Vyaire MicroRPM User manual

MicroRPM
(Respiratory Pressure Meter)
Operating Manual – English
Operating Manual – U.S
Manuel d’utilisation – Français
Benutzerhandbuch – Deutsch
Manual de funcionamiento – Español

Contents
I Introduction - English..................................................8
Contents ............................................................................... 9
PUMA PC Software.................................................................10
Contraindications...................................................................11
Warnings and Cautions...........................................................11
Indications for Use.................................................................12
Operation – Mouth Pressures (PImax/MIP + PEmax/MEP) ...........13
PImax (MIP) Test...................................................................13
PEmax (MEP) Test .................................................................14
Operation – SNIP (Sni Nasal Inspiratory Pressure) ...................15
SNIP Test .............................................................................16
Switching O .......................................................................16
Battery ................................................................................17
Battery Replacement..............................................................17
Cleaning Instructions .............................................................18
External Surfaces of the Spirometer ........................................18
Cleaning accessories..............................................................18
Calibration............................................................................19
Servicing..............................................................................20
Product Lifetime....................................................................21
Trouble Shooting Information..................................................21
Safety Designation per IEC 60601-1 ........................................22
Electromagnetic Compatibility (EMC)
to IEC 60601-1-2 ..................................................................23
Symbols...............................................................................28
Specications........................................................................29
Consumables and Accessoires .................................................30
3

II Introduction - U.S. .....................................................33
Package Contents..................................................................34
PUMA PC Software.................................................................35
Contraindications...................................................................36
Warnings and Cautions...........................................................36
Indications for Use.................................................................37
Operation – Mouth Pressures (PImax/MIP + PEmax/MEP) ...........38
PImax (MIP) Test...................................................................38
PEmax (MEP) Test .................................................................39
Operation – SNIP (Sni Nasal Inspiratory Pressure) ...................40
SNIP Test .............................................................................41
Switching O .......................................................................41
BatteryLow Voltage Indication.................................................42
Battery Replacement..............................................................42
Cleaning Instructions .............................................................43
External Surfaces of the Spirometer ........................................43
Cleaning accessories..............................................................44
Calibration............................................................................45
Servicing..............................................................................47
Product Lifetime....................................................................47
Trouble Shooting Information..................................................47
Safety Designation per IEC 60601-1 ........................................48
Electromagnetic Compatibility (EMC)
to IEC 60601-1-2 ..................................................................49
Symbols...............................................................................54
Specications........................................................................55
Consumables / Supporting Products.........................................56
4

III Introduction - Français ..............................................57
Contenu De L’emballage.........................................................59
Le logiciel PUMA....................................................................60
Contre-indications .................................................................61
Avertissements et mises en garde............................................61
Indications d’utilisation...........................................................62
Mode D’emploi – Pressions Buccales.........................................63
Mode D’emploi – Pression Inspiratoire Sni Nasale.....................65
Mise hors tension .................................................................66
Témoin Du Niveau De Charge De La Pile...................................67
Remplacement de la pile.........................................................67
Instructions de nettoyage.......................................................68
Surfaces extérieures du spiromètre .........................................68
Nettoyage des accessoires......................................................69
Etalonnage ...........................................................................70
Entretien..............................................................................72
Durée de vie du produit..........................................................72
Diagnostic des pannes............................................................72
Certicat de sécurité selon la norme CEI 60601-1 ......................73
Compatibilité électromagnétique (CEM) à la norme EN60601-1:2007
74
Symboles .............................................................................80
Spécications........................................................................81
Pièces De Rechange / Accessoires............................................82
Représentant en France..........................................................83
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IV Einführung - Deutsch .................................................84
Inhalt ..................................................................................86
PUMA-PC-Software ................................................................87
Gegenanzeigen .....................................................................88
Warn- und Vorsichtshinweise...................................................88
Gebrauchsanweisung .............................................................90
Betrieb – Munddruck (PImax/MIP + PEmax/MEP).......................91
PImax (MIP) Test...................................................................92
PEmax (MEP) Test .................................................................93
Betrieb – SNIP (Einatemnasendruck)........................................94
SNIP Test .............................................................................95
Ausschalten .........................................................................95
Batterie ..............................................................................96
Batteriewechsel ...................................................................96
Reinigungsanleitung .............................................................97
Außenoberächen des Spirometers ........................................98
Reinigungszubehör ................................................................98
Kalibrierung..........................................................................99
Wartung.............................................................................101
Produktlebensdauer.............................................................101
Informationen zur Fehlerbehebung.........................................101
Sicherheitsbezeichnung gemäß IEC 60601-1 ...........................102
Elektromagnetische Verträglichkeit (EMV) gemäß IEC 60601-1-2103
Symbole.............................................................................108
Technische Daten ................................................................109
Verbrauchsartikel und Zubehör..............................................110
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V Introducción - Español.............................................113
Contenido...........................................................................115
Software PUMA para PC........................................................116
Contraindicaciones...............................................................117
Advertencias y precauciones .................................................117
Indicaciones de uso .............................................................118
Funcionamiento: presiones bucales
(PImáx/MIP + PEmáx/MEP) ..................................................119
Prueba PImáx (MIP).............................................................120
Prueba PEmáx (MEP) ...........................................................121
Funcionamiento: SNIP (Presión de inhalación nasal).................122
Prueba SNIP .......................................................................123
Apagado ............................................................................123
Batería ..............................................................................124
Sustitución de la batería.......................................................124
Instrucciones de limpieza .....................................................125
Supercies externas del espirómetro .....................................125
Accesorios de limpieza .........................................................126
Calibración .........................................................................127
Mantenimiento....................................................................129
Duración del producto..........................................................129
Información para solución de problemas.................................129
Designación de seguridad conforme a IEC 60601-1..................130
Compatibilidad electromagnética (CEM) de acuerdo con IEC 60601-
1-2....................................................................................131
Símbolos............................................................................136
Especicaciones ..................................................................137
Consumibles y accesorios .....................................................138
VI Customer contact information..................................140
7

MicroRPM
(Respiratory Pressure Meter)
Operating Manual
I Introduction - English
The respiratory pressure meter is a hand held instrument designed
for rapid assessment of inspiratory and expiratory muscle strength.
The unit can measure the maximum inspiratory and expiratory
mouth pressures, MIP and MEP, and the Sni Nasal Inspiratory
Pressure, SNIP. The result of each measurement is presented in
units of cmH2O gauge pressure on the liquid crystal display screen.
The unit is easy to operate, battery powered, and is supplied with
all the necessary attachments required for immediate use.
The functionality of the unit may be greatly increased when con-
nected to a PC running PUMA software. This application has many
advanced features including:
• Real time display of pressure/time curves
• Overlay of successive curves
• Predicted values
• Patient database
• Incentive display
• Manoeuvre quality check
• Manoeuvre variability measurement
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Contents
The MicroRPM is supplied as follows:
1. MicroRPM Microcomputer Unit
2. Adapter MicroGard II for RPM Cat.Nr. 36-ASS1307
3. Alkaline battery (type 6LR61) Cat. No. 36-BAT1002
4. Expiratory Pressure Valve Assembly Cat. No. 36-ASS1221
5. Inspiratory Pressure Valve Assembly Cat. No. 36-ASS1222
6. Calibration Screwdriver Cat. No. 36-MEC1299
7. Nasal Probes Size 1-4
8. Nasal Probe Adapter Cat. No. 36-ASS1091
9

PUMA PC Software
The functionality of the portable MicroRPM is greatly increased when
connected to the PUMA PC Software, via an RS232 cable to the
Serial Port on the side of the unit.
PUMA PC Software is available as a free download from www.vyaire.
com/micromedical. Please contact Technical Services for installation
instructions and system requirements.
The PUMA PC Software is a unique, user friendly multi windows
platform for the performance, storage and analysis of the
respiratory muscle strength measurements of PImax or MIP
(Maximum Inspiratory Pressure), PEmax or MEP (Maximum
Expiratory Pressure) and SNIP (Sni Nasal Inspiratory Pressure).
In addition, PUMA PC Software oers the user features such as live
graphical displays, predicted values, printing formats, incentives,
trends, post medication or exercise comparisons and additional
fatigue indicators.
10

Contraindications
• Pathological conditions resulting in relatively large pressure
swings in the abdomen or thorax
• Aneurisms
• Uncontrolled hypertension
• Urinary incontinence
Warnings and Cautions
The following terms are used as follows in this manual:
Caution: Possibility of injury or serious damage
Warning: conditions or practices that could result in personal
injury
Please Note: Important information for avoiding damage to the
instrument or facilitating operation of the instrument.
Note: The device should only be used by qualied personnel trained
in lung function testing.
Note: The Respiratory Pressure Meter should only be connected to
a computer that is manufactured in accordance with EN 60601-1.
Note: Keep the PC out of reach of the patient at all times.
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CAUTION: Read the manual before use .
CAUTION: For batteries, do not attempt to charge, connect
improperly, or dispose of in re as there is possibility of leakage
or explosion. Follow manufacturer’s recommendation for proper
disposal.
WARNING: The instrument is not suitable for use in the presence
of explosive or ammable gases, ammable anaesthetic mixtures
or in oxygen rich environments.

Indications for Use
The Micro RPM (Respiratory Pressure Meter) is a hand held
diagnostic instrument designed for rapid assessment of inspiratory
and expiratory muscle strength. The unit can measure the
maximum inspiratory and expiratory mouth pressures, MIP and
MEP, and the Sni Nasal inspiratory Pressure, SNIP. The system is
intended for use with pediatric and adult patients over the age of 3
years in hospitals, physician oces, laboratories and occupational
health testing environments.
12
CAUTION: Bacterial lters are single patient use. If used on more
than one patient there is a risk of cross-infection. Repeat use may
increase air resistance and lead to an incorrect measurement.
PLEASE NOTE: The product and the battery you have
purchased should not be disposed of as unsorted waste.
Please utilise your local WEEE collection facilities for the
disposal of this product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
CAUTION: When you connect the Respiratory Pressure Meter to
other equipment, always make sure that the whole combination
complies with the international safety standard IEC 60601-1 for
medical electrical systems. During measurements, connect the
Respiratory Pressure Meter only to computers that comply with
IEC/EN 60601-1 / ANSI/AAMI ES60601-1:2005.

PImax (MIP) Test
Slide the MicroRPM switch from ‘O’ to ‘MIP/MEP’, whilst applying
no pressure to the mouthpiece. Rotating segments will be displayed
whilst the unit performs an auto-zero function.
When the MicroRPM is ready a ‘beep’ will be heard and ‘0’ displayed.
Operation – Mouth Pressures (PImax/MIP +
PEmax/MEP)
Insert the battery into the compartment at the rear of the
MicroRPM.
Fit the required Pressure Valve Assembly (‘Inspiratory’ for PImax
(MIP), ‘Expiratory’ for PEmax (MEP)) into the MicroRPM; insert a
new Bacterial Filter into the Pressure Valve Assembly and then
the Rubber Flanged Mouthpiece onto the Bacterial Filter, as shown
below.
13

PEmax (MEP) Test
Slide the MicroRPM switch from ‘O’ to ‘MIP/MEP’, whilst applying
no pressure to the mouthpiece. Rotating segments will be displayed
whilst the unit performs an auto-zero function.
When the MicroRPM is ready a ‘beep’ will be heard and ‘0’ displayed.
To perform the test instruct the subject to insert the mouthpiece
into the mouth, ensuring the ange is positioned over the gums and
inside the lips, whilst the ‘bite blocks’ are between the teeth.
The subject should then inhale to TLC (Total Lung Capacity), lungs
full, then perform a ‘Valsalva’ manoeuvre, a forced exhalation
against the MicroRPM with as much eort as possible for as long as
possible (minimum 2 seconds).
The display will report the result, the maximum average expiratory
pressure sustained over a 1 second period of the test, in cmH2O.
Ideally, the subject should repeat this test 3 times to ascertain a
best value.
To repeat either the PImax or PEmax tests the MicroRPM must
rstly be returned to the ‘O’ position.
To perform the test instruct the subject to insert the mouthpiece
into the mouth, ensuring the ange is positioned over the gums and
inside the lips, whilst the ‘bite blocks’ are between the teeth.
The subject should then exhale to RV (Residual Volume), lungs
empty, then perform a ‘Mueller’ manoeuvre, a forced inhalation
against the MicroRPM with as much eort as possible for as long as
possible (minimum 2 seconds).
The display will report the result, the maximum average inspiratory
pressure sustained over a 1 second period of the test, in
centimetres of water (cmH2O). Ideally, the subject should repeat
this test 3 times to ascertain a best value.
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Operation – SNIP (Sni Nasal Inspiratory
Pressure)
Insert the battery into the rear of the MicroRPM.
Fit the Nasal Probe Adapter into the MicroRPM and then attach the
correct size Nasal Probe, as shown below.
The correct size (1-4) can be ascertained by tting a Nasal Probe to
the unit, then rmly inserting the Nasal Probe into a nostril. Instruct
the subject to block the open nostril with a nger and then to
attempt a sni. The correct Nasal Probe size has been selected once
there is no leakage around the Nasal Probe.
Nasal probe
2
Microcomputer unit
Nasal plug
adapter
15

SNIP Test
Slide the MicroRPM switch from ‘O’ to ‘SNIP’, whilst applying no
pressure to the Nasal Probe. Rotating segments will be displayed
whilst the unit performs an auto-zero function.
When the MicroRPM is ready a ‘beep’ will be heard and ‘0’ displayed.
To perform the test, instruct the subject to insert the chosen Nasal
Probe rmly into a nostril, whilst ensuring the other nostril remains
open throughout the test.
The subject should then breathe normally and at the end of a
normal tidal expiration, FRC (Functional Residual Capacity), be
instructed to perform a short, sharp voluntary sning manoeuvre
with as much eort as possible.
The display will report the result, the peak inspiratory nasal
pressure, in cmH2O.
On subsequent tests the MicroRPM will continue to display the
highest SNIP value, overwriting previous values. Ideally, the subject
should repeat this test 10-15 times to ascertain the highest value.
Switching O
The MicroRPM is switched o by sliding the switch back to the ‘O’
position.
16

Battery
The battery level is automatically checked when the unit is switched
on.
When the battery is low ‘bAt’ will be displayed before the auto-zero
procedure. The MicroRPM may be used when this occurs, but the
battery should be replaced as soon as possible.
When the battery is completely exhausted the unit will beep twice
and turn itself o immediately.
Battery Replacement
Locate the sliding cover situated on the rear of the unit, towards the
bottom of the device.
Place your thumb over the round thumb indent, press gently and
slide the cover to the right to remove it from the unit.
Lift the old battery out, and holding the battery terminal by the
plastic body, pull it o the old battery.
Plug the new battery into the battery terminal, taking care that the
correct polarity is observed.
Push the battery back into the battery holder, and replace the
battery cover onto the guides. Slide the battery cover to the left
until it is fully home.
Note: Please remove the battery if the meter is likely to be unused
for some time.
CAUTION: Do not open the battery cover when the device is
turned on.
CAUTION: The operator should not touch the contacts of the
battery and the patient at the same time.
Please Note: Dispose of the waste battery in accordance with EU
Waste Battery Regulations.
17

Cleaning Instructions
Disinfection of contaminated parts is only eective after having
them carefully pre-cleaned. Vyaire recommends the tested solution
of PeraSafe sterilizing powder (36-SSC5000A) for pre-cleaning and
disinfection. If a dierent solution is used, please follow the given
manufacturer’s instructions.
The device must not be wiped with any aqueous solutions and must
not be exposed to solvents e.g. alcohol, chloride solutions as there
are electronic components inside that will be permanently damaged.
CAUTION: Switch o the device before cleaning.
External Surfaces of the Spirometer
CAUTION: Do not attempt to wash or immerse the Respiratory
Pressure Meter in water or cleaning uid, as there are electronic
components inside that will be permanently damaged
The external housing of the pressure meter may be wiped with
sterile wipes or a damp cloth that has been immersed in a cold
sterilising solution.
Cleaning accessories
Cleaning accessories The MicroRPM unit is protected from
contamination by the MicroGard IIC Filter kit (V-892392 MicroGard
IIC Filter, disposable mouthpiece/nose clip) during mouth
pressures measurements. The MicroGard II Filter Adapter for
RPM (36-ASS1307), the Expiratory and Inspiratory Pressure Valve
Assembly (36-ASS1221, 36-ASS1222) are reusable parts and
needs to be disposed after 6 months of usage. The Nasal Probes
(36-NPROBE01, 36-NPROBE02, 36-NPROBE03, 36- NPROBE04),
however, may be immersed in a cold sterilising solution such as
18

Calibration
The calibration is factory set and should remain stable indenitely.
The calibration may be checked and altered, however, by connecting
the device via the Pressure Calibration Kit (36-ASS1234) to a Water
Manometer, as shown below:
Slide the MicroRPM switch from ‘O’ to ‘SNIP’ whilst applying no
pressure to the unit.
Gently ll the syringe until negative pressure of between 200 and
300cmH2O is read on the Water Manometer. Check that the reading
on the MicroRPM is within 3% of this reading.
PeraSafe (36-SSC5000A). Rinse thoroughly and leave to dry before
reassembly.
Important note: Nasal Probes, which are not sterilized, must be
disposed o immediately after each use.
If there are changes on the material surfaces (cracks, brittleness)
the respective parts must be disposed o.
19

Please Note: Calibration can only be adjusted in a positive
direction, as the MicroRPM measures the highest peak value.
Therefore, if the reading was greater than that on the Water
Manometer, the calibration screw must be turned anti-clockwise
rst, before calibration is attempted.
To calibrate the MicroRPM, connect to the Water Manometer as
before, lling the syringe to obtain the required negative pressure.
To change the calibration, slowly turn the calibration screw in
a clockwise direction until the same value is displayed on the
MicroRPM.
Servicing
If your unit requires service or repair please see page 144 for
contact details.
A full service manual including circuit diagrams and parts list is
available on request.
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