Clement Clarke In-Check M User manual

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Clinically
Effective
Flow Rate
30-60 L/Min
Fig 1. How to use the In-Check M
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Instructions for Use
Consult ‘Instructions for Use’.
Introduction
The In-Check M is an inhalation airow meter that can help educate
and assess patients who use inhaler devices.
Pressurised inhaler devices are designed to deliver medication to the
respiratory tract, and the speed of inhalation through them (the
inspiratory ow) can have a signicant effect on the quantity of drug
delivered and the clinical efcacy of the product.
The In-Check M is designed to simulate the “internal resistance”
of pressurised inhaler devices, and measure inspiratory ow. These
measurements enable the healthcare professional to encourage
patients to modify their inspiratory technique (by inhaling correctly,
i.e. not too fast), in order to achieve a ow rate consistent with clinical
efcacy. The green zone shows the clinically effective ow ranges for
pMDI inhaler devices.
Patients that cannot achieve the suggested inspiratory ow for their
inhaler may not gain maximum benet from their prescribed
medication. Healthcare professionals may wish to take this factor
into account when selecting the device that is the most suitable with
the patient.
Inspiratory Flow and Clinically Effective Flow Range
The inspiratory ow through an inhaler is one of the factors that will
inuence the clinical effect of the drug delivery from that device. The
most effective delivery occurs when the patient achieves a ow within
the clinically effective ow range. Flow rates outside this range, may
result in a diminished deposition and clinical efcacy.
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Pressurised Metered Dose Inhalers (pMDIs)
With most pMDIs, the aerosol is delivered under pressure at high speed
(often over 90 kilometres per hour). The inhalation should be timed with
actuation of the device and should be slow and steady. Inhaling too
fast may cause a greater proportion of the aerosol to impact at the
back of the throat and be subsequently swallowed, thus reducing the
benecial clinical effect and increasing the potential for local and
systemic side effects.
pMDIs with Holding Chamber/Spacer
It is recognised that the optimum inhalation technique for using a pMDI
with a holding chamber/spacer is a slow inhalation (30 to 60 l/min).
As the resistances of most chamber/spacer devices are low, the
In-Check M can be used to provide an approximate resistance for
inspiratory ow measurements to be made.
In-Check M
The In-Check M is a low-range inspiratory ow meter (15 to 120 l/min)
that has an inbuilt resistance, it is calibrated to enable the measurement
of airow as if the patient was using a pMDI.
IMPORTANT
As with any inhalation device, it is important to check for loose foreign
objects before the device is used. The transparent material used in
the construction of the In-Check M enables the user to make a visual
check before inhalation. Patients should be prevented from exhaling
through the device prior to use.

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To reset the In-Check M
Hold the instrument vertically with the mouthpiece uppermost, so that
the rounded end of the meter can be tapped against the other hand or
a horizontal surface, such as a table.
A hard tap will dislodge the magnetic resetting weight, which will return
the red cursor to a start position. With the cursor now at the bottom,
tip the meter through 180 degrees to return the magnetic weight to its
resting position at the mouthpiece end of the device.
Do Not try to reset the In-Check M as if it were a mercury
thermometer – this action causes serious damage to the piston and
pointer.
How to use the In-Check M - see Fig 1
1. Reset the In-Check M.
2. Attach a clean mouthpiece (small mouthpieces can be used with
the supplied adaptor). Disposable one-way inspiratory mouthpieces
are preferred.
3. Ask the patient to exhale fully.
4. Seal lips around the mouthpiece and inhale.
5. Record the inspiratory ow from the position of the red cursor
against the scale. Reset, and repeat two more times, ensuring to
inhale correctly each time.
6. Compare values achieved with target ow. To operate an inhaler
device correctly, the patient should be able to achieve a ow rate
within the clinically effective range.
If after repeated training the patient is not able to achieve these values,
then the healthcare professional may wish to assess the patient’s ability
to use an alternative type of inhaler.
Performance Accuracy
Accuracy +/- 10% or 10 l/min (whichever is the greater) and
repeatability of +/- 5 l/min.

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Cleaning your In-Check M
Where local infection control guidelines exist, these should be
respected.
Immerse In-Check M in warm (but not hot) mild detergent solution for
2-3 minutes (maximum 5 minutes). Agitate the meter to ensure
thorough cleaning.
Rinse in warm water and shake to remove any excess water. It is
important to rinse thoroughly to prevent salt spots appearing on the
inside of the body and the spindle.
To shake excess water from the In-Check M, hold only at the end
furthest away from the mouthpiece.
Allow to dry thoroughly before using again.
The expected life of the In-Check M, in normal use, is two years.
To maintain hygene the In-Check M should be used with disposable
inspiratory one-way mouthpieces. If use of this product is governed by
local infection control guidance, that guidance should be respected in
the absence of local guidance.

Interpreting information from
the In-Check M
In-Check M was introduced in March 2013, in response to customer
feedback, to provide information about inspiratory ow rates that are
associated with clinical efcacy when using pMDI devices.
The information provided is for guidance only. It does not imply that
any particular product will be clinically effective. There are other
aspects than inspiratory ow that contribute towards clinical efcacy.
The information is based on published clinical studies. In some cases
studies may have been performed on a particular formulation with a
specic device and may be suggestive that other formulations will
behave similarly.
The target ow rate is in the green zone on the scale. If a patient
inhales at a ow rate in the red or yellow zone they should be
encouraged to inhale more gently.
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Some common mistakes to look out for
when using pMDIs:
Handling problems (examples)
 •Failure to shake the cannister
• Failure to ‘prime’ the cannister
• Failure to remove mouthpiece cover
• Failure to put the inhaler into the mouth
• Actuating multiple times in quick succession
• Failure to gargle after inhaling steriod
• Failure to seal lips around mouthpiece
Inhalation technique problems (examples)
• Exhaling while actuating
• Stopping inhalation on actuation
• Inhaling too fast
• Actuating at the end of inhalation
• Failure to hold breath

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Bibliography for In-Check
(Please note that references for Clinical Efcacy of different inhaler systems are provided on the laminated card.)
Sanchis J, Corrigan C, Levy M L, Viejo J L. Inhaler Devices - From theory to practice. Respiratory Medicine -
2013;107:495-502.
Banno M, Ibata H, Niimi T, Sato S, Matsushita R. The Usefulness of Inspiratory Flow Rate during Inhalation
Corticosteroid Therapy in Asthma. Respiration 2009;78:387-392.
Janssens W, Vanden Brande P, Hardeman E, et al. Inspiratory ow rates at different levels of resistance in
elderly COPD patients. Eur Respir J. 2008;31:78–83.
Zhang Q L, Zheng J P, Pan W H, He H, Chen G L, An J Y, Yuan L F, Luo D F. Peak inspiratory ow generated
through different analogue dry powder inhalers in Shenzhen healthy preschool children. Zhonghua Er Ke Za Zhi -
2008;46(2):98-103.
Raid A.M. R.A.M. Al-Showair, Walid Y. W.Y. Tarsin, Khaled H. K.H. Assi, Stanley B. S.B. Pearson, Henry
Chrystyn. Can all patients with COPD use the correct inhalation ow with all inhalers and does training help?
Respiratory Medicine - 2007;101, Issue 11:2395-2401.
Walid Y. Tarsin, Stanley B. Pearson, Khaled H. Assi, Henry Chrystyn. Emitted dose estimates from
Seretide(R) Diskus(R) and Symbicort(R) Turbuhaler(R) following inhalation by severe asthmatics. International
Journal of Pharmaceutics - 2006;316, Issues 1-2:131-137.
K.N. Desager, J. Geldhof, R. Claes, W. De Backer. Measurement of Inspiratory Flow Through Three Different
Dry Powder Inhalation Devices Using In-CheckTM in Children with Asthma. Pediatric Asthma, Allergy &
Immunology - 2006;19, No. 1:6-13.
Tiddens H A, Geller D E, Challoner P, Speirs R J, Kesser K C, Overbeek S E, Humble D, Shrewsbury S B,
Standaert T A. Effect of dry powder inhaler resistance on the inspiratory ow rates and volumes of cystic brosis
patients of six years and older. J Aerosol Med. 2006;19(4):456-65.
Andrea S. Melani; Letizia S. Bracci; Marcello Rossi. Reduced Peak Inspiratory Effort through the Diskus and
the Turbuhaler due to Mishandling is Common in Clinical Practice. Clin Drug Invest. 2005;25(8):543-549.
Amirav I, Newhouse MT, Mansour Y. Measurement of peak inspiratory ow with In-Check DIAL device to
simulate low-resistance (Diskus) and high-resistance (Turbohaler) dry powder inhalers in children with asthma.
Pediatr Pulmonol. 2005;39(5):447-51.
Y. Adachi, Y.S. Adachi, T. Itazawa, J. Yamamoto, G. Murakami, T. Miyawaki. Measurement of peak
inspiratory ow rates with an In-Check™ meter to identify preschool children’s ability to use dry powder inhalers;
Diskus and Turbuhaler. The Journal of Allergy and Clinical Immunology - 2004;113, Issue 2:S114.
Newman SP, et al. Eur J Respir Dis Suppl. 1982;119:57-65

Disposable one-way mouthpieces (Inspiratory, bulk, 200) Ref. 3122063
Disposable cardboard mouthpieces (Adult, 5 x 20) Ref. 3125030
Disposable cardboard mouthpieces (Adult, 500) Ref. 3122003
Disposable cardboard mouthpieces (Child, 500) Ref. 3103030
Universal plastic mouthpieces (Sterilisable, 15’s) Ref. 3103095
Adult to paediatric mouthpiece adaptor Ref. 3105027
Note
Please contact manufacturers for additional information
Clement Clarke International Ltd
Edinburgh Way Harlow
Essex CM20 2TT UK
Tele: [phone]
Fax: [phone]
email: [email protected]
Part no: 1902991
Issue no: 2 09/15