CareFusion MicroRPM Operating Manual Issue 1.2 Jan 2014

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 2

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

4

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

9.

Mouth Pressure Bacterial Filters

Cat. No. 36-ASS1091 Cat. No. 36-FIL6050 (50)

7

3

SNIP MIP / MEP OFF

8 4

3

2

1

9 6 2 1 5 4

5

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.

6

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.

7

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.

8

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.

9

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. 10

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.

2

N a sa lp ro b e

N a sa lp ul g a d a p te r

M ci ro com p u te r u n it

11

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.

12

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. 13

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, 36NPROBE04), however, may be immersed in a cold sterilising solution such as PeraSafe (36-SSC5000A). Rinse thoroughly and leave to dry before reassembly.

14

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: C onnec tni g lni e

Fem a el Lue r T P ei ce

N asa lp ul g adap te r

10 9

S y rni ge

8 7 6 5 4 3 2 1 0

M anom e te r

cm H O 2

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.

15

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.

S e r ai l po r t

C a lbi ra toi n sc rew

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.

16

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

17

Safety Designation per IEC 60601-1 Type of protection against electrical shock

Internally powered Equipment

Degree of protection against electrical shock

Type B applied part

Power Equipment

Battery.

Battery life:

2000 tests.

Degree of Electrical connection between equipment and Patient

Equipment designed as non-electrical connection to the patient.

Degree of mobility

Transportable

Mode of operation

Continuous

Classification according to IEC 60601-1 Respiratory Pressure Meter

Applied part, type B

WARNING: No modification of this equipment is allowed. WARNING: Do not connect devices that are not specified as part of the system.

Note: When you connect other equipment to the unit, always make sure that the whole combination complies with the international safety standard IEC 60601-1 for medical electrical systems. During measurements, connect the MicroRPM only to computers that comply with IEC/EN 60601-1 / ANSI/AAMI ES60601-1:2005. WARNING: The user must not touch any voltage-carrying parts and the patient at the same time.

18

Electromagnetic Compatibility (EMC) to EN60601-1:2007 WARNING: Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation The MicroRPM has been tested to EN60601-1-2:2007, regarding its ability to operate in an environment containing other electrical/electronic equipment (including other medical devices). The purpose of this testing is to ensure that the MicroRPM is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the MicroRPM. Despite the testing of the MicroRPM that has been undertaken, normal operation of the MicroRPM can be affected by other electrical/electronic equipment and portable and mobile RF communications equipment. As the MicroRPM is medical equipment, special precautions are needed regarding EMC (electromagnetic compatibility). It is important that the MicroRPM is configured and installed/put into service, in accordance with the instructions/guidance provided herein and is used only in the configuration as supplied. Changes or modifications to the MicroRPM may result in increased emissions or decreased immunity of the MicroRPM in relation to EMC performance. The MicroRPM should be used only with the accessories (RS232 cables) supplied (which are referenced in the accessories section of this manual). None of the MicroRPM cables should be extended in length by the user. If any cables are extended by the user or non approved accessories are used, this may result in an increased level of emissions or decreased level of immunity, in relation to the MicroRPM EMC. None of the MicroRPM accessories should be used with other devices, as this may result in an increased level of emissions or decreased level of immunity, in relation to the other devices’ EMC. The MicroRPM has an essential performance – The respiratory pressure readings on the product must remain within a tolerance of +/- 3% and the unit firmware must not cease responding. Warning: In the event the product is operated in the presence of significant Electromagnetic Fields (particularly in the frequency range 40-60MHz), whilst in the PC connected mode, ensure the results on the unit and PC are the same. If the results differ then re-locating the product away from sources of interference should resolve any issue. WARNING: The MicroRPM should not be used adjacent to or stacked with other equipment. If adjacent or stacked use with other equipment is necessary, the MicroRPM and the other equipment should be observed / monitored, to verify normal operation in the configuration in which it will be used.

19

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The MicroRPM is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroRPM should assure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance The MicroRPM uses RF energy only for RF emissions Group 1 its internal function. Therefore, its RF CISPR11 emissions are very low and are not likely to cause any interference in nearby electronic equipment. The MicroRPM is suitable for use in all RF emissions Class B establishments, including domestic CISPR11 establishments and those directly connected to the public low-voltage Harmonic Emissions [Not Applicable] power supply network that supplies buildings used for domestic purpose. IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

[Not applicable]

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The MicroRPM is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroRPM should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Test test level Level Environment Guidance Electrostatic +/- 6 kV +/- 6 kV Floors should be wood, discharge contact contact concrete or ceramic (ESD) tile. If floors are IEC 61000-4-2 +/- 8 kV air +/- 8 kV air covered with synthetic material, the relative humidity should be at least 30%. Electrical fast +/- 2 kV for +/- 1 kV for Mains power quality transient/burst power supply input/output should be that of a IEC 61000-4-4 lines lines typical commercial or hospital environment. +/- 1 kV for input/output lines

20

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-411

+/- 1 kV line(s) to line (s) +/- 2 kV line(s) to earth < 5% UT (>95% dip in UT) for 0.5% cycle

Not Applicable

Mains power quality should be that of a typical commercial or hospital environment.

Not Applicable

Mains power quality should be that of a typical commercial or hospital environment. If the user of the micro RPM requires continued operation during power main interruptions, it is recommended that the micro RPM be powered from an uninterruptible power supply or a battery.

40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

< 5% UT (>95% dip in UT) for 5s 3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.

21