Micro Direct MicroRPM Operating Manual

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.
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
1
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
2
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)
3 2 4
6 8 2
9
1
SNIP
MIP / MEP
OFF
3 1 7
4
5
3
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/respiratory­care/cardio-pulmonary-diagnostics/pulmonary-function­testing/spirometers/spirometry-software-and-firmware­downloads.
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.
4
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.
5
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
6
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.
7
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
8
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.
Nasal probe
2
Microcomputer unit
Nasal plug adapter
9
The correct size (1-4) can be determined 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 has been selected once there is not leakage around the nasal probe.
SNIP Test
Slide the MicroRPM switch from ‘Off’ to ‘SNIP’, while
applying no pressure to the nasal probe. 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 chosen
nasal probe firmly into a nostril, while 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 maneuver 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 determine the highest value.
Switching Off
The MicroRPM is switched off by sliding the switch back to the ‘Off’ position.
10
Battery Low Voltage Indication
The battery level is checked when the unit is switched on.
When the battery is nearly exhausted ‘bAt’ is displayed
before the auto-zero procedure begins. The unit may be used when this occurs provided the test is performed immediately. 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 after turning on.
Note: If the respiratory pressure meter is not used for long periods, the battery should be removed to prevent damage to the instrument by possible leakage.
Battery Replacement
Locate the sliding cover situated on the rear of the unit, toward 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 in place.
Note: Please remove the battery if the meter is likely to be unused for some time.
11
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 your local waste battery regulations.
Cleaning Instructions
Disinfection of contaminated parts is only effective after careful preliminary cleaning. Please follow the manufacturer’s instructions for the solution you are using.
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 surfaces of the pressure meter and the inspiratory and expiratory valves may be wiped with a disinfection wipe such as a Protex wipe (order #48-70). This should be performed after every patient.
Sterilization
The rubber flanged mouthpieces can be sterilized using ETO – Ethylene Oxide Sterilization.
12
Cleaning accessories
The MicroRPM unit is protected from contamination by the Bacterial Filter (36-FIL6050) during mouth pressures measurements.
The Rubber Flanged Mouthpiece (MTH6400), the Expiratory and Inspiratory Pressure Valve Assembly (ASS1221 and ASS1222) and the Nasal Probes (NPROBE01, NPROBE02, NPROBE03, NPROBE04), however, may be immersed in a cold sterilizing solution. Rinse thoroughly and allow to dry before reassembly.
Important note: Used mouthpieces and Nasal Probes, which are not sterilized, must be disposed of immediately after each use.
If there are changes on the material surfaces (cracks, brittleness) the respective parts must be disposed of.
Calibration
Calibration is factory set and should remain stable indefinitely. However, calibration may be checked by connecting the device to a manometer as shown below:
Manometer
cm H O
2
0
2 1
3
6
4
5
8 7
9
Syringe
10
Connecting line
Female Luer T Piece
Nasal plug adapter
13
Turn the respiratory pressure meter on to the SNIP position. Very slowly fill the syringe until a negative pressure of
between 200 and 300 cmH2O is obtained on the manometer.
The reading on the respiratory pressure meter should be within 3% of the manometer reading.
If adjustment is required, the following procedure must be followed.
The calibration may only be adjusted in a positive direction as the meter monitors the peak pressure value. Therefore, if the respiratory pressure meter reading was greater than the manometer reading the calibration screw must be turned anti-clockwise a few turns before calibration is attempted.
Serial port
Calibration screw
Connect the respiratory pressure meter to the manometer as previously shown. Fill the syringe to obtain the required negative pressure and turn the calibration screw slowly in a clockwise direction until the same value is displayed on the meter.
14
Servicing
If your unit requires service or repair, please see page 24 for contact details.
A full service manual including circuit diagrams and parts list is available on request.
Product Lifetime
The MicroRPM is designed for a product lifetime of five years.
15
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 spent/discharged
Replace the battery
Slide switch connection
Return unit for servicing
Display shows reading before test has been performed
Internal tubing to pressure sensor kinked
Return unit for servicing
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
Portable
Mode of operation
Continuous
Classifications according to IEC 60601-1
Respiratory Pressure Meter
Applied part, type B
WARNING: No modification of this equipment is allowed.
16
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 60101-1 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 conductive parts and the patient at the same time.
Electromagnetic Compatibility (EMC) to EN60601­1:2007
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 EN60606-1-2:2007, regarding the 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.
17
Changes or modifications to the MicroRPM may results 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’s 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 a minimum basic 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 vent the product is operated in the presence of significant electromagnetic fields (particularly in the frequency range 40-60MHz) while in the PC connected mode, ensure the results on the unit and PC are the same. If the results differ, then relocating 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.
18
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
RF emissions CISPR 11
Group 1
The MicroRPM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
RF emissions CISPR 11
Group B
The MicroRPM is suitable for use in all establishments, including residential establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes
Harmonic emissions IEC61000-3-2
Not Applicable
Voltage fluctuations / flicker emissions IEC61000-3-3
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 Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment -
Guidance
Electrostatic discharge (ESD) IEC61000-4-2
+/- 6 kV contact +/- 8 kV air
+/- 6 kV contact +/- 8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transient / burst IEC61000-4-4
+/- 2 kV for power supply lines
+/- 1 kV for input / output lines
+/- 1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment
Surge IEC61000-4-5
+/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth
Not Applicable
Mains power quality should be that of a typical commercial or hospital environment
19
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11
< 5% UT (> 95% dip in UT) For 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (> 95% dip in UT) for 5 s
Not Applicable
Mains power quality should be that of a typical commercial or hospital environment. If the user of the MicroRPM requires continued operation during power mains interruptions, it is recommended that the MicroRPM be powered from an uninterruptible power supply or a battery
Power frequency (50/60 Hz) Magnetic field IEC61000-4-8
3 A / m
3 A / m
Power frequency magnetic fields should be at levels characteristic 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.
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
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment ­Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the MicroRPM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
20
Conducted RF IEC61000-4-6
Radiated RF IEC61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 Mhz to 2.5 Ghz
3 V
3 V/m
Recommended separation distance (d)
d = 1.2√P d = 1.2√ P 80 MHz to 800 MHz d = 2.3√ P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MicroRPM is used exceeds the applicable RF compliance level above, the MicroRPM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the MicroRPM
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m
21
Recommended separation distances between portable and mobile RF communications equipment and the MicroRPM
The MicroRPM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MicroRPM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MicroRPM as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Output Power of Transmitter in Watts (W) Separation Distance in Meters (m) according to Frequency of Transmitter
150 KHz to 80 MHz
d = 1.2 √ P
80 MHz to 800 MHz
d = 1.2 √ P
800 MHz to 2.5 GHz
d = 2.4 √ P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures objects and people.
22
Symbols
Type B device
In accordance with Directive 93/42/EEC
Disposal in compliance with your local recycling facility
Consult the instructions for use
Date of Manufacture
Manufacturer
Serial Number
Single Patient Use
Rx only
Federal U.S. law restricts this device to sale by or on the order of a physician (Rx only)
23
Specifications
Measurements
Maximum Expiratory Pressure (MEP) Maximum Inspiratory Pressure (MIP) Sniff Nasal Inspiratory Pressure (SNIP)
With PumaTM
Maximum Rate of Pressure Development (MRPD) Maximum Rate of Relaxation (MRR)
Operating Pressure
+/- 300 cmH2O (+/- 5 PSID)
Burst Pressure
+/- 700 CmH2O (+/- 20 PSID)
Accuracy
+/- 3%
Resolution
1 cmH2O
Power Supply
Single Alkaline 9V battery
Dimensions
~6.5” x 2.5” x 1”
Weight (Unit with battery)
~ 6 ounces
Weight (in carry case)
~1 pound 10 ounces
Operating Temperature
32 – 104 0F
Operating Humidity
30% - 90% RH
Storage & Transport Temperature
-4 – 158 0F
Storage & Transport Humidity
10% - 90% RH
24
Consumables / Supporting Products
Cat. No. Description
MTH6400 Rubber mouthpiece ASS1221 Expiration pressure valve assembly ASS1222 Inspiration pressure valve assembly FIL6050 Mouth pressure bacterial filters NPROBE00 Nasal probes sizes 1 to 4 NPROBE01 Extra small nasal probes (10 per box) NPROBE02 Small nasal probes (10 per box) NPROBE03 Medium nasal probes (10 per box) NPROBE04 Large nasal probes (10 per box) ASS1091 Nasal probe adapter 48-70 Protex Disinfectant Wipe (100/canister)
To place an order for consumables/supporting products
or for general enquiries please contact Micro Direct on: Tel: (207) 786-7808
Toll-Free: (800) 588-3381 (US and Canada only) Fax: (207) 786-7280 Email: sales@mdspiro.com
support@mdspiro.com
Website: www.mdspiro.com
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