Care Fusion MicroRPM User manual

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

1
Contents
IIntroduction - English..................................................4
Contents.................................................................................. 5
PUMA PC Software .................................................................... 6
Contraindications...................................................................... 7
Warnings and Cautions.............................................................. 7
Indications for Use.................................................................... 8
Operation –Mouth Pressures (PImax/MIP + PEmax/MEP) .............. 9
PImax (MIP) Test...................................................................... 9
PEmax (MEP) Test .................................................................. 10
Operation –SNIP (Sniff Nasal Inspiratory Pressure) .................... 11
SNIP Test .............................................................................. 12
Switching Off ......................................................................... 12
Battery.................................................................................. 13
Battery Replacement............................................................... 13
Cleaning Instructions .............................................................. 14
External Surfaces of the Spirometer.......................................... 14
Cleaning accessories ............................................................... 14
Calibration ............................................................................. 15
Servicing ............................................................................... 16
Trouble Shooting Information................................................... 17
Safety Designation per IEC 60601-1 ......................................... 18
Electromagnetic Compatibility (EMC) to EN60601-1:2007 ........... 19
Symbols ................................................................................ 24
Specifications ......................................................................... 25
Consumables and Accessories .................................................. 26
II. Introduction –U.S .....................................................29
Package Contents ................................................................... 30
PUMA PC Software .................................................................. 31
Contraindications.................................................................... 32
Warnings and Cautions............................................................ 32

2
Indications for Use.................................................................. 33
Operation –Mouth Pressures.................................................... 34
Operation –Sniff Nasal Inspiratory Pressure .............................. 36
Switching Off ......................................................................... 37
Battery Low Voltage Indication ................................................. 37
Battery Replacement............................................................... 38
Cleaning Instructions .............................................................. 39
External Surfaces of the Spirometer.......................................... 39
Cleaning accessories ............................................................... 39
Calibration ............................................................................. 40
Servicing ............................................................................... 42
Trouble Shooting Information................................................... 42
Safety Designation per IEC 60601-1 ......................................... 43
Electromagnetic Compatibility (EMC) to EN60601-1:2007 ........... 44
Symbols ................................................................................ 49
Specifications ......................................................................... 50
Consumables / Supporting Products .......................................... 51
III. Introduction - Français..............................................52
Contenu De L’emballage .......................................................... 53
Le logiciel PUMA ..................................................................... 55
Contre-indications................................................................... 56
Avertissements et mises en garde............................................. 56
Indications d'utilisation............................................................ 57
Mode D’emploi – Pressions Buccales.......................................... 58
Mode D’emploi – Pression Inspiratoire Sniff Nasale ..................... 60
Mise hors tension.................................................................... 62
Témoin Du Niveau De Charge De La Pile.................................... 62
Remplacement de la pile.......................................................... 62
Instructions de nettoyage ........................................................ 63
Surfaces extérieures du spiromètre........................................... 64
Accessoires de nettoyage......................................................... 64
Etalonnage ............................................................................ 65

3
Entretien ............................................................................... 67
Diagnostic des pannes............................................................. 67
Certificat de sécurité selon la norme CEI 60601-1....................... 68
Compatibilité électromagnétique (CEM) à la norme EN60601-
1:2007 .................................................................................. 69
Symboles............................................................................... 74
Spécifications ......................................................................... 76
Pièces De Rechange / Accessoires............................................. 77
IV Einführung - Deutsch.................................................79
Inhalt.................................................................................... 80
PUMA-PC-Software.................................................................. 81
Gegenanzeigen....................................................................... 82
Warn- und Vorsichtshinweise ................................................... 82
Gebrauchsanweisung .............................................................. 84
Betrieb –Munddruck (PImax/MIP + PEmax/MEP) ....................... 85
PImax (MIP) Test.................................................................... 86
PEmax (MEP) Test .................................................................. 87
Betrieb –SNIP (Einatemnasendruck)......................................... 88
SNIP Test .............................................................................. 89
Ausschalten ........................................................................... 89
Batterie ................................................................................. 90
Batteriewechsel ...................................................................... 90
Reinigungsanleitung................................................................ 91
Außenoberflächen des Spirometers ........................................... 91
Reinigungszubehör.................................................................. 91
Kalibrierung ........................................................................... 92
Wartung ................................................................................ 94
Informationen zur Fehlerbehebung ........................................... 94
Sicherheitsbezeichnung gemäß IEC 60601-1 .............................. 95
Elektromagnetische Verträglichkeit (EMV) gemäß EN60601-
1:2007 .................................................................................. 96
Symbole ...............................................................................103

4
Technische Daten ..................................................................104
Verbrauchsartikel und Zubehör................................................105
VIntroducción - Español ............................................108
Contenido .............................................................................110
Software PUMA para PC ..........................................................111
Contraindicaciones.................................................................112
Advertencias y precauciones ...................................................112
Indicaciones de uso................................................................113
Funcionamiento: presiones bucales (PImáx/MIP + PEmáx/MEP) ..114
Prueba PImáx (MIP)...............................................................115
Prueba PEmáx (MEP)..............................................................116
Funcionamiento: SNIP (Presión de inhalación nasal)...................117
Prueba SNIP..........................................................................118
Apagado...............................................................................118
Batería .................................................................................119
Sustitución de la batería .........................................................119
Instrucciones de limpieza........................................................120
Superficies externas del espirómetro........................................120
Accesorios de limpieza............................................................120
Calibración............................................................................121
Mantenimiento ......................................................................123
Información para solución de problemas...................................124
Designación de seguridad conforme a IEC 60601-1....................125
Compatibilidad electromagnética (CEM) de acuerdo con
EN60601-1:2007 ...................................................................126
Símbolos ..............................................................................132
Especificaciones.....................................................................134
Consumibles y accesorios .......................................................135
VI Customer contact information .................................137

4
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 Sniff 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 connected
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

5
Contents
The MicroRPM is supplied as follows:
1. MicroRPM Microcomputer Unit
2. Rubber Flanged Mouthpiece Cat. No. 36-MTH6400
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. Mouth Pressure Bacterial Filters Cat. No. 36-FIL6050 (50)
3
2
4
6
8
2
9
1
SNIP
MIP / MEP
OFF
3
1
7
4
5

6
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.carefusion.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 (Sniff Nasal Inspiratory Pressure). In addition, PUMA PC
Software offers the user features such as live graphical displays,
predicted values, printing formats, incentives, trends, post medication
or exercise comparisons and additional fatigue indicators.

7
Note: The Repiratory 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.
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 qualified personnel trained
in lung function testing.
CAUTION: Read the manual before use
CAUTION: For batteries, do not attempt to charge, connect
improperly, or dispose of in fire 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 flammable gases, flammable anaesthetic mixtures or
in oxygen rich environments.

8
CAUTION: Bacterial filters 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.
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
Sniff Nasal inspiratory Pressure, SNIP. The system is intended for use
with pediatric and adult patients over the age of 3 years in hospitals,
physician offices, laboratories and occupational health testing
environments.

9
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.
PImax (MIP) Test
Slide the MicroRPM switch from ‘Off’ 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.

10
To perform the test instruct the subject to insert the mouthpiece into
the mouth, ensuring the flange 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 effort 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.
PEmax (MEP) Test
Slide the MicroRPM switch from ‘Off’ 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 flange 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 effort 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.

11
To repeat either the PImax or PEmax tests the MicroRPM must firstly
be returned to the ‘Off’ position.
Operation –SNIP (Sniff 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 fitting a Nasal Probe to
the unit, then firmly inserting the Nasal Probe into a nostril. Instruct
the subject to block the open nostril with a finger and then to attempt
a sniff. The correct Nasal Probe size has been selected once there is
no leakage around the Nasal Probe.
Nasalprobe
2
Microcomputerunit
Nasalplug adapter

12
SNIP Test
Slide the MicroRPM switch from ‘Off’ 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 firmly 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 sniffing manoeuvre with as much
effort 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 Off
The MicroRPM is switched off by sliding the switch back to the ‘Off’
position.

13
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 off 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 off 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.

14
Cleaning Instructions
Disinfection of contaminated parts is only effective after having them
carefully pre-cleaned. CareFusion recommends the tested solution of
PeraSafe sterilizing powder (36-SSC5000A) for pre-cleaning and
disinfection. If a different 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 off 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 fluid, 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
The MicroRPM unit is protected from contamination by the Bacterial
Filter (36-FIL6050) during mouth pressures measurements.
The Rubber Flanged Mouthpiece (36-MTH6400), the Expiratory and
Inspiratory Pressure Valve Assembly (36-ASS1221, 36-ASS1222) and
the Nasal Probes (36-NPROBE01, 36-NPROBE02, 36-NPROBE03, 36-
NPROBE04), however, may be immersed in a cold sterilising solution
such as PeraSafe (36-SSC5000A). Rinse thoroughly and leave to dry
before reassembly.

15
Important note: Used mouthpieces and Nasal Probes, which are not
sterilized, must be disposed off immediately after each use.
If there are changes on the material surfaces (cracks, brittleness) the
respective parts must be disposed off.
Calibration
The calibration is factory set and should remain stable indefinitely.
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:
Manometer
cmHO
2
0
2
1
3
6
4
5
8
7
9
Syringe
10
Connecting line Female Luer TPiece Nasalplug adapter
Slide the MicroRPM switch from ‘Off’ to ‘SNIP’ whilst applying no
pressure to the unit.
Gently fill 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.

16
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 first, before
calibration is attempted.
Serial port
Calibration screw
To calibrate the MicroRPM, connect to the Water Manometer as
before, filling 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 137 for contact
details.
A full service manual including circuit diagrams and parts list is
available on request.

17
Trouble Shooting Information
Should you encounter problems operating your MicroRPM unit, please
consult the table below:
Problem
Possible Cause
Solution
unit will not turn on
Battery is
exhausted
Replace the battery
Slide switch
connetion
Return unit for
servicing.
Display shows reading
before test has been
performed
Internal tubing to pressure sensor
kinked
Return unit for servicing