals. We have presented the
information in a common, consistent format to allow comparison between devices.
We gave suppliers an opportunity to check and comment on the report prior to
publication.
Evidence of accuracy
We searched for peer reviewed literature relating to the performance of the
spirometers included in the market review. The following questions were considered:
• Have the performance criteria in the ATS/ERS guidelines for accuracy and
repeatability been met?
• Has the performance of any of the spirometers identified in the market review
been compared with that of other spirometers or a reference device (ie a
bellows or rolling-seal cylinder device) in human subject trials?
A literature search on Medline was completed in August 2008 using the spirometer
makes and models as the search terms. Relevant literature was also requested from
the manufacturers / suppliers.
Thirteen peer-reviewed articles were identified. These were classified as covering

one or more of the following areas:
• waveform comparison – a computer-driven mechanical syringe used to
recreate the waveforms defined by the ATS/ERS guidelines (3 articles)
[13,14,15]
• device comparison – comparison of the device under test with a reference
spirometer using human subjects (9 articles) [14-22]
• calibration – repeatability and consistency checks using calibration syringes (5
articles) [13,22-25].
Device comparison and calibration cannot be used as evidence for spirometer

accuracy as calibration only checks consistency and repeatability. There are no
accepted protocols for accuracy measurement using device comparison with human
subjects.

Market review 16
Of the three peer-reviewed articles discussing the accuracy of spirometers, Lüstro et

al [15] collected independent and in-house test reports from the manufacturers for
the spirometers being considered but carried out no laboratory tests of their own.
They did not report whether the spirometers achieved the accuracy specified in the
ATS/ERS guidelines. This paper has been excluded from our review.
In addition to the peer-reviewed articles, manufacturers/suppliers were also asked to

provide any other unpublished evidence on spirometer performance. Twenty-five
unpublished reports were received. These were categorised into the following three
types:
• full test report by an independent test house, including results showing the
spirometer’s accuracy to the ATS/ERS waveforms (8 reports) [26-33]
• full test report by the manufacturer, including results showing the spirometer’s
accuracy to the ATS/ERS waveforms (10 reports) [34-43]
• summary report by an independent test house, stating the spirometer’s
accuracy to ATS/ERS waveforms (7 reports) [44-50].
Spirometers for which we found insufficient evidence of accuracy to ATS/ERS

guidelines are indicated in the Market review tables.

Market review 17
Table 2. Comparison of handheld spirometers
Clement-Clarke Clement-Clarke
One Flow FVC Memo / FVC Memo Kit One Flow FVC Screen
(Supplier: Clement-Clarke) (Supplier: Clement-Clarke)
Type of measurement sensor differential pressure differential pressure
Type of spirometry screening/monitoring screening/monitoring
Post bronchodilator tests no no
Automatic diagnosis capability no no
Real time graphical display no no
4 measured & calculated parameters: 4 measured & calculated parameters:

Lung function parameters
FVC, FEV1, PEF, FEV1/FVC FVC, FEV1, PEF, FEV1/FVC
Claims to meet ATS/ERS guidelines yes yes
full test report by manufacturer full test report by manufacturer

(manufacturer claims same algorithm as All-Flow) (manufacturer claims same algorithm as All-Flow)
FEV1 0.2-9.95 litres / ±3% or ±0.1l FEV1 0.2-9.95 litres / ±3% or ±0.1l
Volume range & accuracy
FVC 0.2-9.95 litres / ±5.5% or ±0.1l FVC 0.2-9.95 litres / ±5.5% or ±0.1l
Flow range & accuracy PEF 20-995 l/min / ±6% or ±10 l/min PEF 20-995 l/min / ±6% or ±10 l/min
Type of display monochrome LCD monochrome LCD
ERS 93 (for 18-70 years)

Comparison with reference values Knudson (for 9-18 years)
Knudson (for 9-18 years)
(with Kit software only)
Printing via PC software (with Kit) no
Data transfer USB (with Kit) no
Memory capacity internal memory: 100 PEF, 100 FEV1 & 100 FVC none
"Kit" includes spirometer, PC cable, software &

Additional features storage case
additional mouthpiece; Storage case
Physical size (H x W x D) 114 x 98 x 44 mm 114 x 98 x 44 mm
Weight 0.150 kg (exc batteries) 0.150 kg (exc batteries)
4 x 1.5V AAA batteries 4 x 1.5V AAA batteries

Power
(not supplied) (not supplied)
Battery capacity approx. 6 months (3 measurements per day) approx. 6 months (3 measurements per day)
Training on-site training available on request on-site training available on request
List price (exc. VAT) £250.00 / £300.00 (inc. Kit) £295.00
Consumable prices (exc. VAT) mouthpieces (100) £21.50 mouthpieces (100) £21.50
Servicing costs (exc. VAT) information available on request information available on request
Optional extras (exc. VAT) calibration syringe £125.00 calibration syringe £125.00

Market review 18
Clement-Clarke Clement-Clarke
One Flow Tester Memo / Tester Memo Kit One Flow Tester Screen
(Supplier: Clement-Clarke) (Supplier: Clement-Clarke)
Type of measurement sensor differential pressure differential pressure
2 measured parameters: 2 measured parameters:

FEV1, PEF FEV1, PEF
full test report by manufacturer full test report by manufacturer

(manufacturer claims same algorithm as All-Flow) (manufacturer claims same algorithm as All-Flow)
Volume range & accuracy 0.6-9.95 litres / ±3% or ±0.1l 0.6-9.95 litres / ±3% or ±0.1l
Flow range & accuracy 60-995 l/min / ±6% or ±10 l/min 60-995 l/min / ±6% or ±10 l/min

Comparison with reference values Knudson (for 9-18 years)
Knudson (for 9-18 years)
(with Kit software only)
Printing via PC software (with Kit) no
Data transfer USB (with Kit) no
Memory capacity internal memory: 120 PEF & 120 FEV1 none
"Kit" includes spirometer, PC cable, software &

Additional features storage case
additional mouthpiece; Storage case
Weight 0.150 kg (exc batteries) 0.150 kg (exc batteries)
4 x 1.5V AAA batteries 4 x 1.5V AAA batteries

Power
(not supplied) (not supplied)
Battery capacity approx. 6 months (3 measurements per day) approx. 6 months (3 measurements per day)
Training on-site training available on request on-site training available on request
List price (exc. VAT) £115.00 / £178.00 (inc. Kit) £115.00
Consumable prices (exc. VAT) mouthpieces (100) £21.50 mouthpieces (100) £21.50
Servicing costs (exc. VAT) information available on request information available on request
Optional extras (exc. VAT) calibration syringe £125.00 calibration syringe £125.00

Market review 19
Cosmed, Italy Medical International Research (MIR), Italy

Spiropalm /Spiropalm + SpiroBank II
(Supplier: Physiological Measurements Ltd) (Supplier: Pulmolink)
turbine (Spiropalm) or
Type of measurement sensor turbine (disposable or reusable)
disposable pneumotach (Spiropalm +)
Type of spirometry diagnostic diagnostic
Post bronchodilator tests yes yes
Automatic diagnosis capability yes yes
Real time graphical display yes (on unit & with PC software) yes
over 50 measured & calculated standard parameters

Lung function parameters 32 measured & calculated parameters
with unlimited user defined parameters
summary report by independent test house

Measurement accuracy (manufacturer claims same algorithm as Pony FX) & summary report by independent test house
full test report by manufacturer
Volume range & accuracy 0-12 litres / ±2% up to 10 litres / ±3% or 0.05l
0.03-20 litres/sec (Spiropalm) / ±2%

Flow range & accuracy ±16 litres/sec / ±5% or 0.200 litres/sec
0.01-16 litres/sec (Spiropalm+) / ±2%
Type of display monochrome 320 x 240 pixel (50 x 40 mm) LCD monochrome 128x64 pixel LCD
ERS 93 (ECCS1983), NHANES III, Crapo 1981,

Adult: ERS; Knudson; Morris/Bass; Multicentrico
Knudson 83, ECCS 1971, ITS, Zapletal, Multicentrico
Comparison with reference values Barcellona
Barcelona, Pneumobil, Gutierrez, LAM, THAI 2000,
Paediatric: Knudson; Zapletal
Pereira 2006, Norma Mexicana, Austria (Forche)
Printing USB direct printout or via PC software via PC software
serial RS232, USB, wireless Bluetooth,

Data transfer USB
transtelephonic
internal memory: 300 patients 600 tests; internal memory: 6000 spirometry tests or
Memory capacity
PC software patient database 1000 hours SpO2 monitoring
PC software as standard; broncho-challenge tests PC software as standard; internal temperature sensor

(dilator, metacholine & user-defined protocols); test for BTPS conversion; lung age estimation; bronchial
Additional features
measurement quality control; paediatric challenge test; paediatric incentive animation; carrying
encouragement software; automatic BPTS correction case
Weight 0.300 kg 0.180 kg (exc batteries)
external mains adaptor or Li-Ion rechargeable

Power 4 x 1.5V AAA batteries or via USB
batteries
Battery capacity not specified not specified
basic training included; cardio-respiratory training courses available on

Training
advanced training available on request request
List price (exc. VAT) £1,050.00 £675.00
disposable turbine (100) £80.00; reusable turbine

£190.00; anti-bacterial filters (each) £0.65
Consumable prices (exc. VAT) information available on request
1 way paper mouthpieces (100) £46.12
noseclips (100) £40.60
Servicing costs (exc. VAT) not applicable £65.00 per hour
6 minute walk test £1,050

Optional extras (exc. VAT) pulse oximetry £450 pulse oximetry £ 250.00
3 litre calibration syringe £300

Market review 20
Medical International Research (MIR), Italy Medical International Research (MIR), Italy
SpiroDoc SpiroTel
(Supplier: Pulmolink) (Supplier: Medisave (UK) Ltd)
Type of measurement sensor turbine (reusable) turbine (reusable)

FVC, FEV1, FEV1%, PEF, FEF25-75%, FET FVC, FEV1, FEV1%, PEF, FEF25-75%, FET
Measurement accuracy no evidence of ATS/ERS waveform testing no evidence of ATS/ERS waveform testing
Volume range & accuracy up to 10 litres / ±3% or 0.05l up to 10 litres / ±3% or 0.05l
Flow range & accuracy ±16 litres/sec / ±5% or 0.200 litres/sec ±16 litres/sec / ±5% or 0.200 litres/sec
Type of display monochrome 16x2 character LCD monochrome 16x2 character LCD
Comparison with reference values ERS, Knudson, USA (Crapo, Bass, Morris) not specified
Printing direct printing via (optional) cable via remote PC or server software
Data transfer serial RS232 transtelephonic, serial RS232, PC modem or internet
Memory capacity last test & best test of current patient not specified
pulse oximetry; telemedicine for remote monitoring

outpatient use; PC software as standard; symptom
Additional features carrying bag
questionnaire; sleep apnoea screening; walking test
recording; test quality control
Weight 0.100 kg (inc battery) 0.100 kg (inc battery)
Power single 3V CR123A lithium coin cell single 3V CR123A lithium coin cell
cardio-respiratory training courses available on

Training information not provided
request
List price (exc. VAT) £225.00 £257.25
reusable turbine £190.00

anti-bacterial filters (each) £0.65
Consumable prices (exc. VAT) information not provided
on-site: £295 (half day up to 25 items);

Servicing costs (exc. VAT) £65.00 per hour £445 (ful day);
spirometer sent to supplier: £24.50
pulse oximetry £250.00

Optional extras (exc. VAT) information not provided
RS232 serial/parallel converter printer cable £138.00

Market review 21
Micro Medical Micro Medical

Micro Micro DiaryCard
(Supplier: Cardinal Health) (Supplier: Cardinal Health)
Type of measurement sensor turbine turbine
Type of spirometry diagnostic screening/monitoring
2 measured parameters: 4 measured & calculated parameters:

FEV1, FVC FEV1, FVC, PEF, FVC/FEV6
Volume range & accuracy 0.1-9.99 litres / ±3% 0.1-9.99 litres / ±3%
Flow range & accuracy 0.2-15.0 litres/sec / ±3% 0.2-15.0 litres/sec / ±3%
Type of display monochrome LCD monochrome 16x2 character LCD
Comparison with reference values no no
Printing no via PC software
Data transfer no serial RS232
7000 tests,
Memory capacity none
1500 with flow/volume graphs
PC software as standard; electronic diary, patient

Additional features reminder alarm & PIN number protection functions
designed for clinical trials
Weight 0.190 kg 0.200 kg
Power single 9V PP3 battery single 9V PP3 battery
Battery capacity approx. 24 hours continuous use typical life 3 months
Training Micro Medical spirometry training courses (£195.00) Micro Medical spirometry training courses (£195.00)
List price (exc. VAT) £195.00 £POA
anti-bacterial filters (box) from £18.50 anti-bacterial filters (box) from £18.50
Consumable prices (exc. VAT) paper mouthpieces (box) from £25.00 paper mouthpieces (box) from £25.00
noseclips (pk) £3 noseclips (pk) £3
annual service not required; requires user cleaning & annual service not required; requires user cleaning &
Servicing costs (exc. VAT) periodic calibration checks only; periodic calibration checks only;
return to base for all repairs return to base for all repairs
Optional extras (exc. VAT) 3 litre calibration syringe £295.00 3 litre calibration syringe £295.00

Market review 22

MicroDL MicroGP
Real time graphical display yes (with PC software) yes (with optional PC software)

Lung function parameters FEV1, FVC, PEF, FEV1/FVC; MEF50%, MEF25%, FEV1, FVC, PEF, FEV1/FVC; MEF50%, MEF25%,
MMEF, FET MMEF, FET
Comparison with reference values ECCS (adult); Zapletal, Solymar, Cogswell (child) ECCS (adult); Zapletal, Solymar, Cogswell (child)
via serial output (Canon or HP versions) via serial output (Canon or HP versions)
Printing
or PC software or (optional) PC software
Data transfer serial RS232 serial RS232
Memory capacity 500 tests including graphs (optional) PC software patient database
PC software as standard; electronic diary function;

Additional features
traffic light patient asthma warning ; modem facility
Power single 9V PP3 battery single 9V PP3 battery
Battery capacity approx. 24 hours continuous use approx. 24 hours continuous use
PC software £395.00
Optional extras (exc. VAT) 3 litre calibration syringe £295.00
3 litre calibration syringe £295.00

Market review 23

MicroLoop MicroPlus
Post bronchodilator tests yes no
Automatic diagnosis capability yes no
Real time graphical display yes no
5 or 6 measured & calculated parameters (depending

on version):
Lung function parameters 41 user-selectable measured & calculated parameters
FEV1, FVC, PEF & FER (FEV1%) or
FEV1, PEF, MMEF, FEV6 & FEV1/FEV6%
Type of display colour, touch-sensitive LCD monochrome LCD
various depending on national preferences (inc.

Comparison with reference values no
NHANES III)
via docking station to HP printers; or (optional) PC

Printing via (optional) PC software
software
Data transfer USB 1.1 serial RS232
Memory capacity internal memory: 2000+ patients inc. graphs (optional) PC software patient database
optional PC software; lung age and automatic test

result interpretation; BMI & dyspnoea score; on-
Additional features
screen child incentive feature; quality assurance
prompts; carrying case
Weight 0.315 kg (exc. transducer) 0.190 kg
mains or rechargeable 3.7V lithium polymer battery

Power single 9V PP3 battery
pack
Battery capacity approx. 6 hours approx. 24 hours continuous use
SpO2 option £360.00

MMEF & FEV6 when used with
PC software from £395.00
Optional extras (exc. VAT) PC software £395.00
Challenge software from £165.00

Market review 24
Micro Medical NDD, Switzerland

PulmoLife EasyOne “World”
(Supplier: Cardinal Health) (Supplier: Intermedical (UK) Limited)
Type of measurement sensor turbine ultrasound
Type of spirometry screening/monitoring diagnostic or screening/monitoring
Post bronchodilator tests no yes
Automatic diagnosis capability no yes
Real time graphical display no yes
2 measured & calculated parameters:

FEV1, FEV1%
peer-reviewed article & full test report by independent

Measurement accuracy summary report by independent test house
test house
Volume range & accuracy 0.0-8.0 litres / ±3% ±12 litres / ±2% or 0.050 litres
1-16 litres/sec / ±2% or 0.02 litres/sec

Flow range & accuracy 0.0-14.0 litres/sec / ±3%
PEF: 1-16 litres/sec / ±5% or 0.02litres/sec
Type of display monochrome LCD monochrome 64x160 pixel LCD
Adult: ERS (ECCS), Roca, Austria, NHANES III,

Knudson 1976 & 1983, Crapo, Morris, Cherniak,
Comparison with reference values ECCS, NHANES III, Asian (Chinese) Berglund, Gulsvik, Hedenstroem, Asia 1-4, JRS2001,
Gore, Pereira, Finnish
Child: Zapletal, Dockery, Hsu, Hibbert
Printing no direct to printer or via PC software
Data transfer no USB
Memory capacity no approx. 700 tests
PC software; disposable spirette mouthpieces; test

Additional features lung age interpretation; storage pouch
measurement quality checks
Physical size (H x W x D) 131 x 59 x 38 mm 83 x 158 43 mm
Power single 3V CR2450 lithium ion coin cell 2 x AA 1.5V batteries
Battery capacity not specifed approx. 400 tests
Training Micro Medical spirometry training courses (£195.00) training courses available on request
List price (exc. VAT) £95.00 £1,195.00
anti-bacterial filters (box) from £18.50

Consumable prices (exc. VAT) paper mouthpieces (box) from £25.00 disposable mouthpieces (50) £52 (200) £192
noseclips (pk) £3
annual service not required; requires user cleaning &

Servicing costs (exc. VAT) periodic calibration checks only; not applicable
return to base for all repairs
PC software £355
Optional extras (exc. VAT) 3 litre calibration syringe £295.00

Market review 25
nSpire nSpire
PiKo-1 PiKo-6
(Supplier: nSpire Health Limited) (Supplier: nSpire Health Limited)
Type of measurement sensor pressure - strain gauge pressure - strain gauge
2 measured parameters: 3 measured & calculated parameters:

FEV1, PEF FEV1, FEV6, FEV1/FEV6
0.15-9.99 litres / ±3.5% or 0.1 litres 0.15-9.99 litres / ±4% or 0.1 litres
(whichever is greater) (whichever is greater)
15-999 litres/min / ±5% or 20 litres/min

Flow range & accuracy not applicable
(whichever is greater)
Comparison with reference values user defined user defined
Printing via PC software via PC software
Data transfer Bi-directional IR port (RS232) Bi-directional IR port (RS232)
Memory capacity 96 tests 96 tests
Additional features warning indicator for cough or abnormal blow warning indicator for cough or abnormal blow
Power 2 x type 357 Ag2O button batteries 2 x type 357 Ag2O button batteries
Battery capacity 1 year (average of 6 blows per day) 6 months (average of 6 blows per day)
Training free of charge training course free of charge training course
one-way cardboard mouthpiece (200) £29.00 one-way cardboard mouthpiece (200) £29.00
mouthpiece adaptor £3.50 mouthpiece adaptor £3.50
Consumable prices (exc. VAT)
plastic mouthpiece (10) £4.00 plastic mouthpiece (10) £4.00
noseclips (25) £11.90 noseclips (25) £11.90
Servicing costs (exc. VAT) not applicable not applicable
Optional extras (exc. VAT) PiKoNet software with cradle £50 PiKoNet software with cradle £50

Market review 26
Sibelmed, Spain
Schiller AG, Switzerland
Datospir 70
Spirovit SP-2
(Supplier: ProAct Medical Ltd.)
(Supplier: Amazon Medical Ltd.)
Note: Soon to be discontinued
Type of measurement sensor pneumotach turbine
screening/monitoring or diagnostic
Type of spirometry diagnostic
(with optional software)
Post bronchodilator tests yes yes (with optional PC software)
Automatic diagnosis capability yes yes (with optional PC software)
Real time graphical display yes yes (with optional PC software)
up to 40 measured & calculated parameters

Lung function parameters up to 27 measured & calculated parameters
(with optional PC software)
summary report by independent test house (rebadged

Measurement accuracy no evidence of ATS/ERS waveform testing
Welch Allyn SP-2)
Volume range & accuracy 0 to ±15 litres / <3% range not specified / 3% or 0.05 litres
Flow range & accuracy 0 to ±16 litres/sec / <3% ±16 litres/sec / 5% or 0.125 litres/sec
Type of display monochrome backlit 160x100 pixel LCD monochrome LCD
ECCS, Crapo, Morris, Knudson, Knudson 76, Austria,

Comparison with reference values ERS, Separ
Berglund, Finnish, Indian, Composite, Polgar
to infrared compatible external printer or via infrared direct external printing (via optional serial or parallel
Printing
adaptor adaptors) or via (optional) PC software
Data transfer infrared serial RS232
250 tests (with graphics) or

Memory capacity up to 50 patient tests
800 tests (without graphics)
four grey levels on LCD; lung age; claimed ACOEM,

Additional features on-screen paediatric incentives; storage case
BTS, NIOSH & OSHA compliance
Power 2 x 1.5V AA batteries single 9V PP3 battery
Battery capacity up to 300 tests or 30 hours not specified
Training available on request information not provided
disposable mouthpieces (10) £18.00

adult disposable mouthpieces(100) £10.00
Consumable prices (exc. VAT) nose clip £1.30
paediatric disposable mouthpieces (100) £11.00
alkaline AA battery £1.80
safety & performance testing £60.00

Servicing costs (exc. VAT) comprehensive £90.00 information not provided
extended warranty £130.00
Maximum Voluntary Ventilation (MVV) £220.00

Optional extras (exc. VAT) spirometry software £203.00
calibration pump (2 litre) £240.00

Market review 27
Sibelmed, Spain Viasys Healthcare

Datospir Micro Jaeger SpiroPro
(Supplier: ProAct Medical Ltd.) (Supplier: Cardinal Health)
Type of measurement sensor turbine pneumotach
screening/monitoring and diagnostic screening/monitoring or diagnostic

Type of spirometry
(depending on operating mode) (with optional software)
Automatic diagnosis capability yes (optional on models A & B) yes (with optional PC software)
Real time graphical display yes (with optional PC software) yes
Lung function parameters 43 measured & calculated parameters 12 measured and calculated perameters
Volume range & accuracy 0 to 10 litres / ±3% or 0.05 litres, whichever is greater 0.1-8.0 litres / ±3% or 0.05 litres
Flow range & accuracy 1 to ±16 litres/sec / 5% or 0.2 litres/sec 0.1-16.0 litres/sec / ±3% or 0.4 litres/sec
Type of display monochrome LCD (touchscreen on models B & C) monochrome touchscreen LCD
ERS, Separ, Knudson, Crapo, Zapletal, Morris,

Austriacas, Brasileras, Polgar-Weng, P.Padilla-
Comparison with reference values ECCS, Zapletal , NHANES III, Knudson
Mexico, Hankinson (NHANES III), Golshan (Iran),
Gutierrez (Chile), A.J.Cruz (Mexico)
direct external printing via USB (optional on direct external printing via serial output or via
Printing
model B) or via (optional) PC software (optional) PC software
serial RS232, USB (optional on model B) or wireless

Data transfer serial RS232
bluetooth (all model option)
Memory capacity 1000 tests (with graphics) (optional on model A) internal memory: 500 measurements
three models: A, B or C; Spirometry software

(standard on model C only); hospital & home modes;
Additional features battery charger; printer cable
automatic BPTS correction; 4 digit PIN security;
carrying case
Weight 0.250 kg 0.200 kg (inc. battery)
Power single 1.5V AA battery 3.6V rechargeable lithium ion battery
Battery capacity not specified approx. 10 hours of continuous use
Training information not provided Micro Medical spirometry training courses (£195.00)
List price (exc. VAT) £1,371.00 £1,150.00
disinfectable pneumotachs (10) £29

paper mouthpieces (box)from £25.00
noseclips (pk) £3

Servicing costs (exc. VAT) information not provided periodic calibration checks only;
PC software including SVC £140.00

Optional extras (exc. VAT) information not provided pulse oximetry software and probe including
6 minute walk test and trend £727.00

Market review 28
Vitalograph Vitalograph
Vitalograph 2120 Vitalograph asma-1
(Supplier: Vitalograph Ltd.) (Supplier: Vitalograph Ltd.)
Type of measurement sensor Fleisch pneumotachograph stator/rotor
Type of spirometry diagnostic screening/monitoring
Post bronchodilator tests yes no
Automatic diagnosis capability yes no
Real time graphical display yes (with optional PC software) no
2 measured parameters:
Lung function parameters 30 user-selectable measured & calculated parameters
FEV1, PEF
Measurement accuracy full test report by manufacturer full test report by independent test house
Volume range & accuracy >8 litres / <±3% 0-9.99 litres / <±3%
Flow range & accuracy ±14 litres/sec / ±5% 0-999 litres/min / <±5%
Comparison with reference values ERS, Polgar no
via base station, PC reporting software, (optional)

Printing no
base station printer or (optional) spirometry software
Data transfer serial RS232 no
internal memory: 140 tests (with graphics) or

Memory capacity internal memory: 600 tests
(optional) PC software patient database
quality of blow indicator; personal best (reference)

reporting PC software as standard; audio feedback;
Additional features values; management zones; automatic assessment of
Smart feature for routine testing
test quality
Physical size (H x W x D) 2120: 215 x 70 x 130 mm; base: 130 x 300 x 250 mm 113 x 63 x 48 mm
Weight 2120: 0.520 kg; base: 1.350 kg 0.055g
2120: 3 x 1.2V AA rechargeable NiCd batteries

Power 2 x 1.5V AAA batteries
base station charger: mains
Battery capacity minimum 4 hours 6 months typical use
free of charge user training available; free of charge user training available;
Training national 1 day workshop £190.00; national 1 day workshop £190.00;
customised courses provided customised courses provided
£1,495.00
List price (exc. VAT) £2,053.00 (with spirometry software) £25.00
£2,129.00 (with base station)
bacterial viral filters (50) £42.00; mouthpieces (200)

£39.00; mini mouthpieces (50) £20.00;
Consumable prices (exc. VAT) one-way mouthpieces (200) £25.00
long mouthpieces (130) £25.00; noseclips (200)
£52.00; flow meshes (10) £30.00
2120 annual service: £234 on-site or £164 return to

Servicing costs (exc. VAT) base; on-site test & calibration service: £495 - full day not applicable
up to 44 devices; £320 - half day up to 24 devices
Spirotrac IV spirometry software £720.00

printer cable £102.00
Optional extras (exc. VAT) storage briefcase £96.00
base station with built-in printer £925.00

Market review 29
Vitalograph copd-6 (Model 4000) Vitalograph Lung Monitor (Model 4000)
Type of measurement sensor stator/rotor stator/rotor
Automatic diagnosis capability USB version only no

Lung function parameters FEV1, FEV1%, FEV6, FEV6%, FEV1/FEV6,
FEV1, FEV6, FEV1/FEV6
FEV1/FEV6%
full test report by manufacturer & full test report by

full test report by manufacturer & full test report by
Measurement accuracy independent test house (manufacturer claims same
independent test house
algorithm as copd-6)
0-9.99 litres
Volume range & accuracy 0-9.99 litres / <±3%
<±3%
Flow range & accuracy not applicable not applicable
Comparison with reference values NHANES III no
Printing PC reporting software (USB version only) PC reporting software (USB version only)
Data transfer USB version only USB version only
Memory capacity no internal memory: 200 tests
quality of blow indicator; obstructive index; COPD quality of blow indicator; personal best % indication;
Additional features classification; lung age indicator; carry pouch; USB carry pouch; USB version includes reports software
version includes reports software CD & USB cable CD & USB cable
Power 2 x 1.5V AAA batteries 2 x 1.5V AAA batteries
Battery capacity 6 months typical use 6 months typical use
£52.00 £120.00
List price (exc. VAT)
£130.00 (USB version) £150.00 (USB version)
bacterial viral filters (50) £42.00 bacterial viral filters (50) £42.00
mouthpieces (200) £39.00 mouthpieces (200) £39.00
mini mouthpieces (50) £20.00 mini mouthpieces (50) £20.00
noseclips (200) £52.00 noseclips (200) £52.00
on-site test & calibration service available; on-site test & calibration service available;
Servicing costs (exc. VAT) £495 - full day up to 44 devices; £495 - full day up to 44 devices;
£320 - half day up to 24 devices £320 - half day up to 24 devices
Optional extras (exc. VAT)

Market review 30
Vitalograph
Vitalograph micro
(Supplier: Vitalograph Ltd.)
Type of measurement sensor Fleisch pneumotachograph
Type of spirometry screening/monitoring
Post bronchodilator tests no
Automatic diagnosis capability yes, on printout
Real time graphical display no

Lung function parameters FVC, FEV1, FEV1%, PEF (plus FEV6, FEF25, FEF50,
FEF75, FEF25-75 on report)
Claims to meet ATS/ERS guidelines yes
Measurement accuracy full test report by manufacturer
0 to 9.99 litres / <±3% or 0.05 litres, whichever is

greater
Flow range & accuracy up to 16.65 litres/sec / ±10% or 0.333 litres/sec
Type of display monochrome LCD
Comparison with reference values ERS, Polgar
Printing PC print utility software
Data transfer serial RS232
Memory capacity last best test
print utility software and serial cable as standard;

Additional features
2 minute auto shutdown
Physical size (H x W x D) 145 x 70 x 40 mm
Weight 0.165 kg
Power single 9V PP3 battery
Battery capacity 400 tests
free of charge user training available;

Training national 1 day workshop £190.00;
customised courses provided
List price (exc. VAT) £355.00
bacterial viral filters (50) £42.00

mouthpieces (200) £39.00
long mouthpieces (130) £25.00
mini mouthpieces (50) £20.00
serial spirometry record cards (6x50) £60.00
Micro annual service: £211 on-site or

£72 return to base;
Servicing costs (exc. VAT)
on-site test & calibration service: £495 - full day up to
44 devices; £320 - half day up to 24 devices

small padded carrying case £33.00

Market review 31
Table 3. Evidence of accuracy testing for handheld spirometers
Peer-reviewed article
Summary report by
Full test report by
Full test report by

Independent Test
Independent Test
Manufacturer
Comments
House
House
Manufacturer Model
Clement Clarke One Flow FVC Memo* [34]
Clement Clarke One Flow FVC Screen* [34]
Clement Clarke One Flow Tester Memo* [34]
Clement Clarke One Flow Tester Screen* [34]
Cosmed Spiropalm* [35] [44]
Medical International Research SpiroBank II [45]
Medical International Research SpiroDoc No evidence
Medical International Research SpiroTel No evidence
Micro Medical Micro No evidence
Micro Medical Micro DiaryCard No evidence
Micro Medical MicroDL No evidence
Micro Medical MicroGP No evidence
Micro Medical MicroLoop No evidence
Micro Medical MicroPlus No evidence
Micro Medical PulmoLife [46]
NDD EasyOne [14] [26]
nSpire PiKo-1 No evidence
nSpire PiKo-6 No evidence
Schiller Spirovit SP-2 [47]
Sibelmed Datospir 70 No evidence
Sibelmed Datospir Micro No evidence
Viasys Jaeger SpiroPro No evidence
Vitalograph 2120 [36]
Vitalograph asma-1 [27]
Vitalograph copd-6 [28] [37]
Vitalograph Lung Monitor* [28] [37]
Vitalograph micro [38]
* Manufacturer claims the device uses the same measurement algorithm as another device which has evidence of accuracy
testing to ATS/ERS waveforms

Market review 32
Table 4. Comparison of desktop spirometers

Cosmed, Italy Fukuda Sangyo, Japan
Pony FX / Pony FX Flowsafe ST-75 SpiroAnalyzer
(Supplier: Physiological Measurements Ltd) (Supplier: Pulmolink)
turbine (Pony FX) or

Type of measurement sensor replaceable screen-type flowmeter
disposable pneumotach (Pony FX Flowsafe)
Real time graphical display yes (on unit & with PC software) yes

summary report by independent test house & full test

Measurement accuracy no evidence of ATS/ERS waveform testing
report by manufacturer
Volume range & accuracy 0-12 litres / ±2% 0-8 litres / ±3% or 0.05l, whichever is greater
0.03-20 litres/sec / ±2% (Pony FX) 0 to ±14 litres/sec / ±5% or 0.2 litres/sec, whichever is
Flow range & accuracy
0.00-16 litres/sec / ±2% (Pony FX Flowsafe) greater
Type of display colour 320 x 240 pixel (120 x 90 mm) LCD monochrome 128x128 pixel LCD

Knudson 83, ECCS 1971, ITS, Zapletal, Multicentrico
Comparison with reference values ERS 93 (ECCS 82), Spain, Norway, Austria, Finland
Barcelona, Pneumobil, Gutierrez, LAM, THAI 2000,
integrated 115 mm wide thermal printer, integrated thermal printer or

Printing
USB direct printout or via PC software (optional) PC software
Data transfer USB or serial RS232 serial RS232
internal memory: 300 patients 600 tests; internal memory: 150 patients including best trial
Memory capacity
PC software patient database waveform
PC software as standard; broncho-challenge tests

(dilator, metacholine & user-defined protocols); test PC software included; bronchial challenge test;
Additional features
measurement quality control; paediatric automatic calibration
encouragement software; automatic BPTS correction
external mains adaptor or Li-ion 12V 2150mA

Power mains or rechargeable battery
batteries
Battery capacity not specified approx. 16 hours continuous use
basic training included; cardio-respiratory training courses available on

Training
advanced training available on request request
flow sensor £112.90; anti-bacterial filters (each) £0.65

Consumable prices (exc. VAT) information available on request paper mouthpieces (50) £6.82; noseclips (100) £40.60
thermal paper (20) £44.00
Servicing costs (exc. VAT) not applicable £65.00 per hour
airways resistance (Rocc/Rint) £1,200

Optional extras (exc. VAT) pulse oximetry £450
carrying case £121.00

Market review 33
Medical International Research (MIR), Italy Medical International Research (MIR), Italy
SpiroLab II SpiroLab III
(Supplier: Medisave (UK) Ltd) (Supplier: Pulmolink)
Type of measurement sensor turbine (reusable) turbine (disposable or reusable)
Real time graphical display yes yes
Lung function parameters 32 measured & calculated parameters 37 measured & calculated parameters
Measurement accuracy full test report by independent test house full test report by independent test house
Volume range & accuracy up to 10 litres / ±3% or 0.05l up to 10 litres / ±3% or 0.05l
Flow range & accuracy ±16 litres/sec / ±5% or 0.200 litres/sec ±16 litres/sec / ±5% or 0.200 litres/sec
Type of display colour 320x240 pixel LCD colour 320x240 pixel LCD
ERS, Knudson, Morris/Bass, Multicentrico Barcellona, ERS, Knudson, Morris/Bass, Multicentrico Barcellona,
Knudson (child), Zapletal (child) Knudson (child), Zapletal (child)
internal thermal printer; direct external printing or via internal thermal printer; direct external printing or via
Printing
(optional) PC software (optional) PC software
Data transfer serial RS232 serial RS232, USB, wireless Bluetooth
Memory capacity internal memory: 1500 tests internal memory: 6000 tests
PC software as standard; internal temperature sensor PC software as standard; internal temperature sensor
for BTPS conversion; test quality control; lung age for BTPS conversion; test quality control; lung age
Additional features
estimation; bronchial challenge test; paediatric estimation; bronchial challenge test; paediatric
incentive animations; carrying case incentive animations; carrying case
Power mains or rechargeable NimH battery pack mains or rechargeable NimH battery pack

request
disposable turbine (100) £80.00

thermal paper (5) £3.50
on-site: £295 (half day up to 25 items);

Servicing costs (exc. VAT) £445 (ful day); £65.00 per hour
spirometer sent to supplier: £24.50
Optional extras (exc. VAT) pulse oximetry £250.00

Market review 34
Micro Medical NDD, Switzerland

MicroLab Easy-On Desk
(Supplier: Cardinal Health) (Supplier: Intermedical (UK) Ltd)
Type of measurement sensor turbine ultrasound
41 user-selectable measured & calculated

Lung function parameters over 50 measured & calculated parameters
parameters
Measurement accuracy summary report by independent test house no evidence of ATS/ERS waveform testing
Volume range & accuracy 0.1-9.99 litres / ±3% 0-10 litres / ±2% or 0.050 litres
1-14 litres/sec / ±5% or0.02 litres/sec

Flow range & accuracy 0.2-15.0 litres/sec / ±3%
(whichever is greater)
monochrome 128 x 128 pixel LCD

Type of display colour, touch-sensitive 240x160 pixel LCD
(16 characters, 16 lines)
ITS (Intermountain Thoracic Society), Knudson

various depending on national preferences (inc.
Comparison with reference values '83, Morris/Polgar, ECCS '93, Spain, Japan,
NHANES III)
Norway, Chile, Austria, Finland
integrated thermal printer; via serial or USB output

Printing integrated thermal printer
to HP printers; or (optional) PC software
Data transfer serial RS232 and USB 1.1 RS232
Memory capacity internal memory: 2000 patients inc. graphs 145 patients plus best waveform
optional PC software; airways resistance

measurement; lung age and automatic test result
bronchoprovacation with various standard
Additional features interpretation; BMI & dyspnoea score; on-screen
protocols; user modifiable
child incentive feature; quality assurance prompts;
carrying case
Weight 0.630 kg (exc. transducer) 1.6 kg
Power mains or rechargeable 7.2V NiMH battery pack mains
Battery capacity approx. 6 hours not applicable
Training Micro Medical spirometry training courses (£195.00) training available on request

Consumable prices (exc. VAT) paper mouthpieces (box) from £25.00 spirette mouthpieces (50) £52 (200) £192
noseclips (pk) £3
annual service not required; requires user cleaning

Servicing costs (exc. VAT) & periodic calibration checks only; not applicable
SpO2 option £360.00

PC software from £395.00
Optional extras (exc. VAT) 3 litre calibration syringe £245
Challenge software from £165.00

Market review 35
nSpire Schiller AG, Switzerland

KoKo Legend Spirovit SP-1
(Supplier: nSpire Health Limited) (Supplier: Amazon Medical Ltd.)
Type of measurement sensor pneumotach pneumotach (disposable or reusable)

Measurement accuracy full test report by independent test house (manufacturer claims same algorithm as Spirovit
SP-2)
Volume range & accuracy ±16 litres / ±3% or 0.10 litres 0 to ±15 litres / <3%
Flow range & accuracy ±16 litres/sec / ±3% or 0.10 litres 0 to ±14 litres/sec / <3%
Type of display colour touchscreen LCD monochrome 192x64 pixel LCD
Hankinson (NHANES III), Crapo 1981, Polgar

(Paediatrics), ERS 93 (ECCS), Perreira (Brazil), Adult: ECCS, Austria, Crapo, Morris, Knudson 76,
Gore (Australia), Gulsvik (Norway), Hedenstroem Polgar, Berglund, Finland, India, Composite
(Sweden), Separ (Spain), Thai, Forche (Austria), Child: Quanier & Tammeling, Austria, India,
Viljanen (Finland), Knudson 1976, Wang Knudson, Knudson 76, Polgar
(paediatrics)
integrated thermal printer or direct external integrated thermal printer or via (optional) PC
Printing
printing via USB software
Data transfer USB serial RS232
approx. 750 patients / 6000 test series per

Memory capacity (optional) up to 100 tests
compact flash memory card
on-screen incentive graphics; network on-screen patient incentives; claimed ACOEM, BTS,
Additional features
connectivity; PC data import to KoKo PFT NIOSH & OSHA compliance
external mains adaptor or rechargeable NiMH

Power mains or rechargeable battery
battery
Battery capacity approx. 3 hours continuous testing 6 hours of normal use
training courses available on request

Training available on request
DVD training module
baterial filters (100) £75.00; cardboard disposable sensor plastic mouthpieces (10) £20.00
mouthpiece (100) £20.00 (200) £29.00; reusable sensor cardboard mouthpieces (10)
mouthpiece adaptor £29.00; noseclips (25) £17.50; reusable sensor filters (100) £39.00
£11.95; thermal printer rolls (4) £9.00 nose clip £1.30

Servicing costs (exc. VAT) annual service £230.00 comprehensive £90.00

PC software £150.00
memory option £144.00
Optional extras (exc. VAT) carrying case £30.00
resistance option £1975.00
transport bag £48.00

Market review 36
Sibelmed, Spain Sibelmed, Spain

Datospir 110 Datospir 120
(Supplier: ProAct Medical Ltd.) (Supplier: ProAct Medical Ltd.)
Type of measurement sensor disposable Lilly Fleisch, turbine or disposable Lilly
Lung function parameters over 40 measured & calculated parameters over 40 measured & calculated parameters
0 to 10 litres / ±3% or 0.05 litres, whichever is 0 to 10 litres

greater ±3% or 0.05 litres, whichever is greater
0 to ±16 litres/sec
Flow range & accuracy 0 to ±16 litres/sec / 5% or 0.2 litres/sec
5% or 0.2 litres/sec
Type of display blue monochrome backlit 320x240 pixel LCD blue monochrome backlit 320x240 pixel LCD
Comparison with reference values ERS, Separ ERS, Separ
integrated thermal printer or direct external integrated thermal printer or direct external printing
Printing
printing (option on model A) (option on models A & B)
Data transfer serial RS232 or internet serial RS232 or internet
150 tests (with graphics) (optional on model A) or

150 or 500 tests (with graphics) (depending on
Memory capacity 500 tests (with graphics) (optional on both
model & option)
models)
four models: A, B, C & D; best test selection; on-

two models: A and C; best test selection; on-
screen paediatric incentives; 58mm printer (model
screen paediatric incentives (optional on Model
Additional features A) & 112mm printer (models B, C & D);
A); 58mm printer (model A) & 112mm printer
bronchoconstriction tests (standard on model D
(model C)
only)
external mains adaptor or (optional) rechargeable external mains adaptor or (optional) rechargeable
Power
battery battery on models A & B only
Training information not provided information not provided
Model A: £1777.00 inc. PC software

List price (exc. VAT) £1,699.00
Model C: £2358.00 inc. PC software
Consumable prices (exc. VAT) information not provided information not provided
Servicing costs (exc. VAT) information not provided information not provided
Optional extras (exc. VAT) information not provided information not provided

Market review 37
Vitalograph Alpha (Model 6000) Vitalograph Compact
Type of measurement sensor Fleisch pneumotachograph Fleisch pneumotachograph

Lung function parameters 14 measured and calculated parameters
parameters
peer-reviewed article, full test report by independent

Measurement accuracy full test report by manufacturer
test house & full test report by manufacturer
Volume range & accuracy 10 litres / <±3% 10 litres / <±3%
Flow range & accuracy ±0.02 to ±16 litres/sec / ±5 to 10% ±0.02 to ±16 litres/sec / ±5 to 10%
Type of display colour LCD colour touchscreen LCD
Comparison with reference values ERS, Polgar user selectable options
integrated thermal printer or PC reporting integrated thermal printer, direct external printing or
Printing
software PC reporting software
Data transfer USB serial RS232 or USB
internal memory: 9 tests

Memory capacity internal memory: 200 tests
removable compact flash: unlimited
Additional features carrying case on-screen patient incentives
external mains adaptor or internal rechargeable

Power external mains adaptor
NimH battery pack
Battery capacity minimum 2.5 hours not applicable
bacterial viral filters (50) £42.00; mouthpieces bacterial viral filters (50) £42.00; mouthpieces (200)
(200) £39.00; mini mouthpieces (50) £20.00; £39.00; mini mouthpieces (50) £20.00
Consumable prices (exc. VAT) thermal paper (5) £59.80; noseclips (200) £52.00; thermal paper (5) £59.80; noseclips (200) £52.00
flow meshes (10) £30.00; serial spirometry record flow meshes (10) £30.00
cards (6x50) £60.00 serial spirometry record cards (6x50) £60.00
Alpha annual service: £280 on-site or

Compact annual service: £280 on-site or
Servicing costs (exc. VAT) on-site test & calibration service: £495 - full day
on-site test & calibration service: £495 - full day up
up to 44 devices; £320 - half day up to 24
to 44 devices; £320 - half day up to 24 devices
devices
1 or 3 litre calibration syringe £295.00

Optional extras (exc. VAT) 1 or 3 litre calibration syringe £295.00 briefcase £96.00
fabric carrying case £40.00

Market review 38
Vitalograph Gold Standard (Model 2150) Vitalograph Gold Standard+ (Model 2160)
Type of measurement sensor dry wedge type bellows dry wedge type bellows
Type of spirometry screening/monitoring diagnostic
Post bronchodilator tests yes, on same chart paper yes
Automatic diagnosis capability no, manual interpretation yes
Real time graphical display yes, on chart paper yes, on chart paper
records volume-time graph for manual 27 user-selectable measured & calculated

interpretation parameters
Measurement accuracy full test report by manufacturer full test report by manufacturer
up to 8 litres / <±3% or 0.05 litres, whichever is up to 8 litres / <±3% or 0.05 litres, whichever is
greater greater
Flow range & accuracy not applicable not applicable
Type of display vitalogram waxed chart monochrome 20x4 character LCD
Comparison with reference values no ERS, Polgar
direct chart recording, direct external printing or

Printing direct chart recording
(optional) spirometry software
Data transfer no serial RS232
Memory capacity not applicable internal memory: 160 tests
inkless stylus; records at 20 mm/second over inkless stylus; records at 20 mm/second over
Additional features
12 seconds 12 seconds; audio feedback
Power external mains adaptor external mains adaptor
Battery capacity not applicable not applicable
bacterial viral filters (50) £42.00; mouthpieces bacterial viral filters (50) £42.00; mouthpieces (200)
(200) £39.00; long mouthpieces (130) £25.00 £39.00; long mouthpieces (130) £25.00
Consumable prices (exc. VAT) 12 second charts (200) £73.00; noseclips (200) 12 second charts (200) £73.00; noseclips (200)
£52.00; washable breathing tubes (5) £90.00 £52.00; washable breathing tubes (5) £90.00
disposable long breathing tubes (10) £93.00 disposable long breathing tubes (10) £93.00
Gold Standard annual service: £321 on-site or Gold Standard annual service: £321 on-site or £251
£251 return to base; return to base;
Servicing costs (exc. VAT)
on-site test & calibration service: £495 - full day on-site test & calibration service: £495 - full day up
up to 44 devices; £320 - half day up to 24 devices to 44 devices; £320 - half day up to 24 devices
pedestal stand £268.00

pedestal stand £268.00 1 or 3 litre calibration syringe £295.00
1 or 3 litre calibration syringe £295.00 spirometry software £720.00
printer cable £102.00

Market review 39
Table 5. Evidence of accuracy testing for desktop spirometers
Summary report by
Full test report by
Full test report by

Independent Test
Independent Test
Manufacturer
Comments
House
House
Manufacturer Model
Cosmed Pony FX [35] [44]
Fukuda Sangyo ST-75 SpiroAnalyser No evidence
Medical International Research SpiroLab II [29]
Medical International Research SpiroLab III [29]
Micro Medical Micro MicroLab [48]
NDD Easy-On Desk No evidence
nSpire KoKo Legend [30]
Schiller Spirovit SP-1* [47]
Vitalograph Alpha (model 6000) [39]
Vitalograph Compact [13] [31] [40]
Vitalograph Gold Standard (2150) [41]
Vitalograph Gold Standard+ (2160) [41]

Market review 40
Table 6. Comparison of PC-based spirometers
Clement-Clarke Cosmed, Italy

All-Flow MicroQuark
(Supplier: Clement-Clarke) (Supplier: Physiological Measurement Ltd)
Type of measurement sensor Fleisch pneumotach turbine
Real time graphical display yes yes (with PC software)


Measurement accuracy (manufacturer claims same algorithm as Pony FX) &
(rebadged IQTeQ Spirometer)
Volume range & accuracy up to 10 litres / ± 3% or 0.05l, whichever is greater 0-12 litres / ±2%
FEF25-75 up to 16 litres / ±5% or 0.2 l/sec,

whichever is greater
Flow range & accuracy 0.03-20 litres/sec / ±2%
PEF up to 16 litres / ±10% or 0.4 l/sec,
whichever is greater
Type of display computer display computer display

Crapo, ECCS, Cherniak, Morris,Knudson 1983, Knudson 83, ECCS 1971, ITS, Zapletal, Multicentrico
Hsu Schoenberg, NHANES III 1999 (Hankinson) Barcelona, Pneumobil, Gutierrez, LAM, THAI 2000,
Data transfer USB USB
Memory capacity PC software patient database PC software patient database
broncho-challenge tests (dilator, metacholine & user-

defined protocols); test measurement quality control;
Additional features test measurement quality control
paediatric encouragement software; automatic BPTS
correction
Power via USB via USB
basic training included;

Training on-site training available on request
advanced training available on request
Consumable prices (exc. VAT) mouthpieces (100) £21.50 information available on request
Servicing costs (exc. VAT) information available on request not applicable
Optional extras (exc. VAT) calibration syringe £125.00 3 litre calibration syringe £300

Market review 41
Medical Graphics Corporation, USA Medical International Research (MIR), Italy

CPFS/D USB MiniSpir
(Supplier: Medical Graphics UK) (Supplier: Pulmolink)
Type of measurement sensor Pitot tube pneumotach turbine (disposable or reusable)
Lung function parameters over 50 measured & calculated parameters 32 measured & calculated parameters
Measurement accuracy summary report by independent test house no evidence of ATS/ERS waveform testing
Volume range & accuracy over 10 litres / ±3% or 0.050l, whichever is greater up to 10 litres / ±3% or 0.05l
Flow range & accuracy ±18 litres/sec / ±3% or 0.050l, whichever is greater ±16 litres/sec / ±5% or 0.200 litres/sec
Adult: ERS; Knudson; Morris/Bass; Multicentrico

Comparison with reference values over 30 authors including NHANES III Barcellona
Paediatric: Knudson; Zapletal
PC software as standard; patient database; paediatric PC software as standard; internal temperature sensor
Additional features incentives; networking; bronchial challenge; lung age for BTPS conversion; lung age estimation; bronchial
estimate; trending; user defined predicted challenge test; carrying case

request
List price (exc. VAT) information not provided £525.00
disposable turbine (100) £80.00

Consumable prices (exc. VAT) information not provided anti-bacterial filters (each) £0.65
Servicing costs (exc. VAT) information not provided £65.00 per hour
Optional extras (exc. VAT) information not provided pulse oximetry £ 250.00

Market review 42
Medisoft, Belgium Micro Medical

Blue Spiro SpiroUSB
(Supplier: Pulmolink) (Supplier: Cardinal Health)
Type of measurement sensor Lilly pneumotachograph turbine
Automatic diagnosis capability no yes
Measurement accuracy no evidence of ATS/ERS waveform testing summary report by independent test house
Volume range & accuracy not specifed 0.1-9.99 litres / ±3%
Flow range & accuracy ±0.03-15 litres/sec / <3% 0.2-15.0 litres/sec / ±3%
Comparison with reference values ERS plus editor function various depending on national preferences
Data transfer wireless Bluetooth USB
PC software as standard; lung age interpretation; on-

Additional features PC software as standard; bronchial challenge test screen child incentive feature; optional transducer
stand
Physical size (H x W x D) 135 mmH x 60mm diameter 90 x 60 x 50 mm
Weight 0.300 kg (exc battery) 0.130 kg
Power single 9V PP3 battery via USB
Battery capacity approx. 8 hours continuous operation not applicable

Training Micro Medical spirometry training courses (£195.00)
request

Consumable prices (exc. VAT) paper mouthpieces (box) from £25.00
noseclips (pk) £3

Servicing costs (exc. VAT) £65.00 per hour periodic calibration checks only;

data backup facilities £POA
Medisoft network software £POA
Optional extras (exc. VAT) data transfer & reception (HL7) £POA 3 litre calibration syringe £295.00
PC £POA
printer £POA
carrying case £POA

Market review 43
NDD, Switzerland nSpire

Easy-On PC KoKo PFT
(Supplier: Intermedical (UK) Ltd) (Supplier: nSpire Health Limited)
Type of measurement sensor ultrasound Fleisch pneumotach
Type of spirometry diagnostic or screening/monitoring diagnostic
Measurement accuracy no evidence of ATS/ERS waveform testing full test report by independent test house
Volume range & accuracy ±12 litres / ±2% or 0.050 litres ±16 litres / ±3% or 0.10 litres
1-16 litres/sec / ±2% or 0.02 litres/sec

Flow range & accuracy ±16 litres/sec / ±3% or 0.10 litres
PEF: 1-16 litres/sec / ±5% or 0.02litres/sec
Crapo 1981, Polgar (Paediatric), ITS 1984,

Knudsen 1976/1983, ECCS 1983/1993, Hankinson
(NHANES III) 2000, Toronto 1991, Morris F
Adult: ERS (ECCS), Roca, Austria, NHANES III,
1988/1971, Gore (Australia) 1995, Pereira (Brazil)
Knudson 1976 & 1983, Crapo, Morris, Cherniak,
1996, Dejsomritrutai (Thai) 1996, Miller 1996, Eigen
Comparison with reference values Berglund, Gulsvik, Hedenstroem, Asia 1-4,
(pre-school paediatrics), Vilijanen/KLNW (Finland),
JRS2001, Gore, Pereira, Finnish
Hendenstram/Solymar (Sweden), Gulsvik (Norway),
Child: Zapletal, Dockery, Hsu, Hibbert
SEPAR (Spain), Forche (Austria), Hibbert
(Paediatrics), Shands (mixed), Wang (paediatrics),
Peniera (Brazil) 2002
child incentive graphics; lung age interpretation;

Bronchial challenge tests; on-screen incentive
Additional features choice of 8 tests; Challenge/Provacation on
graphics; network connectivity
"Expert" version
Training training courses available on request training courses available on request
£1,015.00
List price (exc. VAT) £995.00
("Expert" version £1,425.00)
baterial filters (100) £75.00

cardboard mouthpiece (100) £20.00 (200) £29.00
Consumable prices (exc. VAT) spirette mouthpieces (50) £52 (200) £192
mouthpiece adaptor £29.00
Servicing costs (exc. VAT) not applicable annual service £270.00
Optional extras (exc. VAT) 3 litre calibration syringe £245 3 litre calibration syringe £250.00

Market review 44
nSpire Schiller AG, Switzerland

Zan 100 Handy PC-Spirometry
(Supplier: nSpire Health Limited) (Supplier: Amazon Medical Ltd.)
Type of measurement sensor variable orifice pneumotach pneumotach (disposable or reusable)

Measurement accuracy no evidence of ATS/ERS waveform testing (manufacturer claims same algorithm as Spirovit
SP-2)
Volume range & accuracy 0.0-20.0 litres / <±2% 0 to ±15 litres / <3%
Flow range & accuracy 0.05-15.0 litres/sec / ±2% 0 to ±14 litres/sec / <3%
Comparison with reference values ECCS 1983/1993 and others NHANES III
Data transfer USB serial RS232 or USB (with adaptor)
claimed ACOEM, BTS, NIOSH & OSHA

Additional features on-screen incentive graphics
compliance
disposable: 118 x 36 x 28 mm
Physical size (H x W x D) 100 x 90 x 45 mm
reusable: 125 x 36 x 28 mm
disposable: 0.120 kg
Weight 0.250 kg
reusable: 0.160 kg
Power via USB via serial port or USB (with adaptor)
Training training courses available on request available on request
disposable sensor plastic mouthpieces (10) £20.00

cardboard mouthpiece (100) £20.00 (200) £29.00 reusable sensor cardboard mouthpieces (10)
Consumable prices (exc. VAT) mouthpiece adaptor £29.00 £17.50
noseclips (25) £11.95 reusable sensor filters (100) £39.00
nose clip £1.30

Servicing costs (exc. VAT) annual service £270.00 comprehensive £90.00

Rocc varies depending on options
pump adaptor £12.50
Optional extras (exc. VAT) rhinomanometry varies depending on options
PC or notebook (if required)
serial to USB adaptor (if required)

Market review 45
Sibelmed, Spain Vitalograph

Datospir 600 Vitalograph Pneumotrac
(Supplier: ProAct Medical Ltd.) (Supplier: Vitalograph Ltd.)
Type of measurement sensor Fleisch, turbine or disposable Lilly Fleisch pneumotachograph

parameters
Measurement accuracy no evidence of ATS/ERS waveform testing full test report by manufacturer
0 to 10 litres / ±3% or 0.05 litres, whichever is 0 to 8 litres / <±3% or 0.05 litres, whichever is
greater greater
Flow range & accuracy 0 to ±16 litres/sec / 5% or 0.2 litres/sec ±14 litres/sec / ±5%
Separ, Ceca, Knudson, Crapo, Zapletal, Morris,

Comparison with reference values Sumariales, Austriacas, Gutierrez (Chile), user selectable from 27 options
Brasilenas, Mexico, Perez Padilla
Data transfer USB or internet USB
Memory capacity via PC software patient database PC software patient database
on-screen paediatric incentives; spirometry software as standard; network

Additional features
bronchoconstriction tests connectivity; hygiene drying fan
external mains adaptor or (optional) rechargeable

Power via USB ( 9V for hygiene drying fan)
battery
free of charge user training available;

Training information not provided national 1 day workshop £190.00;
customised courses provided
List price (exc. VAT) information not provided £995.00
bacterial viral filters (50) £42.00; mouthpieces

(200) £39.00; long mouthpieces (130) £25.00;
mini mouthpieces (50) £20.00; noseclips (200)
£52.00;flow meshes (10) £30.00
Pneumotrac annual service: £234 on-site or £164

return to base; on-site test & calibration service:
Servicing costs (exc. VAT) information not provided
£495 - full day up to 44 devices; £320 - half day up
to 24 devices
5-user software licence £1159.00

Optional extras (exc. VAT) information not provided

Market review 46
Welch Allyn
SpiroPerfect
(Suppliers: Hospitals - Welch Allyn UK;
Primary Care - Authorised distributors)
Type of measurement sensor pneumotach (disposable)
Type of spirometry diagnostic
Post bronchodilator tests yes
Automatic diagnosis capability yes
Real time graphical display yes
Claims to meet ATS/ERS guidelines yes
Measurement accuracy full test report by independent test house
Volume range & accuracy 0.0-14.0 litres / (accuracy to ATS)
Flow range & accuracy 0.0-14.0 litres/sec / (accuracy to ATS)
Type of display computer display
Berglund 1963, Crapo 1981, Composite, Dockery

1983, ECCS/Quanjer 1993, Falaschetti 995,
Gulsvik 2001, Hedenstrom 1986, Hsu 1979,
Comparison with reference values Knudson 1976, Koillinen 1998, Kory 1961, Morris
1971, NHANES III 1999, Polgar 1971,
Schoenberg 1978, Solymar 1980, Vilijanen 1981,
Zapletal 1969 plus others at user request
Printing via PC software
Data transfer USB
Memory capacity via PC software patient database
PC software as standard; lung age indication; on-

Additional features screen child incentive feature; network
connectivity; telemedicine option
Physical size (H x W x D) sensor: 100 mm (H) x 37mm (diameter)
Weight sensor: 0.010 kg
Power via USB
Battery capacity not applicable
supplied with Spirometry Reference &

Training
Effort acceptability posters
List price (exc. VAT) £1,056.00
disposable sensor (25) £27.00

Servicing costs (exc. VAT) annual service not required
supplied with or without

a 3 litre calibration syringe £239.00

Market review 47
Table 7. Evidence of accuracy testing for PC-based spirometers
Summary report by
Full test report by
Full test report by

Independent Test
Independent Test
Manufacturer
Comments
House
House
Manufacturer Model
Clement Clarke All Flow [34]
Cosmed MicroQuark* [42] [44]
Medical Graphics CPFS/D USB [49]
Medical International Research MiniSpir No evidence
Medisoft Blue Spiro No evidence
Micro Medical SpiroUSB [50]
NDD Easy-On PC No evidence
nSpire KoKo PFT [32]
nSpire Zan 100 Handy No evidence
Schiller PC-Spirometry* [47]
Sibelmed Dataspir 600 No evidence
Vitalograph Pneumotrac [43]
Welch Allyn SpiroPerfect [33]

Market review 48
Choosing a spirometer
The product information presented in this buyers’ guide should be used with the
following questions to shortlist spirometers that best meet requirements. Under each
question is a list of relevant features to consider.
1. For which patient group is the spirometer to be used?
• Type of spirometry
• Post bronchodilator tests
• Lung function parameters
• Comparison with reference values
2. In what setting is the spirometer to be used (e.g. GP surgery, hospital clinic)?

• Automatic diagnosis capability
• Real time graphical display
• Type of display
• Printing
• Data transfer
• Memory capability
• Additional features
• Physical size
• Weight
• Power
• Training
3. What are the lifetime costs of the device?

• Battery capacity
• List price
• Consumable prices
• Servicing costs
• Optional extras
4. How accurate is the spirometer and does it comply with guidelines?

• Type of measurement sensor
• Claims to meet ATS/ERS guidelines
• Measurement accuracy – table 8 lists the spirometers in the market review for
which we found evidence of testing to ATS/ERS guidelines, for the level of
evidence see tables 3, 5 and 7
• Volume range and accuracy
• Flow range and accuracy

Market review 49
Table 8. Spirometers for which there is evidence of accuracy testing to ATS/ERS waveforms
Spirometer type
PC-based
Handheld
Desktop
Device
Clement Clarke All Flow
Clement Clarke One Flow FVC Memo*
Clement Clarke One Flow FVC Screen*
Clement Clarke One Flow Tester Memo*
Clement Clarke One Flow Tester Screen*
Cosmed MicroQuark*
Cosmed Pony FX
Cosmed Spiropalm*
Medical Graphics CPFS/D USB
Medical International Research (MIR) Spirobank II
Medical International Research (MIR) Spirolab II
Medical International Research (MIR) Spirolab III
Micro Medical MicroLab
Micro Medical PulmoLife
Micro Medical SpiroUSB
NDD EasyOne
nSpire KoKo Legend
nSpire KoKo PFT
Schiller PC-Spirometry*
Schiller Spirovit SP-1*
Schiller Spirovit SP-2
Vitalograph 2120
Vitalograph Alpha
Vitalograph asma-1
Vitalograph Compact
Vitalograph copd-6
Vitalograph Gold Standard (2150)
Vitalograph Gold Standard+ (2160)
Vitalograph Lung Monitor*
Vitalograph micro
Vitalograph Pneumotrac
Welch Allyn SpiroPerfect

Market review 50
Once a shortlist of devices has been created, we recommend that demonstrations or

short term loans are arranged with suppliers. The loan period should be used to
assess qualities that have not been considered in this guide, such as usability, build
quality and ergonomic features.

Acknowledgements 51
We should like to thank the following for their contribution to this buyers’ guide.
Nigel Clayton, Chief Physiologist at North West Lung Centre, Wythenshawe Hospital,
Manchester.
Peter Close, Chief Clinical Physiologist, Lung Function, Freeman Hospital, Newcastle
upon Tyne.
Brendan Cooper, Consultant Clinical Scientist at the Lung Investigation Unit, Queen
Elizabeth Hospital, Birmingham.
Helen Hambleton, Respiratory Nurse Specialist, Barnet and Chase Farm Hospitals
NHS Trust.
Kevin Holton, COPD NSF Project Manager, Department of Health.
Sue Ord, Category Manager, NHS Supply Chain.
Manufacturers and suppliers.

Glossary 52
ATS
American Thoracic Society.
Bronchodilator
A bronchodilator is a drug that relaxes and dilates the bronchial passageways and
aids breathing. It is particularly used in the treatment of asthma.
BTPS
Body temperature, ambient pressure, saturated with water vapour.
COPD
Chronic obstructive pulmonary disease.
Desktop spirometer
A spirometer that is intended to be placed on a desk or bench, or supported by a
stand during normal use.
ERS
European Respiratory Society.
MEFx%
Maximum expiratory flow when x% of the FVC remains to be exhaled (e.g. MEF50% is
when 50% of FVC remains).
FEF25-75%
Forced expiratory flow between 25 and 75% of FVC (also called the maximum mid-
expiratory flow, MMEF).
FEFx%
Maximum expiratory flow when x% of FVC has been exhaled (e.g. FEF25% is when
25% of FVC has been exhaled).
FER
Forced expiratory ratio – the FEV1/FVC ratio.
FET
Forced expiratory time.

Glossary 53
FEVt
Time forced expiratory volume.
FEV1
Volume of air exhaled during the first second of FVC.
FVC
Forced vital capacity.
Handheld spirometer
A spirometer that is intended to be held in the hand during normal use.
LCD
Liquid crystal display.
Li-ion
Lithium ion.
NiMH
Nickel metal hydride.
PC
Personal computer.
PC-based spirometer
A spirometer that is operated and records measurements via a PC.
PEF
Peak expiratory flow.
POA
Price on application.
RS232
Serial communication interface standard used for data transfer between device and
PC.
USB
Universal serial bus used for data transfer between device and PC.
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for Detection of Small Airways Obstruction. Pediatric Pulmonology 2005,
39(2): 178-184.
[21] Keskinen H, Pirila P, Nordman H & Nurminen M. Pocket-sized spirometer for
monitoring brochial challenge procedures. Clinical Physiology 1996, 16(6):
633-643.
[22] Godschalk I, Brackel H, Peters J & Bogaard J. Assessment of accuracy and
applicability of a portable electronic diary card spirometer for asthma
treatment. Respiratory Medicine 1996, 90(): 619-622.
[23] Walters J, Wood-Baker R, Walls J & Johns D. Stability of the EasyOne
ultrasonic spirometer for use in general practice. Respirology 2006, 11: 306-
310.
[24] Perez-Padilla R, Vazquez-Garcia J, Maquez M, Jardim J, Pertuze J, Lisboa C,
Muino A, Lopez M, Talamo C, de Oca M, Valdivia G & Menezes A. The Long-
Term Stability of Portable Spirometers used in a Multinational Study of the
Prevalence of Chronic Obstructive Pulmonary Disease. Respiratory Care
2006, 51(10): 1167-1171.
[25] Dirken A, Madsen F, Pedersen O, Vedel A & Kok-Jensen A. Long term
performance of a hand held spirometer. Thorax 1996, 51: 973-976.
[26] Shipp N, Crapo R, Jensen R & Kaelin O. NDD Medical Technologies EasyOne
Spirometer Test Report. LDS Hospital, 2000.
http://www.ndd.ch/UserData/Download_00147_00.pdf

References 56
[27] Gallo H, Crapo R, Jensen R & Hemes P. Vitalograph asma-1 Test Report.
Intermountain LDS Hospital, 2008.
http://www.vitalograph.co.uk/pdf_library/productleaflets/asthma_copd/Vitalogra
ph_asma-1_LDS_Test_Report.pdf
[28] Gallo H, Crapo R, Jensen R & Hemes P. Vitalograph copd-6 Test Report.
Intermountain LDS Hospital, 2008.
http://www.vitalograph.co.uk/pdf_library/productleaflets/asthma_copd/Vitalogra
ph_copd-6_LDS_Test_Report.pdf
[29] Flint A, Howell H, Crapo R, Jensen R, Boschetti Sacco B & Pennacchietti M.
Medical International Research (MIR) Spirolab II and Spirolab spirometers.
LDS Hospital, 2003.
[30] Gallo H, Crapo R & Jensen R. Ferraris Respiratory KoKo Legend Test Report.
LDS Hospital, 2005.
[31] Berlin S, Jensen R, Crapo R & Mitchell P. Vitalograph Compact Spirometer.
LDS Hospital, 1990.
[32] Gallo H, Crapo R, Jensen R & Good R. nSpire Health Koko PFT System Test
Report. Intermountain LDS Hospital, 2007.
[33] Howell H, Crapo R & Jensen R. Welch Allyn SpiroPerfect USB Test Report.
LDS Hospital, 2005.
[34] Clement Clarke. IQTeQ Spirometer, 2002.
[35] Di Pietro A & Brugnoli P. ATS 94 Validation: Pony FX. Cosmed S.r.l., 2004.
[36] Byrne L & Lalui A. 2120 version 2 - Accuracy and Precision Testing to 1994
ATS Standards. Vitalograph, 1999.
[37] Kelly E. ATS/ERS 2005 Performance Test Report: Vitalograph copd-6.
Vitalograph, 2008.
[38] Byrne L & Peters M. Micro - Accuracy and Precision Testing to 1994 ATS
Standards. Vitalograph, 1999.
[39] Mullane T. ATS/ERS 2005 Performance Test Report: Vitalograph Alpha.
Vitalograph, 2007.
[40] Kelly E. Accuracy and Precision Testing on Hardware to 1994 ATS Standards:
Vitalograph Compact. Vitalograph, 2004.
[41] Byrne L & Peters M. 2150/2160 Validation. Vitalograph, 1999.
[42] Cosmed. ATS 1994 requirements: microQuark Test report. Cosmed S.r.l,
2008.
[43] Mullane T. Vitalograph Pneumotrac ATS Performance Test Report DUXL01D
Transducer. Vitalograph, 2004.
[44] Howell H, Crapo R & Jensen R. Cosmed Pony FX Test Report. LDS Hospital,
2004.
References 57
[45] Crapo R. Spirobank Spirometer. LDS Hospital, 1999.

[46] Howell H, Crapo R & Jensen R. Micro Medical PulmoLife Test Report. LDS
Hospital, 2005.
[47] Flint A, Howell H, Crapo R & Jensen R. Welch Allyn SP-2 Spirometer. LDS
Hospital, 2001.
[48] Howell H, Crapo R & Jensen R. Micro Medical Micro Lab Spirometer Test
Report. LDS Hospital, 2002.
[49] Jensen R, Crapo R, Berlin S, Norlien J & Kuznia J. MedGraphics Spirometry
System using disposable pneumotach. LDS Hospital, 1991.
[50] Howell H, Crapo R & Jensen R. Micro Medical SpiroUSB Test Report. LDS
Hospital, 2005.
[51] Leasing. http://www.pasa.nhs.uk/pasaweb/productsandservices/leasing, 2008
[52] EU Procurement Thresholds.
http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_
procurement_thresholds_.asp, 2008.
[53] Preparing a business case.
http://www.ogc.gov.uk/stdtoolkit/reference/documentation/p13_buscase.html,
2007.
[54] OPPM - operational purchasing procedures manual.
http://nww.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm, 2008.
[55] European Union Tendering Timetable.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4070620, 2004.
[56] NHS trust operational purchasing procedures manual - TOPPM.
http://nww.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm, 2008.
[57] Desk guide to procurement - 2005 edition.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4109316, 2005.

Appendix 1: Supplier contact details 58
Amazon Medical Ltd

Carrington Business Park Tel: 0161 776 4336
Carrington Fax: 0161 776 4339
Manchester
website: www.amazonmedical.co.uk
M31 4XL
email: sales@amazonmedical.co.uk
Cardinal Health UK
The Crescent Tel: 01256 388599
Jays Close Fax: 01256 388596
Basingstoke
website: www.cardinalhealth.com
RG22 4BS
email: mps_ukinfo@cardinal.com
Clement Clarke International

Edinburgh Way Tel: 01279 414969
Harlow Fax: 01279 456304
Essex
website: www.clementclarke.com
CM20 2TT
email: resp@clement-clarke.com
Intermedical (UK) Ltd

Unit 6, Mill Hall Business Estate Tel: 01732 522444
Aylesford Fax: 01732 872883
Kent
website: www.intermedical.co.uk
ME20 7JZ
email: sales@intermedical.co.uk
Medical Graphics UK Ltd

Unit 9, Clifton Centre Tel: 01452 617150
Bamel Way Fax: 01452 613973
Gloucester Business Park
website: www.medicalgraphicsuk.com
Gloucestershire
email: sales@medicalgraphicsuk.com
GL3 4BH

Medisave
Unit 1, Littlesea Industrial Estate Tel: 0800 804 6447
Weymouth Fax: 0800 804 6448
Dorset
website: www.medisave.co.uk
DT4 9DN
email: via website
nSpire Health Ltd

Unit 10, Harforde Court Tel: 01992 526334
John Tate Road Fax: 01992 526320
Hertford
website: www.nspirehealth.com
SG13 7NW
email: via website
Physiological Measurements Ltd

61 Lloyd Street Tel: 0870 246 1888
Oswestry Fax: number not provided
Shropshire
website: www.physiologicalmeasurements.com
SY11 1NL
email: info@physiologicalmeasurements.com
ProAct Medical Ltd

9-13 Oakley Hay Lodge Tel: 0845 051 4244
Great Folds Road Fax: 0845 051 4255
Great Oakley
website: www.proactmedical.co.uk
Northamptonshire
email: sales@proactmedical.co.uk
NN18 9AS
Pulmolink
Redwood House Tel: 01233 713070
Canterbury Road Fax: 01233 713859
Charing
website: www.pulmolink.co.uk
Kent
email: sales@pulmolink.co.uk
TN27 0EU

Vitalograph Ltd
Maids Moreton Tel: 01280 827110
Buckingham Fax: 01280 823302
MK18 1SW
website: www.vitalograph.co.uk
email: sales@vitalograph.co.uk
Welch Allyn
Cublington Road Tel: 0207 365 6780
Aston Abbotts Fax: 0207 365 9694
Buckinghamshire
website: www.welchallyn.co.uk
HP22 4ND
email: via website

Appendix 2: EU procurement procedure 61
EU procurement procedure
Lease options
National frameworks are in place for operating leases to help the NHS procure
leases more cost efficiently and effectively. The framework came into place on 1st
April 2007 and runs for two years. Further details are available from the PASA
website [51].
EU procedures
The Public Sector Directive (2004/18/EC) has been transposed into UK law. This has
been achieved by means of the following statutory instruments:
• the Public Contracts Regulations SI 2006 No.5 (the regulations)
• the Utilities Contracts Regulations SI 2006 No. 6 (not relevant to this guide).
The regulations apply to contracts worth more than £90,319 (from January 1st 2008)
[52] over their whole life, and specify the procedures to be followed for public sector
contracting, including adherence to strict timetables, requirements for advertising,
invitation to tender and the award of contract. Organisations undertaking a
procurement exercise covered by the regulations must give all suppliers an equal
opportunity to express an interest in tendering for the contract by placing a contract
notice in the Official Journal of the European Union (OJEU).
At all stages of the procurement process, the purchaser must be demonstrably fair,
as any decision made can be challenged by the unsuccessful suppliers.
Establishing a procurement strategy

To achieve a successful outcome, decisions need to be made on:
• whether an existing contract/agreement can be used
• the need to consider sustainable development issues
• whether EU directives apply
• the type and form of contract
• sourcing potential suppliers
• duration of contract and opportunity to review/extend
• payment schedules
• how to minimise any risks with the chosen strategy, including supplier appraisal
and evaluation/clarification of suppliers’ bids.
Preparing a business case

A business case should be drafted and approved before conducting any procurement
exercise. Further guidance on preparing business cases is available from the Office
of Government Commerce [53] and an illustrative example is provided in the NHS
PASA Operational Purchasing Procedures Manual, Procedure 1-01 [54].

Appendix 2: EU procurement procedure 62
The EU tendering exercise

EU procurements usually take between 4 and 6 months to complete. This needs to
be taken into account in the planning stages. The length of the exercise depends on
the chosen procedure (open or restricted). Further information is available from the
Department of Health [55].
The procurement panel

A multidisciplinary team should be selected to guide the purchase. Representatives
from clinical, user, technical, estates and financial areas should be considered.
Identifying potential suppliers

Criteria for supplier selection must be established. A supplier pre-qualification
questionnaire may be employed as an initial screen to exclude unsuitable suppliers
which asks for details such as skills and experience of the service engineers.
Evaluation criteria
Performance specifications should be derived from local operational requirements,
and agreed by the procurement panel. They will form the basis for assessing the
adequacy of suppliers’ technical specifications, provided in response to the technical
specification questionnaire.
It is important to have agreed on the performance specifications of the product as

they will be used in the adjudication against company specifications.
Requests for features which are supplier-specific are not permitted under the
regulations. Very specific features which are not supported by operational
requirements are also not allowed.
Award of contract
Following award of the contract to the successful supplier; unsuccessful suppliers
may need to be debriefed. This is at the supplier’s request.
Buyers must be aware of the ‘Alcatel’ procedure (see the Trust Operational
Purchasing Procedures Manual [56], Procedure No.T-08, section 6 - ‘Mandatory
Standstill Period’).
For more information on procurement please refer to the Department of Health

Website [57].

Author and report information 63
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A J Sims straight to your mailbox contact:
Regional Medical Physics Dept

Freeman Hospital Centre for Evidence-based Purchasing
High Heaton Room 152C
Newcastle upon Tyne Skipton House
NE7 7DN 80 London Road
SE1 6HL
Tel: 0191 2137787
Fax: 0191 2130290 Tel: 020 7972 6080
Email: RMPDFHevaluation@nuth.nhs.uk Fax: 020 7975 5795
www.rmpd.org.uk Email: cep@pasa.nhs.uk
www.pasa.nhs.uk/cep
About CEP © Crown Copyright 2009
The Centre for Evidence-based
Purchasing (CEP) is part of the Policy and
Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support the
uptake of useful, safe and innovative
products and related procedures in health
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Buyers’ guide

Economic considerations ...................................................................... 11

Comparison of handheld spirometers.................................................................... 17

Evidence of accuracy testing for handheld spirometers ........................................ 31

Comparison of desktop spirometers...................................................................... 32

Evidence of accuracy testing for desktop spirometers .......................................... 39

Comparison of PC-based spirometers .................................................................. 40

Evidence of accuracy testing for PC-based spirometers ....................................... 47

Choosing a spirometer .......................................................................................... 48

Appendix 1: Supplier contact details ..................................................... 58

Appendix 2: EU procurement procedure ............................................... 61

Author and report information................................................................ 63

CEP08055: March 2009

CEP08055: March 2009

To make a diagnosis from spirometry, the patient’s measurements must be

CEP08055: March 2009

Repeatability of the PEF measurement is assessed by repeating waveforms 1, 4, 8

British and international standard

CEP08055: March 2009

What does spirometry measure?

Three basic measurements are provided by the FVC manoeuvre:

Depending on the type of spirometer (volume-displacement spirometer or flow-

CEP08055: March 2009

Volume-time and flow-volume curves

Figure 1. Volume-time curve for a normal adult [6]

Figure 2. Flow-volume curve for a normal adult [6]

CEP08055: March 2009

Figure 3. Flow-volume loop for a normal adult [6]

CEP08055: March 2009

Table 1 is a list of spirometer characteristics to be considered when purchasing.

Table 1. Device considerations

CEP08055: March 2009

CEP08055: March 2009

• Anti-bacterial or bacterial viral filters and flow mesh:

CEP08055: March 2009

Cost effectiveness of spirometry

CEP08055: March 2009

• sustainable production and consumption – working towards achieving more with

CEP08055: March 2009

End of life disposal

CEP08055: March 2009

Collation of product information

Thirteen peer-reviewed articles were identified. These were classified as covering

Device comparison and calibration cannot be used as evidence for spirometer

CEP08055: March 2009

Of the three peer-reviewed articles discussing the accuracy of spirometers, Lüstro et

In addition to the peer-reviewed articles, manufacturers/suppliers were also asked to

Spirometers for which we found insufficient evidence of accuracy to ATS/ERS

CEP08055: March 2009

Table 2. Comparison of handheld spirometers

Type of measurement sensor differential pressure differential pressure

Type of spirometry screening/monitoring screening/monitoring

Post bronchodilator tests no no

Automatic diagnosis capability no no

Real time graphical display no no

4 measured & calculated parameters: 4 measured & calculated parameters:

Claims to meet ATS/ERS guidelines yes yes

full test report by manufacturer full test report by manufacturer

Type of display monochrome LCD monochrome LCD

ERS 93 (for 18-70 years)

Printing via PC software (with Kit) no

Data transfer USB (with Kit) no

"Kit" includes spirometer, PC cable, software &