Micro Direct MicroRPM Manuale utente

Respiratory Pressure Meter

Operating Manual

Federal (USA) law restricts this device to sale by or on the

order of a physician or licensed practitioner.

Micro Direct, Inc.

803 Webster Street

Lewiston, ME 04240

1-800-588-3381

www.mdspiro.com

064-45 US

Issue 1.4

September 2016

Table of Contents

Introduction.........................................................................1

Package Contents ..............................................................2

PUMA PC Software............................................................2

Contraindications................................................................4

Warnings and Cautions ......................................................4

Indications for Use..............................................................5

Operation –mouth pressures (PImax/MIP + PEmax/MEP).6

PImax (MIP) Test................................................................7

PEmax (MEP) Test.............................................................7

Operation –SNIP (Sniff Nasal Inspiratory Pressure)...........8

SNIP Test...........................................................................9

Switching Off ......................................................................9

Battery Low Voltage Indication .........................................10

Battery Replacement........................................................10

Cleaning Instructions........................................................11

External Surfaces of the Spirometer.................................11

Sterilization.......................................................................11

Cleaning accessories........................................................12

Calibration ........................................................................12

Servicing...........................................................................14

Product Lifetime................................................................14

Trouble Shooting Information............................................15

Symbols............................................................................22

Specifications ...................................................................23

Consumables / Supporting Products.................................24

Introduction

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

Maneuver quality check

Maneuver variability measurement

Package Contents

The respiratory pressure meter is supplied with the

following items: -

1. Microcomputer unit

2. Rubber mouthpiece (Cat. No. MTH6400)

3. Alkaline PP3 battery

4. Expiration pressure valve assembly (Cat. No. ASS1221)

5. Inspiration pressure valve assembly (Cat. No. ASS1222)

6. Calibration screwdriver

7. Nasal probe sample pack (Cat. No. NPROBE01 x-small;

NPROBE02 small; NPROBE03 medium and

NPROBE04 large)

8. Nasal probe adapter (Cat. No. ASS1091)

9. Mouth pressure bacterial filters (Cat. No. FIL6050)

SNIP

MIP / MEP

OFF

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

http://www.carefusion.co.uk/our-products/respiratory-

care/cardio-pulmonary-diagnostics/pulmonary-function-

testing/spirometers/spirometry-software-and-firmware-

downloads.

The PUMA PC Software is unique, user friendly multi

windows platform for the performance, storage and analysis

of the respiratory muscle strength measurement 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.

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.

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 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

anesthetic mixtures or in oxygen rich environments.

CAUTION: Bacterial filters are single patient use. If used on

more than one patient, there is a risk of cross-infection.

Repeated 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 utilize your local recycling

facility 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 MicroRPM (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 adults

and pediatric patients over the age of 3 years in hospitals,

physician offices, laboratories and occupational health

testing environments.

Operation –mouth pressures (PImax/MIP +

PEmax/MEP)

Insert the battery into the battery 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 the “off” position to the

MIP/MEP position, while applying no pressure to the

mouthpiece. Rotating segments will be displayed while the

unit performs an auto-zero function.

When the MicroRPM is ready a ‘beep’ will be heard and ‘0’

will be 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, while the ‘bite blocks’ are

between the teeth.

The subject should then exhale to RV (Residual Volume),

lungs empty, then perform a ‘Mueller’ maneuver, a forced

inhalation against the MicroRPM with as much effort as

possible for as long as possible (minimum of 2 seconds).

The display will report the result, the maximum average

inspiratory pressure sustained over a 1 second period of the

test, in centimeters of water (cmH20). Ideally, the subject

should repeat this test three times to establish the best

value.

PEmax (MEP) Test

Slide the MicroRPM switch from ‘Off’ to ‘MIP/MEP’, while

applying no pressure to the mouthpiece. Rotating segments

will be displayed while 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, while the ‘bite blocks’ are

between the teeth.

The subject should then inhale to TLC (Total Lung

Capacity), lungs full, then perform a ‘Valsalva’ maneuver, 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

three times to establish a best value.

To repeat either the PImax or PEmax tests, the MicroRPM

must first 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.

Nasalprobe

Microcomputerunit

Nasalplug adapter

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